A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients With Multiple Sclerosis.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 405
- 试验地点
- 2
- 主要终点
- Responder criterion based on consistency of improved response in walking speed on the Timed 25-Foot Walk (T25-FWT)
研究概览
简要总结
The primary objective is to assess the activity of nerispirdine in improving the ability to walk, in patients with multiple sclerosis (MS).
Secondary objectives:
- To assess other measures of walking ability, tiredness, and lower limb muscular strength, spasticity, clinical assessment by subject and clinical assessment of change by the Study Investigator
- To assess the safety and tolerance of nerispirdine
- To evaluate the pharmacokinetics (PK) parameters of nerispirdine
详细描述
Total duration per patient is approximately 19 weeks in total, comprising a 3-week screening period inclusive of a 2-week placebo run-in period, a 14-week treatment period, and a 2-week placebo run-out (follow-up) period
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically definite MS (according to McDonald criteria),
排除标准
- •Multiple sclerosis exacerbation or clinical relapse within 6-month prior to the screening visit.
- •Subject who is not able to complete two trials of a timed 25 foot walk, with or without an assisted device,
- •Patients without valid V1, V2, and V4 T25-FW measurements are not eligible for randomization.
- •Female patients who are either pregnant or breastfeeding.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Nerispirdine 50mg
Nerispirdine 50mg once daily for 14 weeks
干预措施: Nerispirdine (Drug)
Placebo
Placebo for Nerispirdine once daily for 14 weeks
干预措施: placebo (Drug)
Nerispirdine 200mg
Nerispirdine 200mg once daily for 14 weeks
干预措施: Nerispirdine (Drug)
Nerispirdine 100mg
Nerispirdine 100mg once daily for 14 weeks
干预措施: Nerispirdine (Drug)
结局指标
主要结局
Responder criterion based on consistency of improved response in walking speed on the Timed 25-Foot Walk (T25-FWT)
时间窗: 14 weeks
次要结局
- Change from baseline to endpoint in the 12-item MS Walking Scale (MSWS-12)(14 weeks)