Study of Fampridine-SR Tablets in Multiple Sclerosis Patients
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
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
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Patient with clinically defined multiple sclerosis
- All patients must be able to complete two trials of a timed 25 foot walk
Exclusion criteria
- Female patients who are either pregnant or breastfeeding.
Trial design
Primary purpose
Allocation
Interventional model
Masking
240 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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