Diabetic NeuropathyPhase 2/3NCT00235443
A Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy
A Phase 2/3 study testing lacosamide in people with Diabetic Neuropathy, run by UCB Pharma at 84 sites in United States.
Trial summary
Phase 2/3 open-label trial to assess the safety and tolerability of long-term treatment with lacosamide (SPM 927) in subjects with painful diabetic neuropathy. The safety and tolerability of the different doses of lacosamide will be investigated. Read more about this study
- Who is it for?
- Ages 32 to 81 years
- Conditions the study is for
- 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
- 451 participants
- Where
- 84 sitesUnited States
- Study dates
- Sep 2004to Jul 2008
- Phase
- Phase 2/3
- 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 32 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who completed Study SP665, SP742, or SP768 and, in the investigators opinion, might benefit from long-term administration of SPM 927. Exception: subjects who prematurely discontinued Study SP742 or SP768 due to lack of efficacy or due to intolerability to trial medication may be eligible to participate in Study SP745, after consultation with the medical monitor.
Who cannot join
- Subject has clinically relevant electrocardiogram (ECG) abnormalities, or QT-corrected (QTc) interval >=500 milliseconds (ms), and/or a QTc interval increase of >=60ms from the mean pre-dose QTc value at Visit 2 of Studies SP665, SP742 or SP768.
- Subject has aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >=3 times the upper limit of the normal range (ULN) with total bilirubin >=2 times ULN or transaminases (AST and/or ALT) >=5 times ULN.
- Subject has a clinically relevant medical condition that, in the opinion of the investigator, jeopardizes or compromises the subject's ability to participate in this trial.
Trial locations and contacts
84 sites in 1 country.
84 sites in 1 country
United States84 sites
Study site
Albany, New York
Study site
Amarillo, Texas
Study site
Ann Arbor, Michigan
Study site
Anniston, Alabama
Study site
Bennington, Vermont
Study site
Bradenton, Florida
Study site
Bristol, Tennessee
Study site
Brockton, Massachusetts
Study site
Charlotte, North Carolina
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Clearwater, Florida
Study site
Crestview Hills, Kentucky
Study site
Dallas, Texas
Study site
Denver, Colorado
Study site
Elk Grove Village, Illinois
Study site
Evansville, Indiana
Study site
Fort Myers, Florida
Study site
Fort Worth, Texas
Study site
Great Falls, Montana
Study site
Greensboro, North Carolina
Study site
Greenville, North Carolina
Study site
Greer, South Carolina
Study site
Hoover, Alabama
Study site
Hot Springs, Arkansas
Study site
Houston, Texas
Study site
Huntsville, Alabama
Study site
Irvine, California
Study site
Jonesboro, Arkansas
Study site
Las Vegas, Nevada
Study site
Lawrenceville, New Jersey
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Little Rock, Arkansas
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Los Angeles, California
Study site
Louisville, Kentucky
Study site
Madisonville, Kentucky
Study site
Marietta, Georgia
Study site
Medford, Oregon
Study site
Mineola, New York
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Nashville, Tennessee
Study site
New Port Richey, Florida
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Newark, Delaware
Study site
North Chicago, Illinois
Study site
Northport, Alabama
Study site
Ocala, Florida
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Oklahoma City, Oklahoma
Study site
Omaha, Nebraska
Study site
Owings Mills, Maryland
Study site
Paducah, Kentucky
Study site
Pembroke Pines, Florida
Study site
Peoria, Arizona
Study site
Phoenix, Arizona
Study site
Pinellas Park, Florida
Study site
Portland, Oregon
Study site
Raleigh, North Carolina
Study site
Richardson, Texas
Study site
Richmond, Virginia
Study site
Salem, Virginia
Study site
San Antonio, Texas
Study site
San Diego, California
Study site
Santa Monica, California
Study site
South Miami, Florida
Study site
Spokane, Washington
Study site
Spring Valley, California
Study site
St Louis, Missouri
Study site
St. Petersburg, Florida
Study site
Stratford, Connecticut
Study site
Sunrise, Florida
Study site
Tacoma, Washington
Study site
Tallahassee, Florida
Study site
Toledo, Ohio
Study site
Towson, Maryland
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Tucson, Arizona
Study site
Tulsa, Oklahoma
Study site
Tuscaloosa, Alabama
Study site
Tustin, California
Study site
Upland, Pennsylvania
Study site
Virginia Beach, Virginia
Study site
Voorhees Township, New Jersey
Study site
Walnut Creek, California
Study site
Wenatchee, Washington
Study site
West Des Moines, Iowa
Study site
White Plains, New York
Study site
Wilmington, Delaware
Study site
Winston-Salem, North Carolina
About this study
Official title: A Multi-Center, Open-Label, Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Subjects With Painful Distal Diabetic Neuropathy
Phase 2/3 open-label trial to assess the safety and tolerability of long-term treatment with lacosamide (SPM 927) in subjects with painful diabetic neuropathy. The safety and tolerability of the different doses of lacosamide will be investigated.
