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NCT00041717 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Oral Fampridine-SR for the Treatment of Spasticity Resulting From Spinal Cord Injury
A Phase 3 study of Spinal Cord Injury and Muscle Spasticity, sponsored by Acorda Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 213
- Enrollment target
- 20
- Study locations
NCT00041717 is a Phase 3 study of Spinal Cord Injury and Muscle Spasticity that has completed, run by Acorda Therapeutics. The registered enrollment target is 213 participants, above the 84-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (154% higher). The trial reports 20 study locations across 14 states.
The verdict
NCT00041717, a Phase 3 study of Spinal Cord Injury and Muscle Spasticity, has completed, sponsored by Acorda Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 213 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Fampridine-SR
Study Locations (20)
Illinois
- Rehabilitation Institute of Chicago - Chicago
- Advocate Christ Medical Center-Dept. of Physical Medicine & Rehabilitation-EMG - Oak Lawn
- Springfield Clinic-Neuroscience Institute - Springfield
Massachusetts
- Spaulding Rehabilitation Hospital - Boston
- HEALTHSOUTH Braintree Rehabilitation Hospital - Braintree
- HEALTHSOUTH New England Rehabilitation Hospital - Woburn
California
- VA Palo Alto Health Care System - Palo Alto
- Neuro-Therapeutics, Inc - Pasadena
Florida
- Miami Center to Cure Paralysis at the Univ. of Miami School of Medicine - Miami
- Rehabilitation Hospital - Sunrise
Alabama
- Lakeshore Rehabilitation Hospital - Birmingham
Arizona
- Barrow Neurological Institute - Phoenix
Arkansas
- Baptist Medical Center - Little Rock
Delaware
- Neurology Associates, P.A. - Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 213 participants |
| Start Date | 2002-07 |
| Est. Completion | 2004-05 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00041717
The ClinicalTrials.gov registry entry for NCT00041717 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 213 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 84-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (154% higher). The listed sponsor is Acorda Therapeutics, which has 36 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Spinal Cord Injury appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00041717 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Illinois, Massachusetts, California.
Frequently Asked Questions
What is clinical trial NCT00041717 about?
NCT00041717 is a clinical study titled "Safety and Efficacy of Oral Fampridine-SR for the Treatment of Spasticity Resulting From Spinal Cord Injury". 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 electrica...
What is the current status of trial NCT00041717?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 213 participants. The study started on 2002-07. Estimated completion is 2004-05.
What conditions does trial NCT00041717 study?
This clinical trial studies the following conditions: Spinal Cord Injury, Muscle Spasticity.
What interventions are being tested in trial NCT00041717?
The interventions under investigation include: Placebo (OTHER), Fampridine-SR (DRUG).
Who is sponsoring clinical trial NCT00041717?
This trial is sponsored by Acorda Therapeutics, which has 36 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00041717 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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