2023-508813-18-00招募中2 期
A Phase 2, Global, Multicenter, Long-term Safety Study Designed to Assess the Safety and Tolerability of BHV-7000 in Subjects with Refractory Focal Onset Epilepsy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 383
- 试验地点
- 110
- 主要终点
- Safety is assessed by the number of unique subjects with deaths, SAE’s, AE’s leading to discontinuation, moderate and severe AEs and grade 3 and 4 laboratory abnormalities
研究概览
简要总结
To evaluate the safety and tolerability of BHV-7000
研究设计
- 分配方式
- Non-randomized
- 主要目的
- Safety and tolerability of BHV-7000 assessment phase
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Subjects who completed the double-blind phase (DBP) of prior parent study, BHV7000-302 or BHV7000-
- •Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at the Baseline/Day 0 visit.
排除标准
- •Any condition, such as an ongoing AE with/without sequalae, or is poorly tolerating IP in the DBP of the parent study, that would interfere with the subject’s ability to comply with study instructions, place the subject at unacceptable risk, and/or confound the interpretation of safety or efficacy data from the study, as judged by the Investigator.
- •Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures.
结局指标
主要结局
Safety is assessed by the number of unique subjects with deaths, SAE’s, AE’s leading to discontinuation, moderate and severe AEs and grade 3 and 4 laboratory abnormalities
Safety is assessed by the number of unique subjects with deaths, SAE’s, AE’s leading to discontinuation, moderate and severe AEs and grade 3 and 4 laboratory abnormalities
次要结局
未报告次要终点
研究者
Research and Development Medical Director
Scientific
Biohaven Therapeutics Ltd.
研究点 (110)
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