Multiple Sclerosis Clinical Trial

Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial

Summary

The purpose of the study is to evaluate the safety, tolerability and activity of Fampridine-SR when administered for up to 36 additional months in patients who previously participated in the MS-F204 study or until it becomes commercially available, whichever comes first.

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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 MS patients over a long period of time.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patient must have been previously enrolled in the Acorda Therapeutics MS-F204 study and received either Fampridine-SR or placebo
Patient with clinically defined multiple sclerosis (the diagnostic criteria based on: McDonald WI, et al. Recommended Diagnostic Criteria for Multiple Sclerosis: Guidelines from the International Panel on the Diagnosis of Multiple Sclerosis. Annals of Neurology. 2001; 50: 121-127)
Patient must be at least 18 years of age. Any patient who is now over the age of 70 must be in good overall health in the judgment of the investigator
Patient must be of adequate cognitive function, as judged by the Investigator
Patients who are women of childbearing potential must have a negative urine pregnancy test at the screening visit

Exclusion Criteria:

Female patients who are either pregnant or breastfeeding.
Women of childbearing potential who are not using a specified birth control method
Patients discontinued prematurely from the MS-F204 study
Patients with a history of seizures or with evidence of past, or possible epileptiform activity on an EEG
Patient with either a clinically significant abnormal ECG or laboratory values at the MS-F204 EXT screening visit
Patient with severe renal impairment
Patient with angina, uncontrolled hypertension, clinically significant cardiac arrhythmias, or any other clinically significant cardiovascular abnormality, as judged by the Investigator
Patient with a known allergy to pyridine-containing substances or any of the inactive ingredients of the Fampridine-SR tablet
Patient who has received an investigational drug (other than Fampridine-SR or placebo under MS-F204 study) within 30 days of the MS-F204EXT screening visit or a patient who is scheduled to enroll in an investigational drug trial at any time during this study
Patient who has a history of drug or alcohol abuse within the past year

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

214

Study ID:

NCT00649792

Recruitment Status:

Completed

Sponsor:

Acorda Therapeutics

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There are 42 Locations for this study

See Locations Near You

Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center
Phoenix Arizona, 85013, United States
HOPE Research Institute
Phoenix Arizona, 85050, United States
Neurological Associates
Fayetteville Arkansas, 72703, United States
Alta Bates Summit Medical Center - Research and Education Institute
Berkeley California, 94705, United States
USC, Keck School of Medicine Health Care Consultation Center
Los Angeles California, 90033, United States
UC Davis
Sacramento California, 95817, United States
Yale University MS Center
New Haven Connecticut, 06510, United States
Shepherd Center
Atlanta Georgia, 30309, United States
University of Chicago
Chicago Illinois, 60637, United States
Consultants in Neurology, Ltd.
Northbrook Illinois, 60062, United States
Indiana University MS Center
Indianapolis Indiana, 46202, United States
Associates in Neurology, PSC
Lexington Kentucky, 40503, United States
Maryland Center for MS
Baltimore Maryland, 21201, United States
Lahey Clinic
Lexington Massachusetts, 02421, 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 School of Medicine
St. Louis Missouri, 63110, United States
Advanced Neurology Specialists
Great Falls Montana, 59405, United States
UMDNJ
Newark New Jersey, 07103, United States
Gimbel MS Center at Holy Name Hospital
Teaneck New Jersey, 07666, United States
Jacobs Neurological Institute Buffalo General Hospital
Buffalo New York, 14203, United States
Corinne Goldsmith Dickinson Center for MS
New York New York, 10029, United States
Columbia University Multiple Sclerosis Clinical Care Center
New York New York, 10032, United States
University of Rochester
Rochester New York, 14642, United States
SUNY Stony Brook
Stony Brook New York, 11794, United States
CMC - Neuroscience & Spine Institute, Division of Neurology
Charlotte North Carolina, 28207, United States
Raleigh Neurology Associates
Raleigh North Carolina, 27607, United States
Wake Forest University, Dept of Neurology, M.S. Research
Winston-Salem North Carolina, 27157, United States
The Center for Neurological Services
Bismarck North Dakota, 58501, United States
Cleveland Clinic Foundation
Cleveland Ohio, 44195, 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
Neurological Research Center, Inc.
Bennington Vermont, 05201, United States
Fletcher Allen Health Care
Burlington Vermont, 05401, United States
MS Center at Evergreen
Kirkland Washington, 98034, United States
CAMC Health Education & Research Institute
Charleston West Virginia, 25304, United States
Center for Neurological Disorders of Aurora, St. Luke's Medical Center
Milwaukee Wisconsin, 53215, 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
River Valley Health c/o Stan Cassidy Centre for Rehabilitation
Fredericton New Brunswick, E3B 0, Canada
QEII Health Sciences Centre, Nova Scotia Rehabilitation Centre Site
Halifax Nova Scotia, B3H 4, Canada

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

214

Study ID:

NCT00649792

Recruitment Status:

Completed

Sponsor:


Acorda Therapeutics

How clear is this clinincal trial information?

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