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

This study has been completed.

First Received on July 12, 2002. Last Updated on June 23, 2005 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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: 4-Aminopyridine

U.S. FDA Resources

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

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00041717 History of Changes
Other Study ID Numbers:	SCI-F301/302
Study First Received:	July 12, 2002
Last Updated:	June 23, 2005
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 February 12, 2012