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
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
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History