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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02771379
Other study ID # SNT-IV-003
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT02796274 - Historical Case Record Survey of Visual Acuity Data From Patients With Leber's Hereditary Optic Neuropathy (LHON)
Completed NCT02774005 - Study to Assess the Efficacy and Safety of Raxone in LHON Patients Phase 4
Recruiting NCT04912843 - Gene Therapy Clinical Trial for the Treatment Of Leber's HereDitary Optic Neuropathy Phase 2/Phase 3
Terminated NCT01389817 - Near-infrared Light-emitting Diode (NIR-LED) Therapy for Leber's Hereditary Optic Neuropathy (LHON) Phase 1/Phase 2
Completed NCT05555784 - Evaluation of Impact of Disease and Visual Disability on Quality of Life and Loss of Independence of Patients Living in France With Leber's Hereditary Optic Neuropathy (LHON) Through Qualitative and Quantitative Data Collection