A Phase 3b, Open-label, Multicenter, Two-Period, Slow-titration and Food Effect Study to Assess the Safety and Efficacy of KarXT in Participants With DSM-5 Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 173
- 试验地点
- 6
- 主要终点
- Number of Participants With TEAEs From First Dose to End of Study Follow up.
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of slowly increasing dose and food effect of KarXT in adult participants with schizophrenia.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 (American Psychiatric Association 2013) criteria and confirmed by Mini International Neuropsychiatric Interview (MINI) for Schizophrenia and Psychotic Disorder Studies version 7.0.
- •Positive and Negative Syndrome Scale (PANSS) total score of ≤ 80 at screening and Baseline.
- •Clinical Global Impression-Severity (CGI-S) score of ≤ 4 at screening and Baseline.
- •Willing and able to discontinue all antipsychotic medications prior to baseline visit.
排除标准
- •History or presence of clinically significant cardiovascular, pulmonary, renal, hematologic, gastrointestinal (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.
- •Any primary DSM-5 disorder other than schizophrenia within 12 months before screening.
- •History of treatment resistance to schizophrenia medications.
- •History of allergy/hypersensitivity to KarXT.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
KarXT on empty stomach and with food
干预措施: KarXT (Drug)
结局指标
主要结局
Number of Participants With TEAEs From First Dose to End of Study Follow up.
时间窗: From first dose to end of study follow up (63 days)
Number of participants with Treatment Emergent Adverse Events (TEAEs) from first dose to end of study follow up. An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention.
Number of Participants With TEAEs at the End of Period 1 and Period 2.
时间窗: Period 1 (From first dose to day 28) Period 2 (day 29 to day 56)
Number of participants with TEAEs at the end of period 1 and period 2. An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention.
Number of Participants With Serious TEAEs at the End of Period 1 and Period 2.
时间窗: Period 1 (From first dose to day 28); Period 2 (day 29 to day 56); Overall (63 days)
Number of participants with TEAEs at the end of period 1 and period 2. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.
Number of Participants With TEAEs Leading to Treatment Discontinuation.
时间窗: Period 1 (From first dose to day 28); Period 2 (day 29 to day 56); Overall (63 days)
Number of participants with TEAEs leading to treatment discontinuation.
Number of Participants With Pro-cholinergic and Anticholinergic TEAEs.
时间窗: Period 1 (From first dose to day 28); Period 2 (day 29 to day 56); Overall (63 days)
The number of participants experiencing adverse events related to procholinergic symptoms (believed to be associated with xanomeline) and anticholinergic symptoms (believed to be associated with trospium) symptoms. Examples of procholinergic symptoms include vomiting, nausea, diarrhea, sweating and hyper-salivation. Examples of anticholinergic include dizziness, confusion, hallucinations, and somnolence.
次要结局
- Change From Baseline in PANSS Total Score, Positive Score and Negative Score(From first dose to end of treatment (56 days))
- Change From Baseline in Marder Factor Score.(From first dose to end of treatment (56 days))
- Change From Baseline in CGI Severity Score(From first dose to end of treatment (56 days))
- Number of Participants With Spontaneously Reported AESIs(From first dose to end of study follow up (63 days))
- Number of Participants With Clinically Significant Changes in Vital Signs(From first dose to end of study follow up (63 days))
- Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments(From first dose to end of study follow up (63 days))
- Number of Participants With Clinically Significant Changes in 12-lead ECGs(From first dose to end of study follow up (63 days))
- Number of Participants Who Exhibited Suicidal Behavior as Assessed by C-SSRS(From first dose to end of study follow up (63 days))