Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
942 participants
INTERVENTIONAL
2011-03-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dexpramipexole
Dexpramipexole
Oral tablet 150mg twice daily for up to 18 months.
Placebo
Placebo
Oral tablet twice daily for up to 18 months.
Interventions
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Dexpramipexole
Oral tablet 150mg twice daily for up to 18 months.
Placebo
Oral tablet twice daily for up to 18 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Clinically significant abnormal laboratory values.
* Pregnant women or women breastfeeding.
* Prior exposure to dexpramipexole.
* Currently taking pramipexole or other dopamine agonists.
18 Years
80 Years
ALL
No
Sponsors
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Knopp Biosciences
INDUSTRY
Responsible Party
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Principal Investigators
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Merit Cudkowicz, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Professor of Neurology of the Harvard Medical School
Locations
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Barrow Neurological Institute - St. Joseph's Hospital
Phoenix, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
University of California at San Francisco - Fresno
Fresno, California, United States
University of California, Irvine
Orange, California, United States
University of California, Davis
Sacramento, California, United States
California Pacific Medical Center
San Francisco, California, United States
Hospital for Special Care
New Britain, Connecticut, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
University of South Florida Medical Center
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Massachusetts General Hospital
Charlestown, Massachusetts, United States
St. Mary's Health Care
Grand Rapids, Michigan, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Neurology Associates, P.C.
Lincoln, Nebraska, United States
University of Nevada School of Medicine
Las Vegas, Nevada, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Columbia University
New York, New York, United States
Research Foundation of the State University of New York
Syracuse, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University
Winston-Salem, North Carolina, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Providence ALS Center
Portland, Oregon, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
ALS Center at Penn
Philadelphia, Pennsylvania, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Neurology
Dallas, Texas, United States
Methodist Neurological Institute
Houston, Texas, United States
University of Texas Health Sciences Center
San Antonio, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Virginia Health System
Charlottesville, Virginia, United States
University of Washington
Seattle, Washington, United States
Prince of Wales Hospital
Randwick, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Calvary Health Care Bethlehem
Melbourne, Victoria, Australia
AZ St-Lucas
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
Univ of Calgary / Foothills MC
Calgary, Alberta, Canada
CHUM - Hopital Notre Dame
Montreal, Quebec, Canada
Mcgill University
Montreal, Quebec, Canada
London Health Sciences Centre
London, , Canada
Sunnybrook and Women's College and Health Sciences Centre
Toronto, , Canada
University of British Columbia
Vancouver, , Canada
CHRU de Lille - Hôpital Roger Salengro
Lille, , France
CHU de Limoges - Hôpital Dupuytren
Limoges, , France
Centre Hospitalier La Timone
Marseille, , France
CHU Gui de Chauliac
Montpellier, , France
CHU de Nice - Hôpital de l'Archet 1
Nice, , France
Hôpital La Pitié Salpétrière
Paris, , France
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Bergmannsheil Gmbh
Bochum, , Germany
Medizinische Hochschule Hannover (MHH)
Hanover, , Germany
Universitätsklinikum Jena
Jena, , Germany
University of Ulm, RKU
Ulm, , Germany
Beaumont Hospital
Dublin, , Ireland
Academisch Medisch Centrum
Amsterdam, , Netherlands
UMC St. Radboud
Nijmegen, , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
Hospital Universitario de Bellvitge
Barcelona, , Spain
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital La Paz
Madrid, , Spain
Hospital Carlos III
Madrid, , Spain
Sahlgrenska Universitetssjukhuset
Gothenburg, , Sweden
Karolinska Universitetssjukhuset, Solna
Stockholm, , Sweden
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Walton Centre for Neurology & Neurosurgery
Liverpool, , United Kingdom
Kings College Hospital NHS Foundation Trust
London, , United Kingdom
Newcastle University Hospital - Clinical Ageing Research Unit
Newcastle, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Sheffield Institute for Transnational Neuroscience
Sheffield, , United Kingdom
Countries
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References
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Cudkowicz ME, van den Berg LH, Shefner JM, Mitsumoto H, Mora JS, Ludolph A, Hardiman O, Bozik ME, Ingersoll EW, Archibald D, Meyers AL, Dong Y, Farwell WR, Kerr DA; EMPOWER investigators. Dexpramipexole versus placebo for patients with amyotrophic lateral sclerosis (EMPOWER): a randomised, double-blind, phase 3 trial. Lancet Neurol. 2013 Nov;12(11):1059-67. doi: 10.1016/S1474-4422(13)70221-7. Epub 2013 Sep 23.
Other Identifiers
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EUDRA CT NO: 2010-022818-19
Identifier Type: -
Identifier Source: secondary_id
223AS302
Identifier Type: -
Identifier Source: org_study_id
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