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Clinical Trials in the USA / NCT07221877
Recruiting Phase 4

A Study to Evaluate the Effect of KarXT on Urological Safety

NCT07221877 · tracked via the Priya Life Science USA tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 4
Started
2026-01-20
Last updated
2026-06-03

Condition(s) studied

Schizophrenia

Investigational drug(s) / intervention(s)

Xanomeline/trospium chloride

Xanomeline/trospium chloride: Specified dose on specified days

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria * 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 Criteria * 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. * Other protocol-defined Inclusion/Exclusion criteria apply

Primary outcome measure(s)

Trial sites (13)

FacilityCityRegionStatus
Pillar Clinical Research- Little Rock Little Rock Arkansas Recruiting
Clinical Innovations, Inc. dba CITrials Bellflower California Recruiting
CenExel CNS - Garden Grove Garden Grove California Recruiting
ATP Clinical Research Orange California Recruiting
Innovative Clinical Research Lauderhill Florida Recruiting
Health Synergy Clinical Research West Palm Beach Florida Recruiting
Uptown Research Institute Chicago Illinois Recruiting
Pillar Clinical Research -Chicago Chicago Illinois Recruiting
IMA Clinical Research Las Vegas Las Vegas Nevada Recruiting
Hassman Research Institute Marlton Site Marlton New Jersey Recruiting
Adams Clinical Philadelphia Philadelphia Pennsylvania Recruiting
Local Institution - 0001 Austin Texas Not Yet Recruiting
InSite Clinical Research DeSoto Texas Recruiting

More Bristol-Myers Squibb trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07221877 on ClinicalTrials.gov ↗ ← All trials in the USA