NCT07284745尚未招募3 期
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of KarXT + KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 176
- 试验地点
- 90
- 主要终点
- Change From Baseline in the Aberrant Behavior Checklist Irritability (ABC-I) Score at Week 8
研究概览
简要总结
The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and 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
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have a confirmed diagnosis of ASD, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria, confirmed by the K-SADS-PL and must be experiencing symptoms of irritability.
- •Participants must have ABC-I ≥18 (Irritability subscale of the ABC) and CGIS specific to irritability ≥4, at screening and baseline (Day 1).
排除标准
- •Participants must not have a current primary DSM-5 diagnosis of bipolar disorder, including bipolar II disorder, schizophrenia, schizoaffective disorder, major depressive episode as determined by clinical instrument, or post-traumatic stress disorder (PTSD).
- •Exception Include: Participants with comorbid ADHD, provided that attention deficit/hyperactivity disorder (ADHD) is not the primary disorder, the participant is adequately treated and based on the investigator judgment the disorder is clinically stable.
- •Participants must not have history/presence of clinically significant disease or disorder that would jeopardize participant safety or validity of study results.
- •Participants must not have a risk for suicidal behavior, and any clinically significant abnormal laboratory test.
- •Other protocol-defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
KarXT + KarX-EC Arm
Experimental
干预措施: KarXT (Drug)
Placebo
Placebo Comparator
干预措施: KarXT + KarX-EC Matching Placebo (Drug)
KarXT + KarX-EC Arm
Experimental
干预措施: KarX-EC (Drug)
结局指标
主要结局
Change From Baseline in the Aberrant Behavior Checklist Irritability (ABC-I) Score at Week 8
时间窗: Week 8
Change From Baseline in the Aberrant Behavior Checklist Irritability (ABC-I) Score at Week 8
时间窗: Week 8
次要结局
- Number of Participants With Procholinergic Symptoms(Up to approximately 12 weeks)
- Number of Participants With Anticholinergic Symptoms(Up to approximately 12 weeks)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(Up to approximately 12 weeks)
- Number of Participants With Serious Adverse Events (SAEs)(Up to approximately 12 weeks)
- Number of Participants With Adverse Events of Special Interest (AESIs)(Up to approximately 12 weeks)
- Plasma concentrations of KarXT(Up to approximately 8 weeks)
- Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Week 8(Week 8)
- Number of Participants With ABC-I Response at Week 8(Week 8)
- Change From Baseline on the ABC Subscale for Social Withdrawal at Week 8(Week 8)
- Change From Baseline on the Stereotypic Behavior Subscale at Week 8(Week 8)
- Change From Baseline on the Inappropriate Speech Subscale at Week 8(Week 8)
- Clinical Global Impression-Improvement (CGI-I) Score at Week 8(Week 8)
- Number of Participants With AEs Leading to Discontinuation of Study Intervention(Up to approximately 8 weeks)
- Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Week 8(Week 8)
- Number of Participants With ABC-I Response at Week 8(Week 8)
- Change From Baseline on the ABC Subscale for Social Withdrawal at Week 8(Week 8)
- Change From Baseline on the Stereotypic Behavior Subscale at Week 8(Week 8)
- Change From Baseline on the Hyperactivity/Noncompliance Subscale at Week 8(Week 8)
- Change From Baseline on the Inappropriate Speech Subscale at Week 8(Week 8)
- Clinical Global Impression-Improvement (CGI-I) Score at Week 8(Week 8)
- Number of Participants With Procholinergic Symptoms(Up to approximately 10 weeks)
- Number of Participants With Anticholinergic Symptoms(Up to approximately 10 weeks)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(Up to approximately 10 weeks)
- Number of Participants With Serious Adverse Events (SAEs)(Up to approximately 10 weeks)
- Number of Participants With Adverse Events of Special Interest (AESIs)(Up to approximately 10 weeks)
- Number of Participants With AEs Leading to Discontinuation of Study Intervention(Up to approximately 8 weeks)
研究者
研究点 (90)
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