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Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Duchenne Muscular Dystrophy

key information

study id #: NCT02851797

condition: Duchenne Muscular Dystrophy

status: recruiting

purpose:

it is a randomised, double blind, parallel group, placebo controlled study. A total of 213 male ambulant subjects will be randomised 2:1 (givinostat:placebo). Subjects will be stratified for their concomitant use of steroids in 4 strata: 1. Deflazacort daily regimen 2. Deflazacort intermittent regimen 3. Other steroids daily regimen 4. Other steroids intermittent regimen. The study duration is planned for 19 months.

intervention: givinostat, placebo

mechanism of action: Histone deacetylase (HDAC) inhibitor to reduce inflammation and promote muscle health

results: https://clinicaltrials.gov/ct2/show/results/NCT02851797

last updated: December 04, 2019