Post Authorisation Safety Study With Raxone in LHON Patients

Completed

• Conditions: Leber's Hereditary Optic Neuropathy (LHON)
• Interventions: Drug: Idebenone

• Registration Number: NCT02771379
• Lead Sponsor: Santhera Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-25
• Study First Submitted QC: 2016-05-10
• Study First Posted: 2016-05-13
• Study Start: 2016-09
• Primary Completion: 2021-04-16
• Study Completion: 2021-04-16
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-15
• Last Update Posted: 2021-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 229

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients who are treated with Raxone®	Idebenone	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (26)

Universitaetsklinikum Graz; 🇦🇹 Graz, Austria

Medical University of Vienna; 🇦🇹 Vienna, Austria

CHU de Nîmes - Hôpital Carémeau; 🇫🇷 Nîmes, Gard, France

CHU Angers - Hôpital Hôtel Dieu; 🇫🇷 Angers, Maine Et Loire, France

Hopital Roger Salengro - CHU Lille; 🇫🇷 Lille, Nord, France

Hôpital Européen Georges Pompidou; 🇫🇷 Paris, Paris Cedex 15, France

CHU Amiens - Centre Saint Victor; 🇫🇷 Amiens, Somme, France

Hopital Neurologique Pierre Wertheimer; 🇫🇷 Lyon Cedex, France

Hospices Civils de Lyon; 🇫🇷 Lyon, France

Centre Hospitalier National d'Ophtalmologie (CHNO) des Quinze-Vingts; 🇫🇷 Paris, France

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