Clinical trial NCT00483652: Study of Fampridine-SR Tablets in Multiple Sclerosis Patients
Official title: Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR (10 mg b.i.d. [Bis in Die, Twice Daily]) in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
MS
walking
leg strength
demyelination
Lead sponsor: Acorda Therapeutics
Sponsor class: INDUSTRY
First posted: 2007-06-07
Enrollment: 240
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: 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

Eligibility criteria: Inclusion Criteria:

* Patient with clinically defined multiple sclerosis
* All patients must be able to complete two trials of a timed 25 foot walk

Exclusion Criteria:

* Female patients who are either pregnant or breastfeeding.

Primary outcomes:
measure: Responders Based Upon the Timed 25-Foot Walk [T25FW]
timeFrame: Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77
Secondary outcomes:
measure: Change in Lower Extremity Manual Muscle Test [LEMMT]
timeFrame: Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center
state: Arizona
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Fayetteville
country: United States
facility: Neurological Associates
state: Arkansas
city: Berkeley
country: United States
facility: Alta Bates Summit Medical Center - Research and Education Institute
state: California
city: Los Angeles
country: United States
facility: USC, Keck School of Medicine Health Care Consultation Center
state: California
city: Sacramento
country: United States
facility: UC Davis
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: Northbrook
country: United States
facility: Consultants in Neurology, Ltd.
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University MS Center
state: Indiana
city: Lexington
country: United States
facility: Associates in Neurology, PSC
state: Kentucky
city: Baltimore
country: United States
facility: Maryland Center for MS
state: Maryland
city: Lexington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Golden Valley
country: United States
facility: The Schapiro Center for MS
state: Minnesota
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Great Falls
country: United States
facility: Advanced Neurology Specialists
state: Montana
city: Newark
country: United States
facility: UMDNJ
state: New Jersey
city: Teaneck
country: United States
facility: Gimbel MS Center at Holy Name Hospital
state: New Jersey
city: Buffalo
country: United States
facility: Jacobs Neurological Institute Buffalo General Hospital
state: New York
city: New York
country: United States
facility: Corinne Goldsmith Dickinson Center for MS
state: New York
city: New York
country: United States
facility: Columbia University Multiple Sclerosis Clinical Care Center
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Stony Brook
country: United States
facility: SUNY Stony Brook
state: New York
city: Charlotte
country: United States
facility: CMC - Neuroscience & Spine Institute, Division of Neurology
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University, Dept of Neurology, M.S. Research
state: North Carolina
city: Bismarck
country: United States
facility: The Center for Neurological Services
state: North Dakota
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University MS Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University, MS Center of Oregon, UHS-42
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University Physicians
state: Pennsylvania
city: Bennington
country: United States
facility: Neurological Research Center, Inc.
state: Vermont
city: Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
city: Kirkland
country: United States
facility: MS Center at Evergreen
state: Washington
city: Charleston
country: United States
facility: CAMC Health Education & Research Institute
state: West Virginia
city: Milwaukee
country: United States
facility: Center for Neurological Disorders of Aurora, St. Luke's Medical Center
state: Wisconsin
city: Calgary
country: Canada
facility: Foothills Medical Center
state: Alberta
city: Vancouver
country: Canada
facility: University of British Columbia, Vancouver Coastal Health Research Institute
state: British Columbia
city: Fredericton
country: Canada
facility: River Valley Health c/o Stan Cassidy Centre for Rehabilitation
state: New Brunswick
city: Halifax
country: Canada
facility: QEII Health Sciences Centre, Nova Scotia Rehabilitation Centre Site
state: Nova Scotia
Study officials:
affiliation: Acorda Therapeutics
name: Andrew Blight, PhD
role: STUDY_DIRECTOR
References:
citation: Goodman AD, Brown TR, Edwards KR, Krupp LB, Schapiro RT, Cohen R, Marinucci LN, Blight AR; MSF204 Investigators. A phase 3 trial of extended release oral dalfampridine in multiple sclerosis. Ann Neurol. 2010 Oct;68(4):494-502. doi: 10.1002/ana.22240.