Painful Diabetic NeuropathyPhase 3NCT00220337

A Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy

A Phase 3 study testing Lacosamide in people with Painful Diabetic Neuropathy, run by UCB Pharma at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to determine if lacosamide (SPM 927) is safe if taken for a longer period of time and whether it continues to work well to treat pain. Subjects will receive lacosamide at a dose that will be individually determined to be the one that provides most pain relief with the least side effects. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Painful Diabetic Neuropathy
What is being tested?: Lacosamide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 371 participants
Where: 1 siteGermany
Study dates: 21 Dec 2004to 31 Oct 2007
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Painful diabetic neuropathy

Who cannot join

no clinically relevant liver enzyme abnormalities and impaired renal function, no cardiac abnormalities, no pregnant or nursing females

Trial locations and contacts

1 site in 1 country.

Germany1 site

Study site
Monheim

Other trials in Germany

About this study

Official title: A Multicenter, Open-label Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy

The purpose of this study is to determine if lacosamide (SPM 927) is safe if taken for a longer period of time and whether it continues to work well to treat pain.

Subjects will receive lacosamide at a dose that will be individually determined to be the one that provides most pain relief with the least side effects. The maximum dose will be 600mg/day. Subjects may participate in this trial until October 2007. This time may be extended to allow them to participate until lacosamide is commercially available.

If a subject meet the requirements for the study at Visit 1 and after a two weeks phase without trial medication, s/he enters a Titration Phase to determine the personal optimal dose of lacosamide. When this dose is reached s/he will enter the Maintenance Phase and will be asked to return for visits every 4 weeks for the first 24 weeks and every 12 weeks thereafter.

Conditions: Painful Diabetic Neuropathy
Being tested: Lacosamide
Keywords: Painful diabetic neuropathy, Lacosamide
Medical subject headings: Diabetic Neuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LacosamideDrug
Also called SPM 927
Lacosamide film-coated tablets; two times per day; up to 400 mg/day for 2.75 years

Study groups in NCT00220337
Study group	Role	What they receive
Lacosamide (LCM)	Experimental	Open label active treatment Receives: Drug: Lacosamide

