Study of Oral Fampridine-SR in Multiple Sclerosis

Phase 3

Completed

Conditions: Multiple Sclerosis

Interventions: Drug: Fampridine-SR
Drug: Placebo

Registration Number: NCT00127530

Lead Sponsor: Acorda Therapeutics

Brief Summary: To assess the safety and efficacy of 10 milligram (mg) twice a day (b.i.d.) Fampridine-SR in patients diagnosed with multiple sclerosis (MS), in a double-blind, placebo-controlled, parallel group study.

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 subjects with MS.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 300

Inclusion Criteria

Have a confirmed diagnosis of multiple sclerosis
Are able to walk with or without an assistive 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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fampridine-SR	Fampridine-SR	10 milligram (mg) tablet b.i.d.
Placebo- sugar pill	Placebo	Placebo control

Primary Outcome Measures

Name	Time	Method
Timed Walk Responders (Patients Who Showed Consistent Improvement on the Timed-25 Foot Walk)	Days 14, 42, 70 and 98 of treatment, corresponding to the four on-drug visits during double-blind treatment period.	Patients who showed a faster walking speed for at least three of the four on-drug visits during the double-blind treatment period as compared to the maximum speed for any of the five off-drug visits.

Secondary Outcome Measures

Name	Time	Method
Lower Extremity Manual Muscle Test; Ashworth Score for Spasticity	Days 14, 42, 70, 98

Trial Locations

Locations (34): Thomas Jefferson University Physicians
🇺🇸
Philadelphia, Pennsylvania, United States
University of Washington, MS Research Center
🇺🇸
Seattle, Washington, United States
Cleveland Clinical Foundation
🇺🇸
Cleveland, Ohio, United States
Ohio State University MS Center
🇺🇸
Columbus, Ohio, United States
SUNY - Stony Brook
🇺🇸
Stony Brook, New York, United States
USC, Keck School of Medicine
🇺🇸
Los Angeles, California, United States
University of Alabama
🇺🇸
Birmingham, Alabama, United States
UC Davis
🇺🇸
Sacramento, California, United States
University of Colorado Health Sciences Center
🇺🇸
Denver, Colorado, United States
Shepard 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
The Schapiro Center for MS
🇺🇸
Golden Valley, Minnesota, United States
Washington University SOM
🇺🇸
Saint Louis, Missouri, United States
Gimbel MS Center at Holy Name Hospital
🇺🇸
Teaneck, New Jersey, United States
University of Mexico, MIND Imaging Center
🇺🇸
Albuquerque, New Mexico, United States
Corinne Goldsmith Dickinson Center for MS
🇺🇸
New York, New York, United States
University of Rochester
🇺🇸
Rochester, New York, United States
Carolinas Healthcare System
🇺🇸
Charlotte, North Carolina, United States
Oregon Health & Science University, MS Center of Oregon, UHS-42
🇺🇸
Portland, Oregon, United States
Allegheny General Hospital, Allegheny Neurological Associates
🇺🇸
Pittsburgh, Pennsylvania, United States
University of Texas - Houston
🇺🇸
Houston, Texas, United States
Fletcher Allen Health Care
🇺🇸
Burlington, Vermont, United States
MS Hub Medical Group
🇺🇸
Seattle, Washington, United States
University of British Columbia, Vancouver Coastal Health Research Institute
🇨🇦
Vancouver, British Columbia, Canada
QEII Health Sciences Centre, Nova Scotia Rehabilitation Centre Site
🇨🇦
Halifax, Nova Scotia, Canada
Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center
🇺🇸
Phoenix, Arizona, United States
Multiple Sclerosis Treatment Center
🇺🇸
Derby, Connecticut, United States
Foothills Medical Center
🇨🇦
Calgary, Alberta, Canada
Ottawa Hospital General Campus
🇨🇦
Ottawa, Ontario, Canada
Wayne State University, Department of Neurology
🇺🇸
Detroit, Michigan, United States
Maimonides Medical Center
🇺🇸
Brooklyn, New York, United States
Neurological Research Center, Inc.
🇺🇸
Bennington, Vermont, United States