Spinal Cord DiseasesPhase 3NCT01202227

An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain

A Phase 3 study testing pregabalin in people with Spinal Cord Diseases and Spinal Cord Injuries, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 26 sites in Japan.

Completed

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

Official record

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Trial summary

The purpose of this study is to assess the safety of the long-term use of pregabalin at doses up to 600 mg/day in patients with central neuropathic pain (post spinal cord injury pain, post stroke pain, and multiple sclerosis pain). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Spinal Cord Diseases, Spinal Cord Injuries, Neuralgia
What is being tested?: pregabalin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 104 participants
Where: 26 sitesJapan
Study dates: Sep 2010to Mar 2012
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

Inclusion criteria for subjects to be shifted from Study A0081107
Subjects who completed the 18-week study period in Study A0081107 conducted for chronic neuropathic pain after spinal cord injury;
Subjects who completed assessments of all efficacy endpoints until the end of the treatment phase of the preceding Study A0081107 (V7);
Inclusion criteria for subjects to be new participants in this study
Subjects with central neuropathic pain after stroke or multiple sclerosis;
At least 6 months have passed after the onset of central neuropathic pain;
Pain VAS at least 40mm in Visit 1 and Visit 2;

Who cannot join

Creatinine clearance < 60 mL/min;
Platelet count < 100 × 103/mm3 ; White blood cell (WBC) count < 2500 / mm3; Neutrophil count < 1500/ mm3;
Subjects who are expected to require surgery during the trial;

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

Japan26 sites

Nakamura Hospital
Beppu, Oita Prefecture
Hokkaido Chuo Rosai Hospital Sekison Center
Bibai, Hokkaido
Juntendo University Hospital
Bunkyo-ku, Tokyo
Go neurosurgical clinic
Chikushi-gun, Fukuoka
Senboku Kumiai General Hospital
Daisen, Akita
Brain Attack Center Ota Memorial Hospital
Fukuyama, Hiroshima
Hakodate Central General Hospital
Hakodate, Hokkaido
General Hanamaki Hospital
Hanamaki, Iwate
Okitama Public General Hospital
Higashiokitama-gun, Yamagata
Spinal Injuries Center
Iizuka, Fukuoka
Kamitsuga General Hospital
Kanuma, Tochigi
National Hospital Organization Niigata National Hospital
Kashiwazaki, Niigata
Uchida Rehabilitation Orthopedic Clinic
Kawasaki, Kanagawa
Kumamoto Rehabilitation Hospital
Kikuchi-gun, Kumamoto
Kitasato University Kitasato Institute Medical Center Hospital
Kitamoto, Saitama
Kobe Tokushukai Hospital
Kobe, Hyōgo
Jukoukai hospital
Koto-ku, Tokyo
Aida Kinen Rehabilitation Hospital
Moriya, Ibaraki
National Hospital Organization, Murayama Medical Center
Musashimurayama-shi, Tokyo
Chubu Rosai Hospital
Nagoya, Aichi-ken
Kimura Clinic
Nagoya, Aichi-ken
Nagoya Kyoritsu Clinic
Nagoya, Aichi-ken
Kohnan Hospital
Sendai, Miyagi
Sendai Pain Clinic
Sendai, Miyagi
Tokushima University Hospital
Tokushima
National Hospital Organization Yamagata Hospital
Yamagata

Other trials in Japan

About this study

Official title: An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain (Post Spinal Cord Injury Pain, Post Stroke Pain, And Multiple Sclerosis Pain)

Conditions: Spinal Cord Diseases, Spinal Cord Injuries, Neuralgia, Pain
Being tested: pregabalin
Keywords: Central Nervous System Diseases, Therapeutic Uses, Wounds and Injuries, Trauma, Nervous System, pregabalin
Medical subject headings: Spinal Cord Diseases, Spinal Cord Injuries, Neuralgia, Pain, Central Nervous System Diseases, Wounds and Injuries, Neurologic Manifestations

What participants receive

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

pregabalinDrug
Pregabalin capsules taken twice a daily (150-600mg/day)

Study groups in NCT01202227
Study group	Role	What they receive
Pregabalin	Experimental	Flexible dosing in 4 weeks followed by 48 weeks maintenance and one week taper period Receives: Drug: pregabalin

