EUCTR2015-004775-78-BE进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 504
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Key Inclusion Criteria:
- •- Men and women aged 18 to 75 years inclusive
- •- 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
- •Other protocol-defined inclusion/exclusion criteria may apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 104
排除标准
- •Key Exclusion Criteria:
- •- Has planned surgical intervention for PLSR within the duration of the study.
- •- 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
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究者
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