NCT07288333招募中2 期
A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117570 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 35
研究概览
简要总结
The primary objective for this study is to evaluate the efficacy of NBI-1117570 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults who warrant inpatient hospitalization.
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
- •18 to 55 years of age
- •Primary diagnosis of schizophrenia ≥1 year before screening.
- •Participant is experiencing an acute exacerbation or relapse of symptoms with onset less than 2 months before screening and currently requires hospitalization.
- •Participant must have had a positive response to at least 1 antipsychotic therapy (other than clozapine) for the treatment of a prior acute relapse.
排除标准
- •Considered to be at imminent risk of suicide or injury to self or others.
- •History of epilepsy, seizures, or convulsions.
- •Has orthostatic hypotension, or history of pulmonary hypertension, obstructive coronary artery disease, hypertrophic cardiomyopathy, myocardial infarction, coronary artery revascularization, heart failure, left ventricular hypertrophy, moderate or severe cardiac valvopathy, or other cardiovascular conditions or measures that would preclude participation.
- •Currently taking prohibited medications.
- •Pregnant or lactating.
- •Note: Additional inclusion/exclusion criteria may apply, per protocol.
研究组 & 干预措施
Placebo
Placebo Comparator
Participants will receive placebo matched to NBI-1117570.
干预措施: Placebo (Drug)
NBI-1117570: Higher-dose
Experimental
Participants will receive a higher-dose of NBI-1117570.
干预措施: NBI-1117570 (Drug)
NBI-1117570: Lower-dose
Experimental
Participants will receive a lower-dose of NBI-1117570.
干预措施: NBI-1117570 (Drug)
结局指标
主要结局
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 35
时间窗: Day 35
次要结局
- Number of Participants With Treatment-emergent Adverse Event (TEAEs)(Day 1 up to Day 49)
研究者
研究点 (6)
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