EUCTR2019-001493-28-AT进行中（未招募）1 期
Raxone® treatment for patients with dominant optic atrophy due to OPA1 gene mutation - OPA1
Medizinische Universität Graz, Univ.-Augenklinik0 个研究点目标入组 16 人开始时间: 2020年9月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •ADOA patients with confirmed OPA1 mutation
- •Age of 12 years or more
- •Willingness and ability to comply with study related procedures
- •Informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 3
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 13
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •- patients in the state of pregnancy or lactation at the time of the examination or a planned pregnancy within the next 12 months
- •- patients with allergies or hypersensitivity to the active substance or to any of the excipients contained in Raxone®
- •- patients with hereditary diseases like galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
- •- patients with a high-grade hepatic or renal impairment
- •- previous treatment with idebenone
- •- patients with other diseases which would limit the compliance required for trial participation
- •Before the prescription of the trial medication, the clinical investigator will conduct a detailed medication anamnesis. If there are possible drug interactions, the patient can be excluded from the trial
- •- patients who have participated in other pharmaceutical product or medicine related trials in the last 3 months
- •- Patients with a glaucoma or with any optic neuropathy other than ADOA
- •- Patients with a baseline best- corrected- visual acuity less than counting fingers
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