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A Study to Assess the Efficacy and Safety of Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)

key information

study id #: NCT03439670

condition: Duchenne Muscular Dystrophy

status: recruiting

purpose:

This Phase IIb study is a randomized, double-blind, parallel group, placebo and active-controlled study to evaluate the efficacy, safety, PD, and population PK of vamorolone administered orally at daily doses of 2.0 mg/kg and 6.0 mg/kg versus prednisone 0.75 mg/kg/day and placebo over a Treatment Period of 24 weeks, and to evaluate persistence of effect over a Treatment Period of 48 weeks in ambulant boys ages 4 to <7 years with DMD.

intervention: Vamorolone, Prednisone, Placebo

mechanism of action: Glucocorticoids to delay decline in muscle strength

results: https://clinicaltrials.gov/ct2/show/results/NCT03439670

last updated: December 06, 2019

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