Safety and Efficacy of Oral Fampridine-Sustained Release (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
204
2 countries
30
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 Jun 2002
30 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
June 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 24, 2012
CompletedFirst Posted
Study publicly available on registry
September 12, 2012
CompletedResults Posted
Study results publicly available
February 5, 2014
CompletedAugust 25, 2017
January 1, 2014
1.4 years
August 24, 2012
July 23, 2013
July 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity
The Ashworth evaluates the functioning of two lower extremity muscle groups, the hamstring and quadriceps muscles, while in the supine position. The test measures extension of the right and left hamstring muscle and flexion of the right and left quadriceps muscle using the following 5-point grading scale: 1=no increased tone; 2=slight increase in tone, giving a "catch" when the affected part is moved in flexion or extension; 3=more marked increase in tone, but affected part is easily flexed; 4=considerable increase in tone, passive movement is difficult; 5=affected part is rigid in flexion and extension. The Ashworth Score was determined by adding all individual scores for each muscle group and dividing by four. Higher Ashworth Scores indicated greater spasticity.
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 Mean Subject's Global Impression (SGI) Scores
The SGI is a 7-unit ordinal scale used by the subject to evaluate the effects of study medication on his/her quality of life during the preceding week, with higher scores denoting greater satisfaction. A positive change score in SGI signifies improved outcome. The questionnaire consisted of one question (How do you feel about the effects of the investigational drug over the past 7 days?). The answer was based on a numerical rating scale where 1=terrible; 2=unhappy; 3=mostly dissatisfied; 4=neutral/mixed; 5=mostly satisfied; 6=pleased; 7=delighted.
Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98
Secondary Outcomes (7)
Double-blind Change From Baseline in Mean Spasm Frequency/Severity Scores
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 Mean Clinician's Global Impression (CGI) Scores
Baseline (visits 2,3) average of days 7-14 and double-blind treatment period (visits 4-7) average of days 28-98)
Stable-dose Change From Baseline in Mean American Spinal Injury Association(ASIA) Total Motor Score
Baseline (visits 2,3) average score days 7,14 and stable-dose treatment period (visits 5-7) average score days 56-98
Change From Baseline in Mean International Index of Erectile Function (IIEF) Score
Baseline (visit 1) average score obtained at day 1 and stable treatment period (visit 7) average score day 98
Change From Baseline in Mean Female Sexual Function Index (FSFI) Scores
Baseline (visit 1) average score obtained at day 1 and stable treatment period (visits 4-7) average score days 28-98
- +2 more secondary outcomes
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 (30)
UAB School of Medicine, 190 Spain Rehab Center
Birmingham, Alabama, 35233, United States
Long Beach VA Medical Center
Long Beach, California, 90822, United States
University of California, Davis
Sacramento, California, 95817, United States
Santa Clara Valley Medical Center
San Jose, California, 95128, United States
Craig Hospital
Englewood, Colorado, 80110, United States
Hospital for Special Care
New Britain, Connecticut, 06503, United States
Hines VA Hospital
Hines, Illinois, 60141, United States
Boston University Medical Center
Boston, Massachusetts, 02118, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Rehabilitation Institute of Michigan
Detroit, Michigan, 48201, United States
Minneapolis VA Hospital
Minneapolis, Minnesota, 55417, United States
University of Missouri
Columbia, Missouri, 65212, United States
St. Louis University
St Louis, Missouri, 63104, United States
University of Rochester/Strong Memorial Hospital
Rochester, New York, 14642, United States
SUNY Upstate Clinical Trials Office
Syracuse, New York, 13045, United States
Helen Hayes Hospital
West Haverstraw, New York, 13045, United States
Charlotte Institute of Rehabilitation
Charlotte, North Carolina, 28203, United States
Coastal AHEC
Wilmington, North Carolina, 28402, United States
Ohio State University
Columbus, Ohio, 43210, United States
Miami Valley Hospital- Rehabilitation Institute of Medicine
Dayton, Ohio, 45409, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
VA North Texas Health Care System
Dallas, Texas, 75216, United States
Southwestern Medical Center at Dallas
Dallas, Texas, 75390, United States
INOVA Institute of Research and Education
Falls Church, Virginia, 22042, United States
Medical College of Virginia/VCU
Richmond, Virginia, 23298, United States
University of Washington Medical Center, Dept. of Rehabilitation
Seattle, Washington, 98195, United States
Wood VA Medical Center
Milwaukee, Wisconsin, 53295, United States
Health Sciences Centre
Winnipeg, Manitoba, R3A 1M4, Canada
Chedoke-McMaster Hospital
Hamilton, Ontario, L8N 3Z5, Canada
St. Mary's of the Lake Hospital
Kingston, Ontario, K7L 5A2, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Scientific Officer
- Organization
- Acorda Therapeutics, Inc.
Study Officials
- STUDY DIRECTOR
Andrew Blight, MD
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
August 24, 2012
First Posted
September 12, 2012
Study Start
June 1, 2002
Primary Completion
November 1, 2003
Study Completion
February 1, 2004
Last Updated
August 25, 2017
Results First Posted
February 5, 2014
Record last verified: 2014-01