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A Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in the Treatment of Patients With Leber's Hereditary Optic Neuropathy

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Trial Profile

A Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in the Treatment of Patients With Leber's Hereditary Optic Neuropathy

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 02 Aug 2019

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At a glance

  • Drugs Idebenone (Primary)
  • Indications Leber's hereditary optic atrophy
  • Focus Registrational; Therapeutic Use
  • Acronyms RHODOS
  • Sponsors Santhera Pharmaceuticals

    • Most Recent Events

    • 12 Jun 2018 According to a Santhera Pharmaceuticals media release, the Korean Ministry of Food and Drug Safety (MFDS) has accepted for review Santhera's new drug application (NDA) for Raxone (idebenone) for the treatment of Leber's hereditary optic neuropathy (LHON). This filing is based on the data package filed in the European MAA.
    • 01 Sep 2015 According to a company media release, Santhera Pharmaceuticals re-filed a Marketing Authorization Application (MAA) and in June 2015, the CHMP recommended granting a marketing authorization for Raxone for the treatment of visual impairment in adolescent and adult patients with LHON.
    • 26 Jun 2015 The EMA's Committee for Medicinal Products for Human Use recommended granting a marketing authorization for idebenone for the treatment of visual impairment in adolescent and adult patients with LHON, according to a Santhera Pharmaceuticals media release.

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