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Subjects With Adverse Events (AE) Reported Spontaneously by the Subject or Observed by the Investigator
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
Measured: From Screening until Safety Follow up Visit (up to 140 weeks)
Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Titration Period
Changes in hematology parameters is reported as incidence of marked abnormalities in - Hematocrit (<=.85x Lower Limit Normal [LLN] or >= 1.15x Upper Limit Normal [ULN] - Hemoglobin (<=.85x LLN or >=1.15x ULN) - White Blood Cell (WBC) Count (<=3.0 or >=16.0 G/l) - Basophils (>=5.0%) - Eosinophils (>=10%) - Monocytes (>=20%) - Platelet Count (<=100 or >=600 G/l)
Measured: During the titration period (up to Week 8)
Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Maintenance Period
Changes in hematology parameters is reported as incidence of marked abnormalities in - Hematocrit (<=.85x Lower Limit Normal [LLN] or >= 1.15x Upper Limit Normal [ULN] - Hemoglobin (<=.85x LLN or >=1.15x ULN) - White Blood Cell (WBC) Count (<=3.0 or >=16.0 G/l) - Basophils (>=5.0%) - Eosinophils (>=10%) - Monocytes (>=20%) - Platelet Count (<=100 or >=600 G/l)
Measured: During the maintenance period (up to 136 weeks)
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Titration Period
Changes in clinical chemistry parameters is reported as incidence of marked abnormalities in - Alanine aminotransferase ([ALT] 3x ULN) - Alanine aminotransferase ([ALT] 5x ULN) - Alanine aminotransferase [(ALT] 10x ULN) - Aspartate aminotransferase ([AST] 3x ULN) - Aspartate aminotransferase ([AST] 5x ULN) - Aspartate aminotransferase ([AST] 10x ULN) - Alkaline Phosphatase (3x ULN) - Gamma-glutamyltransferase ([GGT] 3x ULN) - Total Bilirubin (2x ULN) - Albumin (<26 g/l) - Blood Urea Nitrogen (>=14.28 mmol/l) - Creatinine (>=2.0 mg/dl) - Calcium (<=7.6 or >=11.0 mg/dl) - Chloride (<=90 or >=112 mmol/l) - Phosphorus (<=2.0 or >=6.0 mg/dl) - Potassium (<=3.0 or >=6.0 mmol/l) - Sodium (<127 or >151 mmol/l) - Glucose (<50 or >=200 mg/dl) - Total Cholesterol (>6.5 mmol/l) - Uric Acid (>565.06 umol/l)
Measured: During the titration period (up to Week 8)
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Maintenance Period
Changes in clinical chemistry parameters is reported as incidence of marked abnormalities in - Alanine aminotransferase ([ALT] 3x ULN) - Alanine aminotransferase ([ALT] 5x ULN) - Alanine aminotransferase [(ALT] 10x ULN) - Aspartate aminotransferase ([AST] 3x ULN) - Aspartate aminotransferase ([AST] 5x ULN) - Aspartate aminotransferase ([AST] 10x ULN) - Alkaline Phosphatase (3x ULN) - Gamma-glutamyltransferase ([GGT] 3x ULN) - Total Bilirubin (2x ULN) - Albumin (<26 g/l) - Blood Urea Nitrogen (>=14.28 mmol/l) - Creatinine (>=2.0 mg/dl) - Calcium (<=7.6 or >=11.0 mg/dl) - Chloride (<=90 or >=112 mmol/l) - Phosphorus (<=2.0 or >=6.0 mg/dl) - Potassium (<=3.0 or >=6.0 mmol/l) - Sodium (<127 or >151 mmol/l) - Glucose (<50 or >=200 mg/dl) - Total Cholesterol (>6.5 mmol/l) - Uric Acid (>565.06 umol/l)
Measured: During the maintenance period (up to 136 weeks)
Number of Subjects With Urine pH= 5.0 at Baseline, Categorized by Urine pH at Last Visit
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.
Measured: Baseline, Last Visit (up to 140 weeks)
Number of Subjects With Urine pH= 6.0 at Baseline, Categorized by Urine pH at Last Visit
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.
Measured: Baseline, Last Visit (up to 140 weeks)
Number of Subjects With Urine pH= 6.5 at Baseline, Categorized by Urine pH at Last Visit
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.
Measured: Baseline, Last Visit (up to 140 weeks)
Number of Subjects With Urine pH= 7.0 at Baseline, Categorized by Urine pH at Last Visit
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.
Measured: Baseline, Last Visit (up to 140 weeks)
Number of Subjects With Urine pH= 7.5 at Baseline, Categorized by Urine pH at Last Visit
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.
Measured: Baseline, Last Visit (up to 140 weeks)
Number of Subjects With Urine pH= 8.0 at Baseline, Categorized by Urine pH at Last Visit
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.
Measured: Baseline, Last Visit (up to 140 weeks)
Number of Subjects With Urine White Blood Cell Count 'Negative' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive categories (+,++,+++) indicate worsening from Baseline.
Measured: Baseline, Last Visit (up to 140 weeks)
Number of Subjects With Urine White Blood Cell Count 'Trace' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive categories (+,++,+++) indicate worsening from Baseline.
Measured: Baseline, Last Visit (up to 140 weeks)
Number of Subjects With Urine White Blood Cell Count 'Positive +' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive categories (+,++,+++) indicate worsening from Baseline.
Measured: Baseline, Last Visit (up to 140 weeks)
Number of Subjects With Urine White Blood Cell Count 'Positive ++' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive categories (+,++,+++) indicate worsening from Baseline.
Measured: Baseline, Last Visit (up to 140 weeks)
Number of Subjects With Urine Nitrite Status 'Negative' at Baseline, Categorized by Urine Nitrite Status at Last Visit
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, positive, not done (data not available). Positive category indicate worsening from Baseline.
Measured: Baseline, Last Visit (up to 140 weeks)
Number of Subjects With Urine Nitrite Status 'Positive' at Baseline, Categorized by Urine Nitrite Status at Last Visit
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, positive, not done (data not available). Positive category indicate worsening from Baseline.
Measured: Baseline, Last Visit (up to 140 weeks)
Number of Subjects With Urine Urobilinogen Value 3 µmol/l at Baseline, Categorized by Urine Urobilinogen Value at Last Visit
Categories are as following: 3 µmol/l, 16 µmol/l, 33 µmol/l, 66 µmol/l, not done (data not available).
Measured: Baseline, Last Visit (up to 140 weeks)
Number of Subjects With Urine Urobilinogen Value 16 µmol/l at Baseline, Categorized by Urine Urobilinogen Value at Last Visit
Categories are as following: 3 µmol/l, 16 µmol/l, 33 µmol/l, 66 µmol/l, not done (data not available).
Measured: Baseline, Last Visit (up to 140 weeks)
Number of Subjects With Urine Urobilinogen Value 66 µmol/l at Baseline, Categorized by Urine Urobilinogen Value at Last Visit
Categories are as following: 3 µmol/l, 16 µmol/l, 33 µmol/l, 66 µmol/l, not done (data not available).
Measured: Baseline, Last Visit (up to 140 weeks)
Number of Subjects With Urine Protein Status 'Negative' at Baseline, Categorized by Urine Protein Status at Last Visit
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive categories (+,++,+++) indicate worsening from Baseline.
Measured: Baseline, Last Visit (up to 140 weeks)
Number of Subjects With Urine Protein Status 'Trace' at Baseline, Categorized by Urine Protein Status at Last Visit
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.
Measured: Baseline, Last Visit (up to 140 weeks)
Number of Subjects With Urine Protein Status 'Positive +' at Baseline, Categorized by Urine Protein Status at Last Visit
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.
Measured: Baseline, Last Visit (up to 140 weeks)
Number of Subjects With Urine Protein Status 'Positive ++' at Baseline, Categorized by Urine Protein Status at Last Visit
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.
Measured: Baseline, Last Visit (up to 140 weeks)
Number of Subjects With Urine Blood Status 'Negative' at Baseline, Categorized by Urine Blood Status at Last Visit
