Double-Blind, Placebo-Controlled, 21-Week, Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR in Subjects With Multiple Sclerosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 34
- 主要终点
- Timed Walk Responders (Patients Who Showed Consistent Improvement on the Timed-25 Foot Walk)
研究概览
简要总结
To assess the safety and efficacy of 10 milligram (mg) twice a day (b.i.d.) Fampridine-SR in patients diagnosed with multiple sclerosis (MS), in a double-blind, placebo-controlled, parallel group study.
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 subjects with MS.
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
- •Have a confirmed diagnosis of multiple sclerosis
- •Are able to walk with or without an assistive device
排除标准
- •Pregnancy, breastfeeding or females of childbearing potential not using adequate birth control
- •Participating in other investigational drug trials
- •A medical history or clinical findings that preclude entry into the study
- •A medication history that precludes entry into the study
- •Previously treated with 4-aminopyridine (4-AP)
研究组 & 干预措施
Placebo- sugar pill
Placebo control
干预措施: Placebo (Drug)
Fampridine-SR
10 milligram (mg) tablet b.i.d.
干预措施: Fampridine-SR (Drug)
结局指标
主要结局
Timed Walk Responders (Patients Who Showed Consistent Improvement on the Timed-25 Foot Walk)
时间窗: Days 14, 42, 70 and 98 of treatment, corresponding to the four on-drug visits during double-blind treatment period.
Patients who showed a faster walking speed for at least three of the four on-drug visits during the double-blind treatment period as compared to the maximum speed for any of the five off-drug visits.
次要结局
- Lower Extremity Manual Muscle Test; Ashworth Score for Spasticity(Days 14, 42, 70, 98)