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A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study

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Trial Profile

A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 06 Dec 2021

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At a glance

  • Drugs Idebenone (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Adverse reactions; Registrational
  • Acronyms SIDEROS-E
  • Sponsors Santhera Pharmaceuticals

Most Recent Events

  • 14 Oct 2020 This trial has been completed in Belgium as per European clinical database record . global end of the trial 2020-10-05
  • 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 According to a Santhera Pharmaceuticals media release, based on the completed interim analysis which tested for efficacy, the DSMB has recommended the SIDEROS study be discontinued due to futility. As a consequence, the company will discontinue the study including extension and withdraw the European marketing authorization application and end the global development program for Puldysa. Participants who are enrolled in the study will discontinue study medication and complete the follow-up.

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