Clinical trial NCT00127530: Study of Oral Fampridine-SR in Multiple Sclerosis
Official title: Double-Blind, Placebo-Controlled, 21-Week, Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR in Subjects With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Keywords: Walking Ability
Lead sponsor: Acorda Therapeutics
Sponsor class: INDUSTRY
First posted: 2005-08-08
Enrollment: 300
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: To assess the safety and efficacy of 10 milligram (mg) twice a day (b.i.d.) Fampridine-SR in patients diagnosed with multiple sclerosis (MS), in a double-blind, placebo-controlled, parallel group study.

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 subjects with MS.

Eligibility criteria: Inclusion Criteria:

* Have a confirmed diagnosis of multiple sclerosis
* Are able to walk with or without an assistive 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: Timed Walk Responders (Patients Who Showed Consistent Improvement on the Timed-25 Foot Walk)
timeFrame: Days 14, 42, 70 and 98 of treatment, corresponding to the four on-drug visits during double-blind treatment period.
Secondary outcomes:
measure: Lower Extremity Manual Muscle Test; Ashworth Score for Spasticity
timeFrame: Days 14, 42, 70, 98
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Phoenix
country: United States
facility: Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: USC, Keck School of Medicine
state: California
city: Sacramento
country: United States
facility: UC Davis
state: California
city: Denver
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Derby
country: United States
facility: Multiple Sclerosis Treatment Center
state: Connecticut
city: Atlanta
country: United States
facility: Shepard Center
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University MS Center
state: Indiana
city: Baltimore
country: United States
facility: Maryland Center for MS
state: Maryland
city: Detroit
country: United States
facility: Wayne State University, Department of Neurology
state: Michigan
city: Golden Valley
country: United States
facility: The Schapiro Center for MS
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University SOM
state: Missouri
city: Teaneck
country: United States
facility: Gimbel MS Center at Holy Name Hospital
state: New Jersey
city: Albuquerque
country: United States
facility: University of Mexico, MIND Imaging Center
state: New Mexico
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: New York
country: United States
facility: Corinne Goldsmith Dickinson Center for MS
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: Carolinas Healthcare System
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinical 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: Pittsburgh
country: United States
facility: Allegheny General Hospital, Allegheny Neurological Associates
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas - Houston
state: Texas
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: Seattle
country: United States
facility: MS Hub Medical Group
state: Washington
city: Seattle
country: United States
facility: University of Washington, MS Research Center
state: Washington
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: Halifax
country: Canada
facility: QEII Health Sciences Centre, Nova Scotia Rehabilitation Centre Site
state: Nova Scotia
city: Ottawa
country: Canada
facility: Ottawa Hospital General Campus
state: Ontario
Study officials:
affiliation: Acorda Therapeutics
name: Andrew Blight, PhD
role: STUDY_DIRECTOR
References:
citation: Goodman AD, Brown TR, Krupp LB, Schapiro RT, Schwid SR, Cohen R, Marinucci LN, Blight AR; Fampridine MS-F203 Investigators. Sustained-release oral fampridine in multiple sclerosis: a randomised, double-blind, controlled trial. Lancet. 2009 Feb 28;373(9665):732-8. doi: 10.1016/S0140-6736(09)60442-6.