A Study to Evaluate the Effect of KarXT on Urological Safety

NCT07221877 | Recruiting Phase 4 FDA Drug

• 1 other identifier: CN012-0068
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• Change from baseline in voiding dynamics (Qmax) over time

  Up to 12 months

• Change from baseline in post-void residual volume (PVR) over time

  Up to 12 months

Secondary Outcomes (8)

• Number of participants with a change from baseline in urinalysis parameters over time

  Up to 12 months

• Change from baseline in IPSS over time

  Up to 12 months

• Number of participants with electrocardiogram (ECG) abnormalities

  Up to 12 months

• Number of participants with vital sign abnormalities

  Up to 12 months

• Number of participants with Adverse Events (AEs)

  Up to 12 months

Study Arms (1)

KarXT

EXPERIMENTAL

Drug: Xanomeline/trospium chloride

Interventions

Xanomeline/trospium chloride DRUG

Specified dose on specified days

Also known as: KarXT, BMS-986510

KarXT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (13)

Pillar Clinical Research- Little Rock

Little Rock, Arkansas, 72204, United States

RECRUITING

Clinical Innovations, Inc. dba CITrials

Bellflower, California, 90706, United States

RECRUITING

CenExel CNS - Garden Grove

Garden Grove, California, 92845, United States

RECRUITING

ATP Clinical Research

Orange, California, 92866, United States

RECRUITING

Innovative Clinical Research

Lauderhill, Florida, 33319, United States

RECRUITING

Health Synergy Clinical Research

West Palm Beach, Florida, 33407, United States

RECRUITING

Uptown Research Institute

Chicago, Illinois, 60640, United States

RECRUITING

Pillar Clinical Research -Chicago

Chicago, Illinois, 60641, United States

RECRUITING

IMA Clinical Research Las Vegas

Las Vegas, Nevada, 89102, United States

RECRUITING

Hassman Research Institute Marlton Site

Marlton, New Jersey, 08053, United States

RECRUITING

Adams Clinical Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Local Institution - 0001

Austin, Texas, 78754, United States

NOT YET RECRUITING

InSite Clinical Research

DeSoto, Texas, 75115, United States

RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Schizophrenia

Interventions

xanomeline; trospium chloride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2025
• First Posted: October 28, 2025
• Study Start: January 20, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (13)