Read the detailed description
This phase 2/3 open-label trial is being conducted at approximately 100 sites in the US to assess the safety and tolerability of long-term treatment with lacosamide (SPM 927) in subjects with painful diabetic neuropathy. Approximately 525 subjects will be enrolled. To qualify for this trial, subjects with symptoms of painful distal diabetic neuropathy ranging in duration from 6 months to 5 years must have completed trials SP665, SP742, or SP768 and, in the investigator's opinion, may benefit from long-term administration of lacosamide. Subjects will be titrated to their optimal dose of lacosamide (up to 600mg/day). The safety and tolerability of the different doses of lacosamide will be investigated throughout the trial. In addition, to determine what effect lacosamide has on diabetic neuropathic pain, subjects will use a diary to record their daily pain intensity and pain interference with sleep and activity. Subjects' quality of life will also be investigated.
- Conditions
- Diabetic Neuropathy
- Being tested
- lacosamide
- Keywords
- Painful Distal Diabetic Neuropathy
- 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 SPM927
Open-label treatment (two times per day) with film-coated tablets include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, and 600mg/day throughout individual study period.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day Receives: Drug: lacosamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Adverse Events (AEs) Reported Spontaneously by the Subject or Observed by the Investigator.
Number of subjects with adverse events (AEs) reported spontaneously by the subject or observed by the investigator (serious and non-serious).
Measured: Throughout the study up to a maximum study period of 2.8 years
Secondary outcomes (17)
Change From Baseline in Average Daily Pain Score Using an 11-point Likert Scale (0-10).
Change from Baseline in average daily pain score using an 11-point Likert scale (0-10). On Likert scale, 0=no pain and 10=worst possible pain.
Measured: Baseline to end of entire treatment phase (maximum study period of 2.8 years).
Change From Baseline in Average Pain Score as Measured by a 100mm Visual Analogue Scale (VAS).
Change from Baseline in average pain score as measured by a 100mm Visual Analogue Scale (VAS). On VAS 0mm=no pain and 100mm=worst possible pain.
Measured: Baseline to end of entire treatment phase (maximum study period of 2.8 years).
Patient's Global Impression of Change (PGIC) From Baseline in Pain.
Patient's Global Impression of Change (PGIC) from Baseline in Pain. Original categorical responses are much worse, moderately worse, mildly worst, no change, mildly better, moderately better, and much better. Reported results are presented as Better (sum of mildly, moderately, or much better), No Change, or Worse (sum of mildly, moderately, or much worse).
Measured: Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Intensity.
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) for intensity of pain where 0=no pain and 10=most intense pain sensation imaginable.
Measured: Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sharpness
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) for sharpness of pain where 0=not sharp and 10=most sharp sensation imaginable ("like a knife").
Measured: Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Heat
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with heat sensation where 0=not hot and 10=the most hot sensation imaginable ("on fire").
Measured: Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Dullness
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with dullness of pain where 0=not dull and 10=most dull sensation imaginable.
Measured: Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Cold
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with cold sensation where 0=not cold and 10=most cold sensation imaginable ("freezing").
Measured: Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sensitivity
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with sensitivity of pain where 0=not sensitive and 10=most sensitive sensation imaginable ("raw skin").
Measured: Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Itchiness
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with itchiness where 0=not itchy and 10=most itchy sensation imaginable ("like poison oak").
Measured: Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Unpleasantness
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with unpleasantness where 0=not pleasant and 10=most unpleasant sensation imaginable ("intolerable").
Measured: Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Deep Pain
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with deep pain where 0=no deep pain and 10=most intense deep pain sensation imaginable.
Measured: Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Surface Pain
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with surface pain where 0=no surface pain and 10=most intense surface pain imaginable.
Measured: Baseline to Termination Visit
Change From Baseline in Average Pain Interference With Sleep (11-point Likert Scale)
Change from Baseline in average pain interference with sleep (11-point Likert scale) where 0=no interference with sleep and 10=worst possible interference with sleep.
Measured: Baseline to end of entire treatment phase visit
Change From Baseline in Average Pain Interference With Activity (11-point Likert Scale)
Change from Baseline in average pain interference with activity (11-point Likert scale) where 0=no interfence with activity and 10=worst possible interference with activity.
Measured: Baseline to end of entire treatment phase visit
Change From Baseline in Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS)
Change from Baseline in quality of life using the SF-36 Health Survey - Physical Component Summary (PCS). Values range from 0 to 100 with high values indicating a good condition. Positive change in baseline values indicate improvement in quality of life.
Measured: Baseline to Termination Visit
Change From Baseline in Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS)
Change from Baseline in quality of life using the SF-36 Health Survey - Mental Component Summary (MCS). Values range from 0 to 100 with high values indicating a good condition. Positive change in baseline values indicate improvement in quality of life.
Measured: Baseline to Termination Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2005 (estimated)
- Study startSep 2004
- Primary completionJul 2008
- Study completionJul 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00235443
- Sponsor's protocol ID
- SP0745
- Status last verified
- Jul 2017
- First submitted
- 6 Oct 2005
- Last updated
- 17 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Expanded access
- Available
Publications
Shaibani A, Biton V, Rauck R, Koch B, Simpson J. Long-term oral lacosamide in painful diabetic neuropathy: a two-year open-label extension trial. Eur J Pain. 2009 May;13(5):458-63. doi: 10.1016/j.ejpain.2008.05.016. Epub 2008 Jul 10.
