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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02771379

Acronym

PAROS

Enrollment

229

Registered

2016-05-13

Start date

2016-09-30

Completion date

2021-04-16

Last updated

2021-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leber's Hereditary Optic Neuropathy (LHON)

Brief 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.

Interventions

DRUGIdebenone

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patient prescribed Raxone® for the treatment of LHON; * Patient has completed an Informed Consent Form (ICF) indicating that he/she (or a legally acceptable representative) has been informed of all pertinent aspects of the study and has agreed to participate in the study; * Patient is not participating in any interventional study.

Exclusion criteria

* No explicit

Design outcomes

Primary

Measure	Time frame	Description
Long-term safety profile of Raxone® in the treatment of patients with LHON when used under conditions of routine clinical care.	up to 5 years	Safety will be assessed by the collection and analysis of adverse events of special interest (AESIs), frequency and nature of AEs and serious adverse events (SAEs), adverse drug reactions (ADRs) and serious adverse drug reactions (SADRs)

Secondary

Measure	Time frame	Description
Long-term effectiveness of Raxone® in the treatment of patients with LHON when used under conditions of routine clinical care	up to 5 years	According to the Summary of Product Characteristics (SmPC) a patient's vision should be continually monitored therefore effectiveness will be assessed by measuring on-therapy changes in patients' visual acuity (VA), visual fields (VF), colour contrast sensitivity and Retinal Nerve Fibre Layer thickness (RNFL) where available.

Countries

Austria, France, Germany, Greece, Italy, Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026