NCT04708834终止3 期
A Multicenter, Long-Term Open-Label Safety Study of Adjunctive Troriluzole in Subjects With Obsessive Compulsive Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 772
- 试验地点
- 175
- 主要终点
- To evaluate the long term safety and tolerability of troriluzole as adjunctive therapy in subjects with OCD who have had an inadequate response to SSRI, clomipramine, venlafaxine or desvenfaxine treatment
研究概览
简要总结
The purpose of the study is to evaluate the long term safety and tolerability of troriluzole as adjunctive therapy in subjects with obsessive compulsive disorder (OCD).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible subjects are those 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 week 10 visit of BHV4157-302 or BHV4157-303, as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing.
- •It is required that all women of child-bearing potential (WOCBP) who are sexually active agree to use two methods of contraception for the duration of the study
排除标准
- •Subjects who did not successfully complete 10 weeks of treatment in the BHV4157-302 or BHV4157-303 study.
- •Acute suicidality or suicide attempt or self injurious behavior in the last 12 months.
- •Patients who may have received a non-biological investigational agent in any clinical trial within 30 days or a biological agent within 90 days prior to entry, other than what was received in BHV4157-302 or BHV4157-303;
研究组 & 干预措施
Troriluzole (BHV-4157)
Experimental
200 mg daily first 2 weeks, 280 daily following first 2 weeks
干预措施: Troriluzole (BHV-4157) (Drug)
结局指标
主要结局
To evaluate the long term safety and tolerability of troriluzole as adjunctive therapy in subjects with OCD who have had an inadequate response to SSRI, clomipramine, venlafaxine or desvenfaxine treatment
时间窗: Change from Baseline to week 240
Percent change in treatment emergent adverse events, and clinical significant abnormalities in ECG's and lab values after Baseline.
次要结局
未报告次要终点
研究者
研究点 (175)
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