NCT07105098招募中3 期
A Global, Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NBI-1117568 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 284
- 试验地点
- 16
- 主要终点
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5
研究概览
简要总结
The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Participant has a primary diagnosis of schizophrenia
- •Participant is experiencing an acute exacerbation or relapse of symptoms and currently warrants hospitalization.
- •Participants taking prohibited medications, including antipsychotics, must discontinue before study participation
- •Participant is willing and able to remain in an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements
排除标准
- •Participant has known hypersensitivity to any component of the formulation of NBI-1117568
- •Participant has an unstable or poorly controlled medical condition or chronic disease
- •Participant is considered by the investigator to be at imminent risk of suicide or injury to self or others
- •Participant has a diagnosis of moderate or severe substance use disorder (with the exception of nicotine or caffeine dependence) within 6 months prior to screening
- •Participant has a positive alcohol test or drug screen for disallowed substances
- •Participant has a history of poor or suspected poor compliance in clinical research studies and/or in the investigator's opinion, the participant is not capable of adhering to the protocol requirements.
- •Note: Other protocol-specified inclusion/exclusion criteria may apply.
研究组 & 干预措施
Placebo
Placebo Comparator
Participants will receive matching placebo QD orally from Day 1 to Day 35 for a total of 5 weeks.
干预措施: Placebo (Drug)
NBI-1117568
Experimental
Participants will receive NBI-1117568 once daily (QD) orally from Day 1 to Day 35 for a total of 5 weeks.
干预措施: NBI-1117568 (Drug)
结局指标
主要结局
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5
时间窗: Baseline, Week 5
次要结局
- Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 5(Baseline, Week 5)
研究者
研究点 (16)
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