Double-Blind, Placebo-Controlled, 12-Week Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR in Subjects With Moderate to Severe Spasticity Resulting From Chronic, Incomplete Spinal Cord Injury
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 213
- 试验地点
- 45
- 主要终点
- Double-blind Change From Baseline in Subject's Global Impression (SGI) of Treatment
研究概览
简要总结
Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with spinal cord injury, some fibers may be destroyed at the site of injury, while others remain connected but do not work correctly to carry electrical impulses. As a result, subjects with an incomplete spinal cord injury may have spasticity which is muscle spasms or muscle stiffness that makes movement difficult. Fampridine-SR is an experimental drug that increases the ability of the nerve to conduct electrical impulses. This study will examine the effects of Fampridine-SR on moderate to severe lower-limb spasticity, as well as the effects on bodily functions such as bladder control, bowel function and sexual function. The study will also examine the possible risks of taking Fampridine-SR.
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
- Double (Participant, Investigator)
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
- •Incomplete traumatic Spinal Cord Injury (at least 18 months prior and stable for 6 months)
- •Moderate to severe lower-limb spasticity
- •Able to give informed consent and willing to comply with protocol
排除标准
- •Pregnancy
- •History of seizures
- •Existing or history of frequent Urinary Tract Infections
- •History of drug or alcohol abuse
- •Allergy to pyridine-containing substances
- •Received a botox injection 4 months prior to study
- •Received an investigational drug within 30 days
- •Previously treated with 4-aminopyridine (4-AP)
- •Not on stable medication dosing in 3 weeks prior to study
- •Abnormal ECG or laboratory value at screening
研究组 & 干预措施
fampridine-SR 50mg/day
干预措施: Fampridine-SR (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Double-blind Change From Baseline in Subject's Global Impression (SGI) of Treatment
时间窗: Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98
This questionnaire asked the patient to evaluate the effects of investigational drug on his/her quality of life during the preceding week using a 7-point scale (from 1=terrible to 7=delighted). A positive change score in SGI indicates improved outcome.
Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity
时间窗: Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98
The Ashworth Score is the average rating (based on a scale of 1 to 5) of four lower extremity muscle groups; left and right knee flexors and extensors (hamstrings and quadriceps muscles). A higher Ashworth Score indicates a greater degree of abnormal muscle tone (spasticity) and a negative change in score indicates improvement.
次要结局
未报告次要终点