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A Phase III Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy, Safety and Tolerability of Idebenone in Patients With Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids

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Trial Profile

A Phase III Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy, Safety and Tolerability of Idebenone in Patients With Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 29 Nov 2021

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At a glance

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

Most Recent Events

  • 06 Oct 2020 According to a Santhera Pharmaceuticals media release, In connection with this decision, Santhera intends to start a restructuring process, aligning its operations to focus on progressing vamorolone for DMD, lonodelestat for cystic fibrosis and other lung diseases and its discovery-stage gene therapy approach for congenital muscular dystrophy.
  • 06 Oct 2020 Primary endpoint has not been met. (Change From Baseline in Forced Vital Capacity percent predicted (FVC %p) at Week 78), according to a Santhera Pharmaceuticals media release.
  • 06 Oct 2020 According to a Santhera Pharmaceuticals media release, the company will hold a conference call to discuss the update from the study on 6th October.

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