A Phase IIa Double Blind, Randomised, Placebo Controlled, Single Centre Study at the University of Leuven to Assess the Efficacy and Tolerability of Idebenone in 8 - 16 Year Old Males With Cardiac Dysfunction Associated With Duchenne Muscular Dystrophy

Trial Profile

A Phase IIa Double Blind, Randomised, Placebo Controlled, Single Centre Study at the University of Leuven to Assess the Efficacy and Tolerability of Idebenone in 8 - 16 Year Old Males With Cardiac Dysfunction Associated With Duchenne Muscular Dystrophy

Completed
Phase of Trial: Phase II

Latest Information Update: 19 May 2017

At a glance

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

    • 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-700239119) for Raxone (idebenone) in Duchenne muscular dystrophy (DMD).
    • 08 Nov 2016 According to Santhera media release, Swiss Agency for Therapeutic Products (Swissmedic) has accepted for review Santhera's Marketing Authorization Application (MAA) for Raxone (idebenone) for the treatment of Duchenne muscular dystrophy (DMD) in patients with respiratory function decline not taking concomitant glucocorticoids.
    • 21 Jun 2016 According to Santhera media release, a Marketing Authorization Application (MAA) for idebenone (Raxone) for the treatment of Duchenne muscular dystrophy (DMD) in patients with respiratory function decline who are not taking concomitant glucocorticoids has been validated by the European Medicines Agency (EMA).
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