Study of Fampridine-SR Tablets in Multiple Sclerosis Patients

Phase 3

Completed

Conditions: Multiple Sclerosis

Interventions: Drug: Placebo
Drug: Fampridine-SR

Registration Number: NCT00483652

Lead Sponsor: Acorda Therapeutics

Brief Summary: The purpose of the study is to show that individuals treated with Fampridine-SR tablets are significantly more likely to have consistent improvements in their walking than those treated with placebo tablets.

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 240

Inclusion Criteria

Patient with clinically defined multiple sclerosis
All patients must be able to complete two trials of a timed 25 foot walk

Exclusion Criteria

Female patients who are either pregnant or breastfeeding.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo control
Fampridine-SR	Fampridine-SR	10 mg b.i.d.

Primary Outcome Measures

Name	Time	Method
Responders Based Upon the Timed 25-Foot Walk [T25FW]	Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77	A responder is a patient who showed faster walking speed for at least 3 visits out of a possible 4 during the double-blind period than the maximum value achieved in the 5 non-double-blind no-treatment visits (4 before the double-blind period and one after)

Secondary Outcome Measures

Name	Time	Method
Change in Lower Extremity Manual Muscle Test [LEMMT]	Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77	Evaluator rated strength in hip flexors, knee flexors, knee extensors, and ankle dorsiflexors on the following scale: best value = 5.0 (normal muscle strength), worst value = 0.0 (absence of any voluntary contraction). A positive shift in LEMMT score shows improvement in strength. Change in LEMMT scores for the secondary efficacy measure was found by averaging the LEMMT scores on days 14, 28, 42, and 56 (double-blind treatment period) and subtracting the baseline LEMMT score.

Trial Locations

Locations (40): Shepherd Center
🇺🇸
Atlanta, Georgia, United States
Alta Bates Summit Medical Center - Research and Education Institute
🇺🇸
Berkeley, California, United States
CAMC Health Education & Research Institute
🇺🇸
Charleston, West Virginia, United States
Columbia University Multiple Sclerosis Clinical Care Center
🇺🇸
New York, New York, United States
SUNY Stony Brook
🇺🇸
Stony Brook, New York, United States
UC Davis
🇺🇸
Sacramento, California, United States
Wake Forest University, Dept of Neurology, M.S. Research
🇺🇸
Winston-Salem, North Carolina, United States
QEII Health Sciences Centre, Nova Scotia Rehabilitation Centre Site
🇨🇦
Halifax, Nova Scotia, Canada
Associates in Neurology, PSC
🇺🇸
Lexington, Kentucky, United States
UMDNJ
🇺🇸
Newark, New Jersey, United States
MS Center at Evergreen
🇺🇸
Kirkland, Washington, United States
HOPE Research Institute
🇺🇸
Phoenix, Arizona, United States
Yale University MS Center
🇺🇸
New Haven, Connecticut, United States
Maryland Center for MS
🇺🇸
Baltimore, Maryland, United States
Center for Neurological Disorders of Aurora, St. Luke's Medical Center
🇺🇸
Milwaukee, Wisconsin, United States
Thomas Jefferson University Physicians
🇺🇸
Philadelphia, Pennsylvania, United States
The Schapiro Center for MS
🇺🇸
Golden Valley, Minnesota, United States
Advanced Neurology Specialists
🇺🇸
Great Falls, Montana, United States
Lahey Clinic
🇺🇸
Lexington, Massachusetts, United States
Fletcher Allen Health Care
🇺🇸
Burlington, Vermont, United States
Ohio State University MS Center
🇺🇸
Columbus, Ohio, United States
Gimbel MS Center at Holy Name Hospital
🇺🇸
Teaneck, New Jersey, United States
Oregon Health & Science University, MS Center of Oregon, UHS-42
🇺🇸
Portland, Oregon, United States
Foothills Medical Center
🇨🇦
Calgary, Alberta, Canada
Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
Indiana University MS Center
🇺🇸
Indianapolis, Indiana, United States
University of British Columbia, Vancouver Coastal Health Research Institute
🇨🇦
Vancouver, British Columbia, Canada
USC, Keck School of Medicine Health Care Consultation Center
🇺🇸
Los Angeles, California, United States
Neurological Associates
🇺🇸
Fayetteville, Arkansas, United States
Jacobs Neurological Institute Buffalo General Hospital
🇺🇸
Buffalo, New York, United States
CMC - Neuroscience & Spine Institute, Division of Neurology
🇺🇸
Charlotte, North Carolina, United States
Raleigh Neurology Associates
🇺🇸
Raleigh, North Carolina, United States
Corinne Goldsmith Dickinson Center for MS
🇺🇸
New York, New York, United States
The Center for Neurological Services
🇺🇸
Bismarck, North Dakota, United States
River Valley Health c/o Stan Cassidy Centre for Rehabilitation
🇨🇦
Fredericton, New Brunswick, Canada
Neurological Research Center, Inc.
🇺🇸
Bennington, Vermont, United States
Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center
🇺🇸
Phoenix, Arizona, United States
Consultants in Neurology, Ltd.
🇺🇸
Northbrook, Illinois, United States
Washington University School of Medicine
🇺🇸
St. Louis, Missouri, United States
University of Rochester
🇺🇸
Rochester, New York, United States