Spinal Cord Injury Clinical Trial
Official title:
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
NCT number | NCT00041717 |
Other study ID # | SCI-F301 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | July 2002 |
Est. completion date | May 2004 |
Verified date | April 2013 |
Source | Acorda Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 213 |
Est. completion date | May 2004 |
Est. primary completion date | February 2004 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Foothills Provincial General Hospital | Calgary | Alberta |
Canada | Glenrose Rehabilitation Hospital | Edmonton | Alberta |
Canada | Stan Cassidy Centre for Rehabilitation | Fredericton | New Brunswick |
Canada | QEII HSC-Nova Scotia Rehabilitation Centre | Halifax | Nova Scotia |
Canada | Parkwood Hospital Site, St. Joseph's Health Care | London | Ontario |
Canada | The Rehabilitation Centre | Ottawa | Ontario |
Canada | Toronto Rehabilitation Institute, Lyndhurst Centre | Toronto | Ontario |
Canada | G.F. Strong Rehabilitation Centre | Vancouver | British Columbia |
United States | Good Shepherd Rehabilitation | Allentown | Pennsylvania |
United States | Shepherd Spinal Center | Atlanta | Georgia |
United States | Lakeshore Rehabilitation Hospital | Birmingham | Alabama |
United States | Clinical Research Services | Bismarck | North Dakota |
United States | Spaulding Rehabilitation Hospital | Boston | Massachusetts |
United States | HEALTHSOUTH Braintree Rehabilitation Hospital | Braintree | Massachusetts |
United States | UNC Chapel Hill | Chapel Hill | North Carolina |
United States | CAMC Health Education & Research Institute | Charleston | West Virginia |
United States | Rehabilitation Institute of Chicago | Chicago | Illinois |
United States | Drake Center | Cincinnati | Ohio |
United States | Cleveland VAMC | Cleveland | Ohio |
United States | Mary Free Bed Hospital & Rehabilitation Center | Grand Rapids | Michigan |
United States | East Carolina University | Greenville | North Carolina |
United States | Hampton VA Hospital | Hampton | Virginia |
United States | Baptist Medical Center | Little Rock | Arkansas |
United States | Bryn Mawr Rehabilitation Hospital | Malvern | Pennsylvania |
United States | Miami Center to Cure Paralysis at the Univ. of Miami School of Medicine | Miami | Florida |
United States | Montana Neuroscience | Missoula | Montana |
United States | Advocate Christ Medical Center-Dept. of Physical Medicine & Rehabilitation-EMG | Oak Lawn | Illinois |
United States | VA Palo Alto Health Care System | Palo Alto | California |
United States | Neuro-Therapeutics, Inc | Pasadena | California |
United States | Barrow Neurological Institute | Phoenix | Arizona |
United States | HEALTHSOUTH Harmarville Rehabilitation Hospital | Pittsburgh | Pennsylvania |
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
United States | Richmond VA Medical Center (Hunter Holmes McGuire) | Richmond | Virginia |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Washington University School of Medicine, Div. of Rehab/Neurology | Saint Louis | Missouri |
United States | Rehabilitation Services University of Utah Hospitals and Clinics | Salt Lake City | Utah |
United States | Northeastern Rehabilitation Associates | Scranton | Pennsylvania |
United States | Springfield Clinic-Neuroscience Institute | Springfield | Illinois |
United States | Rehabilitation Hospital | Sunrise | Florida |
United States | National Rehabilitation Hospital | Washington | District of Columbia |
United States | Kessler Institute of Rehabilitation | West Orange | New Jersey |
United States | The Burke Rehabilitation Hospital | White Plains | New York |
United States | Neurology Associates, P.A. | Wilmington | Delaware |
United States | Wake Forest University | Winston-Salem | North Carolina |
United States | HEALTHSOUTH New England Rehabilitation Hospital | Woburn | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Acorda Therapeutics |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 |
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