Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Safety and Efficacy of Oral Fampridine-SR for the Treatment of Spasticity Resulting From Spinal Cord Injury
NCT00041717 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 213 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Acorda Therapeutics, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00041717 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Illinois, Massachusetts, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00041717?
The interventions under investigation include: Placebo (OTHER), Fampridine-SR (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00041717?
This trial is sponsored by Acorda Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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