Expanded Access Program for Idebenone in Patients With Leber's Hereditary Optic Neuropathy Who Completed the LEROS Study (US EAP LHON)

Santhera

Status

Conditions: Leber's Hereditary Optic Neuropathy

Treatments: Drug: Idebenone 150 MG Oral Tablet

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT04381091

SNT-EAP-IDE-004

Details and patient eligibility

About

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

Full description

see above

Sex: All

Volunteers: No Healthy Volunteers

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.