NCT03033108已完成2 期
A Phase 2a Multicenter, Randomized, Masked Study Evaluating the Pharmacodynamics of Emixustat Hydrochloride in Subjects With Macular Atrophy Secondary to Stargardt Disease
Kubota Vision Inc.0 个研究点目标入组 23 人开始时间: 2017年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 主要终点
- Change in Electrical Response of the Retina to a Flash of Light, as Measured by Electroretinogram
研究概览
简要总结
This is a pharmacodynamics study of emixustat hydrochloride in subjects with macular atrophy secondary to Stargardt disease.
详细描述
This is a multicenter, randomized, masked study to characterize the pharmacodynamics, safety and tolerability of emixustat in subjects with macular atrophy secondary to Stargardt disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Emixustat Dose 1
Experimental
lowest dose of once-daily oral emixustat
干预措施: Emixustat (Drug)
Emixustat Dose 2
Experimental
middle dose of once-daily oral emixustat
干预措施: Emixustat (Drug)
Emixustat Dose 3
Experimental
highest dose of once-daily oral emixustat
干预措施: Emixustat (Drug)
结局指标
主要结局
Change in Electrical Response of the Retina to a Flash of Light, as Measured by Electroretinogram
时间窗: Baseline and 1 month
Percent suppression compared to baseline of rod b-wave amplitude recovery after a photobleaching light.
次要结局
- Percentage of Subjects With Adverse Events, by Severity and Seriousness(1 month)
研究者
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