CTIS2023-506214-52-00招募中1 期
Pilot study of safety and efficacy of nicotinamide (vitamin B3) in OPA1 Dominant Optic Atrophy -NICOPA1-TO
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Major patients, Patients with DOA or DOA+ due to a heterozygous pathogenic variant in the OPA1 gene, Nicotinamide-naïve patients (> 3 months), Patients able to take oral medication, and comply with specific study procedures, Patients affiliated with or benefiting from a social security scheme, Signature of voluntary, free and informed consent to participate in the study
排除标准
- •Asymptomatic patients (= healthy carriers of an OPA1 mutation who have not developed optic neuropathy), Persons unable to give consent, Patients with other associated severe ophthalmological pathologies (advanced glaucoma, retinal pathology)., Patients treated with Idebenone, Patients with transaminase levels (ASAT and/or ALAT) twice the high normal value, Pregnant, breast-feeding or parturient women, Patients with a contraindication to nicotinamide, Person deprived of liberty by administrative or judicial decision, Patients under legal protection, Persons under compulsory psychiatric care
研究者
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