Safety and Efficacy of Oral Fampridine-SR for the Treatment of Spasticity Resulting From Spinal Cord Injury
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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.
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
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Resource links provided by the National Library of Medicine
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 ]
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 ]
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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