NCT07288567招募中3 期
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (13 to 17 Years of Age)
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
- 166
- 试验地点
- 84
- 主要终点
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of KarXT for treatment of Schizophrenia in adolescents.
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
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizophrenia as defined by the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition,Text Revision (DSM-5-TR) criteria, confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-PL) and experiencing symptoms of psychosis at screening (Visit 1).
- •PANSS total score of at least 70 at screening (Visit 1) and randomization (Visit 2).
- •Participant has a CGI-S score of ≥ 4 at screening (Visit 1) and randomization (Visit 2).
排除标准
- •Any primary DSM-5-TR disorder other than schizophrenia within 12 months before screening.
- •History or presence of clinically significant cardiovascular, pulmonary, hepatic impairment, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results.
- •All grades of hepatic impairment (mild [Child-Pugh Class A], moderate [Child-Pugh Class B], and severe [Child-Pugh Class C]). Participants with known intellectual disability defined as an IQ less than 70; or, either clinical evidence or known social or school history indicative of intellectual disability.
- •Any neurological disorder, except for Tourette's Syndrome.
- •Participants who have either a systolic blood pressure (sBP) or diastolic blood pressure (dBP) meeting criteria for stage 2 HTN, regardless of the presence or absence of symptoms.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
KarXT
Experimental
干预措施: KarXT (Drug)
Placebo
Placebo Comparator
干预措施: KarXT Matching Placebo (Other)
结局指标
主要结局
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
时间窗: Week 5
次要结局
- Change From Baseline in Children's Global Assessment Scale (CGAS)) Score(Week 5)
- Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score(Week 5)
- Change From Baseline in PANSS Positive Subscale Score(Week 5)
- Change From Baseline in PANSS Negative Subscale Score(Week 5)
- Change From Baseline in PANSS Marder Negative Factor Score(Week 5)
- Number of Participants With PANSS Response(Week 5)
- Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Score(Week 5)
研究者
研究点 (84)
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