NCT03697161已完成2 期
A Phase 2, Randomized, Double-Blind, Parallel-Group Study Evaluating the Safety, Tolerability, and Efficacy of OV101 in Fragile X Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events (TEAE)
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability and efficacy of oral OV101 (gaboxadol) in subjects with Fragile X syndrome.
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
- 13 Years 至 22 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Is male and 13 to 22 years old (inclusive) at the time of informed consent.
- •Has a diagnosis of FXS with a confirmed FMR1 full mutation (≥200 CGG repeats).
排除标准
- •Concomitant disease or condition that are clinically significant and would limit study participation
- •Clinically significant lab abnormalities or vital signs at the time of screening
- •History of uncontrollable seizure disorder or seizure episodes within 6 months of screening or change in the anticonvulsant pharmacotherapy in the past 3 months.
- •Unable or does not have a caregiver able to comply with study requirements.
- •Enrolled in any clinical trial within the 30 days before screening.
研究组 & 干预措施
OV101 (gaboxadol) Regimen 2
Experimental
Twice Daily
干预措施: OV101 (gaboxadol) (Drug)
OV101 (gaboxadol) Regimen 1
Experimental
Once Daily
干预措施: OV101 (gaboxadol) (Drug)
OV101 (gaboxadol) Regimen 3
Experimental
Three Times Daily
干预措施: OV101 (gaboxadol) (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events (TEAE)
时间窗: Week 12
Number of Participants with Treatment Emergent Adverse Events
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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