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 ]
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 ]
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