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CompletedNCT02771379

Post Authorisation Safety Study With Raxone in LHON Patients

A Non-interventional Study of Clinical Experience in Patients Prescribed Raxone® for the Treatment of Leber's Hereditary Optic Neuropathy (LHON)

Status
Completed
Phase
Study type
Observational
Enrollment
229 (actual)
Sponsor
Santhera Pharmaceuticals · Industry
Sex
All
Age
Healthy volunteers
Not accepted

Summary

This study is a multicentre, prospective, non-interventional post-authorisation safety study (PASS) of the clinical outcomes for patients with LHON treated with Raxone®. No medication will be provided as part of this study. Raxone® will be obtained through commercial channels.

Conditions

Interventions

TypeNameDescription
DRUGIdebenoneRaxone 900mg/day as per Raxone SmPC and medical judgement of treating physician.

Timeline

Start date
2016-09-01
Primary completion
2021-04-16
Completion
2021-04-16
First posted
2016-05-13
Last updated
2021-07-16

Locations

26 sites across 6 countries: Austria, France, Germany, Greece, Italy, Netherlands

Source: ClinicalTrials.gov record NCT02771379. Inclusion in this directory is not an endorsement.

Post Authorisation Safety Study With Raxone in LHON Patients (NCT02771379) · Clinical Trials Directory