CTIS2024-510770-25-00招募中1 期
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Adjunctive KarXT in Subjects with Inadequately Controlled Symptoms of Schizophrenia - KAR-012
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 380
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
- 性别
- All
入选标准
- •Subject is aged =18 to <60 years at the time of randomization (Visit 3), PANSS Marder Positive symptom factor = 4 on 2 (or more) items (PANSS items, delusions, hallucinations, grandiosity, suspiciousness and persecution, stereotyped thinking, somatic concern, unusual thought content or lack of judgment and insight), at Screening (Visit 1) and randomization (Day 1, Visit 3), Subjects with = 20-point decrease in PANSS total score between Visit 1 and Visit 3, Subject is willing and able to visit the clinic in an outpatient setting for the study duration, follow instructions, and comply with the protocol requirements, Body Mass Index (BMI) must be within 18 to 40 kg/m2 (inclusive of both values), Subject resides in a stable living situation, in the opinion of the Investigator, Subject has identified a reliable informant/ caregiver willing and able to assist with study activities as needed throughout the subject's participation in the study. The informant needs to be physically present at the Baseline visit, but can complete the remaining study visits assessments via phone (as needed and as per local regulations). In Bulgaria, the informant needs to be physically present at the Baseline visit and should be physically present at all study visits where the Investigator determines that his/her input would be beneficial, Women of childbearing potential (WOCP), or men whose sexual partners are WOCP, must be able and willing to use at least 1 highly effective method of contraception during the study and for at least 1 menstrual cycle (e.g., 30 days) after the last dose of study drug. Sperm donation is not allowed for 30 days after the final dose of the study drug. A female subject is considered to be a WOCP after menarche and until she is in a postmenopausal state for 12 months or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, or bilateral oophorectomy). For the definition and list of highly effective methods of contraception, see APPENDIX 2., Subject is capable of providing signed Informed Consent Form (ICF) before any study assessments will be performed, Subject has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the Diagnostic Statistical Manual 5 (DSM-5) criteria and confirmed by Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorder Studies (MINI) version 7.0.2, Subject is currently being treated with stable dosing of monotherapy risperidone, paliperidone, aripiprazole, or their LAIs, ziprasidone, lurasidone, or cariprazine and has been taking this treatment with the same dosing regimen for at least 8 weeks at the time of Day 1 (Visit 3) (supported by documentation), The subject has had at least one previous inadequate response to above antipsychotics that was dosed appropriately (within the label) for at least 6 weeks, The subject has not required psychiatric hospitalization, incarceration in prison, acute crisis intervention, or other increase in the level of care due to symptom exacerbation within 8 weeks of Screening and is psychiatrically stable in the opinion of the Investigator, To be eligible for randomization, subjects need to have detectable levels of background antipsychotic medication (measured at Visit 1), PANSS total score = 70 at Screening (Visit 1) and randomization (Day 1, Visit 3), CGI-S scale with a score = 4 (moderate) at Screening (Visit 1) and randomization
排除标准
- •Any primary DSM-5 disorder other than schizophrenia within 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), History of irritable bowel syndrome (with or without constipation) or any serious constipation requiring treatment within the last 6 months, Risk of suicidal behavior during the study as determined by the Investigator's clinical assessment and/ or C-SSRS as confirmed by the following: a. Answers Yes on items 4 or 5 (C-SSRS – ideation) with the most recent episode occurring within the 2 months before Screening or, b. Answers Yes to any of the 5 items (C-SSRS behavior) with an episode occurring within the 12 months before Screening, Clinically significant abnormal finding on the physical examination, medical history, ECG (QTc of > 450 msec in males and > 470 msec in females), or clinical laboratory results at Screening, Urine toxicology screen is positive for phencyclidine, amphetamines, opiates, cocaine, or alcohol (clinically significant alcohol use in the opinion of the Investigator), Subject is currently taking, or plans to take while in the study, any prohibited concomitant medication as outlined in APPENDIX 4, Pregnant, lactating, or less than 3 months postpartum, If, in the opinion of the Investigator and/or Sponsor/Medical Monitor, subject is unsuitable for enrollment in the study or subject has any finding that, in the view of the Investigator and/or Sponsor/ Medical Monitor, may compromise the safety of the subject or affect his/her ability to adhere to the protocol visit schedule or fulfill visit requirements, Positive test for coronavirus (COVID-19) within 2 weeks before or at Screening, Subjects with extreme concerns relating to global pandemics, such as COVID-19 that would obscure ratings or be expected to disrupt adherence to trial procedures, Unable to taper and discontinue a concomitant medication that would preclude participation in the double-blind adjunctive treatment (e.g., cannot stop anticholinergic), The subject has a history of moderate to severe substance use disorder (other than nicotine) within the past 12 months a. A Screening subject with mild substance use disorder within the 12 months before Screening must be discussed with the Medical Monitor before being allowed into the study b. Subjects who test positive for cannabis at Screening may be permitted to enroll in consultation with the Medical Monitor if the subject's pattern of use is not indicative of a moderate to severe substance use disorder, Subjects with prior exposure to KarXT, Subjects who experienced any adverse effects due to xanomeline or trospium, Participation in another clinical study in which the subject was enrolled within 3 months before Screening, Risk of violent or destructive behavior as per Investigator's judgment that would interfere with subject's participation, Current involuntary hospitalization or incarceration or on parole/probation, For all male subjects only, any one of the following: a. History of bladder stones b. History of recurrent urinary tract infections c. Serum prostate specific antigen (PSA) >10 ng/mL d. An IPSS of 5 (almost always) on either item 1, 3, 5, or 6 e. A sum of scores on IPSS items 1, 3, 5, and 6 of =9, Subject has a history of treatment-resistant schizophrenia defined as: Failure to minimally respond to 2 adequate courses of APD pharmacotherapy Note: Failure to minimally respond is defined as persistence of at symptoms of moderate severity in 2 or more psychoti
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