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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
|
|
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
Hide Study Locations| United States, Arizona | |
| Barrow Neurological Institute at St. Joseph Hospital and Medical Center | |
| Phoenix, Arizona, United States, 85013 | |
| United States, California | |
| USC School of Medicine | |
| Los Angeles, California, United States, 90033 | |
| United States, Connecticut | |
| Yale University MS Center | |
| New Haven, Connecticut, United States, 06510 | |
| United States, Georgia | |
| MS Center at Shepherd Center | |
| Atlanta, Georgia, United States, 30309 | |
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| United States, Maryland | |
| University of Maryland at Baltimore | |
| Baltimore, Maryland, United States, 21210 | |
| United States, Minnesota | |
| Fairview MS Center | |
| Minneapolis, Minnesota, United States, 55454 | |
| United States, Missouri | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New Jersey | |
| Gimbel MS Center | |
| Teaneck, New Jersey, United States, 07666 | |
| United States, New Mexico | |
| University of New Mexico | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, New York | |
| SUNY Stony Brook | |
| Stony Brook, New York, United States, 11794 | |
| Mt. Sinai School of Medicine - MS Center | |
| New York, New York, United States, 10029 | |
| Maimonides MS Care Center | |
| Brooklyn, New York, United States, 11219 | |
| University of Rochester Medical School | |
| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| Carolinas Medical Center MS Clinic | |
| Charlotte, North Carolina, United States, 28207 | |
| United States, Ohio | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| United States, Oregon | |
| Oregon Health Sciences University; MS Center | |
| Portland, Oregon, United States, 97201 | |
| United States, Pennsylvania | |
| Thomas Jefferson University | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Texas | |
| University of Texas-Houston | |
| Houston, Texas, United States, 77030 | |
| United States, Washington | |
| University of Washington MS Clinical Center | |
| Seattle, Washington, United States, 98195 | |
| Swedish Medical MS Center | |
| Seattle, Washington, United States, 98122 | |
| United States, Wisconsin | |
| University of Wisconsin | |
| Madison, Wisconsin, United States, 53792 | |
| Canada, Alberta | |
| University of Calgary and Foothills Hospital | |
| Calgary, Alberta, Canada, T2N 2T9 | |
| Canada, Ontario | |
| St. Michael's Hospital | |
| Toronto, Ontario, Canada, M5B 1WB | |
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 |