A Study of OV101 in Individuals With Fragile X Syndrome
赞助:
Ovid Therapeutics Inc.
合作者:
信息的提供 (责任方):
，
| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | October 1, 2018 | ||
| 首次发布日期e ICMJE | October 5, 2018 | ||
| 最后更新发布日期 | October 5, 2018 | ||
| 预计研究开始日期 ICMJE | September 17, 2018 | ||
| 预计主要完成日期 | July 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Incidence of adverse events[ Time Frame: Change from baseline to week 12 ] |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | A Study of OV101 in Individuals With Fragile X Syndrome | ||
| 正式标题 ICMJE | A Phase 2, Randomized, Double-Blind, Parallel-Group Study Evaluating the Safety, Tolerability, and Efficacy of OV101 in Fragile X Syndrome | ||
| 简要概况 | The purpose of this study is to assess the safety, tolerability and efficacy of oral OV101 (gaboxadol) in subjects with Fragile X syndrome. |
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| 详细说明 | |||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 2 | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
30 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | September 2019 | ||
| 预计主要完成日期 | July 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - 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). Exclusion Criteria: - 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. | ||
| 性别 |
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| 年龄 | 最小年龄：13 Years ，最大年龄：22 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | United States | ||
| 管理信息 | 数据检测委员会 | Yes | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: Yes 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | Ovid Therapeutics Inc. | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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