CTIS2024-512108-20-00招募中1 期
A Multicenter, Long-Term Open-Label Safety Study of Adjunctive Troriluzole in Subjects with Obsessive Compulsive Disorder
Biohaven Pharmaceuticals Inc.0 个研究点目标入组 1,200 人开始时间: 2024年6月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Eligible subjects who complete study BHV4157-302 or BHV4157-303 and for whom the investigator believes open-label treatment offers an acceptable risk-benefit profile., Determined by the investigator to be medically stable at the final visit of BHV4157-302 or BHV4157-303, (the labs collected at the Week 10 visit for BHV4157-302 or BHV4157-303), as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing., Women of child bearing potential (WOCBP) and fertile men (including those vasectomized for less than 6 months) with female partners who are WOCBP (not having undergone bilateral tubal occlusion procedure and not post- menopausal) must agree to use highly effective birth control, including two methods of contraception, for the duration of the study.
排除标准
- •Subjects who did not successfully complete randomization phase in BHV4157-302/BHV4157-303 study., Acute suicidality or suicide attempt or self injurious behavior in last 12 months., Patients who plan to receive non-biological or biological investigational agent in while enrolled in trial.
研究者
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