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

Phase 3

Completed

Conditions: Spinal Cord Injuries
Spinal Cord Diseases
Neuralgia
Pain

Interventions: Drug: pregabalin

Registration Number: NCT01202227

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

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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 104

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;

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pregabalin	pregabalin	Flexible dosing in 4 weeks followed by 48 weeks maintenance and one week taper period

Primary Outcome Measures

Name	Time	Method
Number of Participants With Peripheral Edema	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 Pitting Edema Related to Deep Vein Thrombosis (DVT)	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	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 Facial/Periorbital Edema	Baseline, Weeks 4, 20, 36, 52, and 53	Number of participants who had facial or periorbital edema.
Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT)	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 Generalized or Abdominal Edema	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)	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)	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)	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)	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 Deterioration in Neurological Examination Findings	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)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (26): Sendai Pain Clinic
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Sendai-city, Miyagi, Japan
Kohnan Hospital
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Sendai, Miyagi, Japan
Kobe Tokushukai Hospital
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Kobe, Hyogo, Japan
General Hanamaki Hospital
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Hanamaki, Iwate, Japan
National Hospital Organization Niigata National Hospital
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Kashiwazaki, Niigata, Japan
Nakamura Hospital
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Beppu, Oita, Japan
Kumamoto Rehabilitation Hospital
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Kikuchi-gun, Kumamoto, Japan
Kitasato University Kitasato Institute Medical Center Hospital
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Kitamoto, Saitama, Japan
Kamitsuga General Hospital
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Kanuma, Tochigi, Japan
Tokushima University Hospital
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Tokushima, Japan
Okitama Public General Hospital
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Higashiokitama-gun, Yamagata, Japan
National Hospital Organization Yamagata Hospital
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Yamagata, Japan
Jukoukai hospital
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Koto-ku, Tokyo, Japan
National Hospital Organization, Murayama Medical Center
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Musashimurayama-shi, Tokyo, Japan
Juntendo University Hospital
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Bunkyo-ku, Tokyo, Japan
Chubu Rosai Hospital
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Nagoya, Aichi, Japan
Kimura Clinic
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Nagoya, Aichi, Japan
Go neurosurgical clinic
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Chikushi-gun, Fukuoka, Japan
Senboku Kumiai General Hospital
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Daisen, Akita, Japan
Hokkaido Chuo Rosai Hospital Sekison Center
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Bibai, Hokkaido, Japan
Brain Attack Center Ota Memorial Hospital
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Fukuyama, Hiroshima, Japan
Uchida Rehabilitation Orthopedic Clinic
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Kawasaki, Kanagawa, Japan
Spinal Injuries Center
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Iizuka, Fukuoka, Japan
Nagoya Kyoritsu Clinic
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Nagoya, Aichi, Japan
Hakodate Central General Hospital
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Hakodate, Hokkaido, Japan
Aida Kinen Rehabilitation Hospital
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Moriya, Ibaraki, Japan