Post Authorisation Safety Study With Raxone in LHON Patients

Santhera Pharmaceuticals229 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

229

Conditions

Leber's Hereditary Optic Neuropathy (LHON)

Interventions

IdebenoneDRUG

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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 exclusion criteria exist to avoid selection bias and to allow for documentation of routine clinical practice.

Locations (26)

Universitaetsklinikum Graz

Graz, Austria

Outcomes

Primary Outcomes

Long-term safety profile of Raxone® in the treatment of patients with LHON when used under conditions of routine clinical care.

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)

Time frame: up to 5 years

Secondary Outcomes

Long-term effectiveness of Raxone® in the treatment of patients with LHON when used under conditions of routine clinical care

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.

Time frame: up to 5 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.