Safety and Efficacy of Oral Fampridine-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

NCT00041717

Run by

Acorda Therapeutics

People needed

213

Starts

2002-07-01

Expected to finish

2004-05-01

Last updated by the study team

2020-01-14

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

• Lakeshore Rehabilitation Hospital — Birmingham, Alabama, United States
• Barrow Neurological Institute — Phoenix, Arizona, United States
• Baptist Medical Center — Little Rock, Arkansas, United States
• VA Palo Alto Health Care System — Palo Alto, California, United States
• Neuro-Therapeutics, Inc — Pasadena, California, United States
• Neurology Associates, P.A. — Wilmington, Delaware, United States
• National Rehabilitation Hospital — Washington D.C., District of Columbia, United States
• Miami Center to Cure Paralysis at the Univ. of Miami School of Medicine — Miami, Florida, United States
• Rehabilitation Hospital — Sunrise, Florida, United States
• Shepherd Spinal Center — Atlanta, Georgia, United States
• Rehabilitation Institute of Chicago — Chicago, Illinois, United States
• Advocate Christ Medical Center-Dept. of Physical Medicine & Rehabilitation-EMG — Oak Lawn, Illinois, United States
• Springfield Clinic-Neuroscience Institute — Springfield, Illinois, United States
• Spaulding Rehabilitation Hospital — Boston, Massachusetts, United States
• HEALTHSOUTH Braintree Rehabilitation Hospital — Braintree, Massachusetts, United States
• HEALTHSOUTH New England Rehabilitation Hospital — Woburn, Massachusetts, United States
• Mary Free Bed Hospital & Rehabilitation Center — Grand Rapids, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University School of Medicine, Div. of Rehab/Neurology — St Louis, Missouri, United States
• Montana Neuroscience — Missoula, Montana, United States
• Kessler Institute of Rehabilitation — West Orange, New Jersey, United States
• The Burke Rehabilitation Hospital — White Plains, New York, United States
• UNC Chapel Hill — Chapel Hill, North Carolina, United States
• East Carolina University — Greenville, North Carolina, United States
• Wake Forest University — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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