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace (H), positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.
Measured: Baseline, Last Visit (up to 140 weeks)
Number of Subjects With Urine Blood Status 'Trace (N)' at Baseline, Categorized by Urine Blood Status at Last Visit
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace (H), positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.
Measured: Baseline, Last Visit (up to 140 weeks)
Number of Subjects With Urine Blood Status 'Trace (H)' at Baseline, Categorized by Urine Blood Status at Last Visit
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace (H), positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.
Measured: Baseline, Last Visit (up to 140 weeks)
Number of Subjects With Urine Blood Status 'Positive +' at Baseline, Categorized by Urine Blood Status at Last Visit
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace (H), positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.
Measured: Baseline, Last Visit (up to 140 weeks)
Number of Subjects With Urine Blood Status 'Positive ++' at Baseline, Categorized by Urine Blood Status at Last Visit
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace (H), positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.
Measured: Baseline, Last Visit (up to 140 weeks)
Number of Subjects With Urine Ketone Status 'Negative' at Baseline, Categorized by Urine Ketone Status at Last Visit
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace, small, moderate, not done (data not available).
Measured: Baseline, Last Visit (up to 140 weeks)
Number of Subjects With Urine Ketone Status 'Trace' at Baseline, Categorized by Urine Ketone Status at Last Visit
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace, small, moderate, not done (data not available).
Measured: Baseline, Last Visit (up to 140 weeks)
Number of Subjects With Urine Ketone Status 'Small' at Baseline, Categorized by Urine Ketone Status at Last Visit
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace, small, moderate, not done (data not available).
Measured: Baseline, Last Visit (up to 140 weeks)
Number of Subjects With Urine Ketone Status 'Moderate' at Baseline, Categorized by Urine Ketone Status at Last Visit
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace, small, moderate, not done (data not available).
Measured: Baseline, Last Visit (up to 140 weeks)
Number of Subjects With Urine Bilirubin Status 'Negative' at Baseline, Categorized by Urine Bilirubin Status at Last Visit
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, positive +, positive ++, not done (data not available). Positive category (+, ++) indicate worsening from Baseline.
Measured: Baseline, Last Visit (up to 140 weeks)
Number of Subjects With Urine Bilirubin Status 'Positive +' at Baseline, Categorized by Urine Bilirubin Status at Last Visit
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, positive +, positive ++, not done (data not available). Positive category (+, ++) indicate worsening from Baseline.
Measured: Baseline, Last Visit (up to 140 weeks)
Number of Subjects With Urine Bilirubin Status 'Positive ++' at Baseline, Categorized by Urine Bilirubin Status at Last Visit
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, positive +, positive ++, not done (data not available). Positive category (+, ++) indicate worsening from Baseline.
Measured: Baseline, Last Visit (up to 140 weeks)
Number of Subjects With Urine Glucose Value 'Negative' at Baseline, Categorized by Urine Glucose Value at Last Visit
Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, >= 111 mmol/l, not done (data not available).
Measured: Baseline, Last Visit (up to 140 weeks)
Number of Subjects With Urine Glucose Value 5.5 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit
Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, >= 111 mmol/l, not done (data not available).
Measured: Baseline, Last Visit (up to 140 weeks)
Number of Subjects With Urine Glucose Value 14 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit
Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, >= 111 mmol/l, not done (data not available).
Measured: Baseline, Last Visit (up to 140 weeks)
Number of Subjects With Urine Glucose Value 28 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit
Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, >= 111 mmol/l, not done (data not available).
Measured: Baseline, Last Visit (up to 140 weeks)
Number of Subjects With Urine Glucose Value 55 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit
Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, >= 111 mmol/l, not done (data not available).
Measured: Baseline, Last Visit (up to 140 weeks)
Number of Subjects With Urine Glucose Value >=111 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit
Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, >= 111 mmol/l, not done (data not available).
Measured: Baseline, Last Visit (up to 140 weeks)
Percentage of Subjects With Marked Abnormalities in Vital Signs After Start of Treatment
Changes in vital signs examination findings is reported as percentage of subjects with marked abnormalities in - Systolic Blood Pressure (SBP) >=180 mmHg and increase of >=20 mmHg - Systolic Blood Pressure >=90 mmHg and decrease of >=20 mmHg - Diastolic Blood Pressure (DBP) >=105 mmHg and increase of >=15 mmHg - Diastolic Blood Pressure >=50 mmHg and decrease of >=15 mmHg - Pulse Rate (PR) >=120 beats/min and increase of >=15 beats/min - Pulse Rate >=50 beats/min and decrease of >=15 beats/min
Measured: During study period (up to 140 weeks)
Percentage of Subjects With Marked Abnormalities in Physical Examination Findings After Start of Treatment.
Changes in physical examination findings is reported as percentage of subjects with marked abnormalities in following categories: - Ears, Eyes, Nose, Mouth, Throat - Cardiovascular - Peripheral vascular - Pulmonary - Musculoskeletal - Hepato- / Gastrointestinal - Renal / Genitourological - Neurological - Metabolic / Endocrine - Psychiatric - Hematological / Lymphatic Nodes - Dermatological - Other The percentages are based on the number of subjects with examinations done at each visit for each body system.
Measured: Last Visit (up to 140 weeks)
Percentage of Subjects With Marked Abnormalities in Neurological Examination Findings After Start of Treatment
Changes in neurological examination findings is reported as percentage of subjects with marked abnormalities in following categories: - General - Cranial Nerves - Reflexes - Muscle Strength and Tone - Coordination and Cerebellar Function - Motor System - Sensation: Upper Extremities - Sensation: Lower Extremities The percentages are based on the number of subjects with examinations done at last visit for each category or parameter.
Measured: Last Visit (up to 140 weeks)
Percentage of Subjects With Abnormal Electrocardiogram (ECG) Findings
Changes in 12-lead ECGs is reported as percentage of subjects with abnormal ECG findings categorized in 'Abnormal, possibly insignificant' and 'Abnormal, possibly significant' based on the alert criterion by the ECG vendor and not on the investigator's assessment.
Measured: Last Visit (up to 140 weeks)
Percentage of Subjects Who Withdrew Due to Adverse Events (AEs)
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
Measured: During the study period (up to 140 weeks)
Number of Subjects With Urine Protein Status 'Positive +++' at Baseline, Categorized by Urine Protein Status at Last Visit
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.
Measured: Last Visit (up to 140 weeks)

