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:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
NCT ID:
NCT04561466
Eligibility Criteria:
Inclusion Criteria:
* Adult patients in whom the diagnosis of LHON obtained on anamnestic, clinical and ancillary testing / laboratory data. LHON should have occurred for less than 5 years and must be genetically proved with a 3460 or 11778 mitochondrial DNA mutation. Given the mode of transmission, genetic research may have been carried out in a maternal relative
Exclusion Criteria:
* \* Any optic neuropathy for which the diagnosis of LHON is not formally confirmed or genetically proven;
* LHON that started for more than 5 years;
* LHON associated with another primary mutation than 3460 or 11778
* Children or adult patients under guardianship or deprived of liberty by administrative or judicial decision;
* Women of childbearing age ; pregnant or lactating women;
* Patients who do not have affiliation to a social protection scheme (national or private insurance / beneficiary or assignee);
* Patient who did not give its written, informed and signed consent;
* Allergy to fibrate, bezafibrate and / or BEFIZAL® 200mg (Arrow Generiques) or one of these constituents;
* Photosensitivity reactions related to fibrates;
* Patient already receiving treatment with fibrates or HMG Co-A reductase inhibitors or anticoagulants;
* Hepatic insuffisiency or dysfunction with increased of transaminases (AST and ALT) over 3 times of the normal;
* Renal insufficiency with serum creatinine\> 15 mg / L (\> 135 mg / dL) Biliary pathology
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04561466
Study Brief:
Protocol Section:
NCT04561466