US EAP LHON: Expanded Access Program for Idebenone in Patients With Leber's Hereditary Optic Neuropathy Who Completed the LEROS Study
Sponsor
Santhera Pharmaceuticals (Industry)
Overall Status
Available
CT.gov ID
NCT04381091
Collaborator
(none)
Study Details
Study Description
Brief Summary
Expanded Access Program for Idebenone in Patients with Leber's Hereditary Optic Neuropathy who completed the LEROS Study
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Expanded Access
Official Title:
Expanded Access Program for Idebenone in Patients With Leber's Hereditary Optic Neuropathy Who Completed the LEROS Study
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Santhera Pharmaceuticals
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Santhera Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT04381091
Other Study ID Numbers:
- SNT-EAP-IDE-004
First Posted:
May 8, 2020
Last Update Posted:
May 8, 2020
Last Verified:
May 1, 2020