Safety and Efficacy of Oral Fampridine-SR for the Treatment of Spasticity Resulting From Spinal Cord Injury
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.
Spinal Cord Injury
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||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|
- Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity [ Time Frame: Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98 ] [ Designated as safety issue: No ]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.
- Double-blind Change From Baseline in Subject's Global Impression (SGI) of Treatment [ Time Frame: Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98 ] [ Designated as safety issue: No ]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.
|Study Start Date:||July 2002|
|Study Completion Date:||May 2004|
|Primary Completion Date:||February 2004 (Final data collection date for primary outcome measure)|
|Active Comparator: fampridine-SR 50mg/day||
25mg bid (twice daily)
|Placebo Comparator: Placebo||
Please refer to this study by its ClinicalTrials.gov identifier: NCT00041717
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|Study Director:||Andrew Blight||Acorda Therapeutics|