Clinical Trial: Post Authorisation Safety Study With Raxone in LHON Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: A Non-interventional Study of Clinical Experience in Patients Prescribed Raxone® for the Treatment of Leber's Hereditary Optic Neuropathy (LHON)

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.


Detailed Summary:
Sponsor: Santhera Pharmaceuticals

Current Primary Outcome: 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)


Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: Santhera Pharmaceuticals

Dates:
Date Received: April 25, 2016
Date Started: September 2016
Date Completion:
Last Updated: March 1, 2017
Last Verified: March 2017