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).Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
Dexpramipexole, Placebo
Placebo:
Phase:
Phase 3
Study Chair(s)/Principal Investigator(s):
Merit Cudkowicz, MD, MSc, Professor of Neurology of the Harvard Medical School
Clinicaltrials.gov ID:
Neals Affiliated?
Yes
Coordinating Center Contact Information
Biogen Idec
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:
Knopp Biosciences
Estimated Enrollment:
942
Estimated Study Start Date:
02 / 28 / 2011
Estimated Study Completion Date:
11 / 01 / 2012
Posting Last Modified Date:
06 / 07 / 2021
Date Study Added to neals.org:
01 / 21 / 2011
Minimum Age:
18 Years
Maximum Age:
80 Years
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.
Barrow Neurological Institute - St. Joseph's Hospital
Phoenix, Arizona
85013
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas
72205
United States
University of California at San Francisco - Fresno
Fresno, California
93701
United States
University of California, Irvine
Orange, California
92868
United States
University of California, Davis
Sacramento, California
95817
United States
California Pacific Medical Center
San Francisco, California
94115
United States
Hospital for Special Care
New Britain, Connecticut
06053
United States
Mayo Clinic - Jacksonville
Jacksonville, Florida
32224
United States
University of Miami Miller School of Medicine
Miami, Florida
33136
United States
University of South Florida Medical Center
Tampa, Florida
33612
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
21287
United States
Massachusetts General Hospital
Charlestown, Massachusetts
02129
United States
St. Mary's Health Care
Grand Rapids, Michigan
49503
United States
Hennepin County Medical Center
Minneapolis, Minnesota
55404
United States
Mayo Clinic - Rochester
Rochester, Minnesota
55905
United States
Washington University School of Medicine
Saint 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
Columbia University
New York, New York
10032
United States
Research Foundation of the State University of New York
Syracuse, New York
12201
United States
Carolinas Medical Center
Charlotte, North Carolina
28207
United States
Duke University Medical Center
Durham, North Carolina
27705
United States
Wake Forest University
Winston-Salem, North Carolina
27157
United States
The Cleveland Clinic Foundation
Cleveland, Ohio
44195
United States
Ohio State University
Columbus, Ohio
43210
United States
Providence ALS Center
Portland, Oregon
97213
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania
15213
United States
Penn State Hershey Medical Center
Hershey, Pennsylvania
17033
United States
Drexel University College of Medicine
Philadelphia, Pennsylvania
19129
United States
ALS Center at Penn
Philadelphia, Pennsylvania
19107
United States
Vanderbilt University Medical Center
Nashville, Tennessee
37232
United States
Texas Neurology
Dallas, Texas
75214
United States
Methodist Neurological Institute
Houston, Texas
77030
United States
University of Texas Health Sciences Center
San Antonio, Texas
78229
United States
University of Utah
Salt Lake City, Utah
84132
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
Calvary Health Care Bethlehem
Melbourne, Victoria
3121
Australia
Westmead Hospital
Westmead, New South Wales
2145
Australia
Royal Brisbane and Women's Hospital
Herston, Queensland
4029
Australia
UZ Leuven
Leuven 3000
Belgium
AZ St-Lucas
Gent 9000
Belgium
London Health Sciences Centre
London
Canada
University of British Columbia
Vancouver
Canada
Mcgill University
Montreal, Quebec
H3A 2B4
Canada
CHUM - Hopital Notre Dame
Montreal, Quebec
H2L 4M1
Canada
Univ of Calgary / Foothills MC
Calgary, Alberta
T2V 1P9
Canada
Sunnybrook and Women's College and Health Sciences Centre
Toronto M4N 3M5
Canada
CHRU de Lille - Hôpital Roger Salengro
Lille 59037
France
CHU de Limoges - Hôpital Dupuytren
Limoges
France
Centre Hospitalier La Timone
Marseille
France
CHU Gui de Chauliac
Montpellier 34295
France
CHU de Nice - Hôpital de l'Archet 1
Nice
France
Hôpital La Pitié Salpétrière
Paris 75013
France
Universitätsklinikum Jena
Jena
Germany
University of Ulm, RKU
Ulm
Germany
Bergmannsheil Gmbh
Bochum
Germany
Charité - Universitätsmedizin Berlin
Berlin
Germany
Medizinische Hochschule Hannover (MHH)
Hannover
Germany
Beaumont Hospital
Dublin Dublin 9
Ireland
Academisch Medisch Centrum
Amsterdam 1105 AZ
Netherlands
UMC St. Radboud
Nijmegen 6525 GA
Netherlands
Universitair Medisch Centrum Utrecht
Utrecht 3584 CX
Netherlands
Hospital La Paz
Madrid 28046
Spain
Hospital Carlos III
Madrid
Spain
Hospital Vall d'Hebron
Barcelona
Spain
Hospital Universitario de Bellvitge
Barcelona 8907
Spain
Sahlgrenska Universitetssjukhuset
Göteborg 41345
Sweden
Karolinska Universitetssjukhuset, Solna
Stockholm 17176
Sweden
Queen Elizabeth Hospital
Birmingham B15 2TH
United Kingdom
Walton Centre for Neurology & Neurosurgery
Liverpool L9 7LJ
United Kingdom
Kings College Hospital NHS Foundation Trust
London SE5 8AF
United Kingdom
Newcastle University Hospital - Clinical Ageing Research Unit
Newcastle NE4 5PL
United Kingdom
John Radcliffe Hospital
Oxford
United Kingdom
Sheffield Institute for Transnational Neuroscience
Sheffield S10 2HQ
United Kingdom