跳至主要内容
临床试验/NCT00483652
NCT00483652已完成3 期

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

Acorda Therapeutics40 个研究点 分布在 2 个国家目标入组 240 人开始时间: 2007年5月最近更新:
适应症
干预措施
相关药物

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

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 Comparator

Placebo control

干预措施: Placebo (Drug)

Fampridine-SR

Active Comparator

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)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (40)

Loading locations...

相似试验