MS Trial Alert:
Fampridine-SR Study Enrolling Patients With MS


July 22, 2005


This page came from: http://www.nationalmssociety.org/Research-2005July22.asp

Summary: Investigators at aproximately 30 centers in the United States and Canada are enrolling participants in a 21-week clinical trial testing the safty and effectivenessof Fampridine-SR (an oral, sustained release formula of 4-aminopyridine being developed by Acorda Therapeutics) compared with inactive placebo to improve walking ability in 240 people with multiple sclerosis.

Rationale: Fampridine-SR blocks tiny pores, or potassium channels, on the surface of nerve fibers, and thus may improve the conduction of nerve signals in nerve fibers whose myelin coating has been damaged by MS. Dr. Andrew Goodman (University of Rochester, New York) and colleagues recently reported the results of a study of Fampridine-SR to treat MS symptoms (American Committee for Treatment and Research in MS, 2004). In a double-blinded, placebo-controlled dosing study, 206 people with MS received either Fampridine-SR - taken twice daily - or inactive placebo for 12 weeks. The results indicated a trend (an effect which does not quite reach statistical significance) toward improved walking speed in the Fampridine-SR groups, and a significant increase in leg strength. Side effects included dizziness, insomnia and nausea, with two people in the highest dose group having seizures (one from an accidental overdose). That dose is not being included in the current study. The current study was designed based on these and other study results.

Eligibility and Details: People eligible for participation include individuals 18-70 years of age with clinically definite MS in any form. Participants must have adequate cognitive function to understand and sign the informed consent, and must be able to perform the required study procedures, which include tests of walking speed. Participants should be able to walk, although with some difficulty. Women of childbearing potential must have a negative pregnancy test.

Individuals on a disease-modifying therapy are permitted to participate but should discuss the details of their therapy with the study coordinator. The primary outcome measure for the study will be an improvement in walking ability, which will be measured using the "Timed 25 Foot Walk" test and the "MS Walking Scale-12." Secondary outcomes will include measurements of leg strength and muscle spasticity (stiffness and involuntary muscle spasms). Safety is being evaluated based on reports of side effects, measurement of vital signs, blood tests, and electrocardiograms.

Contact: Below is a list of the sites participating in the study. All sites are not yet enrolling patients. For information about study enrollment at a site near you, please call 877-716-2518 toll-free, weekdays from 10:00 a.m. to 4:00 p.m. (EST).

SITES:

United States
University of Alabama, Birmingham, AL
St. Joseph's Hospital and Medical Center, Phoenix, AZ
University of Southern California, Los Angeles, CA
University of California, Davis, CA
University of Colorado, Denver, CO
Multiple Sclerosis Treatment Center, Derby, CT
Shepherd Center, Atlanta, GA
University of Chicago, Chicago, IL
Indiana University, Indianapolis, IN
Maryland Center for MS, Baltimore, MD
Wayne State University, Detroit, MI
The Schapiro Center for MS, Golden Valley, MN
Washington University, St. Louis, MO
Carolinas Healthcare System, Charlotte, NC
Holy Name Hospital, Teaneck, NJ
University of New Mexico, Albuquerque, NM
State University of New York, Stony Brook, NY
Corinne Goldsmith Dickinson Center for MS, New York, NY
Maimonides Medical Center, Brooklyn, NY
University of Rochester, Rochester, NY
Ohio State University, Columbus, OH
Cleveland Clinic Foundation, Cleveland, OH
Oregon Health & Science University, Portland, OR
Thomas Jefferson University Physicians, Philadelphia, PA
Allegheny General Hospital, Pittsburgh, PA
University of Texas, Houston, TX
University of Washington, Seattle, WA
MS Hub Medical Group, Seattle, WA
Fletcher Allen Health Care, Burlington, VT
Neurological Research Center, Inc., Bennington, VT

Canada
Foothills Medical Center, Calgary, Alberta, Canada
Ottawa Hospital General Campus, Ottawa, Ontario, Canada
QEII Health Sciences Centre, Halifax, Nova Scotia, Canada
University of British Columbia, Vancouver, British Columbia, Canada

http://www.nationalmssociety.org/Research-2005Ju1y22.asp