At a glance
ClinicalIndex Comparison Record- ✓Confirmed diagnosis of Multiple Sclerosis
- ✓Able to walk with or without an assisted device
- ✕Pregnancy, breastfeeding, or female of childbearing potential without adequate birth control
- ✕Prior treatment with 4-aminopyridine (4-AP)
- ✕Participation in other investigational drug trials
- ✕Medical history or clinical findings that preclude entry into the study
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Double-Blind, Placebo-Controlled, 20-Week, Parallel Group Study to Evaluate Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple Sclerosis
In Brief
A Phase 2 clinical trial evaluating Placebo, 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP), and 2 other interventions for Multiple Sclerosis. Completed, enrolled 206 participants across 25 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
Placebo for 15 weeks
2 week up titration (10 mg) 12 weeks stable dose (10 mg) 1 week down titration (10 mg)
10 mg twice daily for 1 week 15 mg twice daily for 14 weeks 2 week up titration (10 mg x 1 week, 15 mg x 1 week) 12 weeks stable dose (15 mg) 1 week down titration (10 mg)
2 week up titration (10 mg x 1 week, 15 mg x 1 week) 12 weeks stable dose (20 mg) 1 week down titration (15 mg x 3 days, 10 mg x 4 days)