A Phase 3, Randomized, Two-part Study With a 5-week Double-blind Part (Randomized, Parallelgroup, Placebo-controlled) Followed by a 52-week Open-label Extension Part to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Patients With Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) Schizophrenia

简要总结

主要结局

次要结局

• Change from baseline in PANSS positive score(At week 5)
• Change from baseline in PANSS Negative Marder Factor score(At week 5)
• Change from baseline in Clinical Global Impressions-Severity (CGI-S) score(At week 5)
• Number of participants wtih adverse events (AEs)(Up to day 35)
• Number of participants wtih adverse events of special interest (AESIs)(Up to week 57)
• Number of participants wtih a change from baseline in clinical chemistry evaluations(Up to week 57)
• Change from baseline in PANSS negative score(At week 5)
• The percentage of PANSS responders (a ≥ 30% change in PANSS total score)(At week 5)
• Number of participants with procholinergic symptoms(Up to week 57)
• Number of participants with anticholinergic symptoms(Up to week 57)
• Number of participants wtih a change from baseline in urinalysis evaluations(Up to week 57)
• Change from baseline in Simpson-Angus Scale (SAS) score(Up to day 35)
• Change from baseline in Barnes Akathisia Rating Scale (BARS) score(Up to day 35)
• Change from baseline in Abnormal Involuntary Movement Scale (AIMS) score(Up to day 35)
• Change from baseline in body weight(Up to day 35)
• Blood pressure (BP) sitting and standing after 2 minutes(Up to week 57)
• Change from baseline in body mass index (BMI)(Up to day 35)
• International Prostate Symptom Score (IPSS)(Up to week 57)
• Heart rate (HR) sitting and standing after 2 minutes(Up to week 57)
• Number of participants wtih a change from baseline in hematology evaluations(Up to week 57)
• Number of participants wtih a change from baseline in 12-lead electrocardiogram (ECG) evaluations(Up to week 57)
• Number of participants wtih a change from baseline in coagulation evaluations(Up to week 57)
• Number of participants wtih a change from baseline in drug screen evaluations(Up to week 57)
• Number of participants wtih physical examination abnormalities(Up to week 57)
• Number of participants wtih suicidal ideation with the use of the Columbia-Suicide Severity Rating Scale (C-SSRS)(Up to week 57)
• Maximum observed plasma concentration (Cmax)(Up to day 35)
• Number of participants wtih serious TEAEs(Up to week 57)
• Area under the plasma concentration-time curve (AUC)(Up to day 35)
• Change from OLE baseline in CGI-S score(At week 57)
• Time of maximum observed plasma concentration (Tmax)(Up to day 35)
• Number of participants wtih TEAEs leading to discontinuation of study intervention(Up to week 57)
• Percentage of PANSS responders(At week 57)
• Change from OLE baseline in PANSS total score(At week 57)