Last updated on July 2019

Phase III Study of Edasalonexent in Boys With Duchenne Muscular Dystrophy


Brief description of study

The PolarisDMD study is a Phase 3, global study to evaluate the efficacy and safety of edasalonexent in pediatric patients with a genetically confirmed diagnosis of DMD. Male patients from 4-7 years of age (up to 8th birthday) will be enrolled.

Edasalonexent is an orally administered small molecule that inhibits NF-kB, which is the key link between loss of dystrophin and disease pathology and plays a fundamental role in the initiation and progression of skeletal and cardiac muscle disease in DMD.

Detailed Study Description

The study includes a 52-week, randomized, double-blind, placebo-controlled period, followed by a 2-week follow- up. Approximately 125 boys with DMD will be enrolled in this trial, with 2 boys receiving edasalonexent for every 1 boy receiving placebo.

Following completion of the treatment period, patients may elect to continue in a separate open-label extension study.

Clinical Study Identifier: NCT03703882

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Kennedy Krieger Institute

Baltimore, MD United States
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Arkansas Children's Hospital

Little Rock, AR United States
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UC Davis

Sacramento, CA United States
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Nemours Children's Hospital

Orlando, FL United States
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Rare Disease Research, LLC

Atlanta, GA United States
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University of Michigan

Ann Arbor, MI United States
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University of Minnesota

Minneapolis, MN United States
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Las Vegas Clinic

Las Vegas, NV United States
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Cincinnati Children's Hospital

Cincinnati, OH United States
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MetroHealth Medical Center

Cleveland, OH United States
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Cook Children's Medical Center

Fort Worth, TX United States
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University of Utah

Salt Lake City, UT United States
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CHU Sainte-Justine

Montréal, QC Canada
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CHU Sainte-Justine

Montréal, QC Canada
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CHU Sainte-Justine

Montréal, QC Canada
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CHU Sainte-Justine

Montréal, QC Canada
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CHU Sainte-Justine

Montréal, QC Canada
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CHU Sainte-Justine

Montréal, QC Canada
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CHU Sainte-Justine

Montréal, QC Canada
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CHU Sainte-Justine

Montréal, QC Canada
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CHU Sainte-Justine

Montréal, QC Canada
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CHU Sainte-Justine

Montréal, QC Canada
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CHU Sainte-Justine

Montréal, QC Canada
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CHU Sainte-Justine

Montréal, QC Canada
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CHU Sainte-Justine

Montréal, QC Canada
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CHU Sainte-Justine

Montréal, QC Canada
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CHU Sainte-Justine

Montréal, QC Canada
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CHU Sainte-Justine

Montréal, QC Canada
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CHU Sainte-Justine

Montréal, QC Canada
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