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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
206
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)
Barrow Neurological Institute at St. Joseph Hospital and Medical Center
Phoenix, Arizona, United States
USC MS Comprehensive Care Center
Los Angeles, California, United States
Yale University MS Center
New Haven, Connecticut, United States
Shepherd Center
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
University of Maryland at Baltimore
Baltimore, Maryland, United States
Fairview MS Center
Minneapolis, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Gimbel MS Center
Teaneck, New Jersey, United States
University of New Mexico
Albuquerque, New Mexico, United States
...and 15 more locations
Median Percent Change From Baseline in Average Walking Speed on Timed 25-Foot Walk Test
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).
Time frame: Baseline (placebo run-in period); 12-week stable dose period
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.