Secondary outcomes (65)

Change in Average Pain Interference With Sleep From the Baseline Week to the 7 Days Prior to Each Visit
Pain interference scores at each visit (sleep and activity respectively) were defined as the average of the respective daily interference scores during the 7 last available days prior to the corresponding visit. An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement in symptoms from Baseline. Subjects rated pain interference over the past 12 hours for 7 days prior to each visit and an average value was calculated for each subject.
Measured: Baseline, Visit 2.1, Visit 2.2, Visit 2.4, Visit 2.5, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8, Visit 9.0, Visit 9.1, Visit 9.2, Visit 9.3, Visit 9.4, Visit 9.5, Visit 9.6, Visit 9.7, Visit 9.8, Visit 9.9
Change in Average Pain Interference With General Activity From the Baseline Week to the 7 Days Prior to Each Visit
Pain interference scores at each visit (sleep and activity respectively) were defined as the average of the respective daily interference scores during the 7 last available days prior to the corresponding visit. An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement in symptoms from Baseline. Subjects rated pain interference over the past 12 hours for 7 days prior to each visit and an average value was calculated for each subject.
Measured: Baseline, Visit 2.1, Visit 2.2, Visit 2.4, Visit 2.5, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8, Visit 9.0, Visit 9.1, Visit 9.2, Visit 9.3, Visit 9.4, Visit 9.5, Visit 9.6, Visit 9.7, Visit 9.8, Visit 9.9
Change in Current Pain From Visit 2 (Baseline) to Each Subsequent Visit as Measured by a 100 mm Visual Analogue Scale (VAS)
A 100 mm visual analogue scale (VAS) was used to assess the subject's current pain. The subject rated their current pain from 0 (no pain) to 100 (worst possible pain). A negative value indicates improvement in symptoms.
Measured: Baseline, Visit 2.1, Visit 2.2, Visit 2.4, Visit 2.5, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8, Visit 9.0, Visit 9.1, Visit 9.2, Visit 9.3, Visit 9.4, Visit 9.5, Visit 9.6, Visit 9.7, Visit 9.8, Visit 9.9
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 4
The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.
Measured: Visit 4
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 6
The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.
Measured: Visit 6
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.0
The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.
Measured: Visit 9.0
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.1
The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.
Measured: Visit 9.1
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.2
The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.
Measured: Visit 9.2
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.3
The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.
Measured: Visit 9.3
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.4
The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.
Measured: Visit 9.4
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.5
The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.
Measured: Visit 9.5
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.6
The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.
Measured: Visit 9.6
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.7
The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.
Measured: Visit 9.7
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.8
The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.
Measured: Visit 9.8
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Termination Visit
The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.
Measured: Termination Visit (last treatment visit)
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 4
Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the Neuropathic Pain Symptoms Inventory (NPSI) at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Baseline, Visit 4
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 6
Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Baseline, Visit 6
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.0
Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Baseline, Visit 9.0
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.1
Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain), and are reported in categories below and 2 temporal questions (duration of pain, number of pain attacks). This assessment was done only in subjects from countries in which a validated version of the NPSI was available. Total NPSI scale ranged from 0 (no pain) to 100 (maximum pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline.
Measured: Baseline, Visit 9.1
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.2
Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Baseline, Visit 9.2
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.3
Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Baseline, Visit 9.3
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.4
Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Baseline, Visit 9.4
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.5
Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Baseline, Visit 9.5
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.6
Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Baseline, Visit 9.6
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.7
Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Baseline, Visit 9.7
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.8
Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Baseline, Visit 9.8
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Termination Visit
Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Baseline, Termination Visit (last treatment visit)
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 2 (Baseline)
Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Visit 2 (Baseline)
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 4
Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Visit 4
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 6
Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Visit 6
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.0
Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Visit 9.0
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.1
Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Visit 9.1
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.2
Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Visit 9.2
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.3
Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Visit 9.3
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.4
Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Visit 9.4
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.5
Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Visit 9.5
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.6
Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Visit 9.6
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.7
Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Visit 9.7
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.8
Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Visit 9.8
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Termination Visit
Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Termination Visit (last treatment visit)
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 2 (Baseline)
Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Visit 2 (Baseline)
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 4
Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Visit 4
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 6
Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Visit 6
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.0
Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Visit 9.0
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.1
Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Visit 9.1
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.2
Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Visit 9.2
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.3
Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Visit 9.3
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.4
Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Visit 9.4
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.5
Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Visit 9.5
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.6
Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Visit 9.6
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.7
Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Visit 9.7
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.8
Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Visit 9.8
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Termination Visit
Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.
Measured: Termination Visit (last treatment visit)
Change in Quality of Life From Visit 2 (Baseline) to Visit 4
Quality of life was analyzed using the Short Form-36 (SF-36) Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the physical component Summary (PCS) score of the SF-36. Items 5-8 primarily contribute to the mental component summary (MCS) score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.
Measured: Baseline, Visit 4
Change in Quality of Life From Visit 2 (Baseline) to Visit 6
Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.
Measured: Baseline, Visit 6
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.0
Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.
Measured: Baseline, Visit 9.0
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.1
Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.
Measured: Baseline, Visit 9.1
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.2
Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.
Measured: Baseline, Visit 9.2
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.3
Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.
Measured: Baseline, Visit 9.3
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.4
Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.
Measured: Baseline, Visit 9.4
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.5
Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.
Measured: Baseline, Visit 9.5
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.6
Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.
Measured: Baseline, Visit 9.6
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.7
Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.
Measured: Baseline, Visit 9.7
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.8
Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.
Measured: Baseline, Visit 9.8
Change in Quality of Life From Visit 2 (Baseline) to Termination Visit
Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.
Measured: Baseline, Termination Visit (last treatment visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Dec 200431 Oct 2007

