A Phase 2, Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of BHV-7000 in Treatment of Bipolar I Disorder
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 94
- 试验地点
- 29
- 主要终点
- Number of Participants With Clinically Significant Laboratory Abnormalities
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety and tolerability of BHV-7000 in subjects with bipolar I disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have successfully completed the parent study, BHV7000-
- •WOCBP must have a negative urine pregnancy test at Baseline visit.
- •WOCBP must not be breastfeeding or lactating at Baseline visit or any point in the study.
排除标准
- •Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures.
- •Subjects who, in the opinion of the Investigator, will not be able to adhere to the Schedule of Assessments and/or may have difficulties complying with the treatment regimen over an extended duration of a long-term, outpatient study.
- •Investigator deems subject at imminent risk of danger to others or themself.
研究组 & 干预措施
BHV-7000
干预措施: BHV-7000 (Drug)
结局指标
主要结局
Number of Participants With Clinically Significant Laboratory Abnormalities
时间窗: Up to 52 weeks
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 or 4 laboratory abnormalities.
Number of Participants With Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and AEs judged to be related to study medication
时间窗: Up to 52 weeks
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with SAEs, AEs leading to discontinuation, AEs judged to be related to study medication that are observed during the Double-blind Treatment Phase (21 days).
Number of Participants With Vital Sign Abnormalities
时间窗: Up to 52 weeks
Number of Participants With Electrocardiogram (ECG) Abnormalities specific to QTc elevation
时间窗: Up to 52 weeks
次要结局
未报告次要终点