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| Sponsor: | Acorda Therapeutics |
|---|---|
| Information provided by (Responsible Party): | Acorda Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00648908 |
Purpose
The purpose of this study is to evaluate the safety, tolerability and activity of Fampridine-SR when administered for up to 36 additional months in subjects who previously participated in Acorda Therapeutics Protocol MS-F203.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis |
Drug: Fampridine-SR |
Phase III |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple Sclerosis Who Participated in the MS-F203 Trial |
| Enrollment: | 268 |
| Study Start Date: | June 2006 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
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 over a long period of time.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 32 Study Locations| Study Director: | Bonnie Faust | Acorda Therapeutics |
More Information
| Responsible Party: | Acorda Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00648908 History of Changes |
| Other Study ID Numbers: | MS-F203EXT |
| Study First Received: | March 28, 2008 |
| Last Updated: | November 2, 2011 |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
|
multiple sclerosis MS walking leg strength demyelination |
|
Multiple Sclerosis Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |
Pathologic Processes 4-Aminopyridine Potassium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses |