A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of Dexpramipexole in Subjects With Amyotrophic Lateral Sclerosis
The purpose of this study is to determine whether dexpramipexole (150 mg twice daily) is safe and effective in the treatment of Amyotrophic Lateral Sclerosis (ALS).
Disease:Amyotrophic Lateral Sclerosis (ALS), Familial ALS, Sporadic ALS
Study Type:Interventional Trial
Study Category:Drug Trial
Study Status:Not enrolling
Study Chair(s)/Principal Investigator(s):
Medical Director EMPOWER Study, Biogen Idec
Clinicaltrials.gov ID (11 digit #):NCT01281189
Coordinating Center Contact InformationBiogen Idec
Full Study Summary:
Amyotrophic Lateral Sclerosis (ALS) is a rapidly progressive, degenerative disease of motor neurons in the brain and spinal cord that leads to muscle atrophy and spasticity in limb and bulbar muscles resulting in weakness and loss of ambulation, oropharyngeal dysfunction, weight loss, and ultimately respiratory failure. The purpose of this study is to determine whether dexpramipexole (150 mg twice daily) is safe and effective in the treatment of ALS.
Study Sponsor:Biogen Idec
Estimated Study Start Date:02/28/2011
Estimated Study Completion Date:11/02/2016
Posting Last Modified Date:12/31/2012
Date Study Added to alsconsortium.org:11/01/2011
Time since Symptom Onset:<24 months
Time since Diagnosis:N/A
Can participants use Riluzole?Yes
Aged 18 to 80 years old, inclusive, on Day 1.
Diagnosis of sporadic or familial ALS.
Onset of first ALS symptoms within 24 months prior to Day 1.
World Federation of Neurology El Escorial criteria are met for a possible, laboratory-supported probable, probable, or definite ALS diagnosis.
Upright slow vital capacity (SVC) of 65% or more at screening.
Patients taking or not taking Riluzole are eligible for this study: if a patient has never taken Riluzole, he or she is eligible; if a patient is currently taking Riluzole, he or she must have been on a stable dose for at least 60 days; if a patient has discontinued Riluzole, he or she must have stopped taking it for at least 30 days.
Must be able to swallow tablets at the time of study entry.
Other medically significant illness.
Clinically significant abnormal laboratory values.
Pregnant women or women breastfeeding.
Prior exposure to dexpramipexole.
Currently taking pramipexole or other dopamine agonists.
Other protocol-defined inclusion/exclusion criteria may apply.
Site Contact Information
Barrow Neurological Institute - St. Joseph's Hospital
Phoenix, Arizona 85013
University of Arkansas for Medical Sciences
Little Rock, Arkansas
University of California at San Francisco - Fresno
University of California, Irvine
University of California, Davis
Sacramento, California 95817
California Pacific Medical Center
San Francisco, California 94115
Hospital for Special Care
New Britain, Connecticut 06053
Mayo Clinic - Jacksonville
Jacksonville, Florida 32224
niversity of Miami Miller School of Medicine
Miami, Florida 33136
University of South Florida Medical Center
Tampa, Florida 33612
Atlanta, Georgia 30322
Chicago, Illinois 60611
Indianapolis, Indiana 46202
University of Iowa
Iowa City, Iowa 52242
University of Kansas Medical Center
Kansas City, Kansas 66160
Johns Hopkins University School of Medicine
Massachusetts General Hospital
Charlestown, Massachusetts 02129
St. Mary's Health Care
Grand Rapids, Michigan 49503
Hennepin County Medical Center
Minneapolis, Minnesota 55404
Mayo Clinic - Rochester
Washington University School of Medicine
St Louis, Missouri 63110
Neurology Associates, P.C.
Lincoln, Nebraska 68506
University of Nevada School of Medicine
Las Vegas, Nevada 89102
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03756
New York, New York 10032
Research Foundation of the State University of New York
Syracuse, New York
Carolinas Medical Center
Charlotte, North Carolina 28207
Duke University Medical Center
Durham, North Carolina
Wake Forest University
Winston-Salem, North Carolina 27157
The Cleveland Clinic Foundation
Ohio State University
Columbus, Ohio 43210
Providence ALS Center
Portland, Oregon 97213
Penn State Hershey Medical Center
Hershey, Pennsylvania 17033
ALS Center at Penn
Drexel University College of Medicine
University of Pittsburgh Medical Center
Vanderbilt University Medical Center
Nashville, Tennessee 37232
Dallas, Texas 75214
Methodist Neurological Institute
Houston, Texas 77030
University of Texas Health Sciences Center
San Antonio, Texas 78229
University of Utah
Salt Lake City, Utah
University of Virginia Health System
Charlottesville, Virginia 22908
University of Washington
Seattle, Washington 98195
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
Prince of Wales Hospital
Randwick, New South Wales,
Westmead, New South Wales, 2145
- Study Results