Study of Oral Fampridine-SR in Multiple Sclerosis

NCT ID: NCT00127530

Last Updated: 2018-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2006-09-30

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo- sugar pill

Placebo control

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

sugar pill, twice a day (b.i.d.)

Fampridine-SR

10 milligram (mg) tablet b.i.d.

Group Type: EXPERIMENTAL

Fampridine-SR

Intervention Type: DRUG

Tablets, 10 mg, twice daily, 14 weeks

Interventions

Fampridine-SR

Tablets, 10 mg, twice daily, 14 weeks

Intervention Type: DRUG

Placebo

sugar pill, twice a day (b.i.d.)

Intervention Type: DRUG

Other Intervention Names

Sustained release 4-aminopyridine, 4-AP

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Acorda Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Blight, PhD

Role: STUDY_DIRECTOR

Acorda Therapeutics

Locations

University of Alabama

Birmingham, Alabama, United States

Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

USC, Keck School of Medicine

Los Angeles, California, United States

UC Davis

Sacramento, California, United States

University of Colorado Health Sciences Center

Denver, Colorado, United States

Multiple Sclerosis Treatment Center

Derby, Connecticut, United States

Shepard Center

Atlanta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Indiana University MS Center

Indianapolis, Indiana, United States

Maryland Center for MS

Baltimore, Maryland, United States

Wayne State University, Department of Neurology

Detroit, Michigan, United States

The Schapiro Center for MS

Golden Valley, Minnesota, United States

Washington University SOM

St Louis, Missouri, United States

Gimbel MS Center at Holy Name Hospital

Teaneck, New Jersey, United States

University of Mexico, MIND Imaging Center

Albuquerque, New Mexico, United States

Maimonides Medical Center

Brooklyn, New York, United States

Corinne Goldsmith Dickinson Center for MS

New York, New York, United States

University of Rochester

Rochester, New York, United States

SUNY - Stony Brook

Stony Brook, New York, United States

Carolinas Healthcare System

Charlotte, North Carolina, United States

Cleveland Clinical Foundation

Cleveland, Ohio, United States

Ohio State University MS Center

Columbus, Ohio, United States

Oregon Health & Science University, MS Center of Oregon, UHS-42

Portland, Oregon, United States

Thomas Jefferson University Physicians

Philadelphia, Pennsylvania, United States

Allegheny General Hospital, Allegheny Neurological Associates

Pittsburgh, Pennsylvania, United States

University of Texas - Houston

Houston, Texas, United States

Neurological Research Center, Inc.

Bennington, Vermont, United States

Fletcher Allen Health Care

Burlington, Vermont, United States

MS Hub Medical Group

Seattle, Washington, United States

University of Washington, MS Research Center

Seattle, Washington, United States

Foothills Medical Center

Calgary, Alberta, Canada

University of British Columbia, Vancouver Coastal Health Research Institute

Vancouver, British Columbia, Canada

QEII Health Sciences Centre, Nova Scotia Rehabilitation Centre Site

Halifax, Nova Scotia, Canada

Ottawa Hospital General Campus

Ottawa, Ontario, Canada

Countries

United States; Canada

References

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.

Reference Type: RESULT

PMID: 19249634 (View on PubMed)

Other Identifiers

MS-F203

Identifier Type: -

Identifier Source: org_study_id