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



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

For Condition: Spinal Cord Injury,Muscle Spasticity
Status: Completed
Sponsor(s): Acorda Therapeutics ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 360

Location and Contact Information:

Hampton VA Hospital
Hampton,  Virginia,  23667
United States
 

Hospital for Special Care
New Britain,  Connecticut,  06503
United States
 

Good Shepherd Rehabilitation
Allentown,  Pennsylvania, 
United States
 

Cleveland VAMC
Cleveland,  Ohio,  44106
United States
 

VA Palo Alto Health Care System
Palo Alto,  California,  94304
United States
 

Health Sciences Centre
Winnipeg,  Manitoba,  R3A 1M4
Canada
 

UNC Chapel Hill
Chapel Hill,  North Carolina,  27599
United States
 

Charlotte Institute of Rehabilitation
Charlotte,  North Carolina,  28203
United States
 

Kessler Institute of Rehabilitation
West Orange,  New Jersey,  07052
United States
 

National Rehabilitation Hospital
Washington D.C.,  District of Columbia,  20010
United States
 

Santa Clara Valley Medical Center
San Jose,  California,  95128
United States
 

QEII HSC-Nova Scotia Rehabilitation Centre
Halifax,  Nova Scotia,  B3M 4K4
Canada
 

Mayo Clinic
Rochester,  Minnesota,  55905
United States
 

Wake Forest University
Winston Salem,  North Carolina,  27157
United States
 

Hines VA Hospital
Hines,  Illinois,  60141
United States
 

Miami Valley Hospital- Rehabilitation Institute of Medicine
Dayton,  Ohio,  45409
United States
 

Montana Neuroscience
Missouli,  Montana, 
United States
 

Craig Hospital
Englewood,  Colorado,  80110
United States
 

G.F. Strong Rehabilitation Centre
Vancouver,  British Columbia,  V5Z 2G9
Canada
 

Rehabilitation Institute of Chicago
Chicago,  Illinois,  60611
United States
 

INOVA Institute of Research and Education
Falls Church,  Virginia,  22042
United States
 

HEALTHSOUTH Harmarville Rehabilitation Hospital
Pittsburgh,  Pennsylvania,  15238
United States
 

Parkwood Hospital Site, St. Joseph's Health Care
London,  Ontario,  N6C 5J1
Canada
 

Rehabilitation Institute of Michigan
Detroit,  Michigan,  48201
United States
 

Clinical Research Services
Bismark,  North Dakota,  58501
United States
 

Mary Free Bed Hospital & Rehabilitation Center
Grand Rapids,  Michigan,  49503
United States
 

University of Michigan
Ann Arbor,  Michigan,  48109
United States
 

Minneapolis VA Hospital
Minneapolis,  Minnesota,  55417
United States
 

The Burke Rehabilitation Hospital
White Plains,  New York,  10605
United States
 

Coastal AHEC
Wilmington,  North Carolina,  28402
United States
 

University of Washington Medical Center, Dept. of Rehabilitation
Seattle,  Washington,  98195
United States
 

Neurology Associates, P.A.
Wilmington,  Delaware,  19806
United States
 

Bryn Mawr Rehabilitation Hospital
Malvern,  Pennsylvania,  19355
United States
 

Long Beach VA Medical Center
Long Beach,  California,  90822
United States
 

Chedoke-McMaster Hospital
Hamilton,  Ontario,  L8N 3Z5
Canada
 

St. Mary's of the Lake Hospital
Kingston,  Ontario,  K7L 5A2
Canada
 

Southwestern Medical Center at Dallas
Dallas,  Texas,  75390
United States
 

Springfield Clinic-Neuroscience Institute
Springfield,  Illinois,  62702
United States
 

Thomas Jefferson University Hospital
Philadelphia,  Pennsylvania,  19107
United States
 

Lakeshore Rehabilitation Hospital
Birmingham,  Alabama,  35209
United States
 

Advocate Christ Medical Center-Dept. of Physical Medicine & Rehabilitation-EMG
Oak Lawn,  Illinois,  60453
United States
 

