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: 26 Jan 2018

At a glance

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

    • 26 Jan 2018 According to a Santhera Pharmaceuticals media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has maintained its negative opinion on the type II extension application for Raxone (idebenone) in Duchenne muscular dystrophy (DMD).
    • 24 Jan 2018 According to a Santhera Pharmaceuticals media release, company had an oral explanation at the CHMP of the European Medicines Agency in relation to the re-examination of its MAA for Raxone (idebenone) in Duchenne muscular dystrophy on Jan 23 2018. The company now anticipates that the CHMP will maintain its original position to issue a negative opinion on Santhera's MAA filed as Type II variation of its existing marketing authorization for Leber's hereditary optic neuropathy.
    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top