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 23, 2019
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|
|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|
|Estimated Study Completion Date :||February 2021|
|Patients who are treated with Raxone®||
Raxone 900mg/day as per Raxone SmPC and medical judgement of treating physician.
Other Name: Raxone®
- 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)
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02771379
|Contact: Vanessa Ferreira||PAROS@Santhera.com|