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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: Completed Phase 3 study of Spinal Cord Injury and Muscle Spasticity, sponsored by Acorda Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Ashworth Score is the average rating (based on a scale of 1 to 5) of four lower extremity muscle groups; left and right knee flexors and extensors (hamstrings and quadriceps muscles). A higher Ashworth Score indicates a greater degree of abnormal muscle tone (spasticity) and a negative change in score indicates improvement.
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 |
What the finished NCT00041717 record still lists
NCT00041717 is an interventional study that assigns participants to a tested intervention. The registered 213 participants enrollment target is mid-sized for trials with a published cap, above the 84-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (154% higher).
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
Similar trials for Spinal Cord Injury
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00041717's enrollment target sits among peer trials
213 6th of 99 higher than 94 of 99 other Spinal Cord Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Spinal Cord Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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