Post Authorisation Safety Study With Raxone in LHON Patients (PAROS)

Santhera

Status: Completed

Conditions: Leber's Hereditary Optic Neuropathy (LHON)

Treatments: Drug: Idebenone

Study type: Observational

Funder types: Industry

Identifiers

NCT02771379

SNT-IV-003

Details and patient eligibility

About

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.

Enrollment: 229 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

229 participants in 1 patient group

Patients who are treated with Raxone®

Treatment:

Drug: Idebenone