Study of Fampridine-SR Tablets in Multiple Sclerosis Patients
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- Responders Based Upon the Timed 25-Foot Walk [T25FW] [ Time Frame: Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77 ] [ Designated as safety issue: No ]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)
- Change in Lower Extremity Manual Muscle Test [LEMMT] [ Time Frame: Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77 ] [ Designated as safety issue: No ]Evaluator rated strength in hip flexors, knee flexors, knee extensors, and ankle dorsiflexors on the following scale: best value = 5.0 (normal muscle strength), worst value = 0.0 (absence of any voluntary contraction). A positive shift in LEMMT score shows improvement in strength. Change in LEMMT scores for the secondary efficacy measure was found by averaging the LEMMT scores on days 14, 28, 42, and 56 (double-blind treatment period) and subtracting the baseline LEMMT score.
|Study Start Date:||May 2007|
|Study Completion Date:||May 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
placebo (sugar pill)
Other Name: placebo
Active Comparator: Fampridine-SR
10 mg b.i.d.
Tablets, 10 mg, twice daily, 9 weeks
Other Name: 4-aminopyridine
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
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|Study Director:||Andrew Blight, PhD||Acorda Therapeutics|