What is being measured

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

Number of Participants With Peripheral Edema
Number of participants who had peripheral edema in lower extremities. Edema was categorized as follows: trace, pitting 1 (lower leg), 2 (lower leg to knee), and 3 (above knee and /or presacral edema).
Measured: Baseline, Weeks 4, 20, 36, 52, and 53
Number of Participants With Facial/Periorbital Edema
Number of participants who had facial or periorbital edema.
Measured: Baseline, Weeks 4, 20, 36, 52, and 53
Number of Participants With Generalized or Abdominal Edema
Number of participants who had generalized or abdominal edema.
Measured: Baseline, Weeks 4, 20, 36, 52, and 53
Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT)
DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.
Measured: Baseline, Weeks 4, 20, 36, 52, and 53
Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT)
DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.
Measured: Baseline, Weeks 4, 20, 36, 52, and 53
Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT)
DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.
Measured: Baseline, Weeks 4, 20, 36, 52, and 53
Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT)
DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.
Measured: Baseline, Weeks 4, 20, 36, 52, and 53
Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT)
DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.
Measured: Baseline, Weeks 4, 20, 36, 52, and 53
Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT)
DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.
Measured: Baseline, Weeks 4, 20, 36, 52, and 53
Number of Participants With Visual Field Deteriorated
Number of participants who had normal visual field at baseline and showed abnormal result after the study treatment, assessed by confrontational visual field test (neurological examination).
Measured: 53 weeks
Number of Participants With Deterioration in Neurological Examination Findings
Worsening of the condition relative to baseline was reported as deteriorated. Assessment categories are as follows: normal or abnormal for Cranial Nerve Function, Mental State, and Coordination; normal, mild, moderate, or severe ataxia for Gait; none/absent, normal, or hyper-reflexic for Deep Tendon Reflexes; absent or present for Abnormal Reflexes; normal, mild, moderate, or severe weakness for Muscle Strength; slight, more marked, or considerable increase, or affected parts rigid in flexion or extension for Muscle Tone; absent or present for Sensory Function.
Measured: 53 weeks
Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS)
The Sheehan-STS is an 8-item prospective rating scale that tracks treatment-emergent suicidal ideation and behaviors. Participants who reported a score of ≥1 (5-point scale ranging from 0: not at all to 4: extremely) for Item 2, 3, 4 or 5 of the Sheehan-STS prognostic scale is considered to have suicidal ideation as the scores are mapped to Category 4 (suicide ideation) of the Columbia Classification Algorithm of Suicide Assessment.
Measured: Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52

Secondary outcomes (4)

Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Total Scores
The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.
Range: 0 to 45 for total score. Change = observation mean minus baseline mean. Negative change indicated improvement.
Measured: Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Sensory Scores
The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.
Range: 0 to 33 for sensory score. Change = observation mean minus baseline mean. Negative change indicated improvement.
Measured: Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Affective Scores
The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.
Range: 0 to 12 for affective score. Change = observation mean minus baseline mean. Negative change indicated improvement.
Measured: Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52
Change From Baseline in the Modified Brief Pain Inventory (10 Item) (mBPI-10)Total Scores at Last Evaluation Score
The mBPI-10 is a self administered questionnaire that assesses pain interference with functional activities over the past week. These items are measured on an 11 point scale, ranging from "does not interfere" (0) to "completely interferes" (10). A composite score, the Pain Interference Index, will be calculated by averaging the 10 items that comprise the scale.
Change = observation mean at Week 52 minus baseline mean.
Measured: Baseline, Week 52

Timeline

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

Sep 2010Mar 2012

First posted15 Sep 2010 (estimated)
Study startSep 2010
Primary completionMar 2012
Study completionMar 2012

