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

NCT ID: NCT00649792

Last Updated: 2012-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 214 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2011-04-30

Brief 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.

Detailed 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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Fampridine-SR

Tablets, 10 mg, BID (twice daily)

Intervention Type: DRUG

Other Intervention Names

4-aminopyridine

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Acorda Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bonnie Faust

Role: STUDY_DIRECTOR

Acorda Therapeutics

Locations

Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

HOPE Research Institute

Phoenix, Arizona, United States

Neurological Associates

Fayetteville, Arkansas, United States

Alta Bates Summit Medical Center - Research and Education Institute

Berkeley, California, United States

USC, Keck School of Medicine Health Care Consultation Center

Los Angeles, California, United States

UC Davis

Sacramento, California, United States

Yale University MS Center

New Haven, Connecticut, United States

Shepherd Center

Atlanta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Consultants in Neurology, Ltd.

Northbrook, Illinois, United States

Indiana University MS Center

Indianapolis, Indiana, United States

Associates in Neurology, PSC

Lexington, Kentucky, United States

Maryland Center for MS

Baltimore, Maryland, United States

Lahey Clinic

Lexington, Massachusetts, United States

Wayne State University, Department of Neurology

Detroit, Michigan, United States

The Schapiro Center for MS

Golden Valley, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Advanced Neurology Specialists

Great Falls, Montana, United States

UMDNJ

Newark, New Jersey, United States

Gimbel MS Center at Holy Name Hospital

Teaneck, New Jersey, United States

Jacobs Neurological Institute Buffalo General Hospital

Buffalo, New York, United States

Corinne Goldsmith Dickinson Center for MS

New York, New York, United States

Columbia University Multiple Sclerosis Clinical Care Center

New York, New York, United States

University of Rochester

Rochester, New York, United States

SUNY Stony Brook

Stony Brook, New York, United States

CMC - Neuroscience & Spine Institute, Division of Neurology

Charlotte, North Carolina, United States

Raleigh Neurology Associates

Raleigh, North Carolina, United States

Wake Forest University, Dept of Neurology, M.S. Research

Winston-Salem, North Carolina, United States

The Center for Neurological Services

Bismarck, North Dakota, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ohio State University MS Center

Columbus, Ohio, United States

Oregon Health & Science University, MS Center of Oregon, UHS-42

Portland, Oregon, United States

Thomas Jefferson University Physicians

Philadelphia, Pennsylvania, United States

Neurological Research Center, Inc.

Bennington, Vermont, United States

Fletcher Allen Health Care

Burlington, Vermont, United States

MS Center at Evergreen

Kirkland, Washington, United States

CAMC Health Education & Research Institute

Charleston, West Virginia, United States

Center for Neurological Disorders of Aurora, St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Foothills Medical Center

Calgary, Alberta, Canada

University of British Columbia, Vancouver Coastal Health Research Institute

Vancouver, British Columbia, Canada

River Valley Health c/o Stan Cassidy Centre for Rehabilitation

Fredericton, New Brunswick, Canada

QEII Health Sciences Centre, Nova Scotia Rehabilitation Centre Site

Halifax, Nova Scotia, Canada

Countries

United States; Canada

Related Links

http://www.acorda.com/clinical.asp

Click here for more information about Fampridine-SR clinical trials

Other Identifiers

MS-F204 EXT

Identifier Type: -

Identifier Source: org_study_id