Post Authorisation Safety Study With Raxone in LHON Patients

• Status: Completed
• Trial end date: 2021-04-16
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Santhera Pharmaceuticals
• Treatments: Idebenone

Criteria

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.