Expanded Access Program for Idebenone in Patients With Leber's Hereditary Optic Neuropathy Who Completed the LEROS Study

• Conditions: Leber's Hereditary Optic Neuropathy

• Registration Number: NCT04381091
• Lead Sponsor: Santhera Pharmaceuticals

Brief Summary

Expanded Access Program for Idebenone in Patients with Leber's Hereditary Optic Neuropathy who completed the LEROS Study

Detailed Description

see above

Study Timeline

• Study First Submitted: 2020-05-05
• Study First Submitted QC: 2020-05-05
• Study First Posted: 2020-05-08
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-21

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients who completed the LEROS study, who attended the end of study visit in LEROS and who in the opinion of investigator could benefit from continuation of idebenone treatment.
• Signed and dated Informed Consent Form (to be obtained at the Enrollment Visit from patient or parent/legal guardian (if applicable) prior to dispensing idebenone to the patient).

Exclusion Criteria

• Patients who, in the opinion of the LEROS investigator, had unacceptable tolerability of idebenone treatment in LEROS trial.
• Patients who prematurely discontinued the LEROS study.

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified