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| Sponsor: | Acorda Therapeutics |
|---|---|
| Information provided by: | Acorda Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00127530 |
Purpose
To assess the safety and efficacy of 10 milligram (mg) twice a day (b.i.d.) Fampridine-SR in patients diagnosed with multiple sclerosis (MS), in a double-blind, placebo-controlled, parallel group study.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis |
Drug: Fampridine-SR Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| 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, 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 |
|---|---|
|
Placebo Comparator: Placebo- sugar pill
Placebo control
|
Drug: Placebo
sugar pill, twice a day (b.i.d.)
Other Name: placebo
|
|
Experimental: Fampridine-SR
10 milligram (mg) tablet b.i.d.
|
Drug: Fampridine-SR
Tablets, 10 mg, twice daily, 14 weeks
Other Name: Sustained release 4-aminopyridine, 4-AP
|
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.
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 34 Study Locations| Study Director: | Andrew Blight, PhD | Acorda Therapeutics |
More Information
| Responsible Party: | Andrew Blight/Chief Scientific Officer, Acorda Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00127530 History of Changes |
| Other Study ID Numbers: | MS-F203 |
| Study First Received: | August 4, 2005 |
| Results First Received: | April 12, 2011 |
| Last Updated: | May 11, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Walking Ability |
|
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 |