Post Authorisation Safety Study With Raxone in LHON Patients

Leber's Hereditary Optic Neuropathy (LHON) Clinical Trial

— PAROS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02771379
• Other study ID #: SNT-IV-003
• Status: Completed
• Start date: September 2016
• Est. completion date: April 16, 2021

Study information

• Verified date: July 2021
• Source: Santhera Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: April 16, 2021
• Est. primary completion date: April 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Leber's Hereditary Optic Neuropathy (LHON)
• Optic Atrophy, Hereditary, Leber
• Optic Nerve Diseases

Intervention

Drug:
• Idebenone
Raxone 900mg/day as per Raxone SmPC and medical judgement of treating physician.

Locations

Country	Name	City	State
Austria	Universitaetsklinikum Graz	Graz
Austria	Medical University of Vienna	Vienna
France	CHU Amiens - Centre Saint Victor	Amiens	Somme
France	CHU Angers - Hôpital Hôtel Dieu	Angers	Maine Et Loire
France	Hopital Roger Salengro - CHU Lille	Lille	Nord
France	Hospices Civils de Lyon	Lyon
France	Hopital Neurologique Pierre Wertheimer	Lyon Cedex
France	CHU de Nîmes - Hôpital Carémeau	Nîmes	Gard
France	Centre Hospitalier National d'Ophtalmologie (CHNO) des Quinze-Vingts	Paris
France	Fondation Ophtalmologique Adolphe de Rothschild	Paris
France	Hôpital Européen Georges Pompidou	Paris	Paris Cedex 15
Germany	Universitaetsklinikum Essen	Essen
Germany	Universitaetsklinikum Freiburg	Freiburg
Germany	Universitaetsklinikum Hamburg-Eppendorf	Hamburg
Germany	Universitaetsklinikum Heidelberg	Heidelberg
Germany	Friedrich-Baur-Institut	Munich
Germany	Universitaetsklinikum Muenster	Munster
Germany	Dietrich-Bonhoeffer-Klinikum Neubrandenburg	Neubrandenburg
Germany	Universitaetsklinikum Regensburg	Regensburg
Germany	Julius Maximilians University	Wuerzburg	Bavaria
Greece	Athens Ophthalmological Center	Athens
Italy	Università di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche	Bologna
Italy	Ospedale San Raffaele	Milano
Italy	Azienda Ospedaliera S. Camillo Forlanini	Rome
Netherlands	Universitair Medisch Centrum Groningen	Groningen
Netherlands	Maastricht University Medical Center	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Santhera Pharmaceuticals

Countries where clinical trial is conducted

Austria,  France,  Germany,  Greece,  Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	up to 5 years
Secondary	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.	up to 5 years