RecruitingPhase 4NCT07221877
A Study to Evaluate the Effect of KarXT on Urological Safety
A 12-month Open-label, Phase 4 Multicenter Safety Study to Evaluate the Effect of KarXT on Voiding Dynamics and Urological Safety
Sponsor
Bristol-Myers Squibb
Enrollment
60 participants
Start Date
Jan 20, 2026
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to characterize the effect of KarXT on voiding dynamics and urological safety in participants with DSM-5 schizophrenia.
Eligibility
Min Age: 18 YearsMax Age: 65 Years
Inclusion Criteria3
- Male and Female participants (age 18 to 65 years of age, with a primary diagnosis of schizophrenia based on psychiatric evaluation (DSM-5) and confirmed by MINI (v 7.0.2).
- Participants must have a PANSS total score ≤ 80 and CGI-S score ≤ 4, at screening and baseline, and a BMI ≥18 and ≤ 40 kg/m2.
- Participants must be willing and able to discontinue all antipsychotic medications prior to the baseline visit and be willing and able to comply with protocol requirements.
Exclusion Criteria2
- Participants with newly diagnosed schizophrenia, any other DSM-5 disorder diagnosed within the past 12 months, alcohol or drug use disorder within the past 12 months, history/presence of clinically significant disease or disorder that would jeopardize participant safety or validity of study results.
- Participants at risk for suicidal behavior, as well as individuals who are pregnant or breastfeeding, will be excluded from the study.
Interventions
DRUGXanomeline/trospium chloride
Specified dose on specified days
Locations(14)
View Full Details on ClinicalTrials.gov
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NCT07221877
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