Poster
90
(#90) Efficacy and Safety of Xanomeline and Trospium Chloride in Adults With Early Phase Schizophrenia: Design of a 24-Week, Open-Label, Multicenter, Outpatient Trial
Psych Congress 2025
Abstract: Background: Xanomeline and trospium chloride (X/T) is the first approved treatment for schizophrenia in adults that is a dual M1/M4 preferring muscarinic receptor agonist. Despite the robust data from registrational trials, data from individuals early in the course of their disease are limited. Given the differences in treatment engagement and responsiveness and the potential long-term consequences of treatment early in the disease, this population is of special interest.
Methods: A 24-week, open-label, outpatient trial (NCT06923891) will assess overall treatment satisfaction, efficacy, and safety and tolerability of X/T in adults aged 18-40 years with schizophrenia. All participants will be required to be within 5 years of first antipsychotic treatment for psychosis, have been taking a stable antipsychotic regimen for ≥8 weeks with ≥4 weeks on the same dose, and have a Medication Satisfaction Questionnaire (MSQ) score ≤3, indicating moderate or worse dissatisfaction with the current treatment. Participant recruitment will be balanced based on dissatisfaction due to residual symptoms or problematic side effects. The primary outcome will be treatment satisfaction measured using the MSQ. Secondary outcomes will include assessments of efficacy, safety and tolerability, overall satisfaction, and cognition in participants with baseline impairment.
Results: Approximately 172 participants across ~20 sites will be recruited. Recruitment has started, and the trial design will be presented.
Conclusion: This trial will add to a growing body of data to better understand treatment satisfaction, efficacy, safety, and tolerability of X/T in adults with schizophrenia early in the course of their disease.
Short Description: Xanomeline and trospium chloride (X/T) is approved by the U.S. Food and Drug Administration for the treatment of schizophrenia in adults; however, the mean age of subjects in registrational trials suggested the disease duration was 10-20 years. Because early treatment and disease stabilization are important to retain/regain functioning, this 24-week, open-label, multicenter outpatient trial will assess treatment satisfaction, efficacy, and safety and tolerability of X/T in adults with schizophrenia early in the illness course.
Name of Sponsoring Organization(s): Bristol Myers Squibb
Methods: A 24-week, open-label, outpatient trial (NCT06923891) will assess overall treatment satisfaction, efficacy, and safety and tolerability of X/T in adults aged 18-40 years with schizophrenia. All participants will be required to be within 5 years of first antipsychotic treatment for psychosis, have been taking a stable antipsychotic regimen for ≥8 weeks with ≥4 weeks on the same dose, and have a Medication Satisfaction Questionnaire (MSQ) score ≤3, indicating moderate or worse dissatisfaction with the current treatment. Participant recruitment will be balanced based on dissatisfaction due to residual symptoms or problematic side effects. The primary outcome will be treatment satisfaction measured using the MSQ. Secondary outcomes will include assessments of efficacy, safety and tolerability, overall satisfaction, and cognition in participants with baseline impairment.
Results: Approximately 172 participants across ~20 sites will be recruited. Recruitment has started, and the trial design will be presented.
Conclusion: This trial will add to a growing body of data to better understand treatment satisfaction, efficacy, safety, and tolerability of X/T in adults with schizophrenia early in the course of their disease.
Short Description: Xanomeline and trospium chloride (X/T) is approved by the U.S. Food and Drug Administration for the treatment of schizophrenia in adults; however, the mean age of subjects in registrational trials suggested the disease duration was 10-20 years. Because early treatment and disease stabilization are important to retain/regain functioning, this 24-week, open-label, multicenter outpatient trial will assess treatment satisfaction, efficacy, and safety and tolerability of X/T in adults with schizophrenia early in the illness course.
Name of Sponsoring Organization(s): Bristol Myers Squibb
