A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of BIIB074 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 502
- 试验地点
- 2
- 主要终点
- Change from Baseline to Week 14 in the weekly average of the daily neuropathic pain score on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS)
研究概览
简要总结
The primary objective of the study is to evaluate the efficacy of two dose regimens of BIIB074 on neuropathic pain in participants with pain from lumbosacral radiculopathy (PLSR). Secondary objectives are to evaluate the efficacy of 2 dose regimens of BIIB074 on additional neuropathic pain measures and assessments of low back pain, disability, and quality of life; To investigate the safety and tolerability of 2 dose regimens of BIIB074 and To characterize the pharmacokinetics (PK) of BIIB074 in this population.
详细描述
This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 body weight ≥50 kg for men and ≥45 kg for women
- •Must have diagnosis of neuropathic PLSR
- •Has duration of neuropathic (leg) pain of at least 6 months before Screening
- •Has an intensity of ≥4 and ≤9 on the Numerical Rating Scale based on a paper-based question at Screening and on Day 1 that asks for the average pain intensity of neuropathic (leg) pain due to PLSR over the last week
排除标准
- •Has planned surgical intervention for PLSR within the duration of the study. (Subjects with persistent radicular pain after prior surgery are eligible.)
- •Has a history of peripheral neuropathy (e.g., due to diabetes, alcohol consumption, other causes, or idiopathic) or evidence of peripheral neuropathy upon neurological examination
- •Has a history or risk of seizures or a history of epilepsy, clinically significant head injury, or related neurological disorders
- •NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
BIIB074 high dose
Administered twice daily (BID)
干预措施: BIIB074 (Drug)
BIIB074 low dose
Administered BID
干预措施: BIIB074 (Drug)
Placebo
Placebo administered BID
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline to Week 14 in the weekly average of the daily neuropathic pain score on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS)
时间窗: Week 14
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=pain as bad as you can imagine.
次要结局
- 50% neuropathic daily pain reduction response(At Week 14)
- 30% neuropathic daily pain reduction response(At Week 14)
- Change from Baseline to Week 14 in the weekly average of the daily neuropathic pain score at each visit(Week 14)
- Change from Baseline to Week 14 in weekly average of the daily pain score for low back pain(Week 14)
- Number of Patient Global Impression of Change (PGIC) responders(At Week 14)
- Change from Baseline to Week 14 on the Oswestry Disability Index(Week 14)
- Change from Baseline to Week 14 in the weekly average of daily sleep score as assessed by the Sleep Numerical Rating Scale (S-NRS)(Week 14)
- Change from Baseline to Week 14 in the Brief Pain Inventory (BPI)- Interference index(Week 14)
- Change from Baseline to Week 14 in the BPI-Pain index(Week 14)
- Change from Baseline to Week 14 on the EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L) health index(Week 14)
- Change from Baseline to Week 14 in Short Form 36 Questionnaire (SF-36)(Week 14)
- Amount of rescue medication used per day(Day 1 to Week 15)
- Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to Week 15)
- Number of participants with clinically significant vital sign abnormalities(Up to Week 15)
- Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities(Up to Week 15)
- Number of participants with clinically significant laboratory assessment abnormalities(Up to Week 15)
- Safety and Tolerability as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)(Up to Week 15)
- Area under the concentration-time curve over the dosing period (AUCtau) at steady state(30 min prior to dosing up to 8 hours post dose)
- Maximum concentration (Cmax)(30 min prior to dosing up to 8 hours post dose)