Study of Fampridine-SR Tablets in Multiple Sclerosis Patients

Phase 3

Completed

Brief Summary: The purpose of the study is to show that individuals treated with Fampridine-SR tablets are significantly more likely to have consistent improvements in their walking than those treated with placebo tablets.

Detailed Description: 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 is an experimental drug that has been reported to possibly improve muscle strength and walking ability for some people with MS. This study will evaluate the effects and possible risks of taking Fampridine-SR in MS patients

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo control
Fampridine-SR	Fampridine-SR	10 mg b.i.d.

Primary Outcome Measures

Name	Time	Method
Responders Based Upon the Timed 25-Foot Walk [T25FW]	Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77	A responder is a patient who showed faster walking speed for at least 3 visits out of a possible 4 during the double-blind period than the maximum value achieved in the 5 non-double-blind no-treatment visits (4 before the double-blind period and one after)

Secondary Outcome Measures

Name	Time	Method
Change in Lower Extremity Manual Muscle Test [LEMMT]	Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77	Evaluator rated strength in hip flexors, knee flexors, knee extensors, and ankle dorsiflexors on the following scale: best value = 5.0 (normal muscle strength), worst value = 0.0 (absence of any voluntary contraction). A positive shift in LEMMT score shows improvement in strength. Change in LEMMT scores for the secondary efficacy measure was found by averaging the LEMMT scores on days 14, 28, 42, and 56 (double-blind treatment period) and subtracting the baseline LEMMT score.

Locations (40): Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center
🇺🇸
Phoenix, Arizona, United States
HOPE Research Institute
🇺🇸
Phoenix, Arizona, United States
Neurological Associates
🇺🇸
Fayetteville, Arkansas, United States
Alta Bates Summit Medical Center - Research and Education Institute
🇺🇸
Berkeley, California, United States
USC, Keck School of Medicine Health Care Consultation Center
🇺🇸
Los Angeles, California, United States
UC Davis
🇺🇸
Sacramento, California, United States
Yale University MS Center
🇺🇸
New Haven, Connecticut, United States
Shepherd Center
🇺🇸
Atlanta, Georgia, United States
Consultants in Neurology, Ltd.
🇺🇸
Northbrook, Illinois, United States
Indiana University MS Center
🇺🇸
Indianapolis, Indiana, United States
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Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States