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 (2)Papers the sponsor has linked to this study.
Other trials for Spinal Cord DiseasesStudies 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 104 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01202227
Sponsor's protocol ID: A0081252
Status last verified: Apr 2013
First submitted: 31 Aug 2010
Last updated: 28 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Ogawa S, Arakawa A, Hayakawa K, Yoshiyama T. Pregabalin for Neuropathic Pain: Why Benefits Could Be Expected for Multiple Pain Conditions. Clin Drug Investig. 2016 Nov;36(11):877-888. doi: 10.1007/s40261-016-0423-x.
PubMed 27448285
Onouchi K, Koga H, Yokoyama K, Yoshiyama T. An open-label, long-term study examining the safety and tolerability of pregabalin in Japanese patients with central neuropathic pain. J Pain Res. 2014 Jul 28;7:439-47. doi: 10.2147/JPR.S63028. eCollection 2014.
PubMed 25114584

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?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain (Post Spinal Cord Injury Pain, Post Stroke Pain, And Multiple Sclerosis Pain)
ClinicalTrials.gov ID: NCT01202227
Acronym / sponsor ID: A0081252
Conditions: Spinal Cord Diseases, Spinal Cord Injuries, Neuralgia, Pain
Keywords: Central Nervous System Diseases, Therapeutic Uses, Wounds and Injuries, Trauma, Nervous System, pregabalin
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 104 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Sep 2010
Primary completion: Mar 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 15 Sep 2010 (estimated)
Results: Posted 17 May 2013

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Pregabalin	Experimental	Drug: pregabalinFlexible dosing in 4 weeks followed by 48 weeks maintenance and one week taper period

Who may qualify

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

Key inclusion criteria (7 listed)

Inclusion criteria for subjects to be shifted from Study A0081107
Subjects who completed the 18-week study period in Study A0081107 conducted for chronic neuropathic pain after spinal cord injury;
Subjects who completed assessments of all efficacy endpoints until the end of the treatment phase of the preceding Study A0081107 (V7);
Inclusion criteria for subjects to be new participants in this study
Subjects with central neuropathic pain after stroke or multiple sclerosis;

Key exclusion criteria (3 listed)

Creatinine clearance < 60 mL/min;
Platelet count < 100 × 103/mm3 ; White blood cell (WBC) count < 2500 / mm3; Neutrophil count < 1500/ mm3;
Subjects who are expected to require surgery during the 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
pregabalinPregabalin capsules taken twice a daily (150-600mg/day)	Drug	Pregabalin

Primary outcome

Number of Participants With Peripheral Edema
Time frame: Baseline, Weeks 4, 20, 36, 52, and 53
Number of participants who had peripheral edema in lower extremities. Edema was categorized as follows: trace, pitting 1 (lower leg), 2 (lower leg to knee), and 3 (above knee and /or presacral edema).
Number of Participants With Facial/Periorbital Edema
Time frame: Baseline, Weeks 4, 20, 36, 52, and 53
Number of participants who had facial or periorbital edema.
Number of Participants With Generalized or Abdominal Edema
Time frame: Baseline, Weeks 4, 20, 36, 52, and 53
Number of participants who had generalized or abdominal edema.
Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT)
Time frame: Baseline, Weeks 4, 20, 36, 52, and 53
DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.
Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT)
Time frame: Baseline, Weeks 4, 20, 36, 52, and 53
DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.
Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT)
Time frame: Baseline, Weeks 4, 20, 36, 52, and 53
DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.
Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT)
Time frame: Baseline, Weeks 4, 20, 36, 52, and 53
DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.
Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT)
Time frame: Baseline, Weeks 4, 20, 36, 52, and 53
DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.
Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT)
Time frame: Baseline, Weeks 4, 20, 36, 52, and 53
DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.
Number of Participants With Visual Field Deteriorated
Time frame: 53 weeks
Number of participants who had normal visual field at baseline and showed abnormal result after the study treatment, assessed by confrontational visual field test (neurological examination).
Number of Participants With Deterioration in Neurological Examination Findings
Time frame: 53 weeks
Worsening of the condition relative to baseline was reported as deteriorated. Assessment categories are as follows: normal or abnormal for Cranial Nerve Function, Mental State, and Coordination; normal, mild, moderate, or severe ataxia for Gait; none/absent, normal, or hyper-reflexic for Deep Tendon Reflexes; absent or present for Abnormal Reflexes; normal, mild, moderate, or severe weakness for Muscle Strength; slight, more marked, or considerable increase, or affected parts rigid in flexion or extension for Muscle Tone; absent or present for Sensory Function.
Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS)
Time frame: Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52
The Sheehan-STS is an 8-item prospective rating scale that tracks treatment-emergent suicidal ideation and behaviors. Participants who reported a score of ≥1 (5-point scale ranging from 0: not at all to 4: extremely) for Item 2, 3, 4 or 5 of the Sheehan-STS prognostic scale is considered to have suicidal ideation as the scores are mapped to Category 4 (suicide ideation) of the Columbia Classification Algorithm of Suicide Assessment.

