Phase 3 Study of Dexpramipexole in ALS

Completed · Phase 3 · Has a placebo group

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

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).

Key facts

Study ID

NCT01281189

Run by

Knopp Biosciences

People needed

942

Starts

2011-03-01

Expected to finish

2012-11-01

Last updated by the study team

2021-06-07

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Barrow Neurological Institute - St. Joseph's Hospital — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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