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: 03 Oct 2017

At a glance

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

    • 03 Oct 2017 According to a Santhera Pharmaceuticals media release, additional data from the study will be presented at the 22nd International Congress of the World Muscle Society (WMS) 2017.
    • 15 Sep 2017 According to a Santhera Pharmaceuticals media release, the company has received a negative opinion for its Type II extension application for Raxone (idebenone) in Duchenne muscular dystrophy (DMD) from Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for its Marketing Authorization Application. The company plans to appeal the opinion and will seek a re-examination by the CHMP.
    • 10 Jun 2017 Biomarkers information updated
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