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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

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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

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 28 Sep 2022

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At a glance

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

    • Most Recent Events

    • 29 May 2020 According to a Santhera Pharmaceuticals media release, the company will host a conference call today to discuss this update.
    • 29 May 2020 According to a Santhera Pharmaceuticals media release, the CHMP opinion is expected in Q4 2020.
    • 29 May 2020 According to a Santhera Pharmaceuticals media release, the company EMA's CHMP has granted a requested extension of the clock-stop in the regulatory procedure for its conditional marketing authorization (CMA) application for Puldysa (idebenone) in Duchenne muscular dystrophy (DMD) to evaluate the potential of conducting an interim analysis to test overwhelming efficacy of its SIDEROS study with a view of including the data in the review procedure and potentially complete the SIDEROS trial early.
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