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.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: Fampridine-SR (4-aminopyridine, 4-AP)	Phase III

Further Study Details: 

Expected Total Enrollment:  240

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

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)

Please refer to this study by ClinicalTrials.gov identifier  NCT00127530

Acorda Therapeutics      914-347-4300    http://www.acorda.com

Alabama
      University of Alabama, Birmingham,  Alabama,  35233,  United States; Recruiting
Arizona
      Barrow Neurology Clinic, St. Joseph''''s Hospital and Medical Center, Phoenix,  Arizona,  85013,  United States; Recruiting
California
      USC, Keck School of Medicine, Los Angeles,  California,  90033,  United States; Recruiting
      UC Davis, Sacramento,  California,  95817,  United States; Recruiting
Colorado
      University of Colorado Health Sciences Center, Denver,  Colorado,  80262,  United States; Recruiting
Connecticut
      Multiple Sclerosis Treatment Center, Derby,  Connecticut,  06418,  United States; Recruiting
Georgia
      Shepard Center, Atlanta,  Georgia,  30309,  United States; Recruiting
Illinois
      University of Chicago, Chicago,  Illinois,  60637,  United States; Recruiting
Indiana
      Indiana University MS Center, Indianapolis,  Indiana,  46202,  United States; Recruiting
Maryland
      Maryland Center for MS, Baltimore,  Maryland,  21201,  United States; Recruiting
Michigan
      Wayne State University, Department of Neurology, Detroit,  Michigan,  48201,  United States; Recruiting
Minnesota
      The Schapiro Center for MS, Golden Valley,  Minnesota,  55422,  United States; Recruiting
Missouri
      Washington University SOM, St. Louis,  Missouri,  63110,  United States; Recruiting
New Jersey
      Gimbel MS Center at Holy Name Hospital, Teaneck,  New Jersey,  07666,  United States; Recruiting
New Mexico
      University of Mexico, MIND Imaging Center, Albuquerque,  New Mexico,  87131,  United States; Recruiting
New York
      SUNY - Stony Brook, Stony Brook,  New York,  11794,  United States; Recruiting
      Corinne Goldsmith Dickinson Center for MS, New York,  New York,  10029,  United States; Recruiting
      Maimonides Medical Center, Brooklyn,  New York,  11220,  United States; Recruiting
      University of Rochester, Rochester,  New York,  14642,  United States; Recruiting
North Carolina
      Carolinas Healthcare System, Charlotte,  North Carolina,  28207,  United States; Recruiting
Ohio
      Cleveland Clinical Foundation, Cleveland,  Ohio,  44095,  United States; Recruiting
      Ohio State University MS Center, Columbus,  Ohio,  43221,  United States; Recruiting
Oregon
      Oregon Health & Science University, MS Center of Oregon, UHS-42, Portland,  Oregon,  97239,  United States; Recruiting
Pennsylvania
      Thomas Jefferson University Physicians, Philadelphia,  Pennsylvania,  19107,  United States; Recruiting
      Allegheny General Hospital, Allegheny Neurological Associates, Pittsburgh,  Pennsylvania,  15212,  United States; Recruiting
Texas
      University of Texas - Houston, Houston,  Texas,  77030,  United States; Recruiting
Vermont
      Fletcher Allen Health Care, Burlington,  Vermont,  05401,  United States; Recruiting
      Neurological Research Center, Inc., Bennington,  Vermont,  05201,  United States; Recruiting
Washington
      University of Washington, MS Research Center, Seattle,  Washington,  98195,  United States; Recruiting
      MS Hub Medical Group, Seattle,  Washington,  98101,  United States; Recruiting
Canada, Alberta
      Foothills Medical Center, Calgary,  Alberta,  T2N 2T9,  Canada; Recruiting
Canada, British Columbia
      University of British Columbia, Vancouver Coastal Health Research Institute, Vancouver,  British Columbia,  V6T 2B5,  Canada; Recruiting
Canada, Nova Scotia
      QEII Health Sciences Centre, Nova Scotia Rehabilitation Centre Site, Halifax,  Nova Scotia,  B3H 4K4,  Canada; Recruiting
Canada, Ontario
      Ottawa Hospital General Campus, Ottawa,  Ontario,  K1H 8L6,  Canada; Recruiting

Study ID Numbers:  MS-F203
Last Updated:  August 22, 2005
Record first received:  August 4, 2005
ClinicalTrials.gov Identifier:  NCT00127530
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23