Study of Oral Fampridine-SR in Multiple Sclerosis



Status:Completed
Conditions:Neurology, Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - 70
Updated:9/13/2018
Start Date:May 2005
End Date:September 2006

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Double-Blind, Placebo-Controlled, 21-Week, Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR in Subjects With Multiple Sclerosis

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.

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.

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)
We found this trial at
31
sites
Birmingham, Alabama 35294
1785
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Birmingham, AL
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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820
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Denver, CO
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
2244
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Rochester, NY
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Albuquerque, New Mexico 87131
649
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Albuquerque, NM
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Atlanta, Georgia 30309
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Atlanta, GA
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Baltimore, Maryland 21201
2301
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Baltimore, MD
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Bennington, Vermont 05201
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Bennington, VT
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4802 10th Ave
Brooklyn, New York 11219
(718) 283-6000
Maimonides Medical Center At 103 years old, Maimonides Medical Center remains a vital and thriving...
2433
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Brooklyn, NY
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111 Colchester Ave
Burlington, Vermont 05401
(802) 847-0000
Fletcher Allen Health Care As Vermont’s University Medical Center, we at Fletcher Allen are committed...
2467
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Burlington, VT
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Calgary, Alberta
1189
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Calgary,
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Charlotte, North Carolina 28203
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Charlotte, NC
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Cleveland, Ohio 44145
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Cleveland, OH
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Columbus, Ohio 43221
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Columbus, OH
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Derby, CT
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Detroit, MI
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Golden Valley, Minnesota 55422
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Golden Valley, MN
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Houston, Texas 77030
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Houston, TX
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Indianapolis, Indiana 46202
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Indianapolis, IN
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Los Angeles, California 90033
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Los Angeles, CA
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New York, NY
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Philadelphia, Pennsylvania 19107
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Philadelphia, PA
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Phoenix, AZ
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Pittsburgh, PA
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Portland, OR
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Sacramento, California 95817
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Sacramento, CA
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Saint Louis, Missouri 63110
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Saint Louis, MO
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Seattle, Washington 98101
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Seattle, WA
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Seattle, WA
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Stony Brook, New York 11794
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Stony Brook, NY
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Teaneck, New Jersey 07666
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Teaneck, NJ
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