Safety and Efficacy of Oral Fampridine-SR for the Treatment of Spasticity Resulting From Spinal Cord Injury

Phase 3

Completed

Conditions: Spinal Cord Injury
Muscle Spasticity

Interventions: Drug: Fampridine-SR
Other: Placebo

Registration Number: NCT00041717

Lead Sponsor: Acorda Therapeutics

Brief Summary: Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with spinal cord injury, some fibers may be destroyed at the site of injury, while others remain connected but do not work correctly to carry electrical impulses. As a result, subjects with an incomplete spinal cord injury may have spasticity which is muscle spasms or muscle stiffness that makes movement difficult. Fampridine-SR is an experimental drug that increases the ability of the nerve to conduct electrical impulses. This study will examine the effects of Fampridine-SR on moderate to severe lower-limb spasticity, as well as the effects on bodily functions such as bladder control, bowel function and sexual function. The study will also examine the possible risks of taking Fampridine-SR.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 213

Inclusion Criteria

Incomplete traumatic Spinal Cord Injury (at least 18 months prior and stable for 6 months)
Moderate to severe lower-limb spasticity
Able to give informed consent and willing to comply with protocol

Exclusion Criteria

Pregnancy
History of seizures
Existing or history of frequent Urinary Tract Infections
History of drug or alcohol abuse
Allergy to pyridine-containing substances
Received a botox injection 4 months prior to study
Received an investigational drug within 30 days
Previously treated with 4-aminopyridine (4-AP)
Not on stable medication dosing in 3 weeks prior to study
Abnormal ECG or laboratory value at screening

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fampridine-SR 50mg/day	Fampridine-SR	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity	Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98	The Ashworth Score is the average rating (based on a scale of 1 to 5) of four lower extremity muscle groups; left and right knee flexors and extensors (hamstrings and quadriceps muscles). A higher Ashworth Score indicates a greater degree of abnormal muscle tone (spasticity) and a negative change in score indicates improvement.
Double-blind Change From Baseline in Subject's Global Impression (SGI) of Treatment	Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98	This questionnaire asked the patient to evaluate the effects of investigational drug on his/her quality of life during the preceding week using a 7-point scale (from 1=terrible to 7=delighted). A positive change score in SGI indicates improved outcome.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (45): Advocate Christ Medical Center-Dept. of Physical Medicine & Rehabilitation-EMG
🇺🇸
Oak Lawn, Illinois, United States
Montana Neuroscience
🇺🇸
Missoula, Montana, United States
Clinical Research Services
🇺🇸
Bismarck, North Dakota, United States
Cleveland VAMC
🇺🇸
Cleveland, Ohio, United States
Good Shepherd Rehabilitation
🇺🇸
Allentown, Pennsylvania, United States
HEALTHSOUTH Harmarville Rehabilitation Hospital
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Pittsburgh, Pennsylvania, United States
CAMC Health Education & Research Institute
🇺🇸
Charleston, West Virginia, United States
Toronto Rehabilitation Institute, Lyndhurst Centre
🇨🇦
Toronto, Ontario, Canada
QEII HSC-Nova Scotia Rehabilitation Centre
🇨🇦
Halifax, Nova Scotia, Canada
The Burke Rehabilitation Hospital
🇺🇸
White Plains, New York, United States
Spaulding Rehabilitation Hospital
🇺🇸
Boston, Massachusetts, United States
Baptist Medical Center
🇺🇸
Little Rock, Arkansas, United States
Neurology Associates, P.A.
🇺🇸
Wilmington, Delaware, United States
Mary Free Bed Hospital & Rehabilitation Center
🇺🇸
Grand Rapids, Michigan, United States
HEALTHSOUTH Braintree Rehabilitation Hospital
🇺🇸
Braintree, Massachusetts, United States
Rehabilitation Services University of Utah Hospitals and Clinics
🇺🇸
Salt Lake City, Utah, United States
Miami Center to Cure Paralysis at the Univ. of Miami School of Medicine
🇺🇸
Miami, Florida, United States
Lakeshore Rehabilitation Hospital
🇺🇸
Birmingham, Alabama, United States
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
Drake Center
🇺🇸
Cincinnati, Ohio, United States
Barrow Neurological Institute
🇺🇸
Phoenix, Arizona, United States
University of Pittsburgh
🇺🇸
Pittsburgh, Pennsylvania, United States
Neuro-Therapeutics, Inc
🇺🇸
Pasadena, California, United States
VA Palo Alto Health Care System
🇺🇸
Palo Alto, California, United States
Rehabilitation Hospital
🇺🇸
Sunrise, Florida, United States
Shepherd Spinal Center
🇺🇸
Atlanta, Georgia, United States
Rehabilitation Institute of Chicago
🇺🇸
Chicago, Illinois, United States
Springfield Clinic-Neuroscience Institute
🇺🇸
Springfield, Illinois, United States
HEALTHSOUTH New England Rehabilitation Hospital
🇺🇸
Woburn, Massachusetts, United States
Washington University School of Medicine, Div. of Rehab/Neurology
🇺🇸
Saint Louis, Missouri, United States
Kessler Institute of Rehabilitation
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West Orange, New Jersey, United States
Wake Forest University
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Winston-Salem, North Carolina, United States
East Carolina University
🇺🇸
Greenville, North Carolina, United States
UNC Chapel Hill
🇺🇸
Chapel Hill, North Carolina, United States
Bryn Mawr Rehabilitation Hospital
🇺🇸
Malvern, Pennsylvania, United States
Northeastern Rehabilitation Associates
🇺🇸
Scranton, Pennsylvania, United States
Hampton VA Hospital
🇺🇸
Hampton, Virginia, United States
Richmond VA Medical Center (Hunter Holmes McGuire)
🇺🇸
Richmond, Virginia, United States
Foothills Provincial General Hospital
🇨🇦
Calgary, Alberta, Canada
Glenrose Rehabilitation Hospital
🇨🇦
Edmonton, Alberta, Canada
G.F. Strong Rehabilitation Centre
🇨🇦
Vancouver, British Columbia, Canada
The Rehabilitation Centre
🇨🇦
Ottawa, Ontario, Canada
Parkwood Hospital Site, St. Joseph's Health Care
🇨🇦
London, Ontario, Canada
National Rehabilitation Hospital
🇺🇸
Washington, District of Columbia, United States
Stan Cassidy Centre for Rehabilitation
🇨🇦
Fredericton, New Brunswick, Canada