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
- 204
- 试验地点
- 30
- 主要终点
- Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity
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 (Drug)
结局指标
主要结局
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 evaluates the functioning of two lower extremity muscle groups, the hamstring and quadriceps muscles, while in the supine position. The test measures extension of the right and left hamstring muscle and flexion of the right and left quadriceps muscle using the following 5-point grading scale: 1=no increased tone; 2=slight increase in tone, giving a "catch" when the affected part is moved in flexion or extension; 3=more marked increase in tone, but affected part is easily flexed; 4=considerable increase in tone, passive movement is difficult; 5=affected part is rigid in flexion and extension. The Ashworth Score was determined by adding all individual scores for each muscle group and dividing by four. Higher Ashworth Scores indicated greater spasticity.
Double-blind Change From Baseline in Mean Subject's Global Impression (SGI) Scores
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 SGI is a 7-unit ordinal scale used by the subject to evaluate the effects of study medication on his/her quality of life during the preceding week, with higher scores denoting greater satisfaction. A positive change score in SGI signifies improved outcome. The questionnaire consisted of one question (How do you feel about the effects of the investigational drug over the past 7 days?). The answer was based on a numerical rating scale where 1=terrible; 2=unhappy; 3=mostly dissatisfied; 4=neutral/mixed; 5=mostly satisfied; 6=pleased; 7=delighted.
次要结局
- Change From Baseline in Mean International Index of Erectile Function (IIEF) Score(Baseline (visit 1) average score obtained at day 1 and stable treatment period (visit 7) average score day 98)
- Adjusted Mean Change in Subject Bladder/Bowel Function Diary Scores(Baseline (visit 1) average score obtained at day 1 and double-blind treatment period (visits 4-7) average score days 28-98)
- Double-blind Change From Baseline in Mean Clinician's Global Impression (CGI) Scores(Baseline (visits 2,3) average of days 7-14 and double-blind treatment period (visits 4-7) average of days 28-98))
- Stable-dose Change From Baseline in Mean American Spinal Injury Association(ASIA) Total Motor Score(Baseline (visits 2,3) average score days 7,14 and stable-dose treatment period (visits 5-7) average score days 56-98)
- Change From Baseline in Mean Female Sexual Function Index (FSFI) Scores(Baseline (visit 1) average score obtained at day 1 and stable treatment period (visits 4-7) average score days 28-98)
- Adjusted Mean Change in Subject Bowel Function Diary Scores(Baseline (visit 1) average score obtained at day 1 and double-blind treatment period (visits 4-7) average score days 28-98)
- Double-blind Change From Baseline in Mean Spasm Frequency/Severity Scores(Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98)