NCT02957617终止2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Biogen
- 入组人数
- 302
- 试验地点
- 3
- 主要终点
- Number of Participants experiencing Adverse Events(AE) and Serious Adverse Events (SAEs)
研究概览
简要总结
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).
详细描述
This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen. This is an extension study to 1014802-203.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has completed Study 1014802-203 for its complete duration.
排除标准
- •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
研究组 & 干预措施
BIIB074
Experimental
BIIB074 orally twice daily
干预措施: BIIB074 (Drug)
结局指标
主要结局
Number of Participants experiencing Adverse Events(AE) and Serious Adverse Events (SAEs)
时间窗: Up to 395 Days
Safety surveillance
次要结局
- Change from Baseline at each visit in the weekly average of the daily neuropathic pain score(Baseline through Week 52)
- 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)(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)(Baseline to Week 52)
- Change from Baseline to Week 52 on the EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L) health index(Baseline to Week 52)
- 50% neuropathic pain reduction response(At Week 52)
- Change from Baseline to Week 52 in the weekly average of the daily pain score for low back pain(Baseline to Week 52)
- Number of Patient Global Impression of Change (PGIC) responder(At Week 52)
- Change from Baseline to Week 52 on the Oswestry Disability Index (ODI)(Baseline to Week 52)
- Change from Baseline to Week 52 in the Brief Pain Inventory (BPI)-Interference Index(Baseline to Week 52)
- Change from Baseline to Week 52 in Short Form 36 Questionnaire (SF-36)(Baseline to Week 52)
- 30% neuropathic pain reduction response(At Week 52)
- Change from Baseline to Week 52 in the BPI - Pain Index(Baseline to Week 52)
研究者
研究点 (3)
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