Safety and Efficacy of Oral Fampridine-Sustained Release (SR) for the Treatment of Spasticity Resulting From Spinal Cord Injury

Completed · Phase 3 · Has a placebo group

Conditions studied: Spinal Cord Injury, Muscle Spasticity

In brief

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.

Key facts

Study ID

NCT01683838

Run by

Acorda Therapeutics

People needed

204

Starts

2002-06-01

Expected to finish

2004-02-01

Last updated by the study team

2017-08-25

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• UAB School of Medicine, 190 Spain Rehab Center — Birmingham, Alabama, United States
• Long Beach VA Medical Center — Long Beach, California, United States
• University of California, Davis — Sacramento, California, United States
• Santa Clara Valley Medical Center — San Jose, California, United States
• Craig Hospital — Englewood, Colorado, United States
• Hospital for Special Care — New Britain, Connecticut, United States
• Hines VA Hospital — Hines, Illinois, United States
• Boston University Medical Center — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Rehabilitation Institute of Michigan — Detroit, Michigan, United States
• Minneapolis VA Hospital — Minneapolis, Minnesota, United States
• University of Missouri — Columbia, Missouri, United States
• St. Louis University — St Louis, Missouri, United States
• University of Rochester/Strong Memorial Hospital — Rochester, New York, United States
• SUNY Upstate Clinical Trials Office — Syracuse, New York, United States
• Helen Hayes Hospital — West Haverstraw, New York, United States
• Charlotte Institute of Rehabilitation — Charlotte, North Carolina, United States
• Coastal AHEC — Wilmington, North Carolina, United States
• Ohio State University — Columbus, Ohio, United States
• Miami Valley Hospital- Rehabilitation Institute of Medicine — Dayton, Ohio, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• VA North Texas Health Care System — Dallas, Texas, United States
• Southwestern Medical Center at Dallas — Dallas, Texas, United States
• INOVA Institute of Research and Education — Falls Church, Virginia, United States
• Medical College of Virginia/VCU — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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