EUCTR2015-004775-78-RO进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-GroupStudy to Evaluate the Efficacy and Safety of BIIB074 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 424
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 pain of a different type in the legs (e.g. due to arthritis) that may interfere with the assessment of neuropathic pain in the legs.
- •-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
- •- Unable to discontinue prior to Day 1 any prohibited concomitant monoamine oxidase inhibitors (MAOIs), potent CYP3A4 inducers or inhibitors, potent UGT inducers or inhibitors, including over the counter preparations, herbal remedies, vitamin, mineral supplements, food or drinks as detailed in 11.5.1.2
- •- Is pregnant or lactating (female subjects only).
- •- Male subject whose partner is pregnant
- •-Has used paracetamol/acetaminophen at a daily dose of equal to or more than 2.5g/day on 5 or more days during 7 consecutive days in the run in phase.- Other protocol-defined inclusion/exclusion criteria may apply.
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