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A Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10-18 Year Old Patients With Duchenne Muscular Dystrophy

Trial Profile

A Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10-18 Year Old Patients With Duchenne Muscular Dystrophy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Sep 2019

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At a glance

  • Drugs Idebenone (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Registrational; Therapeutic Use
  • Acronyms DELOS
  • Sponsors Santhera Pharmaceuticals
  • Most Recent Events

    • 17 Sep 2019 According to a Santhera Pharmaceuticals media release, data from this study will present at the European Paediatric Neurology Society (EPNS), European Respiratory Society (ERS) and World Muscle Society (WMS), 2019.
    • 24 Jun 2019 According to a Santhera Pharmaceuticals media release, the European Medicines Agency (EMA) has completed the validation of marketing authorization application (MAA) for Puldysa (idebenone) in the treatment of respiratory dysfunction in patients with Duchenne muscular dystrophy (DMD) who are not using glucocorticoids. The review process by the EMA's Committee for Medicinal Products for Human Use (CHMP) has begun. Santhera expects an opinion by the CHMP around mid 2020.
    • 27 May 2019 According to a Santhera Pharmaceuticals media release, the company has submitted a marketing authorization application (MAA) for Puldysa (idebenone) for the treatment of respiratory dysfunction in patients with Duchenne muscular dystrophy (DMD) to the European Medicines Agency (EMA). The company is seeking conditional marketing authorization (CMA). Data from DELPHI, DELPHI-Extension, DELOS and SYROS study supported the application.
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