First posted22 Sep 2005 (estimated)
Study start21 Dec 2004
Primary completion31 Oct 2007
Study completion31 Oct 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Painful Diabetic NeuropathyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 371 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00220337
Sponsor's protocol ID: SP0830
Other IDs: 2004-000960-28, 2004
Status last verified: Aug 2022
First submitted: 1 Sep 2005
Last updated: 24 Jul 2023
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
Diabetic Neuropathies, Diabetes Mellitus (Type 2)
Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
RecruitingObservational study
Safety and Effect of Peripheral Nerve Decompression Combined With Peripheral Nerve Stimulation for Painful Diabetic Peripheral Neuropathy
Painful Diabetic Peripheral Neuropathy, Diabetes Complication
Active, not recruitingPhase 3
Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)
Diabetic Peripheral Neuropathic Pain
Not yet recruitingPhase 4
Modality Choice Before and After Failure for the Treatment of Painful Diabetic Neuropathy
Painful Diabetic Neuropathy (PDN), Diabetic Nephropathies

All Painful Diabetic Neuropathy trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Open-label Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy
ClinicalTrials.gov ID: NCT00220337
Acronym / sponsor ID: SP0830
Conditions: Painful Diabetic Neuropathy
Keywords: Painful diabetic neuropathy, Lacosamide
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 371 participants (actual)
Lead sponsor: UCB PharmaIndustry (pharma, biotech, devices)
Collaborators: SCHWARZ BIOSCIENCES GmbH - Part of UCB Group
Study start: 21 Dec 2004
Primary completion: 31 Oct 2007 (actual)
Study completion: 31 Oct 2007 (actual)
First posted: 22 Sep 2005 (estimated)
Results: Posted 24 Jul 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine if lacosamide (SPM 927) is safe if taken for a longer period of time and whether it continues to work well to treat pain.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Lacosamide (LCM)	Experimental	Drug: LacosamideOpen label active treatment

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Painful diabetic neuropathy

Key exclusion criteria (1 listed)

no clinically relevant liver enzyme abnormalities and impaired renal function, no cardiac abnormalities, no pregnant or nursing females

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LacosamideAlso: SPM 927Lacosamide film-coated tablets; two times per day; up to 400 mg/day for 2.75 years	Drug	Lacosamide (LCM)

