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Safety and Efficacy of Oral Fampridine-SR for the Treatment of Spasticity Resulting From Spinal Cord Injury
This study has been completed.
Sponsored by: Acorda Therapeutics
Information provided by: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT00041717
  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
Phase III

MedlinePlus related topics: Spinal Cord Injuries
Drug Information available for: 4-Aminopyridine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Acorda Therapeutics:

Estimated Enrollment: 360
Study Start Date: June 2002
  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: NCT00041717

  Show 75 Study Locations
Sponsors and Collaborators
Acorda Therapeutics
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Study ID Numbers: SCI-F301/302
Study First Received: July 12, 2002
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00041717  
Health Authority: United States: Food and Drug Administration

Keywords provided by Acorda Therapeutics:
spinal cord injury
muscle spasticity

Study placed in the following topic categories:
Spinal Cord Diseases
Wounds and Injuries
Central Nervous System Diseases
Disorders of Environmental Origin
Trauma, Nervous System
Spinal Cord Injuries
Signs and Symptoms
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neurologic Manifestations
4-Aminopyridine

Additional relevant MeSH terms:
Membrane Transport Modulators
Neuromuscular Manifestations
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Nervous System Diseases
Potassium Channel Blockers
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 30, 2009