Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT07258667
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 16 years or older.
* Diagnosis of Leber Hereditary Optic Neuropathy (LHON) due to a confirmed mitochondrial DNA mutation m.11778G\>A or m.3460G\>A.
* Onset of LHON symptoms less than 18 months before inclusion.
* Naïve to nicotinamide treatment for at least 3 months prior to inclusion.
* Able to take oral medication and comply with study procedures.
* Affiliated with or beneficiary of a social security system.
* Signed informed consent (or parental consent for minors; assent for minors when applicable).
Exclusion Criteria:
* Asymptomatic carriers of m.11778G\>A or m.3460G\>A mutations (no clinical LHON).
* LHON due to other mitochondrial DNA mutations or nuclear DNA mutations.
* LHON onset more than 18 months before inclusion.
* Current or recent treatment with idebenone (within 3 months).
* Severe associated ophthalmologic disease (e.g., advanced glaucoma, retinal pathology).
* Patients treated with gene therapy.
* Elevated liver enzymes (ASAT and/or ALAT \> 2× upper normal limit) at screening or within 2 months prior to inclusion.
* Pregnant, breastfeeding, or postpartum women.
* Known contraindication to nicotinamide or allergy/intolerance to lactose or galactose.
* Persons deprived of liberty by judicial or administrative decision.
* Subjects under legal protection or psychiatric care under constraint.
* Unable to provide informed consent.
* Participation in another interventional study affecting LHON management.
* Any condition that, in the investigator's judgment, could compromise patient safety or study integrity.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT07258667
Study Brief:
Protocol Section:
NCT07258667