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
Price :
$35
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At a glance
- Drugs Givinostat (Primary)
- Indications Duchenne muscular dystrophy
- Focus Registrational; Therapeutic Use
- Acronyms EPIDYS
- Sponsors Italfarmaco
- 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.