A Phase 2 Study to Assess Safety and Efficacy of KarXT in Adult Patients With Schizophrenia
赞助:
Karuna Pharmaceuticals
合作者:
信息的提供 (责任方):
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| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | October 3, 2018 | ||
| 首次发布日期e ICMJE | October 5, 2018 | ||
| 最后更新发布日期 | October 5, 2018 | ||
| 预计研究开始日期 ICMJE | September 18, 2018 | ||
| 预计主要完成日期 | November 5, 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Change in Positive and Negative Syndrome Scale (PANSS) total score at Week 5[ Time Frame: 5 Weeks ] |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | A Phase 2 Study to Assess Safety and Efficacy of KarXT in Adult Patients With Schizophrenia | ||
| 正式标题 ICMJE | A Phase 2, Randomized, Double-blinded Study to Assess the Safety, Tolerability, and Efficacy of KarXT in Hospitalized Adults With DSM-5 Schizophrenia | ||
| 简要概况 | This is a Phase 2, randomized, double-blinded, placebo-controlled, inpatient study to examine the efficacy, safety, and tolerability profile of KarXT in adult subjects diagnosed with DSM-5 schizophrenia who are in an acute exacerbation phase. The primary objective of the study is to assess the efficacy of KarXT (a fixed combination of xanomeline and trospium chloride) (xanomeline 125 mg/trospium 30 mg twice daily [BID]) versus placebo in reducing Positive and Negative Syndrome Scale (PANSS) total scores in adult inpatients with a Diagnostic and Statistical Manual‒Fifth Edition (DSM-5) diagnosis of schizophrenia. The secondary objectives of the study are to assess overall safety and tolerability of KarXT in adult inpatients with a DSM-5 diagnosis of schizophrenia. |
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| 详细说明 | |||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 2 | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
160 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | November 5, 2019 | ||
| 预计主要完成日期 | November 5, 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: 1. Subject is aged 18-60 years, inclusive, at screening 2. Subject 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 for Schizophrenia and Psychotic Disorder Studies (MINI) version 7.0.2. 3. Subject is experiencing an acute exacerbation or relapse of symptoms, with onset less than 2 months before screening 4. Positive and Negative Syndrome Scale total score between 80 and 120, inclusive, at screening 1. Score of ≥ 4 (moderate or greater) for ≥ 2 of the following Positive Scale (P) items at screening: 2. Item 1 (P1; delusions) 3. Item 2 (P2; conceptual disorganization) 4. Item 3 (P3; hallucinatory behavior) 5. Item 6 (P6; suspiciousness/persecution) 5. There should not be a change (improvement) in PANSS total score between screening and baseline of more than 20% 6. Subjects taking a depot antipsychotic could not have received a dose of medication for at least 1 and a half injection cycles before baseline (eg, 3 or more weeks off for a 2-week cycle) 7. Subject is capable of providing informed consent 1. A signed ICF must be provided before any study assessments are performed 2. Subject must be fluent (oral and written) in English in order to consent 8. Subject must have CGI-S score of ≥ 4 at screening and baseline visits 9. Body mass index must be ≥ 18 and ≤ 40 kg/m2 10. Both females of child bearing potential and males with partners of child bearing potential must be willing to use a double-barrier method of birth control (ie, any double combination of male or female condom with spermicidal gel, diaphragm, sponge, or cervical cap with spermicidal gel) during the study and for 7 days after the last dose of study drug. Subject has an identified reliable informant Exclusion Criteria: 1. Any primary DSM-5 disorder other than schizophrenia within 12 months before screening (confirmed using MINI version 7.0.2 at screening) 2. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results. Subjects with chronic hepatitis B or hepatitis C may be included provided that their condition is stable and values for liver function test meet the specified criteria of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2 × upper limit of normal. In addition: a. Subjects with chronic hepatitis C may be included if they meet these requirements: i. Evidence of treatment with direct antiviral combination therapy; ii. Evidence of sustained virological response at least 12 weeks posttreatment; and iii. Inclusion of such subjects must be discussed and agreed with the medical monitor 3. History of or high risk of urinary retention, gastric retention, or narrow-angle glaucoma 4. History of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months 5. Has a DSM-5 diagnosis of moderate to severe substance abuse disorder (except tobacco use disorder) within the 12 months before screening (confirmed using MINI version 7.0.2 at screening), or current abuse as determined by urine toxicology screen or alcohol test. A screening subject with mild substance abuse disorder within the 12 months before screening must be discussed and agreed upon with the medical monitor before he/she can be allowed into the study. Clinically significant abnormal finding on the physical examination, medical history, ECG, or clinical laboratory results at screening 6. Pregnant, lactating, or less than 3 months postpartum. Sperm donation is not allowed for 90 days after the final dose of study drug 7. If, in the opinion of the investigator (and/or Sponsor), subject is unsuitable for enrollment in the study or subject has any finding that, in the view of the investigator (and/or Sponsor), may compromise the safety of the subject or affect their ability to adhere to the protocol visit schedule or fulfill visit requirements 8. Subject has had psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days before screening 9. Subject has a history of treatment resistance to schizophrenia medications defined as failure to respond to 2 adequate courses of pharmacotherapy (a minimum of 4 weeks at an adequate dose per the label) or required clozapine within the last 12 months 10. Risk of violent or destructive behavior 11. Current involuntary hospitalization or incarceration 12. Participation in another clinical study in which the subject received an experimental or investigational drug agent within 3 months of screening | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：60 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | United States | ||
| 管理信息 | 数据检测委员会 | Yes | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: Yes 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | Karuna Pharmaceuticals | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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