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Post Authorisation Safety Study With Raxone in LHON Patients (PAROS)

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ClinicalTrials.gov Identifier: NCT02771379
Recruitment Status : Recruiting
First Posted : May 13, 2016
Last Update Posted : July 7, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Leber's Hereditary Optic Neuropathy (LHON) Drug: Idebenone

Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Non-interventional Study of Clinical Experience in Patients Prescribed Raxone® for the Treatment of Leber's Hereditary Optic Neuropathy (LHON)
Study Start Date : September 2016
Estimated Primary Completion Date : February 2021


Group/Cohort Intervention/treatment
Patients who are treated with Raxone® Drug: Idebenone
Raxone 900mg/day as per Raxone SmPC and medical judgement of treating physician.
Other Name: Raxone®




Primary Outcome Measures :
  1. Long-term safety profile of Raxone® in the treatment of patients with LHON when used under conditions of routine clinical care. [ Time Frame: 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 :
  1. Long-term effectiveness of Raxone® in the treatment of patients with LHON when used under conditions of routine clinical care [ Time Frame: 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02771379


Contacts
Contact: Vanessa Ferreira PAROS@Santhera.com

Locations
Austria
Medical University of Vienna Recruiting
Vienna, Austria
France
CHU de Nîmes - Hôpital Carémeau Recruiting
Nîmes, Gard, France, 30029
Principal Investigator: Luc Jeanjean, MD         
CHU Angers - Hôpital Hôtel Dieu Recruiting
Angers, Maine et Loire, France, 49033
Principal Investigator: Christophe Verny, MD         
CHU Reims - Hôpital Robert Debré Not yet recruiting
Reims Cedex, Marne, France, 51092
Principal Investigator: Carl Arndt, MD         
Hopital Roger Salengro - CHU Lille Not yet recruiting
Lille, Nord, France, 59037
Principal Investigator: Sabine Defoort Delemmes, MD         
Hôpital Européen Georges Pompidou Recruiting
Paris, Paris cedex 15, France, 75908
Principal Investigator: Christophe Orssaud, MD         
CHU Amiens - Centre Saint Victor Recruiting
Amiens, Somme, France, 80054
Principal Investigator: Solange Milazzo, MD         
Fondation Ophtalmologique Adolphe de Rothschild Recruiting
Paris, France, 75019
Principal Investigator: Samuel Bidot, MD         
Fondation Ophtalmologique Adolphe de Rothschild Recruiting
Paris, France, 75019
Principal Investigator: Catherine Vignal, MD         
Germany
Julius Maximilians University Not yet recruiting
Wuerzburg, Baden Wuerttemberg, Germany, 97070
Principal Investigator: Thomas Ach, MD         
Charite - Campus Virchow-Klinikum Recruiting
Berlin, Germany, 13353
Principal Investigator: Uwe Pleyer, MD         
Universitaetsklinikum Essen Recruiting
Essen, Germany
Universitaetsklinikum Freiburg Recruiting
Freiburg, Germany
Universitaetsklinikum Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Principal Investigator: Martin Spitzer, MD         
Universitaetsklinikum Heidelberg Recruiting
Heidelberg, Germany
Friedrich-Baur-Institut Recruiting
Munich, Germany
Universitaetsklinikum Muenster Recruiting
Munster, Germany
Universitaetsklinikum Neubrandenburg Recruiting
Neubrandenburg, Germany
Universitaetsklinikum Regensburg Recruiting
Regensburg, Germany
Greece
General Hospital of Athens Not yet recruiting
Athens, Greece, 11527
Principal Investigator: Marilita Moschou, MD         
Athens Ophthalmological Center Recruiting
Athens, Greece, 11528
Principal Investigator: Agathi Kouri, MD         
Italy
Università di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche Not yet recruiting
Bologna, Italy, 40123
Principal Investigator: Valerio Carelli, MD         
Ospedale San Raffaele Not yet recruiting
Milano, Italy, 20132
Principal Investigator: Francesco Maria Bandello, MD         
Azienda Ospedaliera S. Camillo Forlanini Not yet recruiting
Rome, Italy, 00152
Principal Investigator: Anna De Negri, MD         
Netherlands
Universitair Medisch Centrum Groningen Not yet recruiting
Groningen, Netherlands, 9713 GZ
Principal Investigator: Jan-Willem Pott, MD         
Maastricht University Medical Center Not yet recruiting
Maastricht, Netherlands, 6211 LK
Principal Investigator: Noël Bauer, MD         
Oogziekenhuis Rotterdam Not yet recruiting
Rotterdam, Netherlands, 3011 BH
Principal Investigator: Judith van Everdingen, MD         
Sponsors and Collaborators
Santhera Pharmaceuticals

Responsible Party: Santhera Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02771379     History of Changes
Other Study ID Numbers: SNT-IV-003
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: July 7, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Optic Nerve Diseases
Optic Atrophy, Hereditary, Leber
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Optic Atrophies, Hereditary
Optic Atrophy
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Mitochondrial Diseases
Metabolic Diseases
Idebenone
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs