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	Treatment or Intervention	Phase
Multiple Sclerosis	Drug: Fampridine-SR (4-aminopyridine, 4-AP)	Phase II

Further Study Details: 

Expected Total Enrollment:  180

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 assisted 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)

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

Study ID Numbers:  MS-F202
Record last reviewed:  January 2004
Last Updated:  October 13, 2004
Record first received:  January 29, 2003
ClinicalTrials.gov Identifier:  NCT00053417
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08