Study of Fampridine-SR Tablets in Multiple Sclerosis Patients

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00483652
• Other study ID #: MS-F204
• Status: Completed
• Phase: Phase 3
• First received: June 6, 2007
• Last updated: January 4, 2016
• Start date: May 2007
• Est. completion date: May 2008

Study information

• Verified date: January 2016
• Source: Acorda Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: May 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Fampridine-SR
Tablets, 10 mg, twice daily, 9 weeks
• Placebo
placebo (sugar pill)

Locations

Country	Name	City	State
Canada	Foothills Medical Center	Calgary	Alberta
Canada	River Valley Health c/o Stan Cassidy Centre for Rehabilitation	Fredericton	New Brunswick
Canada	QEII Health Sciences Centre, Nova Scotia Rehabilitation Centre Site	Halifax	Nova Scotia
Canada	University of British Columbia, Vancouver Coastal Health Research Institute	Vancouver	British Columbia
United States	Shepherd Center	Atlanta	Georgia
United States	Maryland Center for MS	Baltimore	Maryland
United States	Neurological Research Center, Inc.	Bennington	Vermont
United States	Alta Bates Summit Medical Center - Research and Education Institute	Berkeley	California
United States	The Center for Neurological Services	Bismarck	North Dakota
United States	Jacobs Neurological Institute Buffalo General Hospital	Buffalo	New York
United States	Fletcher Allen Health Care	Burlington	Vermont
United States	CAMC Health Education & Research Institute	Charleston	West Virginia
United States	CMC - Neuroscience & Spine Institute, Division of Neurology	Charlotte	North Carolina
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Ohio State University MS Center	Columbus	Ohio
United States	Neurological Associates	Fayetteville	Arkansas
United States	The Schapiro Center for MS	Golden Valley	Minnesota
United States	Advanced Neurology Specialists	Great Falls	Montana
United States	Indiana University MS Center	Indianapolis	Indiana
United States	MS Center at Evergreen	Kirkland	Washington
United States	Associates in Neurology, PSC	Lexington	Kentucky
United States	Lahey Clinic	Lexington	Massachusetts
United States	USC, Keck School of Medicine Health Care Consultation Center	Los Angeles	California
United States	Center for Neurological Disorders of Aurora, St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Yale University MS Center	New Haven	Connecticut
United States	Columbia University Multiple Sclerosis Clinical Care Center	New York	New York
United States	Corinne Goldsmith Dickinson Center for MS	New York	New York
United States	UMDNJ	Newark	New Jersey
United States	Consultants in Neurology, Ltd.	Northbrook	Illinois
United States	Thomas Jefferson University Physicians	Philadelphia	Pennsylvania
United States	Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	HOPE Research Institute	Phoenix	Arizona
United States	Oregon Health & Science University, MS Center of Oregon, UHS-42	Portland	Oregon
United States	Raleigh Neurology Associates	Raleigh	North Carolina
United States	University of Rochester	Rochester	New York
United States	UC Davis	Sacramento	California
United States	Washington University School of Medicine	St. Louis	Missouri
United States	SUNY Stony Brook	Stony Brook	New York
United States	Gimbel MS Center at Holy Name Hospital	Teaneck	New Jersey
United States	Wake Forest University, Dept of Neurology, M.S. Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Acorda Therapeutics

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responders Based Upon the Timed 25-Foot Walk [T25FW]	A responder is a patient who showed faster walking speed for at least 3 visits out of a possible 4 during the double-blind period than the maximum value achieved in the 5 non-double-blind no-treatment visits (4 before the double-blind period and one after)	Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77	No
Secondary	Change in Lower Extremity Manual Muscle Test [LEMMT]	Evaluator rated strength in hip flexors, knee flexors, knee extensors, and ankle dorsiflexors on the following scale: best value = 5.0 (normal muscle strength), worst value = 0.0 (absence of any voluntary contraction). A positive shift in LEMMT score shows improvement in strength. Change in LEMMT scores for the secondary efficacy measure was found by averaging the LEMMT scores on days 14, 28, 42, and 56 (double-blind treatment period) and subtracting the baseline LEMMT score.	Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77	No

External Links

•   Click here for more information about Fampridine-SR clinical trials