Clinical trial
Expanded Access Program for Idebenone in Patients With Leber's Hereditary Optic Neuropathy Who Completed the LEROS Study
Name
SNT-EAP-IDE-004
Description
Expanded Access Program for Idebenone in Patients with Leber's Hereditary Optic Neuropathy who completed the LEROS Study
Trial arms
Treatment
Idebenone 150 MG Oral Tablet
idebenone 900 mg/day
Size
-1
Eligibility criteria
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.
Protocol
{'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'intermediate': True}}
Updated at
2023-04-21
1 organization
1 product
1 indication
Organization
Santhera PharmaceuticalsProduct
IdebenoneIndication
Leber's Hereditary Optic Neuropathy