Status:
NO_LONGER_AVAILABLE
Expanded Access Program for Idebenone in Patients With Leber's Hereditary Optic Neuropathy Who Completed the LEROS Study
Lead Sponsor:
Santhera Pharmaceuticals
Conditions:
Leber's Hereditary Optic Neuropathy
Eligibility:
All Genders
Brief Summary
Expanded Access Program for Idebenone in Patients with Leber's Hereditary Optic Neuropathy who completed the LEROS Study
Detailed Description
see above
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04381091
Last Update
April 21 2023
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