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

Pain Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01202227
• Other study ID #: A0081252
• Status: Completed
• Phase: Phase 3
• Start date: September 2010
• Est. completion date: March 2012

Study information

• Verified date: April 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Neuralgia
• Pain
• Spinal Cord Diseases
• Spinal Cord Injuries

Intervention

Drug:
• pregabalin
Pregabalin capsules taken twice a daily (150-600mg/day)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline, Weeks 4, 20, 36, 52, and 53
Primary	Number of Participants With Facial/Periorbital Edema	Number of participants who had facial or periorbital edema.	Baseline, Weeks 4, 20, 36, 52, and 53
Primary	Number of Participants With Generalized or Abdominal Edema	Number of participants who had generalized or abdominal edema.	Baseline, Weeks 4, 20, 36, 52, and 53
Primary	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.	Baseline, Weeks 4, 20, 36, 52, and 53
Primary	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.	Baseline, Weeks 4, 20, 36, 52, and 53
Primary	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.	Baseline, Weeks 4, 20, 36, 52, and 53
Primary	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.	Baseline, Weeks 4, 20, 36, 52, and 53
Primary	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.	Baseline, Weeks 4, 20, 36, 52, and 53
Primary	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.	Baseline, Weeks 4, 20, 36, 52, and 53
Primary	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).	53 weeks
Primary	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.	53 weeks
Primary	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.	Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52
Secondary	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.	Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52
Secondary	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.	Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52
Secondary	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.	Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52
Secondary	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.	Baseline, Week 52

External Links

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