Primary outcome

Percentage of Subjects With Adverse Events (AE) Reported Spontaneously by the Subject or Observed by the Investigator
Time frame: From Screening until Safety Follow up Visit (up to 140 weeks)
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Titration Period
Time frame: During the titration period (up to Week 8)
Changes in hematology parameters is reported as incidence of marked abnormalities in - Hematocrit (<=.85x Lower Limit Normal [LLN] or >= 1.15x Upper Limit Normal [ULN] - Hemoglobin (<=.85x LLN or >=1.15x ULN) - White Blood Cell (WBC) Count (<=3.0 or >=16.0 G/l) - Basophils (>=5.0%) - Eosinophils (>=10%) - Monocytes (>=20%) - Platelet Count (<=100 or >=600 G/l)
Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Maintenance Period
Time frame: During the maintenance period (up to 136 weeks)
Changes in hematology parameters is reported as incidence of marked abnormalities in - Hematocrit (<=.85x Lower Limit Normal [LLN] or >= 1.15x Upper Limit Normal [ULN] - Hemoglobin (<=.85x LLN or >=1.15x ULN) - White Blood Cell (WBC) Count (<=3.0 or >=16.0 G/l) - Basophils (>=5.0%) - Eosinophils (>=10%) - Monocytes (>=20%) - Platelet Count (<=100 or >=600 G/l)
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Titration Period
Time frame: During the titration period (up to Week 8)
Changes in clinical chemistry parameters is reported as incidence of marked abnormalities in - Alanine aminotransferase ([ALT] 3x ULN) - Alanine aminotransferase ([ALT] 5x ULN) - Alanine aminotransferase [(ALT] 10x ULN) - Aspartate aminotransferase ([AST] 3x ULN) - Aspartate aminotransferase ([AST] 5x ULN) - Aspartate aminotransferase ([AST] 10x ULN) - Alkaline Phosphatase (3x ULN) - Gamma-glutamyltransferase ([GGT] 3x ULN) - Total Bilirubin (2x ULN) - Albumin (<26 g/l) - Blood Urea Nitrogen (>=14.28 mmol/l) - Creatinine (>=2.0 mg/dl) - Calcium (<=7.6 or >=11.0 mg/dl) - Chloride (<=90 or >=112 mmol/l) - Phosphorus (<=2.0 or >=6.0 mg/dl) - Potassium (<=3.0 or >=6.0 mmol/l) - Sodium (<127 or >151 mmol/l) - Glucose (<50 or >=200 mg/dl) - Total Cholesterol (>6.5 mmol/l) - Uric Acid (>565.06 umol/l)
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Maintenance Period
Time frame: During the maintenance period (up to 136 weeks)
Changes in clinical chemistry parameters is reported as incidence of marked abnormalities in - Alanine aminotransferase ([ALT] 3x ULN) - Alanine aminotransferase ([ALT] 5x ULN) - Alanine aminotransferase [(ALT] 10x ULN) - Aspartate aminotransferase ([AST] 3x ULN) - Aspartate aminotransferase ([AST] 5x ULN) - Aspartate aminotransferase ([AST] 10x ULN) - Alkaline Phosphatase (3x ULN) - Gamma-glutamyltransferase ([GGT] 3x ULN) - Total Bilirubin (2x ULN) - Albumin (<26 g/l) - Blood Urea Nitrogen (>=14.28 mmol/l) - Creatinine (>=2.0 mg/dl) - Calcium (<=7.6 or >=11.0 mg/dl) - Chloride (<=90 or >=112 mmol/l) - Phosphorus (<=2.0 or >=6.0 mg/dl) - Potassium (<=3.0 or >=6.0 mmol/l) - Sodium (<127 or >151 mmol/l) - Glucose (<50 or >=200 mg/dl) - Total Cholesterol (>6.5 mmol/l) - Uric Acid (>565.06 umol/l)
Number of Subjects With Urine pH= 5.0 at Baseline, Categorized by Urine pH at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.
Number of Subjects With Urine pH= 6.0 at Baseline, Categorized by Urine pH at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.
Number of Subjects With Urine pH= 6.5 at Baseline, Categorized by Urine pH at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.
Number of Subjects With Urine pH= 7.0 at Baseline, Categorized by Urine pH at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.
Number of Subjects With Urine pH= 7.5 at Baseline, Categorized by Urine pH at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.
Number of Subjects With Urine pH= 8.0 at Baseline, Categorized by Urine pH at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.
Number of Subjects With Urine White Blood Cell Count 'Negative' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive categories (+,++,+++) indicate worsening from Baseline.
Number of Subjects With Urine White Blood Cell Count 'Trace' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive categories (+,++,+++) indicate worsening from Baseline.
Number of Subjects With Urine White Blood Cell Count 'Positive +' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive categories (+,++,+++) indicate worsening from Baseline.
Number of Subjects With Urine White Blood Cell Count 'Positive ++' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive categories (+,++,+++) indicate worsening from Baseline.
Number of Subjects With Urine Nitrite Status 'Negative' at Baseline, Categorized by Urine Nitrite Status at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, positive, not done (data not available). Positive category indicate worsening from Baseline.
Number of Subjects With Urine Nitrite Status 'Positive' at Baseline, Categorized by Urine Nitrite Status at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, positive, not done (data not available). Positive category indicate worsening from Baseline.
Number of Subjects With Urine Urobilinogen Value 3 µmol/l at Baseline, Categorized by Urine Urobilinogen Value at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Categories are as following: 3 µmol/l, 16 µmol/l, 33 µmol/l, 66 µmol/l, not done (data not available).
Number of Subjects With Urine Urobilinogen Value 16 µmol/l at Baseline, Categorized by Urine Urobilinogen Value at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Categories are as following: 3 µmol/l, 16 µmol/l, 33 µmol/l, 66 µmol/l, not done (data not available).
Number of Subjects With Urine Urobilinogen Value 66 µmol/l at Baseline, Categorized by Urine Urobilinogen Value at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Categories are as following: 3 µmol/l, 16 µmol/l, 33 µmol/l, 66 µmol/l, not done (data not available).
Number of Subjects With Urine Protein Status 'Negative' at Baseline, Categorized by Urine Protein Status at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive categories (+,++,+++) indicate worsening from Baseline.
Number of Subjects With Urine Protein Status 'Trace' at Baseline, Categorized by Urine Protein Status at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.
Number of Subjects With Urine Protein Status 'Positive +' at Baseline, Categorized by Urine Protein Status at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.
Number of Subjects With Urine Protein Status 'Positive ++' at Baseline, Categorized by Urine Protein Status at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.
