Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR (10 mg b.i.d. [Bis in Die, Twice Daily]) in Patients With Multiple Sclerosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 40
- 主要终点
- Responders Based Upon the Timed 25-Foot Walk [T25FW]
研究概览
简要总结
The purpose of the study is to show that individuals treated with Fampridine-SR tablets are significantly more likely to have consistent improvements in their walking than those treated with placebo tablets.
详细描述
Multiple sclerosis (MS) is a disorder of the body's immune system that affects the central nervous system (CNS). Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with MS, the fatty sheath that surrounds and insulates the nerve fibers (called "myelin") deteriorates, causing nerve impulses to be slowed or stopped. As a result, patients with MS may experience periods of muscle weakness and other symptoms such as numbness, loss of vision, loss of coordination, paralysis, spasticity, mental and physical fatigue and a decrease in the ability to think and/or remember. These periods of illness may come (exacerbations) and go (remissions). Fampridine-SR is an experimental drug that has been reported to possibly improve muscle strength and walking ability for some people with MS. This study will evaluate the effects and possible risks of taking Fampridine-SR in MS patients
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 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with clinically defined multiple sclerosis
- •All patients must be able to complete two trials of a timed 25 foot walk
排除标准
- •Female patients who are either pregnant or breastfeeding.
研究组 & 干预措施
Placebo
Placebo control
干预措施: Placebo (Drug)
Fampridine-SR
10 mg b.i.d.
干预措施: Fampridine-SR (Drug)
结局指标
主要结局
Responders Based Upon the Timed 25-Foot Walk [T25FW]
时间窗: Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77
A responder is a patient who showed faster walking speed for at least 3 visits out of a possible 4 during the double-blind period than the maximum value achieved in the 5 non-double-blind no-treatment visits (4 before the double-blind period and one after)
次要结局
- Change in Lower Extremity Manual Muscle Test [LEMMT](Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77)
