Study of Fampridine-SR Tablets in Multiple Sclerosis Patients

NCT ID: NCT00483652

Last Updated: 2016-02-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-05-31

Brief Summary

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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

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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

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo (sugar pill)

Fampridine-SR

10 mg b.i.d.

Group Type ACTIVE_COMPARATOR

Fampridine-SR

Intervention Type DRUG

Tablets, 10 mg, twice daily, 9 weeks

Interventions

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Fampridine-SR

Tablets, 10 mg, twice daily, 9 weeks

Intervention Type DRUG

Placebo

placebo (sugar pill)

Intervention Type DRUG

Other Intervention Names

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4-aminopyridine

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Acorda Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew Blight, PhD

Role: STUDY_DIRECTOR

Acorda Therapeutics

Locations

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

Phoenix, Arizona, United States

Site Status

HOPE Research Institute

Phoenix, Arizona, United States

Site Status

Neurological Associates

Fayetteville, Arkansas, United States

Site Status

Alta Bates Summit Medical Center - Research and Education Institute

Berkeley, California, United States

Site Status

USC, Keck School of Medicine Health Care Consultation Center

Los Angeles, California, United States

Site Status

UC Davis

Sacramento, California, United States

Site Status

Yale University MS Center

New Haven, Connecticut, United States

Site Status

Shepherd Center

Atlanta, Georgia, United States

Site Status

Consultants in Neurology, Ltd.

Northbrook, Illinois, United States

Site Status

Indiana University MS Center

Indianapolis, Indiana, United States

Site Status

Associates in Neurology, PSC

Lexington, Kentucky, United States

Site Status

Maryland Center for MS

Baltimore, Maryland, United States

Site Status

Lahey Clinic

Lexington, Massachusetts, United States

Site Status

The Schapiro Center for MS

Golden Valley, Minnesota, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Advanced Neurology Specialists

Great Falls, Montana, United States

Site Status

UMDNJ

Newark, New Jersey, United States

Site Status

Gimbel MS Center at Holy Name Hospital

Teaneck, New Jersey, United States

Site Status

Jacobs Neurological Institute Buffalo General Hospital

Buffalo, New York, United States

Site Status

Corinne Goldsmith Dickinson Center for MS

New York, New York, United States

Site Status

Columbia University Multiple Sclerosis Clinical Care Center

New York, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

SUNY Stony Brook

Stony Brook, New York, United States

Site Status

CMC - Neuroscience & Spine Institute, Division of Neurology

Charlotte, North Carolina, United States

Site Status

Raleigh Neurology Associates

Raleigh, North Carolina, United States

Site Status

Wake Forest University, Dept of Neurology, M.S. Research

Winston-Salem, North Carolina, United States

Site Status

The Center for Neurological Services

Bismarck, North Dakota, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Ohio State University MS Center

Columbus, Ohio, United States

Site Status

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

Portland, Oregon, United States

Site Status

Thomas Jefferson University Physicians

Philadelphia, Pennsylvania, United States

Site Status

Neurological Research Center, Inc.

Bennington, Vermont, United States

Site Status

Fletcher Allen Health Care

Burlington, Vermont, United States

Site Status

MS Center at Evergreen

Kirkland, Washington, United States

Site Status

CAMC Health Education & Research Institute

Charleston, West Virginia, United States

Site Status

Center for Neurological Disorders of Aurora, St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Site Status

Foothills Medical Center

Calgary, Alberta, Canada

Site Status

University of British Columbia, Vancouver Coastal Health Research Institute

Vancouver, British Columbia, Canada

Site Status

River Valley Health c/o Stan Cassidy Centre for Rehabilitation

Fredericton, New Brunswick, Canada

Site Status

QEII Health Sciences Centre, Nova Scotia Rehabilitation Centre Site

Halifax, Nova Scotia, Canada

Site Status

Countries

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United States Canada

References

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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.

Reference Type RESULT
PMID: 20976768 (View on PubMed)

Related Links

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http://www.acorda.com/clinical.asp

Click here for more information about Fampridine-SR clinical trials

Other Identifiers

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MS-F204

Identifier Type: -

Identifier Source: org_study_id

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