PubMed 18619874
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open-Label, Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Subjects With Painful Distal Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT00235443
- Acronym / sponsor ID
- SP0745
- Conditions
- Diabetic Neuropathy
- Keywords
- Painful Distal Diabetic Neuropathy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 10 Oct 2005 (estimated)
- Results
- Posted 5 Oct 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 2/3 open-label trial to assess the safety and tolerability of long-term treatment with lacosamide (SPM 927) in subjects with painful diabetic neuropathy. The safety and tolerability of the different doses of lacosamide will be investigated.
Detailed description
This phase 2/3 open-label trial is being conducted at approximately 100 sites in the US to assess the safety and tolerability of long-term treatment with lacosamide (SPM 927) in subjects with painful diabetic neuropathy. Approximately 525 subjects will be enrolled. To qualify for this trial, subjects with symptoms of painful distal diabetic neuropathy ranging in duration from 6 months to 5 years must have completed trials SP665, SP742, or SP768 and, in the investigator's opinion, may benefit from long-term administration of lacosamide. Subjects will be titrated to their optimal dose of lacosamide (up to 600mg/day). The safety and tolerability of the different doses of lacosamide will be investigated throughout the trial. In addition, to determine what effect lacosamide has on diabetic neuropathic pain, subjects will use a diary to record their daily pain intensity and pain interference with sleep and activity. Subjects' quality of life will also be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: lacosamideOpen label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day |
Who may qualify
- Ages
- 32 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects who completed Study SP665, SP742, or SP768 and, in the investigators opinion, might benefit from long-term administration of SPM 927. Exception: subjects who prematurely discontinued Study SP742 or SP768 due to lack of efficacy or due to intolerability to trial medication may be eligible to participate in Study SP745, after consultation with the medical monitor.
Key exclusion criteria (3 listed)
- Subject has clinically relevant electrocardiogram (ECG) abnormalities, or QT-corrected (QTc) interval >=500 milliseconds (ms), and/or a QTc interval increase of >=60ms from the mean pre-dose QTc value at Visit 2 of Studies SP665, SP742 or SP768.
- Subject has aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >=3 times the upper limit of the normal range (ULN) with total bilirubin >=2 times ULN or transaminases (AST and/or ALT) >=5 times ULN.
- Subject has a clinically relevant medical condition that, in the opinion of the investigator, jeopardizes or compromises the subject's ability to participate in this trial.
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: SPM927Open-label treatment (two times per day) with film-coated tablets include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, and 600mg/day throughout individual study period. | Drug | 1 |
Primary outcome
Number of Subjects With Adverse Events (AEs) Reported Spontaneously by the Subject or Observed by the Investigator.
Time frame: Throughout the study up to a maximum study period of 2.8 years
Number of subjects with adverse events (AEs) reported spontaneously by the subject or observed by the investigator (serious and non-serious).
17 secondary outcomes
Change From Baseline in Average Daily Pain Score Using an 11-point Likert Scale (0-10).
Time frame: Baseline to end of entire treatment phase (maximum study period of 2.8 years).
Change From Baseline in Average Pain Score as Measured by a 100mm Visual Analogue Scale (VAS).
Time frame: Baseline to end of entire treatment phase (maximum study period of 2.8 years).
Patient's Global Impression of Change (PGIC) From Baseline in Pain.
Time frame: Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Intensity.
Time frame: Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sharpness
Time frame: Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Heat
Time frame: Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Dullness
Time frame: Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Cold
Time frame: Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sensitivity
Time frame: Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Itchiness
Time frame: Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Unpleasantness
Time frame: Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Deep Pain
Time frame: Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Surface Pain
Time frame: Baseline to Termination Visit
Change From Baseline in Average Pain Interference With Sleep (11-point Likert Scale)
Time frame: Baseline to end of entire treatment phase visit
Change From Baseline in Average Pain Interference With Activity (11-point Likert Scale)
Time frame: Baseline to end of entire treatment phase visit
Change From Baseline in Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS)
Time frame: Baseline to Termination Visit
Change From Baseline in Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS)
Time frame: Baseline to Termination Visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 18619874Shaibani A, Biton V, Rauck R, Koch B, Simpson J. Long-term oral lacosamide in painful diabetic neuropathy: a two-year open-label extension trial. Eur J Pain. 2009 May;13(5):458-63. doi: 10.1016/j.ejpain.2008.05.016. Epub 2008 Jul 10.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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 Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
84 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing lacosamide in people with Diabetic Neuropathy, run by UCB Pharma at 84 sites in United States.
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 3 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 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 84 sites in United States. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 5 Oct 2009). 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?
Number of Subjects With Adverse Events (AEs) Reported Spontaneously by the Subject or Observed by the Investigator. (time frame: Throughout the study up to a maximum study period of 2.8 years). 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 NCT00235443, which also lists 1 linked publication.
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 17 Jul 2018.