Study of Oral Fampridine-SR in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00127530
• Other study ID #: MS-F203
• Status: Completed
• Phase: Phase 3
• Start date: May 2005
• Est. completion date: September 2006

Study information

• Verified date: August 2018
• Source: Acorda Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Fampridine-SR
Tablets, 10 mg, twice daily, 14 weeks
• Placebo
sugar pill, twice a day (b.i.d.)

Locations

Country	Name	City	State
Canada	Foothills Medical Center	Calgary	Alberta
Canada	QEII Health Sciences Centre, Nova Scotia Rehabilitation Centre Site	Halifax	Nova Scotia
Canada	Ottawa Hospital General Campus	Ottawa	Ontario
Canada	University of British Columbia, Vancouver Coastal Health Research Institute	Vancouver	British Columbia
United States	University of Mexico, MIND Imaging Center	Albuquerque	New Mexico
United States	Shepard Center	Atlanta	Georgia
United States	Maryland Center for MS	Baltimore	Maryland
United States	Neurological Research Center, Inc.	Bennington	Vermont
United States	University of Alabama	Birmingham	Alabama
United States	Maimonides Medical Center	Brooklyn	New York
United States	Fletcher Allen Health Care	Burlington	Vermont
United States	Carolinas Healthcare System	Charlotte	North Carolina
United States	University of Chicago	Chicago	Illinois
United States	Cleveland Clinical Foundation	Cleveland	Ohio
United States	Ohio State University MS Center	Columbus	Ohio
United States	University of Colorado Health Sciences Center	Denver	Colorado
United States	Multiple Sclerosis Treatment Center	Derby	Connecticut
United States	Wayne State University, Department of Neurology	Detroit	Michigan
United States	The Schapiro Center for MS	Golden Valley	Minnesota
United States	University of Texas - Houston	Houston	Texas
United States	Indiana University MS Center	Indianapolis	Indiana
United States	USC, Keck School of Medicine	Los Angeles	California
United States	Corinne Goldsmith Dickinson Center for MS	New York	New York
United States	Thomas Jefferson University Physicians	Philadelphia	Pennsylvania
United States	Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	Allegheny General Hospital, Allegheny Neurological Associates	Pittsburgh	Pennsylvania
United States	Oregon Health & Science University, MS Center of Oregon, UHS-42	Portland	Oregon
United States	University of Rochester	Rochester	New York
United States	UC Davis	Sacramento	California
United States	Washington University SOM	Saint Louis	Missouri
United States	MS Hub Medical Group	Seattle	Washington
United States	University of Washington, MS Research Center	Seattle	Washington
United States	SUNY - Stony Brook	Stony Brook	New York
United States	Gimbel MS Center at Holy Name Hospital	Teaneck	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Acorda Therapeutics

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timed Walk Responders (Patients Who Showed Consistent Improvement on the Timed-25 Foot Walk)	Patients who showed a faster walking speed for at least three of the four on-drug visits during the double-blind treatment period as compared to the maximum speed for any of the five off-drug visits.	Days 14, 42, 70 and 98 of treatment, corresponding to the four on-drug visits during double-blind treatment period.
Secondary	Lower Extremity Manual Muscle Test; Ashworth Score for Spasticity		Days 14, 42, 70, 98