Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study, sponsored by Acorda Therapeutics.
NCT00053417 is a Phase 2 study that has completed, run by Acorda Therapeutics. The registered enrollment target is 206 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary efficacy variable was the percent change from baseline in average walking speed measured using the Timed 25-Foot Walk Test during the 12-week stable dose period (the average of Study Days 56, 84, and 112), relative to the mean at baseline (placebo run-in period, the average of Study Days 7 and 14).
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 |
What the finished NCT00053417 record still lists
NCT00053417 is an interventional study that assigns participants to a tested intervention. The registered 206 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00053417 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00053417's enrollment target sits among peer trials
206 298th of 2000 higher than 1,703 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03373968 · 206 participants · Phase 2
Givinostat in Duchenne's Muscular Dystrophy Long-term Safety and Tolerability Study
- NCT03550391 · 206 participants · Phase 3
Stereotactic Radiosurgery Compared With Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5 or More Brain Metastases
- NCT04757116 · 206 participants · NA
Post-Market Study to Assess iTind Safety in Comparison to UroLift
- NCT05675865 · 206 participants · NA
Cryoablation for Monomorphic Ventricular Tachycardia
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia