Double-Blind, Placebo-Controlled, 20-Week, Parallel Group Study to Evaluate Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple Sclerosis
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Multiple Sclerosis
- Sponsor
- Acorda Therapeutics
- Enrollment
- 206
- Locations
- 25
- Primary Endpoint
- Median Percent Change From Baseline in Average Walking Speed on Timed 25-Foot Walk Test
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
1
Placebo control, twice a day (b.i.d.)
Intervention: Placebo
2
10 milligram (mg) fampridine b.i.d.
Intervention: 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP)
3
15 mg fampridine b.i.d.
Intervention: 15 mg fampridine-SR (4-aminopyridine, 4-AP)
4
20 mg fampridine b.i.d.
Intervention: 20 mg fampridine-SR (4-aminopyridine, 4-AP)
Outcomes
Primary Outcomes
Median Percent Change From Baseline in Average Walking Speed on Timed 25-Foot Walk Test
Time Frame: Baseline (placebo run-in period); 12-week stable dose period
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).