Number of Subjects With Urine Blood Status 'Negative' at Baseline, Categorized by Urine Blood Status at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace (H), positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.
Number of Subjects With Urine Blood Status 'Trace (N)' at Baseline, Categorized by Urine Blood Status at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace (H), positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.
Number of Subjects With Urine Blood Status 'Trace (H)' at Baseline, Categorized by Urine Blood Status at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace (H), positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.
Number of Subjects With Urine Blood Status 'Positive +' at Baseline, Categorized by Urine Blood Status at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace (H), positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.
Number of Subjects With Urine Blood Status 'Positive ++' at Baseline, Categorized by Urine Blood Status at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace (H), positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.
Number of Subjects With Urine Ketone Status 'Negative' at Baseline, Categorized by Urine Ketone Status at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace, small, moderate, not done (data not available).
Number of Subjects With Urine Ketone Status 'Trace' at Baseline, Categorized by Urine Ketone Status at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace, small, moderate, not done (data not available).
Number of Subjects With Urine Ketone Status 'Small' at Baseline, Categorized by Urine Ketone Status at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace, small, moderate, not done (data not available).
Number of Subjects With Urine Ketone Status 'Moderate' at Baseline, Categorized by Urine Ketone Status at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace, small, moderate, not done (data not available).
Number of Subjects With Urine Bilirubin Status 'Negative' at Baseline, Categorized by Urine Bilirubin Status at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, positive +, positive ++, not done (data not available). Positive category (+, ++) indicate worsening from Baseline.
Number of Subjects With Urine Bilirubin Status 'Positive +' at Baseline, Categorized by Urine Bilirubin Status at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, positive +, positive ++, not done (data not available). Positive category (+, ++) indicate worsening from Baseline.
Number of Subjects With Urine Bilirubin Status 'Positive ++' at Baseline, Categorized by Urine Bilirubin Status at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, positive +, positive ++, not done (data not available). Positive category (+, ++) indicate worsening from Baseline.
Number of Subjects With Urine Glucose Value 'Negative' at Baseline, Categorized by Urine Glucose Value at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, >= 111 mmol/l, not done (data not available).
Number of Subjects With Urine Glucose Value 5.5 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, >= 111 mmol/l, not done (data not available).
Number of Subjects With Urine Glucose Value 14 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, >= 111 mmol/l, not done (data not available).
Number of Subjects With Urine Glucose Value 28 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, >= 111 mmol/l, not done (data not available).
Number of Subjects With Urine Glucose Value 55 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, >= 111 mmol/l, not done (data not available).
Number of Subjects With Urine Glucose Value >=111 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit
Time frame: Baseline, Last Visit (up to 140 weeks)
Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, >= 111 mmol/l, not done (data not available).
Percentage of Subjects With Marked Abnormalities in Vital Signs After Start of Treatment
Time frame: During study period (up to 140 weeks)
Changes in vital signs examination findings is reported as percentage of subjects with marked abnormalities in - Systolic Blood Pressure (SBP) >=180 mmHg and increase of >=20 mmHg - Systolic Blood Pressure >=90 mmHg and decrease of >=20 mmHg - Diastolic Blood Pressure (DBP) >=105 mmHg and increase of >=15 mmHg - Diastolic Blood Pressure >=50 mmHg and decrease of >=15 mmHg - Pulse Rate (PR) >=120 beats/min and increase of >=15 beats/min - Pulse Rate >=50 beats/min and decrease of >=15 beats/min
Percentage of Subjects With Marked Abnormalities in Physical Examination Findings After Start of Treatment.
Time frame: Last Visit (up to 140 weeks)
Changes in physical examination findings is reported as percentage of subjects with marked abnormalities in following categories: - Ears, Eyes, Nose, Mouth, Throat - Cardiovascular - Peripheral vascular - Pulmonary - Musculoskeletal - Hepato- / Gastrointestinal - Renal / Genitourological - Neurological - Metabolic / Endocrine - Psychiatric - Hematological / Lymphatic Nodes - Dermatological - Other The percentages are based on the number of subjects with examinations done at each visit for each body system.
Percentage of Subjects With Marked Abnormalities in Neurological Examination Findings After Start of Treatment
Time frame: Last Visit (up to 140 weeks)
Changes in neurological examination findings is reported as percentage of subjects with marked abnormalities in following categories: - General - Cranial Nerves - Reflexes - Muscle Strength and Tone - Coordination and Cerebellar Function - Motor System - Sensation: Upper Extremities - Sensation: Lower Extremities The percentages are based on the number of subjects with examinations done at last visit for each category or parameter.
Percentage of Subjects With Abnormal Electrocardiogram (ECG) Findings
Time frame: Last Visit (up to 140 weeks)
Changes in 12-lead ECGs is reported as percentage of subjects with abnormal ECG findings categorized in 'Abnormal, possibly insignificant' and 'Abnormal, possibly significant' based on the alert criterion by the ECG vendor and not on the investigator's assessment.
Percentage of Subjects Who Withdrew Due to Adverse Events (AEs)
Time frame: During the study period (up to 140 weeks)
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
Number of Subjects With Urine Protein Status 'Positive +++' at Baseline, Categorized by Urine Protein Status at Last Visit
Time frame: Last Visit (up to 140 weeks)
Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.

