NCT05181995终止2 期
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of 50 mg NYX-783 Once Daily Compared to Placebo in Participants With Post-Traumatic Stress Disorder (PTSD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Aptinyx
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- CAPS-5 (Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of' Mental Disorders, 5th edition)
研究概览
简要总结
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of 50 mg NYX-783 Once Daily Compared to Placebo in Participants with Post-Traumatic Stress Disorder (PTSD)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PTSD (DSM-5 criteria)
- •Stable allowed medications with no planned changes from 30 days prior to screening through study participation
- •Willing to use highly effective birth control
- •Willing to comply with protocol visits and procedures
排除标准
- •Moderate to severe traumatic brain injury
- •Other psychiatric disorders (based on SCID-5-CT) or neurodegenerative disorders
- •Substance use disorder or alcohol use disorder within 6 months prior to screening
- •Psychotherapy or cognitive based therapy within 30 days prior to screening
- •Use of investigational drug within 30 days prior to screening
- •Prior participation in study of NYX-783, NYX-2925 or NYX-458.
研究组 & 干预措施
50 mg NYX-783 QD
Experimental
50 mg NYX-783 QD
干预措施: NYX-783 (Drug)
Placebo
Placebo Comparator
Placebo QD
干预措施: Placebo (Drug)
结局指标
主要结局
CAPS-5 (Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of' Mental Disorders, 5th edition)
时间窗: study endpoint, up to 10 weeks
Change from Baseline in CAPS-5
次要结局
- CGI-S (Clinician Global Impression - Severity)(study endpoint, up to 10 weeks)
- SDS (Sheehan Disability Scale)(study endpoint, up to 10 weeks)
- PGI-S (Patient Global Impression - Severity)(study endpoint, up to 10 weeks)
研究者
研究点 (1)
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