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Randomised, Double Blind, Placebo Controlled, Multicentre Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Duchenne Muscular Dystrophy

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Trial Profile

Randomised, Double Blind, Placebo Controlled, Multicentre Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Duchenne Muscular Dystrophy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Apr 2024

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At a glance

  • Drugs Givinostat (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Registrational; Therapeutic Use
  • Acronyms EPIDYS
  • Sponsors Italfarmaco
  • Most Recent Events

    • 01 Apr 2024 Results published in the Lancet Neurology
    • 22 Mar 2024 According to an Italfarmaco media release, based on results from this trial the U.S. Food and Drug Administration (FDA) has approved Duvyzat (givinostat), for the treatment of patients 6 years or older with Duchenne muscular dystrophy (DMD), a rare X-linked progressive and life-limiting neuromuscular condition with symptoms from early childhood.
    • 19 Mar 2024 According to an Italfarmaco media release, data from this study were published in The Lancet Neurology.
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