Last updated on September 2020

HEALEY ALS Platform Trial - Master Protocol


Brief description of study

The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS.

Detailed Study Description

The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS. This trial is designed as a perpetual platform trial. This means that there is a single Master Protocol dictating the conduct of the trial.

In this trial, multiple investigational products for ALS will be tested simultaneously or sequentially. Each investigational product will be tested in a regimen. Each regimen consists of a placebo-controlled trial, meaning that the active investigational product and matching placebo will be tested in each regimen.

The additional details that govern the testing of each investigational product will be summarized in separate regimen-specific appendices (RSAs). Each regimen will have a separate ClinicalTrials.gov posting, which will include specific information about the regimen. All regimen-specific outcome measures will be detailed in each regimen posting.

Participants will have an equal chance to be randomized to all regimens that are active at the time of screening. Once randomized to a regimen, participants will be randomized in a 3:1 ratio to either study drug or placebo.

The following regimens are active in the trial:

Regimen A - Zilucoplan Regimen B - Verdiperstat Regimen C - CNM-Au8

New regimens will be continuously added as new investigational products become available. The HEALEY ALS Platform Trial will enroll additional participants as each new regimen is available.

Clinical Study Identifier: NCT04297683

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Loma Linda University Health

Loma Linda, CA United States
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Cedars-Sinai Medical Center

Los Angeles, CA United States
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University of Colorado

Aurora, CO United States
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Hospital for Special Care

New Britain, CT United States
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University of Florida

Gainesville, FL United States
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Mayo Clinic Florida

Jacksonville, FL United States
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University of Miami

Miami, FL United States
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Emory University

Atlanta, GA United States
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Northwestern University

Chicago, IL United States
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University of Chicago

Chicago, IL United States
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University of Kentucky

Lexington, KY United States
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Ochsner Health System

New Orleans, LA United States
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University of Maryland

Baltimore, MD United States
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Johns Hopkins University

Baltimore, MD United States
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University of Michigan

Ann Arbor, MI United States
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Henry Ford Health System

Detroit, MI United States
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Spectrum Health

Grand Rapids, MI United States
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Mayo Clinic - Rochester

Rochester, MN United States
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Saint Louis University

Saint Louis, MO United States
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Columbia University

New York, NY United States
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SUNY Upstate

Syracuse, NY United States
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Duke University

Durham, NC United States
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Wake Forest Health Science

Winston-Salem, NC United States
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The Ohio State University

Columbus, OH United States
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Penn State Hershey

Hershey, PA United States
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University of Penn

Philadelphia, PA United States
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Wesley Neurology Clinic

Cordova, TN United States
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Texas Neurology

Dallas, TX United States
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Houston Methodist

Houston, TX United States
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UTHSCSA

San Antonio, TX United States
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University of Virginia

Charlottesville, VA United States
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University of Washington

Seattle, WA United States
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Medical College of Wisconsin

Milwaukee, WI United States
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Recruitment Status: Open


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