Medical College of Virginia/VCU
Richmond,  Virginia,  23298
United States
 

Miami Center to Cure Paralysis at the Univ. of Miami School of Medicine
Miami,  Florida,  33136
United States
 

St. Louis University
St. Louis,  Missouri,  63104
United States
 

Richmond VA Medical Center (Hunter Holmes McGuire)
Richmond,  Virginia,  23249
United States
 

Spaulding Rehabilitation Hospital
Boston,  Massachusetts,  02114
United States
 

HEALTHSOUTH New England Rehabilitation Hospital
Woburn,  Massachusetts,  01801
United States
 

Foothills Provincial General Hospital
Calgary,  Alberta,  T2N 2T9
Canada
 

Drake Center
Cincinnati,  Ohio,  45216
United States
 

East Carolina University
Greenville,  North Carolina,  27858
United States
 

Barrow Neurological Institute
Phoenix,  Arizona,  85013
United States
 

Ohio State University
Columbus,  Ohio,  43210
United States
 

Northeastern Rehabilitation Associates
Scranton,  Pennsylvania,  18501
United States
 

SUNY Upstate Clinical Trials Office
Syracuse,  New York,  13045
United States
 

Boston University Medical Center
Boston,  Massachusetts,  02118
United States
 

Helen Hayes Hospital
West Haverstraw,  New York,  13045
United States
 

HEALTHSOUTH Braintree Rehabilitation Hospital
Braintree,  Massachusetts,  02185
United States
 

Toronto Rehabilitation Institute, Lyndhurst Centre
Toronto,  Ontario,  M5G 3V9
Canada
 

CAMC Health Education & Research Institute
Charleston,  West Virginia,  25304
United States
 

VA North Texas Health Care System
Dallas,  Texas,  75216
United States
 

Stan Cassidy Centre for Rehabilitation
Fredericton,  New Brunswick,  E3B 4R3
Canada
 

Baptist Medical Center
Little Rock,  Arkansas,  72205
United States
 

Glenrose Rehabilitation Hospital
Edmonton,  Alberta,  T5G 0B7
Canada
 

Wood VA Medical Center
Milwaukee,  Wisconsin,  53295
United States
 

Washington University School of Medicine, Div. of Rehab/Neurology
St. Louis,  Missouri,  63110
United States
 

University of California, Davis
Sacramento,  California,  95817
United States
 

Shepherd Spinal Center
Atlanta,  Georgia,  30309
United States
 

Rehabilitation Services University of Utah Hospitals and Clinics
Salt Lake City,  Utah,  84132
United States
 

University of Pittsburgh
Pittsburgh,  Pennsylvania,  15213
United States
 

The Rehabilitation Centre
Ottawa,  Ontario,  K1H 8M2
Canada
 

University of Missouri
Columbia,  Missouri,  65212
United States
 

University of Rochester/Strong Memorial Hospital
Rochester,  New York,  14642
United States
 

Rehabilitation Hospital
Sunrise,  Florida,  33351
United States
 

Neuro-Therapeutics, Inc
Pasadena,  California,  91005
United States
 

UAB School of Medicine, 190 Spain Rehab Center
Birmingham,  Alabama,  35233
United States
 


Additional Information:
Study ID Numbers:
  SCI-F301/302; 
Study Start Date: June 2002
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00041717

Other Muscle Spasticity Studies:
1. Physical Performance Measures for Manual Wheelchair Users

2. Functional Magnetic Micturition in Patients w/SCI

3. Study of an Implantable Functional Neuromuscular Stimulation System for Patients with Spinal Cord Injuries

4. Electrical Control of Bladder in Spinal Cord Injury Patients

5. Study of Bilateral Phrenic Nerve Pacing Via Intramuscular Electrodes Surgically Implanted Into the Diaphragm To Achieve Artificial Ventilation in Patients With Ventilator-Dependent Tetraplegia

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

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