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

Purpose

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.

Condition	Intervention	Phase
Spinal Cord Injury Muscle Spasticity	Drug: Fampridine-SR Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Spinal Cord Injuries

Drug Information available for: Dalfampridine

U.S. FDA Resources

Further study details as provided by Acorda Therapeutics:

Primary Outcome Measures:

Change from baseline in Ashworth score evaluating spasticity [ Time Frame: Baseline stable dose treatment (Average of days 7-14) and baseline double blind treatment period (average of days 28-98) ] [ Designated as safety issue: No ]
The Ashworth score is the average rating by the clinician of four lower extremity muscle groups (left and right knee flexors and extensors), each evaluated on a 1-5 unit ordinal scale
Change from baseline in Subject's Global Impression (SGI) of treatment [ Time Frame: Baseline stable dose treatment (Average of days 7-14) and baseline double blind treatment period (average of days 28-98) ] [ Designated as safety issue: No ]
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

Enrollment:	204
Study Start Date:	June 2002
Study Completion Date:	February 2004
Primary Completion Date:	November 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: fampridine-SR 50mg/day	Drug: Fampridine-SR 25mg bid (twice daily)
Placebo Comparator: Placebo	Drug: Placebo Placebo

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01683838

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Locations

United States, Alabama
UAB School of Medicine, 190 Spain Rehab Center
Birmingham, Alabama, United States, 35233
United States, California
Long Beach VA Medical Center
Long Beach, California, United States, 90822
University of California, Davis
Sacramento, California, United States, 95817
Santa Clara Valley Medical Center
San Jose, California, United States, 95128
United States, Colorado
Craig Hospital
Englewood, Colorado, United States, 80110
United States, Connecticut
Hospital for Special Care
New Britain, Connecticut, United States, 06503
United States, Illinois
Hines VA Hospital
Hines, Illinois, United States, 60141
United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Rehabilitation Institute of Michigan
Detroit, Michigan, United States, 48201
United States, Minnesota
Minneapolis VA Hospital
Minneapolis, Minnesota, United States, 55417
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65212
St. Louis University
St. Louis, Missouri, United States, 63104
United States, New York
University of Rochester/Strong Memorial Hospital
Rochester, New York, United States, 14642
SUNY Upstate Clinical Trials Office
Syracuse, New York, United States, 13045
Helen Hayes Hospital
West Haverstraw, New York, United States, 13045
United States, North Carolina
Charlotte Institute of Rehabilitation
Charlotte, North Carolina, United States, 28203
Coastal AHEC
Wilmington, North Carolina, United States, 28402
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Miami Valley Hospital- Rehabilitation Institute of Medicine
Dayton, Ohio, United States, 45409
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
VA North Texas Health Care System
Dallas, Texas, United States, 75216
Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
United States, Virginia
INOVA Institute of Research and Education
Falls Church, Virginia, United States, 22042
Medical College of Virginia/VCU
Richmond, Virginia, United States, 23298
United States, Washington
University of Washington Medical Center, Dept. of Rehabilitation
Seattle, Washington, United States, 98195
United States, Wisconsin
Wood VA Medical Center
Milwaukee, Wisconsin, United States, 53295
Canada, Manitoba
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1M4
Canada, Ontario
Chedoke-McMaster Hospital
Hamilton, Ontario, Canada, L8N 3Z5
St. Mary's of the Lake Hospital
Kingston, Ontario, Canada, K7L 5A2

Sponsors and Collaborators

Acorda Therapeutics

Investigators

Study Director:

Andrew Blight, MD

Acorda Therapeutics

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Acorda Therapeutics
ClinicalTrials.gov Identifier:	NCT01683838 History of Changes
Other Study ID Numbers:	SCI-F302
Study First Received:	August 24, 2012
Last Updated:	September 10, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Acorda Therapeutics:

spinal cord injury
muscle spasticity

Additional relevant MeSH terms:

Muscle Spasticity
Spinal Cord Injuries
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Cord Diseases

Central Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
4-Aminopyridine
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013