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

Santhera Pharmaceuticals26 sites in 6 countries229 target enrollmentSeptember 2016

ConditionsLeber's Hereditary Optic Neuropathy (LHON)

InterventionsIdebenone

DrugsIdebenone

Overview

Phase: Not Applicable
Intervention: Idebenone
Conditions: Leber's Hereditary Optic Neuropathy (LHON)
Sponsor: Santhera Pharmaceuticals
Enrollment: 229
Locations: 26
Primary Endpoint: Long-term safety profile of Raxone® in the treatment of patients with LHON when used under conditions of routine clinical care.
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2016

End Date

April 16, 2021

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Santhera Pharmaceuticals

Responsible Party

Sponsor

Eligibility 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.

Arms & Interventions

Patients who are treated with Raxone®

Intervention: Idebenone

Outcomes

Primary Outcomes

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)