Safety and Efficacy of Oral Fampridine-SR for the Treatment of Spasticity Resulting From Spinal Cord Injury
Double-Blind, Placebo-Controlled, 12-Week Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR in Subjects With Moderate to Severe Spasticity Resulting From Chronic, Incomplete Spinal Cord Injury
1 other identifier
interventional
213
2 countries
45
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2002
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2002
CompletedFirst Submitted
Initial submission to the registry
July 12, 2002
CompletedFirst Posted
Study publicly available on registry
July 16, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2004
CompletedResults Posted
Study results publicly available
May 31, 2013
CompletedJanuary 14, 2020
April 1, 2013
1.6 years
July 12, 2002
February 26, 2013
January 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity
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.
Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98
Double-blind Change From Baseline in Subject's Global Impression (SGI) of Treatment
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.
Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98
Study Arms (2)
fampridine-SR 50mg/day
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
Lakeshore Rehabilitation Hospital
Birmingham, Alabama, 35209, United States
Barrow Neurological Institute
Phoenix, Arizona, 85013, United States
Baptist Medical Center
Little Rock, Arkansas, 72205, United States
VA Palo Alto Health Care System
Palo Alto, California, 94304, United States
Neuro-Therapeutics, Inc
Pasadena, California, 91005, United States
Neurology Associates, P.A.
Wilmington, Delaware, 19806, United States
National Rehabilitation Hospital
Washington D.C., District of Columbia, 20010, United States
Miami Center to Cure Paralysis at the Univ. of Miami School of Medicine
Miami, Florida, 33136, United States
Rehabilitation Hospital
Sunrise, Florida, 33351, United States
Shepherd Spinal Center
Atlanta, Georgia, 30309, United States
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611, United States
Advocate Christ Medical Center-Dept. of Physical Medicine & Rehabilitation-EMG
Oak Lawn, Illinois, 60453, United States
Springfield Clinic-Neuroscience Institute
Springfield, Illinois, 62702, United States
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02114, United States
HEALTHSOUTH Braintree Rehabilitation Hospital
Braintree, Massachusetts, 02185, United States
HEALTHSOUTH New England Rehabilitation Hospital
Woburn, Massachusetts, 01801, United States
Mary Free Bed Hospital & Rehabilitation Center
Grand Rapids, Michigan, 49503, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Washington University School of Medicine, Div. of Rehab/Neurology
St Louis, Missouri, 63110, United States
Montana Neuroscience
Missoula, Montana, 59802, United States
Kessler Institute of Rehabilitation
West Orange, New Jersey, 07052, United States
The Burke Rehabilitation Hospital
White Plains, New York, 10605, United States
UNC Chapel Hill
Chapel Hill, North Carolina, 27599, United States
East Carolina University
Greenville, North Carolina, 27858, United States
Wake Forest University
Winston-Salem, North Carolina, 27157, United States
Clinical Research Services
Bismarck, North Dakota, 58501, United States
Drake Center
Cincinnati, Ohio, 45216, United States
Cleveland VAMC
Cleveland, Ohio, 44106, United States
Good Shepherd Rehabilitation
Allentown, Pennsylvania, 18103, United States
Bryn Mawr Rehabilitation Hospital
Malvern, Pennsylvania, 19355, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
HEALTHSOUTH Harmarville Rehabilitation Hospital
Pittsburgh, Pennsylvania, 15238, United States
Northeastern Rehabilitation Associates
Scranton, Pennsylvania, 18501, United States
Rehabilitation Services University of Utah Hospitals and Clinics
Salt Lake City, Utah, 84132, United States
Hampton VA Hospital
Hampton, Virginia, 23667, United States
Richmond VA Medical Center (Hunter Holmes McGuire)
Richmond, Virginia, 23249, United States
CAMC Health Education & Research Institute
Charleston, West Virginia, 25304, United States
Foothills Provincial General Hospital
Calgary, Alberta, T2N 2T9, Canada
Glenrose Rehabilitation Hospital
Edmonton, Alberta, T5G 0B7, Canada
G.F. Strong Rehabilitation Centre
Vancouver, British Columbia, V5Z 2G9, Canada
Stan Cassidy Centre for Rehabilitation
Fredericton, New Brunswick, E3B 4R3, Canada
QEII HSC-Nova Scotia Rehabilitation Centre
Halifax, Nova Scotia, B3M 4K4, Canada
Parkwood Hospital Site, St. Joseph's Health Care
London, Ontario, N6C 5J1, Canada
The Rehabilitation Centre
Ottawa, Ontario, K1H 8M2, Canada
Toronto Rehabilitation Institute, Lyndhurst Centre
Toronto, Ontario, M5G 3V9, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Andrew Blight, Ph.D. Chief Scientific Officer
- Organization
- Acorda Therapeutics, Inc.
Study Officials
- STUDY DIRECTOR
Andrew Blight
Acorda Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2002
First Posted
July 16, 2002
Study Start
July 1, 2002
Primary Completion
February 1, 2004
Study Completion
May 1, 2004
Last Updated
January 14, 2020
Results First Posted
May 31, 2013
Record last verified: 2013-04