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

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

Completed
Phase of Trial: Phase II

Latest Information Update: 01 Sep 2015

At a glance

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

    • 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.
    • 14 Apr 2015 According to a Santhera Pharmaceuticals media release, the French National Agency for Medicines and Health Products renewed the temporary authorization for use for idebenone in LHON patients for 2015. This renewed approval will allow patients in France to receive reimbursed treatment with Raxone before a marketing authorization is granted in the European Union.
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