CompletedNot Applicable

Post Authorisation Safety Study With Raxone in LHON Patients

Austria, France229 participantsStarted 2016-09

Plain-language 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.

Who can participate

SexALL

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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.

What they're measuring

Long-term safety profile of Raxone® in the treatment of patients with LHON when used under conditions of routine clinical care.

Timeframe: up to 5 years

Trial details

NCT IDNCT02771379

SponsorSanthera Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-04-16

View on ClinicalTrials.gov More Leber's Hereditary Optic Neuropathy (LHON) trials