A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 213
- 试验地点
- 2
- 主要终点
- Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score at Week 6
研究概览
简要总结
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, multi-arm, multi-stage inpatient study designed to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of NBI-1117568 compared with placebo in adult subjects with a primary diagnosis of schizophrenia, who are experiencing an acute exacerbation or relapse of symptoms.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed informed consent.
- •Subject has a primary diagnosis of schizophrenia.
- •The subject is experiencing an acute exacerbation or relapse of symptoms and currently requires hospitalization.
- •Subjects taking prohibited medications, including antipsychotics, must discontinue before study participation
- •Subject 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
- •An unstable medical condition, chronic disease, or malignancy.
- •Considered by the investigator to be at imminent risk of suicide or injury to self or others.
- •Diagnosis of moderate or severe substance use disorder (with the exception of nicotine or caffeine dependence) within 6 months prior to screening.
- •Positive alcohol test or drug screen for disallowed substances.
- •Have a history of poor or suspected poor compliance in clinical research studies and/or in the investigator's opinion, the subject is not capable of adhering to the protocol requirements.
研究组 & 干预措施
Dose Level A
Participant administered Dose Level A (6 weeks)
干预措施: NBI-1117568 (Drug)
Dose Level B
Participant administered Dose Level B (6 weeks)
干预措施: NBI-1117568 (Drug)
Dose Level C
Participant administered Dose Level C (6 weeks)
干预措施: NBI-1117568 (Drug)
Dose Level D
Participant administered Dose Level D (6 weeks)
干预措施: NBI-1117568 (Drug)
Placebo Schedule
Participant administered placebo (6 weeks)
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score at Week 6
时间窗: Baseline and Week 6
The PANSS evaluates the severity of various symptoms of schizophrenia, and is commonly used to measure symptom reduction in patients taking antipsychotics. Each item is scored on a 7-point severity scale (1=absent; 2=minimal; 3=mild; 4=moderate; 5=moderate severe; 6=severe; 7=extreme). The PANSS total score is derived from the summation of each item. A higher score indicates greater severity.
次要结局
未报告次要终点