NCT07221877招募中4 期
A 12-month Open-label, Phase 4 Multicenter Safety Study to Evaluate the Effect of KarXT on Voiding Dynamics and Urological Safety
Bristol-Myers Squibb13 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年1月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 13
- 主要终点
- Change from baseline in voiding dynamics (Qmax) over time
研究概览
简要总结
The purpose of this study is to characterize the effect of KarXT on voiding dynamics and urological safety in participants with DSM-5 schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female participants (age 18 to 65 years of age, with a primary diagnosis of schizophrenia based on psychiatric evaluation (DSM-5) and confirmed by MINI (v 7.0.2).
- •Participants must have a PANSS total score ≤ 80 and CGI-S score ≤ 4, at screening and baseline, and a BMI ≥18 and ≤ 40 kg/m
- •Participants must be willing and able to discontinue all antipsychotic medications prior to the baseline visit and be willing and able to comply with protocol requirements.
排除标准
- •Participants with newly diagnosed schizophrenia, any other DSM-5 disorder diagnosed within the past 12 months, alcohol or drug use disorder within the past 12 months, history/presence of clinically significant disease or disorder that would jeopardize participant safety or validity of study results.
- •Participants at risk for suicidal behavior, as well as individuals who are pregnant or breastfeeding, will be excluded from the study.
- •Other protocol-defined Inclusion/Exclusion criteria apply
研究组 & 干预措施
KarXT
Experimental
干预措施: Xanomeline/trospium chloride (Drug)
结局指标
主要结局
Change from baseline in voiding dynamics (Qmax) over time
时间窗: Up to 12 months
Change from baseline in post-void residual volume (PVR) over time
时间窗: Up to 12 months
次要结局
- Number of participants with a change from baseline in urinalysis parameters over time(Up to 12 months)
- Number of participants with vital sign abnormalities(Up to 12 months)
- Number of participants with Adverse Events (AEs)(Up to 12 months)
- Change from baseline in IPSS over time(Up to 12 months)
- Number of participants with electrocardiogram (ECG) abnormalities(Up to 12 months)
- Number of participants with AEs of Special Interest (AESIs)(Up to 12 months)
- Number of participants with Serious AEs (SAEs)(Up to 12 months)
- Number of participants with suicidal ideation or behavior(Up to 12 months)
研究者
研究点 (13)
Loading locations...
相似试验
已完成
1 期
A Study to Evaluate the Effects of KarXT on the Drug Levels of Midazolam, Fexofenadine, and DigoxinNCT07118215Karuna Therapeutics, Inc., a Bristol Myers Squibb company62
招募中
3 期
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's DiseaseAlzheimer's DiseaseNCT07011745Bristol-Myers Squibb426
招募中
3 期
A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)Alzheimer DiseaseNCT06585787Karuna Therapeutics, Inc., a Bristol Myers Squibb company406
招募中
1 期
A Study to Evaluate the Safety, Tolerability, and PK of an Injectable Form of KarXTSchizophreniaNCT07061288Bristol-Myers Squibb131
招募中
3 期
A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or LamotrigineManiaBipolar DisorderNCT07140913Bristol-Myers Squibb424