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

Plain Language Summary

Simplified for easier understanding

This study is testing the urological safety of KarXT — a newer medication for schizophrenia — specifically looking at whether it causes bladder or urinary problems. People with schizophrenia who are currently stable (not in an acute episode) are eligible. **You may be eligible if...** - You are between 18 and 65 years old - You have a confirmed diagnosis of schizophrenia (based on psychiatric evaluation and the DSM-5 criteria) - Your schizophrenia is currently stable (PANSS total score ≤80 and CGI-S ≤4) - Your BMI is between 18 and 40 - You are willing to stop your current antipsychotic medications temporarily as instructed **You may NOT be eligible if...** - You have been newly diagnosed with schizophrenia - You have had another significant psychiatric diagnosis, alcohol or drug use disorder in the last 12 months - You have a significant medical condition that could affect your safety or the study results Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGXanomeline/trospium chloride

Specified dose on specified days


Locations(14)

Pillar Clinical Research- Little Rock

Little Rock, Arkansas, United States

Clinical Innovations, Inc. dba CITrials

Bellflower, California, United States

Local Institution - 0009

Culver City, California, United States

CenExel CNS - Garden Grove

Garden Grove, California, United States

ATP Clinical Research

Orange, California, United States

Local Institution - 0003

Miami, Florida, United States

Local Institution - 0004

West Palm Beach, Florida, United States

Uptown Research Institute

Chicago, Illinois, United States

Local Institution - 0010

Chicago, Illinois, United States

IMA Clinical Research Las Vegas

Las Vegas, Nevada, United States

Hassman Research Institute Marlton Site

Marlton, New Jersey, United States

Adams Clinical Philadelphia

Philadelphia, Pennsylvania, United States

Local Institution - 0001

Austin, Texas, United States

InSite Clinical Research

DeSoto, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07221877


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