Clinical Trial: Study to Assess the Efficacy and Safety of Raxone in LHON Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: External Natural History Controlled, Open-Label Intervention Study to Assess the Efficacy and Safety of Long-Term Treatment With Raxone® in Leber's Hereditary Optic Neuropathy (LHON)

Brief Summary: LEROS is an open-label interventional Phase IV study, designed to further assess the efficacy and safety of Raxone® in the long-term treatment of LHON patients.

Detailed Summary:
Sponsor: Santhera Pharmaceuticals

Current Primary Outcome: Proportion of eyes with clinically relevant recovery of visual acuity from Baseline [ Time Frame: 12 months ]

Proportion of eyes with clinically relevant recovery of visual acuity (VA) from Baseline or in which Baseline VA better than 1.0 logMAR was maintained at Month 12 in patients treated with Raxone® ≤1 year after the onset of symptoms, compared to matching external natural history control group


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Santhera Pharmaceuticals

Dates:
Date Received: May 12, 2016
Date Started: May 2016
Date Completion:
Last Updated: May 22, 2017
Last Verified: May 2017