Extension Study to Evaluate the Long-Term Safety, Tolerability, and Maintenance of Effect of BIIB074

Study Overview
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Brief Summary
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The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB074 in participants with neuropathic Pain From Lumbosacral Radiculopathy (PLSR). A secondary objective is to investigate the maintenance of effect during long-term treatment with BIIB074 in participants with neuropathic PLSR. For all efficacy assessments, baseline will be prior to randomization into Study 1014802-203. Another secondary objective is to evaluate the impact of treatment with BIIB074 on quality of life (QoL).

Detailed Description
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This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen. This is an extension study to 1014802-203.

Official Title
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An Uncontrolled, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Maintenance of Effect of BIIB074 (Vixotrigine) in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy

Conditions
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Neuropathic Pain From Lumbosacral Radiculopathy

Intervention / Treatment
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* Drug: BIIB074


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Has completed Study 1014802-203 for its complete duration. Key Exclusion Criteria: Has met an exclusion criterion for the preceding double-blind Phase 2b study (Study 1014802-203). Had a protocol deviation regarding inclusion or exclusion criteria for the double-blind Phase 2b study (Study 1014802-203). Had a treatment-related AE or SAE that would pose an increased risk for continued treatment with BIIB074, or discontinued study treatment in the double-blind Phase 2b study (Study 1014802-203) due to an AE or SAE. Did not return for all study visits after discontinuing treatment in the double-blind phase of the Phase 2b study. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIIB074<br>BIIB074 orally twice daily | Drug: BIIB074<br>* Participants will receive an initial dose regimen of 350mg orally twice daily (BID), which may be reduced to 200mg based on tolerability for up to 12 months.<br>* Other names: CNV1014802;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants experiencing Adverse Events(AE) and Serious Adverse Events (SAEs) | Safety surveillance | Up to 395 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline to Week 52 in the weekly average of the daily neuropathic pain score on the Pain Intensity Numerical Rating Scale (PI-NRS) | Participants will be asked every evening to rate their overall neuropathic pain for the last 24-hour period. PI-NRS is an 11-point pain intensity numerical rating scale (PI-NRS), where 0=no pain and 10=worst possible pain. | Baseline to Week 52 | 
| 50% neuropathic pain reduction response | Response is defined as a ≥50% reduction in the weekly average of the daily neuropathic pain score from Baseline to Week 52. | At Week 52 | 
| 30% neuropathic pain reduction response | Response is defined as a ≥30% reduction in the weekly average of the daily neuropathic pain score from Baseline to week 52. | At Week 52 | 
| Change from Baseline at each visit in the weekly average of the daily neuropathic pain score | Participants will be asked every evening to rate their overall neuropathic pain for the last 24-hour period. | Baseline through Week 52 | 
| Change from Baseline to Week 52 in the weekly average of the daily pain score for low back pain | Participants will be asked every evening to rate their overall low back pain for the last 24-hour period. | Baseline to Week 52 | 
| Number of Patient Global Impression of Change (PGIC) responder | PGIC is a 7-point self-report scale depicting a participant's rating of overall improvement. Participants rate their change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. | At Week 52 | 
| Change from Baseline to Week 52 on the Oswestry Disability Index (ODI) | This is a 10-item questionnaire that evaluates how back (or leg) pain affects the ability to manage in everyday life. Each question is rated on a 5 point scale with higher scores indicating higher level of pain. | Baseline to Week 52 | 
| Change from Baseline to Week 52 in the weekly average of the daily sleep score as assessed by the Sleep Numerical Rating Scale (S-NRS) | Participants will be asked every morning to rate on the 11-point S-NRS how leg pain interfered with their sleep quality where 0=no pain and 10=worst possible pain. | Baseline to Week 52 | 
| Change from Baseline to Week 52 in the Brief Pain Inventory (BPI)-Interference Index | BPI Interference Index is an 11-point numeric rating scale (0 - no interference to 10 - interferes completely) to assess pain-related interference in 7 areas: general activity, mood, walking ability, normal work, including outside the home and housework, relations with other people, enjoyment of life and sleep. | Baseline to Week 52 | 
| Change from Baseline to Week 52 in the BPI - Pain Index | BPI- Pain Index for pain intensity, is used to assess potential pain quality descriptors that may describe participants' pain on a scale of 0 (no pain) to 10 (pain as bad as you can imagine). | Baseline to Week 52 | 
| Change from Baseline to Week 52 on the EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L) health index | The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. It is a health questionnaire that consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. | Baseline to Week 52 | 
| Change from Baseline to Week 52 in Short Form 36 Questionnaire (SF-36) | SF-36 is a self-administered, generic health status questionnaire consisting of 36 questions that measure 8 health concepts: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems and mental health. | Baseline to Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuropathic Pain From Lumbosacral Radiculopathy