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PAROS: Post Authorisation Safety Study With Raxone in LHON Patients

Sponsor
Santhera Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT02771379
Collaborator
(none)
229
Enrollment
26
Locations
55.5
Duration (Months)
8.8
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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 Phase

Study Design

Study Type:
Observational
Actual Enrollment :
229 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 :
Sep 1, 2016
Actual Primary Completion Date :
Apr 16, 2021
Actual Study Completion Date :
Apr 16, 2021

Arms and Interventions

Arm Intervention/Treatment
Patients who are treated with Raxone®

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

    		•

    Outcome Measures

    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. [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universitaetsklinikum Graz Graz Austria 8036
    2 Medical University of Vienna Vienna Austria
    3 CHU de Nîmes - Hôpital Carémeau Nîmes Gard France 30029
    4 CHU Angers - Hôpital Hôtel Dieu Angers Maine Et Loire France 49033
    5 Hopital Roger Salengro - CHU Lille Lille Nord France 59037
    6 Hôpital Européen Georges Pompidou Paris Paris Cedex 15 France 75908
    7 CHU Amiens - Centre Saint Victor Amiens Somme France 80054
    8 Hopital Neurologique Pierre Wertheimer Lyon Cedex France 69677
    9 Hospices Civils de Lyon Lyon France 69002
    10 Centre Hospitalier National d'Ophtalmologie (CHNO) des Quinze-Vingts Paris France 75012
    11 Fondation Ophtalmologique Adolphe de Rothschild Paris France 75019
    12 Julius Maximilians University Wuerzburg Bavaria Germany 97070
    13 Universitaetsklinikum Essen Essen Germany
    14 Universitaetsklinikum Freiburg Freiburg Germany
    15 Universitaetsklinikum Hamburg-Eppendorf Hamburg Germany 20246
    16 Universitaetsklinikum Heidelberg Heidelberg Germany
    17 Friedrich-Baur-Institut Munich Germany
    18 Universitaetsklinikum Muenster Munster Germany
    19 Dietrich-Bonhoeffer-Klinikum Neubrandenburg Neubrandenburg Germany
    20 Universitaetsklinikum Regensburg Regensburg Germany
    21 Athens Ophthalmological Center Athens Greece 11528
    22 Università di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche Bologna Italy 40123
    23 Ospedale San Raffaele Milano Italy 20132
    24 Azienda Ospedaliera S. Camillo Forlanini Rome Italy 00152
    25 Universitair Medisch Centrum Groningen Groningen Netherlands 9713 GZ
    26 Maastricht University Medical Center Maastricht Netherlands 6211 LK

    Sponsors and Collaborators

    • Santhera Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Santhera Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT02771379
    Other Study ID Numbers:
    • SNT-IV-003
    First Posted:
    May 13, 2016
    Last Update Posted:
    Jul 16, 2021
    Last Verified:
    Jul 1, 2021
    Additional relevant MeSH terms:
    Optic Nerve Diseases
    Optic Atrophy, Hereditary, Leber
    Idebenone

    Study Results

    No Results Posted as of Jul 16, 2021