Back to resultsExpanded Access Program for Idebenone in Patients With Leber's Hereditary Optic Neuropathy Who Completed the LEROS Study (US EAP LHON)
Primary Purpose
Leber's Hereditary Optic Neuropathy
Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Idebenone 150 MG Oral Tablet
Sponsored by
About this trial
This is an expanded access trial for Leber's Hereditary Optic Neuropathy
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04381091
Brief Title
Expanded Access Program for Idebenone in Patients With Leber's Hereditary Optic Neuropathy Who Completed the LEROS Study
Acronym
US EAP LHON
Official Title
Expanded Access Program for Idebenone in Patients With Leber's Hereditary Optic Neuropathy Who Completed the LEROS Study
Study Type
Expanded Access
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santhera Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
Expanded Access Program for Idebenone in Patients with Leber's Hereditary Optic Neuropathy who completed the LEROS Study
Detailed Description
see above
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leber's Hereditary Optic Neuropathy
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Idebenone 150 MG Oral Tablet
Intervention Description
idebenone 900 mg/day
10. Eligibility
Sex
All
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.
12. IPD Sharing Statement
Learn more about this trial
Expanded Access Program for Idebenone in Patients With Leber's Hereditary Optic Neuropathy Who Completed the LEROS Study
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