At a glance
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A Randomized, Double-Blind, Placebo-Controlled, Global Phase 3 Study of Edasalonexent in Pediatric Patients With Duchenne Muscular Dystrophy
In Brief
A Phase 3 clinical trial evaluating Edasalonexent and Placebo for Muscular Dystrophy, Duchenne. Completed, enrolled 131 participants across 40 sites in 8 countries.
Detailed 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.
Study Details
Timeline
Interventions
100 mg/kg/day
Placebo