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NCT07221877PHASE4Recruiting

A Study to Evaluate the Effect of KarXT on Urological Safety

Bristol-Myers Squibb

Start Date

1/20/2026

Completion Date

12/30/2027

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 Criteria

Age Range: 18 years to 65 years

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

Interventions

DRUG

Xanomeline/trospium chloride

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Conditions

Schizophrenia

Locations

Pillar Clinical Research- Little Rock

Little Rock, Arkansas 72204

United States

Clinical Innovations, Inc. dba CITrials

Bellflower, California 90706

United States

CenExel CNS - Garden Grove

Garden Grove, California 92845

United States

ATP Clinical Research

Orange, California 92866

United States

Innovative Clinical Research

Lauderhill, Florida 33319

United States

Health Synergy Clinical Research

West Palm Beach, Florida 33407

United States

Uptown Research Institute

Chicago, Illinois 60640

United States

Pillar Clinical Research -Chicago

Chicago, Illinois 60641

United States

IMA Clinical Research Las Vegas

Las Vegas, Nevada 89102

United States

Hassman Research Institute Marlton Site

Marlton, New Jersey 08053

United States

Adams Clinical Philadelphia

Philadelphia, Pennsylvania 19104

United States

Local Institution - 0001

Austin, Texas 78754

United States

InSite Clinical Research

DeSoto, Texas 75115

United States