Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple Sclerosis
Public ClinicalTrials.gov record NCT00053417. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Double-Blind, Placebo-Controlled, 20-Week, Parallel Group Study to Evaluate Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple Sclerosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00053417
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 206 participants
Conditions and interventions
Conditions
Interventions
- 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
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2003
- Primary completion
- Nov 30, 2003
- Completion
- Nov 30, 2003
- Last update posted
- Aug 3, 2011
2003
United States locations
- U.S. sites
- 23
- U.S. states
- 18
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Barrow Neurological Institute at St. Joseph Hospital and Medical Center | Phoenix | Arizona | 85013 | — |
| USC MS Comprehensive Care Center | Los Angeles | California | 90033 | — |
| Yale University MS Center | New Haven | Connecticut | 06510 | — |
| Shepherd Center | Atlanta | Georgia | 30309 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| University of Maryland at Baltimore | Baltimore | Maryland | 21210 | — |
| Fairview MS Center | Minneapolis | Minnesota | 55454 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Gimbel MS Center | Teaneck | New Jersey | 07666 | — |
| University of New Mexico | Albuquerque | New Mexico | 87131 | — |
| Maimonides MS Care Center | Brooklyn | New York | 11219 | — |
| Mt. Sinai School of Medicine - MS Center | New York | New York | 10029 | — |
| University of Rochester Medical School | Rochester | New York | 14642 | — |
| SUNY Stony Brook | Stony Brook | New York | 11794 | — |
| Carolinas Medical Center MS Center | Charlotte | North Carolina | 28207 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Ohio State University | Columbus | Ohio | 43210 | — |
| Oregon Health Sciences University; MS Center | Portland | Oregon | 97201 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| University of Texas-Houston | Houston | Texas | 77030 | — |
| Swedish Medical MS Center | Seattle | Washington | 98122 | — |
| University of Washington School of Medicine | Seattle | Washington | 98195 | — |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00053417, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 3, 2011 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00053417 live on ClinicalTrials.gov.