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

Primary Purpose

Spinal Cord Diseases, Spinal Cord Injuries, Neuralgia

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
pregabalin
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Diseases focused on measuring Central Nervous System Diseases, Therapeutic Uses, Wounds and Injuries, Trauma, Nervous System, pregabalin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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;

Exclusion Criteria:

  • 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;

Sites / Locations

  • Chubu Rosai Hospital
  • Kimura Clinic
  • Nagoya Kyoritsu Clinic
  • Senboku Kumiai General Hospital
  • Go neurosurgical clinic
  • Spinal Injuries Center
  • Brain Attack Center Ota Memorial Hospital
  • Hokkaido Chuo Rosai Hospital Sekison Center
  • Hakodate Central General Hospital
  • Kobe Tokushukai Hospital
  • Aida Kinen Rehabilitation Hospital
  • General Hanamaki Hospital
  • Uchida Rehabilitation Orthopedic Clinic
  • Kumamoto Rehabilitation Hospital
  • Sendai Pain Clinic
  • Kohnan Hospital
  • National Hospital Organization Niigata National Hospital
  • Nakamura Hospital
  • Kitasato University Kitasato Institute Medical Center Hospital
  • Kamitsuga General Hospital
  • Juntendo University Hospital
  • Jukoukai hospital
  • National Hospital Organization, Murayama Medical Center
  • Okitama Public General Hospital
  • Tokushima University Hospital
  • National Hospital Organization Yamagata Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pregabalin

Arm Description

Flexible dosing in 4 weeks followed by 48 weeks maintenance and one week taper period

Outcomes

Primary Outcome Measures

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).
Number of Participants With Facial/Periorbital Edema
Number of participants who had facial or periorbital edema.
Number of Participants With Generalized or Abdominal Edema
Number of participants who had generalized or abdominal edema.
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.
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.
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.
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.
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.
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.
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).
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
August 31, 2010
Last Updated
January 26, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01202227
Brief Title
An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Diseases, Spinal Cord Injuries, Neuralgia, Pain
Keywords
Central Nervous System Diseases, Therapeutic Uses, Wounds and Injuries, Trauma, Nervous System, pregabalin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pregabalin
Arm Type
Experimental
Arm Description
Flexible dosing in 4 weeks followed by 48 weeks maintenance and one week taper period
Intervention Type
Drug
Intervention Name(s)
pregabalin
Intervention Description
Pregabalin capsules taken twice a daily (150-600mg/day)
Primary Outcome Measure Information:
Title
Number of Participants With Peripheral Edema
Description
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).
Time Frame
Baseline, Weeks 4, 20, 36, 52, and 53
Title
Number of Participants With Facial/Periorbital Edema
Description
Number of participants who had facial or periorbital edema.
Time Frame
Baseline, Weeks 4, 20, 36, 52, and 53
Title
Number of Participants With Generalized or Abdominal Edema
Description
Number of participants who had generalized or abdominal edema.
Time Frame
Baseline, Weeks 4, 20, 36, 52, and 53
Title
Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT)
Description
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.
Time Frame
Baseline, Weeks 4, 20, 36, 52, and 53
Title
Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT)
Description
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.
Time Frame
Baseline, Weeks 4, 20, 36, 52, and 53
Title
Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT)
Description
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.
Time Frame
Baseline, Weeks 4, 20, 36, 52, and 53
Title
Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT)
Description
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.
Time Frame
Baseline, Weeks 4, 20, 36, 52, and 53
Title
Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT)
Description
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.
Time Frame
Baseline, Weeks 4, 20, 36, 52, and 53
Title
Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT)
Description
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.
Time Frame
Baseline, Weeks 4, 20, 36, 52, and 53
Title
Number of Participants With Visual Field Deteriorated
Description
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).
Time Frame
53 weeks
Title
Number of Participants With Deterioration in Neurological Examination Findings
Description
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.
Time Frame
53 weeks
Title
Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS)
Description
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.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52
Secondary Outcome Measure Information:
Title
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Total Scores
Description
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.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52
Title
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Sensory Scores
Description
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.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52
Title
Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Affective Scores
Description
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.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52
Title
Change From Baseline in the Modified Brief Pain Inventory (10 Item) (mBPI-10)Total Scores at Last Evaluation Score
Description
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.
Time Frame
Baseline, Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; Exclusion Criteria: 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Chubu Rosai Hospital
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Kimura Clinic
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Nagoya Kyoritsu Clinic
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Senboku Kumiai General Hospital
City
Daisen
State/Province
Akita
Country
Japan
Facility Name
Go neurosurgical clinic
City
Chikushi-gun
State/Province
Fukuoka
Country
Japan
Facility Name
Spinal Injuries Center
City
Iizuka
State/Province
Fukuoka
Country
Japan
Facility Name
Brain Attack Center Ota Memorial Hospital
City
Fukuyama
State/Province
Hiroshima
Country
Japan
Facility Name
Hokkaido Chuo Rosai Hospital Sekison Center
City
Bibai
State/Province
Hokkaido
Country
Japan
Facility Name
Hakodate Central General Hospital
City
Hakodate
State/Province
Hokkaido
Country
Japan
Facility Name
Kobe Tokushukai Hospital
City
Kobe
State/Province
Hyogo
Country
Japan
Facility Name
Aida Kinen Rehabilitation Hospital
City
Moriya
State/Province
Ibaraki
Country
Japan
Facility Name
General Hanamaki Hospital
City
Hanamaki
State/Province
Iwate
Country
Japan
Facility Name
Uchida Rehabilitation Orthopedic Clinic
City
Kawasaki
State/Province
Kanagawa
Country
Japan
Facility Name
Kumamoto Rehabilitation Hospital
City
Kikuchi-gun
State/Province
Kumamoto
Country
Japan
Facility Name
Sendai Pain Clinic
City
Sendai-city
State/Province
Miyagi
Country
Japan
Facility Name
Kohnan Hospital
City
Sendai
State/Province
Miyagi
Country
Japan
Facility Name
National Hospital Organization Niigata National Hospital
City
Kashiwazaki
State/Province
Niigata
Country
Japan
Facility Name
Nakamura Hospital
City
Beppu
State/Province
Oita
Country
Japan
Facility Name
Kitasato University Kitasato Institute Medical Center Hospital
City
Kitamoto
State/Province
Saitama
Country
Japan
Facility Name
Kamitsuga General Hospital
City
Kanuma
State/Province
Tochigi
Country
Japan
Facility Name
Juntendo University Hospital
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Jukoukai hospital
City
Koto-ku
State/Province
Tokyo
Country
Japan
Facility Name
National Hospital Organization, Murayama Medical Center
City
Musashimurayama-shi
State/Province
Tokyo
Country
Japan
Facility Name
Okitama Public General Hospital
City
Higashiokitama-gun
State/Province
Yamagata
Country
Japan
Facility Name
Tokushima University Hospital
City
Tokushima
Country
Japan
Facility Name
National Hospital Organization Yamagata Hospital
City
Yamagata
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25114584
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081252&StudyName=An%20Open-Label%20Long-Term%20Study%20Of%20Pregabalin%20For%20The%20Treatment%20Of%20Central%20Neuropathic%20Pain
Description
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An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain

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