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| Sponsor: | Acorda Therapeutics |
|---|---|
| Information provided by: | Acorda Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00053417 |
Purpose
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 increases the ability of the nerve to conduct electrical impulses. This study will evaluate the effects of Fampridine-SR on the walking ability of subjects with MS, as well as to examine the effects on muscle strength and spasticity. The study will also examine the possible risks of taking Fampridine-SR.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis |
Drug: Fampridine-SR (4-aminopyridine, 4-AP) |
Phase II |
| 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, 20-Week, Parallel Group Study to Evaluate Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple Sclerosis |
| Enrollment: | 206 |
| Study Start Date: | February 2003 |
| Study Completion Date: | December 2003 |
| Primary Completion Date: | December 2003 (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, 15 or 20 mg, twice daily for 15 weeks
|
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2: Experimental
10 mg fampridine b.i.d.
|
Drug: Fampridine-SR (4-aminopyridine, 4-AP)
Tablets, 10, 15 or 20 mg, twice daily for 15 weeks
|
|
3: Experimental
15 mg fampridine b.i.d.
|
Drug: Fampridine-SR (4-aminopyridine, 4-AP)
Tablets, 10, 15 or 20 mg, twice daily for 15 weeks
|
|
4: Experimental
20 mg fampridine b.i.d.
|
Drug: Fampridine-SR (4-aminopyridine, 4-AP)
Tablets, 10, 15 or 20 mg, twice daily for 15 weeks
|
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 25 Study Locations More Information
| Responsible Party: | Acorda Therapeutics ( Andrew Blight/Chief Scientific Officer ) |
| Study ID Numbers: | MS-F202 |
| Study First Received: | January 29, 2003 |
| Last Updated: | December 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00053417 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Walking Ability Muscle strength Spasticity |
|
Autoimmune Diseases Demyelinating Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Nervous System Diseases Sclerosis Cardiovascular Agents Pharmacologic Actions |
Membrane Transport Modulators Multiple Sclerosis Pathologic Processes Therapeutic Uses Potassium Channel Blockers Demyelinating Autoimmune Diseases, CNS 4-Aminopyridine Autoimmune Diseases of the Nervous System |
