NCT00053417

Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple Sclerosis

Double-Blind, Placebo-Controlled, 20-Week, Parallel Group Study to Evaluate Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple Sclerosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Acorda Therapeutics · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Placebo	Placebo for 15 weeks
DRUG	10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP)	2 week up titration (10 mg) 12 weeks stable dose (10 mg) 1 week down titration (10 mg)
DRUG	15 mg fampridine-SR (4-aminopyridine, 4-AP)	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)
DRUG	20 mg fampridine-SR (4-aminopyridine, 4-AP)	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)

Timeline

• Start date: 2003-02-01
• Primary completion: 2003-12-01
• Completion: 2003-12-01
• First posted: 2003-01-30
• Last updated: 2011-08-04
• Results posted: 2011-08-04

Locations

25 sites across 2 countries: United States, Canada