Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR Tablets in Multiple Sclerosis Patients Who Participated in the MS-F203 Trial

NCT ID: NCT00648908

Last Updated: 2012-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 269 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2011-04-30

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and activity of Fampridine-SR when administered for up to 36 additional months, or until it becomes commercially available whichever comes first, in subjects who previously participated in Acorda Therapeutics Protocol MS-F203.

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

Intervention Type: DRUG

Other Intervention Names

4-aminopyridine

Eligibility Criteria

Inclusion Criteria

• subject must have been previously enrolled in Acorda Therapeutics MS-F203 study for multiple sclerosis and received either Fampridine-SR or placebo
• subject is a man or woman with clinical definite multiple sclerosis as defined by McDonald (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)
• subject must be at least 18 years of age. Any subject who is now over the age of 70 must be in good overall health in the judgment of the Investigator
• subject must be of adequate cognitive function, as judged by the Investigator, to understand and sign the IRB/REB-approved informed consent form prior to the performance of any study-specific procedures and is willing to comply with the required scheduling and assessments of the protocol
• subjects who are women of childbearing potential, regardless of sexual activity, must have a negative urine pregnancy test at the Screening Visit.

Exclusion Criteria

• women who are either pregnant or breastfeeding, and women of childbearing potential (defined as not surgically sterile or at least two years post menopausal) who are engaged in active heterosexual relations and, are not using one of the following birth control methods: tubal ligation, implantable contraception device, oral, patch, injectable or transdermal contraceptive, barrier method or sexual activity restricted to vasectomized partner.
• subject discontinued prematurely from the MS-F203 study
• subject has a history of seizures or has evidence of past, or possible, epileptiform activity on an EEG
• subject has either a clinically significant abnormal ECG or laboratory value(s) at the Screening visit, as judged by the Investigator that would preclude entry into the study. ECG and laboratory results from Visit 6 or repeat results from Visit 7 of the MS-F203 study may be used as the baseline for the current study
• subject has angina, uncontrolled hypertension, clinically significant cardiac arrhythmias, or any other clinically significant cardiovascular abnormality, as judged by the Investigator
• subject has a known allergy to pyridine-containing substances or any of the inactive ingredients of the Fampridine-SR tablet (hydroxypropyl methylcellulose, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, opadry white (tablet film coating))
• subject has received an investigational drug, except for Fampridine-SR or matching placebo under protocol MS-F203, within 30 days of the Screening Visit. Subject is scheduled to enroll in an investigational drug trial at any time during this study.
• subject 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

USC, Keck School of Medicine Health Care Consultation Center

Los Angeles, California, United States

UC Davis

Sacramento, California, United States

Shepherd Center

Atlanta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Indiana University MS Center

Indianapolis, Indiana, United States

Maryland Center for MS

Baltimore, Maryland, 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, Div. of Rehab/Neurology

St Louis, Missouri, United States

Advanced Neurology Specialists

Great Falls, Montana, United States

Gimbel MS Center at Holy Name Hospital

Teaneck, New Jersey, United States

Maimonides MS Care Center

Brooklyn, New York, United States

Corinne Goldsmith Dickinson Center for MS

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

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

Allegheny General Hospital, Allegheny Neurological Associates

Pittsburgh, Pennsylvania, United States

University of Texas-Houston

Houston, Texas, 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

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

Ottawa Hospital General Campus

Ottawa, Ontario, 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-F203EXT

Identifier Type: -

Identifier Source: org_study_id