NCT07424404招募中3 期
A Phase 3 Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride in Children and Adolescents With Psychiatric Disorders
Karuna Therapeutics, Inc., a Bristol Myers Squibb company94 个研究点 分布在 8 个国家目标入组 400 人开始时间: 2026年4月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 94
- 主要终点
- Number of participants with treatment emergent adverse events (TEAEs)
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety and tolerability of Xanomeline and Trospium Chloride for the treatment of psychiatric disorders in children and adolescents
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 completed the double-blind treatment period (ie, Visit 8) of Study CN0120020 or the double-blind treatment period (ie, Week 8) of Study CN0120044 or CN0120045 without an adverse event (AE) that, in the opinion of the investigator, may indicate an unacceptable safety risk.
- •De-novo participants must have confirmed diagnosis of ASD with symptoms of irritability, as defined by 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).
排除标准
- •Participants must not have a significant risk of committing violent acts, serious self-harm, or attempting suicide based on history or routine psychiatric status examination, or those who are homicidal or are considered to be a high risk to others, or who have an answer of "Yes" on Questions 4 or 5 on the suicidal ideation section of the "Since Last Visit" version of the C-SSRS at baseline (Visit 1). Nonsuicidal, self-injurious behavior is not exclusionary.
- •Participants must not have any clinically significant abnormality including any finding(s) from the physical examination, vital signs, or ECG at the end of treatment visit of Study CN0120020, CN0120044 or CN00120045 that the investigator, in consultation with the Sponsor Medical Monitor, would jeopardize the safety of the participant.
- •Participants must not have either a systolic blood pressure (sBP) or diastolic blood pressure (dBP) meeting criteria for stage 2 hypertension (HTN), regardless of the presence or absence of symptoms.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Administration of KarXT + KarX-EC for Autism Spectrum Disorder
Experimental
干预措施: KarXT (Drug)
Administration of KarXT + KarX-EC for Autism Spectrum Disorder
Experimental
干预措施: KarX-EC (Drug)
Administration of KarXT for Schizophrenia
Experimental
干预措施: KarXT (Drug)
结局指标
主要结局
Number of participants with treatment emergent adverse events (TEAEs)
时间窗: Up to 56 weeks
Number of participants with adverse events of special interest (AESIs)
时间窗: Up to 56 weeks
Number of participants with serious adverse events (SAEs)
时间窗: Up to 56 weeks
次要结局
- Number or participants with cholinergic symptoms(Up to 56 weeks)
- Number of participants with anticholinergic symptoms(Up to 56 weeks)
- Number of participants with suicidal ideation and behavior assessed using the Columbia Suicide Severity Rating Scale (C-SSRS)(Up to 56 weeks)
- Change from baseline on the Simpson-Angus Scale (SAS)(Up to 52 weeks)
- Change from baseline on the Abnormal Involuntary Movement Scale (AIMS)(Up to 52 weeks)
- Change from baseline on the Barnes-Akathisia Rating Scale (BARS)(Up to 52 weeks)
研究者
研究点 (94)
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