Poster
76
(#76) Real-World Evaluation of Treatment Satisfaction and Xanomeline and Trospium Chloride Utilization (RESKU) Registry of Treatment of Adults With Schizophrenia: Study Design
Psych Congress 2025
Abstract: Background: Xanomeline and trospium chloride (X/T, formerly KarXT) is approved for the treatment of adults with schizophrenia in the United States. The efficacy and safety of X/T were demonstrated in clinical trials; however, real-world data regarding its clinical use are needed.
Methods: RESKU (NCT07101094) is a multicenter, longitudinal, observational study of adults initiating X/T for schizophrenia treatment in routine clinical practice in the United States. RESKU is designed to describe real-world patient profiles, treatment experience, utilization patterns, and outcomes associated with X/T treatment in people with schizophrenia. Sociodemographic, clinical characteristics, and reasons for initiating X/T will be captured at baseline. Prospective observational data on treatment patterns and outcomes, including patient-, clinician-, and care partner-reported measures will be collected at follow-up visits at months 1, 3, and 6. Subjects will be followed for up to 2 years through secondary data sources (eg, insurance claims, electronic health records). Primary objectives are to evaluate patient preference for X/T compared with prior treatments, using the Preference of Medicine scale, and to assess treatment satisfaction, measured by the Medication Satisfaction Questionnaire. Secondary and exploratory objectives include characterizing patient profiles, treatment patterns, schizophrenia symptoms, quality of life, functioning, cognition, safety/tolerability, and healthcare resource utilization and costs associated with X/T treatment.
Results: RESKU will enroll participants from multiple sites across the United States beginning in September 2025.
Conclusion: RESKU will provide critical evidence to comprehensively understand the real-world treatment experience, utilization patterns, and outcomes associated with X/T treatment in adults with schizophrenia.
Short Description: RESKU is a multicenter, longitudinal, observational study of adults initiating xanomeline and trospium chloride (X/T) for the treatment of schizophrenia in routine clinical practice in the United States. The primary objectives are to evaluate patient preference for X/T compared with prior treatments and treatment satisfaction. Secondary and exploratory objectives include characterizing patient profiles, treatment patterns, schizophrenia symptoms, quality of life, functioning, cognition, safety and tolerability, and healthcare resource utilization and costs associated with X/T treatment.
Name of Sponsoring Organization(s): Bristol Myers Squibb
Methods: RESKU (NCT07101094) is a multicenter, longitudinal, observational study of adults initiating X/T for schizophrenia treatment in routine clinical practice in the United States. RESKU is designed to describe real-world patient profiles, treatment experience, utilization patterns, and outcomes associated with X/T treatment in people with schizophrenia. Sociodemographic, clinical characteristics, and reasons for initiating X/T will be captured at baseline. Prospective observational data on treatment patterns and outcomes, including patient-, clinician-, and care partner-reported measures will be collected at follow-up visits at months 1, 3, and 6. Subjects will be followed for up to 2 years through secondary data sources (eg, insurance claims, electronic health records). Primary objectives are to evaluate patient preference for X/T compared with prior treatments, using the Preference of Medicine scale, and to assess treatment satisfaction, measured by the Medication Satisfaction Questionnaire. Secondary and exploratory objectives include characterizing patient profiles, treatment patterns, schizophrenia symptoms, quality of life, functioning, cognition, safety/tolerability, and healthcare resource utilization and costs associated with X/T treatment.
Results: RESKU will enroll participants from multiple sites across the United States beginning in September 2025.
Conclusion: RESKU will provide critical evidence to comprehensively understand the real-world treatment experience, utilization patterns, and outcomes associated with X/T treatment in adults with schizophrenia.
Short Description: RESKU is a multicenter, longitudinal, observational study of adults initiating xanomeline and trospium chloride (X/T) for the treatment of schizophrenia in routine clinical practice in the United States. The primary objectives are to evaluate patient preference for X/T compared with prior treatments and treatment satisfaction. Secondary and exploratory objectives include characterizing patient profiles, treatment patterns, schizophrenia symptoms, quality of life, functioning, cognition, safety and tolerability, and healthcare resource utilization and costs associated with X/T treatment.
Name of Sponsoring Organization(s): Bristol Myers Squibb
