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

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

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT04381091
Acronym
US EAP LHON
Enrollment
Unknown
Registered
2020-05-08
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leber's Hereditary Optic Neuropathy

Brief summary

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

Detailed description

see above

Interventions

DRUGIdebenone 150 MG Oral Tablet

idebenone 900 mg/day

Sponsors

Santhera Pharmaceuticals
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL

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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026