Status:
RECRUITING
Tolerance and Efficacy Nicotinamide (vitamin B3) in Dominant Optic Atrophy OPA1
Lead Sponsor:
University Hospital, Angers
Conditions:
Nicotinamide Adverse Reaction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Dominant Optic Atrophy (hereafter known as DOA) is a neurodegenerative pathology of the optic nerve inducing progressive loss of central visual field and visual acuity. There is currently no proven tr...
Eligibility Criteria
Inclusion
- Adult patients
- Patients with DOA or DOA+ due to a heterozygous pathogenic variant in the OPA1 gene
- Naïve patients (\> 3 months) in terms of taking nicotinamide
- Patients able to take oral medication and comply with specific study procedures
- Patients affiliated or beneficiaries of a social security scheme
- Signature of voluntary, free and informed consent to participate in the study
Exclusion
- Asymptomatic patients (= healthy carriers of an OPA1 mutation but not having developed optic neuropathy)
- Patients with another associated severe ophthalmological pathology (advanced glaucoma, retinal pathology, etc.)
- Patients treated with Idebenone
- Patients with a level of transaminase(s) (ASAT and/or ALAT) twice higher than the high normal value.
- Pregnant, breastfeeding or parturient women
- Patients with a contraindication to nicotinamide
- Persons deprived of liberty by administrative or judicial decision
- Patients subject to a legal protection measure
- Persons undergoing psychiatric treatment under duress
- Persons unable to express their consent
Key Trial Info
Start Date :
January 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06007391
Start Date
January 23 2024
End Date
September 1 2026
Last Update
February 24 2025
Active Locations (1)
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1
Angers University Hospital
Angers, France