Post Authorisation Safety Study With Raxone in LHON Patients
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 229
- 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.
- 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)
Ospedale San Raffaele
🇮🇹Milano, Italy
Universitaetsklinikum Essen
🇩🇪Essen, Germany
CHU Amiens - Centre Saint Victor
🇫🇷Amiens, Somme, France
CHU de Nîmes - Hôpital Carémeau
🇫🇷Nîmes, Gard, France
Universitaetsklinikum Graz
🇦🇹Graz, Austria
Hopital Roger Salengro - CHU Lille
🇫🇷Lille, Nord, France
Azienda Ospedaliera S. Camillo Forlanini
🇮🇹Rome, Italy
Centre Hospitalier National d'Ophtalmologie (CHNO) des Quinze-Vingts
🇫🇷Paris, France
Hopital Neurologique Pierre Wertheimer
🇫🇷Lyon Cedex, France
Medical University of Vienna
🇦🇹Vienna, Austria
Hospices Civils de Lyon
🇫🇷Lyon, France
CHU Angers - Hôpital Hôtel Dieu
🇫🇷Angers, Maine Et Loire, France
Hôpital Européen Georges Pompidou
🇫🇷Paris, Paris Cedex 15, France
Julius Maximilians University
🇩🇪Wuerzburg, Bavaria, Germany
Fondation Ophtalmologique Adolphe de Rothschild
🇫🇷Paris, France
Universitaetsklinikum Freiburg
🇩🇪Freiburg, Germany
Friedrich-Baur-Institut
🇩🇪Munich, Germany
Universitaetsklinikum Regensburg
🇩🇪Regensburg, Germany
Athens Ophthalmological Center
🇬🇷Athens, Greece
Universitaetsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Universitaetsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Università di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche
🇮🇹Bologna, Italy
Universitair Medisch Centrum Groningen
🇳🇱Groningen, Netherlands
Maastricht University Medical Center
🇳🇱Maastricht, Netherlands
Dietrich-Bonhoeffer-Klinikum Neubrandenburg
🇩🇪Neubrandenburg, Germany
Universitaetsklinikum Muenster
🇩🇪Munster, Germany