Phase 3 Study of Dexpramipexole in ALS



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 80
Updated:12/17/2017
Start Date:March 2011
End Date:November 2012

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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).

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.

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.
We found this trial at
44
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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2150 Corbin Avenue
New Britain, Connecticut 06053
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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12901 Bruce B Downs Blvd # 11
Tampa, Florida
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733 North Broadway
Baltimore, Maryland 21205
(410) 955-3182
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
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Charlestown, Massachusetts 02129
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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303 East Superior Street
Chicago, Illinois 60611
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Dallas, Texas 75214
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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200 Jefferson Avenue Southeast
Grand Rapids, Michigan 49503
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Hershey, Pennsylvania 17033
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Houston, Texas 77030
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Jacksonville, Florida 32216
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lincoln, Nebraska 68506
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Minneapolis, Minnesota 55414
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Orange, California 92868
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330 South 9th Street
Philadelphia, Pennsylvania 19107
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2900 W Queen Ln
Philadelphia, Pennsylvania 19129
(215) 991-8100
Drexel University College of Medicine Drexel University College of Medicine represents the consolidation of two...
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Portland, Oregon 97213
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Randwick, New South Wales 2031
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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1 Shields Ave
Sacramento, California 95616
(530) 752-1011
University of California-Davis As we begin our second century, UC Davis is poised to become...
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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45 Castro Street
San Francisco, California 94114
(415) 600-6000
California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
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Winston-Salem, North Carolina 27157
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