4 secondary outcomes

Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Total Scores
Time frame: Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Sensory Scores
Time frame: Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Affective Scores
Time frame: Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52
Change From Baseline in the Modified Brief Pain Inventory (10 Item) (mBPI-10)Total Scores at Last Evaluation Score
Time frame: Baseline, Week 52

Results and safety

Results posted to the registry on 17 May 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pregabalin	103	84

Primary outcome: Number of Participants With Peripheral Edema

Time frame: Baseline, Weeks 4, 20, 36, 52, and 53. Number. Unit: Participants

Measure	Pregabalin n = 103
Trace at Baseline (n=103)	5
Pitting +1 at Baseline (n=103)	9
Pitting +2 at Baseline (n=103)	2
Pitting +3 at Baseline (n=103)	0
Trace at Week 4 (n=101)	8
Pitting +1 at Week 4 (n=101)	8
Pitting +2 at Week 4 (n=101)	4
Pitting +3 at Week 4 (n=101)	1

Population analysed: The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.

Primary outcome: Number of Participants With Facial/Periorbital Edema

Time frame: Baseline, Weeks 4, 20, 36, 52, and 53. Number. Unit: Participants

Measure	Pregabalin n = 103
Baseline (n=103)	0
Week 4 (n=101)	0
Week 20 (n=93)	0
Week 36 (n=90)	0
Week 52/early termination (n=100)	1
Week 53/early termination (n=78)	0

Population analysed: The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.

Primary outcome: Number of Participants With Generalized or Abdominal Edema

Time frame: Baseline, Weeks 4, 20, 36, 52, and 53. Number. Unit: Participants

Measure	Pregabalin n = 103
Baseline (n=103)	0
Week 4 (n=101)	0
Week 20 (n=93)	0
Week 36 (n=90)	0
Week 52/early termination (n=100)	1
Week 53/early termination (n=78)	0

Population analysed: The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.

Primary outcome: Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT)

Time frame: Baseline, Weeks 4, 20, 36, 52, and 53. Number. Unit: Participants

Measure	Pregabalin n = 103
Mild at Baseline (n=103)	2
Moderate at Baseline (n=103)	3
Severe at Baseline (n=103)	1
Mild at Week 4 (n=101)	5
Moderate at Week 4 (n=101)	1
Severe at Week 4 (n=101)	0
Mild at Week 20 (n=93)	3
Moderate at Week 20 (n=93)	0

Population analysed: The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 53 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pregabalin	19 of 103 (18.4%)	91 of 103 (88.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27448285Ogawa S, Arakawa A, Hayakawa K, Yoshiyama T. Pregabalin for Neuropathic Pain: Why Benefits Could Be Expected for Multiple Pain Conditions. Clin Drug Investig. 2016 Nov;36(11):877-888. doi: 10.1007/s40261-016-0423-x.
Derived from this study: PubMed 25114584Onouchi K, Koga H, Yokoyama K, Yoshiyama T. An open-label, long-term study examining the safety and tolerability of pregabalin in Japanese patients with central neuropathic pain. J Pain Res. 2014 Jul 28;7:439-47. doi: 10.2147/JPR.S63028. eCollection 2014.
To obtain contact information for a study center near you, click here.Link 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.

Pfizer CT.gov Call Center study director

Pfizer

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pregabalin in people with Spinal Cord Diseases and Spinal Cord Injuries, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 26 sites in Japan.

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 7 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 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Japan. 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 17 May 2013). 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 Participants With Peripheral Edema (time frame: Baseline, Weeks 4, 20, 36, 52, and 53). The study lists 12 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 NCT01202227, which also lists 2 linked publications.

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 28 Jan 2021.