A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of Dexpramipexole in Subjects With Amyotrophic Lateral Sclerosis

Study Purpose:

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

Phase:

Phase III

Study Chair(s)/Principal Investigator(s):

Medical Director EMPOWER Study, Biogen Idec

Clinicaltrials.gov ID (11 digit #):

NCT01281189

Neals Affiliated?

Yes

Coordinating Center Contact Information

Biogen Idec
.(JavaScript must be enabled to view this email address)
.(JavaScript must be enabled to view this email address) United States

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

Participant Duration:

Estimated Enrollment:

804

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
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    80

    Min Vital Capacity (% predicted normal):

    65

    Time since Symptom Onset:

    <24 months

    Time since Diagnosis:

    N/A

    Can participants use Riluzole?

    Yes


    Inclusion Criteria:

    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.

    Exclusion Criteria:

    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
    United States

    University of Arkansas for Medical Sciences
    Little Rock, Arkansas
    United States

    University of California, Irvine
    Orange, California
    United States

    California Pacific Medical Center
    San Francisco, California 94115
    United States

    University of California, Davis
    Sacramento, California 95817
    United States

    University of California at San Francisco - Fresno
    Fresno, California
    United States

    Hospital for Special Care
    New Britain, Connecticut 06053
    United States

    University of South Florida Medical Center
    Tampa, Florida 33612
    United States

    niversity of Miami Miller School of Medicine
    Miami, Florida 33136
    United States

    Mayo Clinic - Jacksonville
    Jacksonville, Florida 32224
    United States

    Emory University
    Atlanta, Georgia 30322
    United States

    Northwestern University
    Chicago, Illinois 60611
    United States

    Indiana University
    Indianapolis, Indiana 46202
    United States

    University of Iowa
    Iowa City, Iowa 52242
    United States

    University of Kansas Medical Center
    Kansas City, Kansas 66160
    United States

    Johns Hopkins University School of Medicine
    Baltimore, Maryland
    United States

    Massachusetts General Hospital
    Charlestown, Massachusetts 02129
    United States

    St. Mary's Health Care
    Grand Rapids, Michigan 49503
    United States

    Mayo Clinic - Rochester
    Rochester, Minnesota
    United States

    Hennepin County Medical Center
    Minneapolis, Minnesota 55404
    United States

    Washington University School of Medicine
    St Louis, Missouri 63110
    United States

    Neurology Associates, P.C.
    Lincoln, Nebraska 68506
    United States

    University of Nevada School of Medicine
    Las Vegas, Nevada 89102
    United States

    Dartmouth-Hitchcock Medical Center
    Lebanon, New Hampshire 03756
    United States

    Research Foundation of the State University of New York
    Syracuse, New York
    United States

    Columbia University
    New York, New York 10032
    United States

    Duke University Medical Center
    Durham, North Carolina
    United States

    Wake Forest University
    Winston-Salem, North Carolina 27157
    United States

    Carolinas Medical Center
    Charlotte, North Carolina 28207
    United States

    Ohio State University
    Columbus, Ohio 43210
    United States

    The Cleveland Clinic Foundation
    Cleveland, Ohio
    United States

    Providence ALS Center
    Portland, Oregon 97213
    United States

    Drexel University College of Medicine
    Philadelphia, Pennsylvania
    United States

    Penn State Hershey Medical Center
    Hershey, Pennsylvania 17033
    United States

    University of Pittsburgh Medical Center
    Pittsburgh, Pennsylvania
    United States

    ALS Center at Penn
    Philadelphia, Pennsylvania
    United States

    Vanderbilt University Medical Center
    Nashville, Tennessee 37232
    United States

    University of Texas Health Sciences Center
    San Antonio, Texas 78229
    United States

    Texas Neurology
    Dallas, Texas 75214
    United States

    Methodist Neurological Institute
    Houston, Texas 77030
    United States

    University of Utah
    Salt Lake City, Utah
    United States

    University of Virginia Health System
    Charlottesville, Virginia 22908
    United States

    University of Washington
    Seattle, Washington 98195
    United States

    Prince of Wales Hospital
    Randwick, New South Wales,
    Australia

    Westmead Hospital
    Westmead, New South Wales, 2145
    Australia

    Royal Brisbane and Women's Hospital
    Herston, Queensland, 4029
    Australia

  • Study Results