65 secondary outcomes

Change in Average Pain Interference With Sleep From the Baseline Week to the 7 Days Prior to Each Visit
Time frame: Baseline, Visit 2.1, Visit 2.2, Visit 2.4, Visit 2.5, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8, Visit 9.0, Visit 9.1, Visit 9.2, Visit 9.3, Visit 9.4, Visit 9.5, Visit 9.6, Visit 9.7, Visit 9.8, Visit 9.9
Change in Average Pain Interference With General Activity From the Baseline Week to the 7 Days Prior to Each Visit
Time frame: Baseline, Visit 2.1, Visit 2.2, Visit 2.4, Visit 2.5, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8, Visit 9.0, Visit 9.1, Visit 9.2, Visit 9.3, Visit 9.4, Visit 9.5, Visit 9.6, Visit 9.7, Visit 9.8, Visit 9.9
Change in Current Pain From Visit 2 (Baseline) to Each Subsequent Visit as Measured by a 100 mm Visual Analogue Scale (VAS)
Time frame: Baseline, Visit 2.1, Visit 2.2, Visit 2.4, Visit 2.5, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8, Visit 9.0, Visit 9.1, Visit 9.2, Visit 9.3, Visit 9.4, Visit 9.5, Visit 9.6, Visit 9.7, Visit 9.8, Visit 9.9
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 4
Time frame: Visit 4
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 6
Time frame: Visit 6
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.0
Time frame: Visit 9.0
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.1
Time frame: Visit 9.1
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.2
Time frame: Visit 9.2
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.3
Time frame: Visit 9.3
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.4
Time frame: Visit 9.4
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.5
Time frame: Visit 9.5
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.6
Time frame: Visit 9.6
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.7
Time frame: Visit 9.7
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.8
Time frame: Visit 9.8
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Termination Visit
Time frame: Termination Visit (last treatment visit)
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 4
Time frame: Baseline, Visit 4
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 6
Time frame: Baseline, Visit 6
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.0
Time frame: Baseline, Visit 9.0
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.1
Time frame: Baseline, Visit 9.1
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.2
Time frame: Baseline, Visit 9.2
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.3
Time frame: Baseline, Visit 9.3
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.4
Time frame: Baseline, Visit 9.4
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.5
Time frame: Baseline, Visit 9.5
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.6
Time frame: Baseline, Visit 9.6
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.7
Time frame: Baseline, Visit 9.7
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.8
Time frame: Baseline, Visit 9.8
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Termination Visit
Time frame: Baseline, Termination Visit (last treatment visit)
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 2 (Baseline)
Time frame: Visit 2 (Baseline)
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 4
Time frame: Visit 4
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 6
Time frame: Visit 6
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.0
Time frame: Visit 9.0
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.1
Time frame: Visit 9.1
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.2
Time frame: Visit 9.2
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.3
Time frame: Visit 9.3
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.4
Time frame: Visit 9.4
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.5
Time frame: Visit 9.5
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.6
Time frame: Visit 9.6
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.7
Time frame: Visit 9.7
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.8
Time frame: Visit 9.8
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Termination Visit
Time frame: Termination Visit (last treatment visit)

Results and safety

Results posted to the registry on 24 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lacosamide	371	192

Primary outcome: Percentage of Subjects With Adverse Events (AE) Reported Spontaneously by the Subject or Observed by the Investigator

Time frame: From Screening until Safety Follow up Visit (up to 140 weeks). Number. Unit: percentage of participants

Measure	Lacosamide n = 371
Value	80.9

Population analysed: The Safety Set (SS) was defined as all subjects who signed the informed consent form and took at least 1 dose of trial medication.

Primary outcome: Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Titration Period

Time frame: During the titration period (up to Week 8). Number. Unit: percentage of participants

Measure	Lacosamide n = 371
Hematocrit	0.8
Hemoglobin	0.5
White Blood Cell	1.4
Basophils	1.1
Eosinophils	0
Monocytes	0
Platelet Count	1.1

Population analysed: Safety Set included 371 subjects. Only subjects with valid data for hematology parameters are included in the analysis. Here, Number analyzed signifies those subjects who were evaluable for different hematologic parameters.

Primary outcome: Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Maintenance Period

Time frame: During the maintenance period (up to 136 weeks). Number. Unit: percentage of participants

Measure	Lacosamide n = 371
Hematocrit	6.2
Hemoglobin	5.5
WBC Count	2.8
Basophils	2.8
Eosinophils	2.8
Monocytes	0.3
Platelet Count	4.4

Primary outcome: Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Titration Period

Time frame: During the titration period (up to Week 8). Number. Unit: percentage of participants

Measure	Lacosamide n = 371
ALT 3xULN	0.5
ALT 5xULN	0
ALT 10xULN	0
AST 3xULN	0
AST 5xULN	0
AST 10xULN	0
Alkaline Phosphatase	0
GGT 3xULN	0.6

Population analysed: Safety Set included 371 subjects. Only subjects with valid data for clinical chemistry parameters are included in the analysis. Here, Number analyzed signifies those subjects who were evaluable for different clinical chemistry parameters.

65 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Baseline through Safety follow up visit (up to 140 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lacosamide	83 of 371 (22.4%)	229 of 371 (61.7%)	7 of 371

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Painful Diabetic Neuropathy

Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
Diabetic Neuropathies, Diabetes Mellitus (Type 2)
Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
RecruitingObservational study
Safety and Effect of Peripheral Nerve Decompression Combined With Peripheral Nerve Stimulation for Painful Diabetic Peripheral Neuropathy
Painful Diabetic Peripheral Neuropathy, Diabetes Complication
Active, not recruitingPhase 3
Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)
Diabetic Peripheral Neuropathic Pain
Not yet recruitingPhase 4
Modality Choice Before and After Failure for the Treatment of Painful Diabetic Neuropathy
Painful Diabetic Neuropathy (PDN), Diabetic Nephropathies

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

UCB Cares study director

UCB (+1 844 599 2273)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lacosamide in people with Painful Diabetic Neuropathy, run by UCB Pharma at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects With Adverse Events (AE) Reported Spontaneously by the Subject or Observed by the Investigator (time frame: From Screening until Safety Follow up Visit (up to 140 weeks)). The study lists 48 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00220337.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.