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NCT00053417 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple Sclerosis
A Phase 2 study, sponsored by Acorda Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 206
- Enrollment target
NCT00053417 is a Phase 2 study that has completed, run by Acorda Therapeutics. The registered enrollment target is 206 participants.
The verdict
NCT00053417, a Phase 2 study, has completed, sponsored by Acorda Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 206 participants
- Enrollment target
Study Summary
Multiple Sclerosis (MS) is a disorder of the body's immune system that affects the Central Nervous System (CNS). Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with MS, the fatty sheath that surrounds and insulates the nerve fibers (called "myelin") deteriorates, causing nerve impulses to be slowed or stopped. As a result patients with MS may experience periods of muscle weakness and other symptoms such as numbness, loss of vision, loss of coordination, paralysis, spasticity, mental and physical fatigue and a decrease in the ability to think and/or remember. These periods of illness may come (exacerbations) and go (remissions). Fampridine-SR (Sustained Release, SR) is an experimental drug that increases the ability of the nerve to conduct electrical impulses. This study will evaluate the effects of Fampridine-SR on the walking ability of subjects with MS, as well as to examine the effects on muscle strength and spasticity. The study will also examine the possible risks of taking Fampridine-SR.
Interventions
- DRUG Placebo
- DRUG 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP)
- DRUG 15 mg fampridine-SR (4-aminopyridine, 4-AP)
- DRUG 20 mg fampridine-SR (4-aminopyridine, 4-AP)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 206 participants |
| Start Date | 2003-02 |
| Est. Completion | 2003-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00053417
The ClinicalTrials.gov registry entry for NCT00053417 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 206 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Acorda Therapeutics, which has 36 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00053417 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00053417 about?
NCT00053417 is a clinical study titled "Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple Sclerosis". Multiple Sclerosis (MS) is a disorder of the body's immune system that affects the Central Nervous System (CNS). Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with MS, the fatty sheath that surroun...
What is the current status of trial NCT00053417?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 206 participants. The study started on 2003-02. Estimated completion is 2003-12.
What interventions are being tested in trial NCT00053417?
The interventions under investigation include: Placebo (DRUG), 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP) (DRUG), 15 mg fampridine-SR (4-aminopyridine, 4-AP) (DRUG), 20 mg fampridine-SR (4-aminopyridine, 4-AP) (DRUG).
Who is sponsoring clinical trial NCT00053417?
This trial is sponsored by Acorda Therapeutics, which has 36 total clinical trials registered on ClinicalTrials.gov.
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