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

Completed
Phase of Trial: Phase III

Latest Information Update: 24 May 2017

At a glance

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

    • 10 Jun 2017 Biomarkers information updated
    • 24 May 2017 Results of a post-hoc analysis assessing effect of Idebenone on bronchopulmonary adverse events and hospitalizations in patients with Duchene Muscular Dystrophy, presented at the 113th International Conference of the American Thoracic Society.
    • 19 May 2017 According to a Santhera Pharmaceuticals media release, the company anticipates a CHMP opinion in third quarter of 2017, for the Type II Variation extension application filed on the data based on this and other study (CTP-700251508) for Raxone (idebenone) in Duchenne muscular dystrophy (DMD).
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