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

NCT02774005 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 199

Last updated 2023-04-21

Study results available
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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.

Conditions

  • Leber's Hereditary Optic Neuropathy (LHON)

Interventions

DRUG

Idebenone

Sponsors & Collaborators

  • Santhera Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2021-03-29
Completion
2021-03-29

Countries

  • United States
  • Austria
  • Belgium
  • Bulgaria
  • Germany
  • Italy
  • Poland
  • Portugal
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02774005 on ClinicalTrials.gov