Clinical trial NCT00053417: Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple Sclerosis
Official title: Double-Blind, Placebo-Controlled, 20-Week, Parallel Group Study to Evaluate Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis
Keywords: Walking Ability
Muscle strength
Spasticity
Lead sponsor: Acorda Therapeutics
Sponsor class: INDUSTRY
First posted: 2003-01-30
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: INCLUSION CRITERIA:

* Have a confirmed diagnosis of Multiple Sclerosis
* Are able to walk with or without an assisted device

EXCLUSION CRITERIA:

* Pregnancy, breastfeeding or females of childbearing potential not using adequate birth control
* Participating in other investigational drug trials
* A medical history or clinical findings that preclude entry into the study
* A medication history that precludes entry into the study
* Previously treated with 4-aminopyridine (4-AP)

Primary outcomes:
measure: Median Percent Change From Baseline in Average Walking Speed on Timed 25-Foot Walk Test
timeFrame: Baseline (placebo run-in period); 12-week stable dose period
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute at St. Joseph Hospital and Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: USC MS Comprehensive Care Center
state: California
city: New Haven
country: United States
facility: Yale University MS Center
state: Connecticut
city: Atlanta
country: United States
facility: Shepherd Center
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland at Baltimore
state: Maryland
city: Minneapolis
country: United States
facility: Fairview MS Center
state: Minnesota
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Teaneck
country: United States
facility: Gimbel MS Center
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Brooklyn
country: United States
facility: Maimonides MS Care Center
state: New York
city: New York
country: United States
facility: Mt. Sinai School of Medicine - MS Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical School
state: New York
city: Stony Brook
country: United States
facility: SUNY Stony Brook
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center MS Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Portland
country: United States
facility: Oregon Health Sciences University; MS Center
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas-Houston
state: Texas
city: Seattle
country: United States
facility: Swedish Medical MS Center
state: Washington
city: Seattle
country: United States
facility: University of Washington School of Medicine
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
References: