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 ]
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