Multiple Sclerosis Clinical Trial

Study of Oral Fampridine-SR in Multiple Sclerosis

Summary

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.

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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Have a confirmed diagnosis of multiple sclerosis
Are able to walk with or without an assistive device

Exclusion Criteria:

Pregnancy, breastfeeding or females of childbearing potential not using adequate birth control
Participating in other investigational drug trials
A medical history or clinical findings that preclude entry into the study
A medication history that precludes entry into the study
Previously treated with 4-aminopyridine (4-AP)

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

300

Study ID:

NCT00127530

Recruitment Status:

Completed

Sponsor:

Acorda Therapeutics

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There are 34 Locations for this study

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University of Alabama
Birmingham Alabama, 35233, United States
Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center
Phoenix Arizona, 85013, United States
USC, Keck School of Medicine
Los Angeles California, 90033, United States
UC Davis
Sacramento California, 95817, United States
University of Colorado Health Sciences Center
Denver Colorado, 80262, United States
Multiple Sclerosis Treatment Center
Derby Connecticut, 06418, United States
Shepard Center
Atlanta Georgia, 30309, United States
University of Chicago
Chicago Illinois, 60637, United States
Indiana University MS Center
Indianapolis Indiana, 46202, United States
Maryland Center for MS
Baltimore Maryland, 21201, United States
Wayne State University, Department of Neurology
Detroit Michigan, 48201, United States
The Schapiro Center for MS
Golden Valley Minnesota, 55422, United States
Washington University SOM
Saint Louis Missouri, 63110, United States
Gimbel MS Center at Holy Name Hospital
Teaneck New Jersey, 07666, United States
University of Mexico, MIND Imaging Center
Albuquerque New Mexico, 87131, United States
Maimonides Medical Center
Brooklyn New York, 11220, United States
Corinne Goldsmith Dickinson Center for MS
New York New York, 10029, United States
University of Rochester
Rochester New York, 14642, United States
SUNY - Stony Brook
Stony Brook New York, 11794, United States
Carolinas Healthcare System
Charlotte North Carolina, 28207, United States
Cleveland Clinical Foundation
Cleveland Ohio, 44095, United States
Ohio State University MS Center
Columbus Ohio, 43221, United States
Oregon Health & Science University, MS Center of Oregon, UHS-42
Portland Oregon, 97239, United States
Thomas Jefferson University Physicians
Philadelphia Pennsylvania, 19107, United States
Allegheny General Hospital, Allegheny Neurological Associates
Pittsburgh Pennsylvania, 15212, United States
University of Texas - Houston
Houston Texas, 77030, United States
Neurological Research Center, Inc.
Bennington Vermont, 05201, United States
Fletcher Allen Health Care
Burlington Vermont, 05401, United States
MS Hub Medical Group
Seattle Washington, 98101, United States
University of Washington, MS Research Center
Seattle Washington, 98195, United States
Foothills Medical Center
Calgary Alberta, T2N 2, Canada
University of British Columbia, Vancouver Coastal Health Research Institute
Vancouver British Columbia, V6T 2, Canada
QEII Health Sciences Centre, Nova Scotia Rehabilitation Centre Site
Halifax Nova Scotia, B3H 4, Canada
Ottawa Hospital General Campus
Ottawa Ontario, K1H 8, Canada

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

300

Study ID:

NCT00127530

Recruitment Status:

Completed

Sponsor:


Acorda Therapeutics

How clear is this clinincal trial information?

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