A Single Visit, Observational, Follow-up Study of Patients With Leber's Hereditary Optic Neuropathy Following Participation in SNT-II-003 Trial

Trial Profile

A Single Visit, Observational, Follow-up Study of Patients With Leber's Hereditary Optic Neuropathy Following Participation in SNT-II-003 Trial

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-OFU
  • 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.
    • 22 Jan 2013 New trial record
    • 18 Jan 2013 Santhera received a negative opinion on its MAA for Raxone but is requesting a re-examination of the opinion, according to a media release.
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