Clinical trial NCT02771379: Post Authorisation Safety Study With Raxone in LHON Patients
Official title: A Non-interventional Study of Clinical Experience in Patients Prescribed Raxone® for the Treatment of Leber's Hereditary Optic Neuropathy (LHON)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leber's Hereditary Optic Neuropathy (LHON)
Lead sponsor: Santhera Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2016-05-13
Enrollment: 229
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient prescribed Raxone® for the treatment of LHON who have completed the informed consent. This study will be conducted in EU in approximately 45 highly specialized centres in ophthalmology and neuroophthalmology.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Long-term safety profile of Raxone® in the treatment of patients with LHON when used under conditions of routine clinical care.
timeFrame: up to 5 years
Secondary outcomes:
measure: Long-term effectiveness of Raxone® in the treatment of patients with LHON when used under conditions of routine clinical care
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Universitaetsklinikum Graz
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Nîmes
country: France
facility: CHU de Nîmes - Hôpital Carémeau
state: Gard
city: Angers
country: France
facility: CHU Angers - Hôpital Hôtel Dieu
state: Maine Et Loire
city: Lille
country: France
facility: Hopital Roger Salengro - CHU Lille
state: Nord
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
state: Paris Cedex 15
city: Amiens
country: France
facility: CHU Amiens - Centre Saint Victor
state: Somme
city: Lyon Cedex
country: France
facility: Hopital Neurologique Pierre Wertheimer
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Paris
country: France
facility: Centre Hospitalier National d'Ophtalmologie (CHNO) des Quinze-Vingts
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
city: Wuerzburg
country: Germany
facility: Julius Maximilians University
state: Bavaria
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Munich
country: Germany
facility: Friedrich-Baur-Institut
city: Munster
country: Germany
facility: Universitaetsklinikum Muenster
city: Neubrandenburg
country: Germany
facility: Dietrich-Bonhoeffer-Klinikum Neubrandenburg
city: Regensburg
country: Germany
facility: Universitaetsklinikum Regensburg
city: Athens
country: Greece
facility: Athens Ophthalmological Center
city: Bologna
country: Italy
facility: Università di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Rome
country: Italy
facility: Azienda Ospedaliera S. Camillo Forlanini
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
Study officials:
References: