Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Acorda Therapeutics |
---|---|
Information provided by: | Acorda Therapeutics |
ClinicalTrials.gov Identifier: | NCT00127530 |
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 subjects with MS.
Condition | Intervention | Phase |
---|---|---|
Multiple Sclerosis |
Drug: Fampridine-SR (4-aminopyridine, 4-AP) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Double-Blind, Placebo-Controlled, 21-Week, Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR in Subjects With Multiple Sclerosis |
Enrollment: | 301 |
Study Start Date: | May 2005 |
Study Completion Date: | September 2006 |
Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator
Placebo control
|
Drug: Fampridine-SR (4-aminopyridine, 4-AP)
Tablets, 10 mg, twice daily, 14 weeks
|
2: Experimental
10 mg b.i.d.
|
Drug: Fampridine-SR (4-aminopyridine, 4-AP)
Tablets, 10 mg, twice daily, 14 weeks
|
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Acorda Therapeutics ( Andrew Blight/Chief Scientific Officer ) |
Study ID Numbers: | MS-F203 |
Study First Received: | August 4, 2005 |
Last Updated: | December 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00127530 |
Health Authority: | United States: Food and Drug Administration |
Walking Ability |
Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases Demyelinating Autoimmune Diseases, CNS |
4-Aminopyridine Demyelinating diseases Sclerosis Autoimmune Diseases of the Nervous System |
Membrane Transport Modulators Pathologic Processes Molecular Mechanisms of Pharmacological Action Immune System Diseases Therapeutic Uses |
Nervous System Diseases Potassium Channel Blockers Cardiovascular Agents Pharmacologic Actions |