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: 15 Sep 2017

At a glance

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

    • 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.
    • 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.
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