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Phase III Study of Edasalonexent in Boys With Duchenne Muscular Dystrophy — PolarisDMD  

Muscular Dystrophy, Duchenne Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled, Global Phase 3 Study of Edasalonexent in Pediatric Patients With Duchenne Muscular Dystrophy

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03703882
Study type Interventional
Source Catabasis Pharmaceuticals
Contact
Status Completed
Phase Phase 3
Start date October 2, 2018
Completion date September 22, 2020
View Details
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