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Expanded Access Protocol (EAP) of Idebenone in Patients With Duchenne Muscular Dystrophy

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Trial Profile

Expanded Access Protocol (EAP) of Idebenone in Patients With Duchenne Muscular Dystrophy

Status: Recruiting
Phase of Trial: Clinical Phase Unknown

Latest Information Update: 24 Apr 2023

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At a glance

  • Drugs Idebenone (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Expanded access; Therapeutic Use
  • Acronyms BreatheDMD
  • Sponsors Santhera Pharmaceuticals

Most Recent Events

  • 06 Oct 2020 According to a Santhera Pharmaceuticals media release, the company has discontinued the Phase 3 SIDEROS study due to interim futility analysis conducted by DSMB which states that the trial is unlikely to meet its primary endpoint. Furthermore, following up on the recommendation from the DSMB, Santhera will discuss the impact of ending the SIDEROS study on ongoing expanded access programs with the corresponding regulatory bodies.
  • 08 Feb 2018 Status changed from not yet recruiting to recruiting.
  • 07 Feb 2018 New trial record

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