Phase 2
N=206
Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple Sclerosis
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT00053417 ↗Enrolled (actual)
206
Serious AEs
6.3%
Results posted
Aug 2011
Primary outcome: Primary: Median Percent Change From Baseline in Average Walking Speed on Timed 25-Foot Walk Test — 1.2; 7.5; 9.7; 6.9 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- 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)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Acorda Therapeutics
- Primary completion
- Dec 2003
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Percent Change From Baseline in Average Walking Speed on Timed 25-Foot Walk Test |
1.2; 7.5; 9.7; 6.9 | — |
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.
Eligibility Criteria
INCLUSION CRITERIA
- Have a confirmed diagnosis of Multiple Sclerosis
- Are able to walk with or without an assisted device
EXCLUSION CRITERIA
- Pregnancy, breastfeeding or females of childbearing potential not using adequate birth control
- Participating in other investigational drug trials
- A medical history or clinical findings that preclude entry into the study
- A medication history that precludes entry into the study
- Previously treated with 4-aminopyridine (4-AP)
Data sourced from ClinicalTrials.gov (NCT00053417). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.