CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 199 enrolled
Drug / intervention
Idebenonedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02774005
NCT02774005Phase 4Completed
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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)

Santhera Pharmaceuticals·interventional·Posted May 16, 2016·Updated Apr 21, 2023

In Brief

A Phase 4 clinical trial evaluating Idebenone for Leber's Hereditary Optic Neuropathy (LHON). Completed, enrolled 199 participants across 29 sites in 10 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeber's Hereditary Optic Neuropathy (LHON)
CountriesAustria, Belgium, Bulgaria, Germany, Italy, Poland, Portugal, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 16, 2016
Enrollment StartMay 1, 2016
Primary CompletionMar 29, 2021
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 10.1 years ago

Interventions

Idebenonedrug