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An Early Access Program of Raxone® (idebenone) for patients with Duchenne Muscular Dystrophy (DMD)

Trial Profile

An Early Access Program of Raxone® (idebenone) for patients with Duchenne Muscular Dystrophy (DMD)

Status: Recruiting
Phase of Trial: Clinical Phase Unknown

Latest Information Update: 09 Oct 2020

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At a glance

  • Drugs Idebenone (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Expanded access; Therapeutic Use
  • 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.
    • 12 Sep 2017 New trial record
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