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

The purpose of this study is to characterize the effect of KarXT on voiding dynamics and urological safety in participants with DSM-5 schizophrenia.

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Xanomeline/trospium chloride

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: First line of the email MUST contain NCT # and Site #.
• Study Contact Backup: Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72204
      • Recruiting
      • Pillar Clinical Research- Little Rock
      • Contact: Leslie Smith, Site 0017; Phone Number: 501-350-3285
  • California
    • Bellflower, California, United States, 90706
      • Recruiting
      • Clinical Innovations, Inc. dba CITrials
      • Contact: Robert Bota, Site 0007; Phone Number: 562-748-4999
    • Garden Grove, California, United States, 92845
      • Recruiting
      • CenExel CNS - Garden Grove
      • Contact: David Walling, Site 0006; Phone Number: 714-799-7799
    • Orange, California, United States, 92866
      • Recruiting
      • ATP Clinical Research
      • Contact: Gustavo Alva, Site 0016; Phone Number: 949-354-5353
  • Florida
    • Lauderhill, Florida, United States, 33319
      • Recruiting
      • Innovative Clinical Research
      • Contact: Rishi Kakar, Site 0003; Phone Number: 786-512-4106
    • West Palm Beach, Florida, United States, 33407
      • Recruiting
      • Health Synergy Clinical Research
      • Contact: Mohammad Nisar, Site 0004; Phone Number: 786-831-7303
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Recruiting
      • Uptown Research Institute
      • Contact: John Sonnenberg, Site 0005; Phone Number: 773-968-9868
    • Chicago, Illinois, United States, 60641
      • Recruiting
      • Pillar Clinical Research -Chicago
      • Contact: Roueen Rafeyan, Site 0010; Phone Number: 312-865-6336
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Recruiting
      • IMA Clinical Research Las Vegas
      • Contact: Mustafa Rawaf, Site 0013; Phone Number: 702-527-7401
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • Recruiting
      • Hassman Research Institute Marlton Site
      • Contact: Elan Cohen, Site 0002; Phone Number: 267-981-8911
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Adams Clinical Philadelphia
      • Contact: Cassie Blanchard, Site 0014; Phone Number: 631-252-0769
  • Texas
    • Austin, Texas, United States, 78754
      • Not yet recruiting
      • Local Institution - 0001
      • Contact: Site 0001
    • DeSoto, Texas, United States, 75115
      • Recruiting
      • InSite Clinical Research
      • Contact: Benji Kurian, Site 0015; Phone Number: 214-497-3151

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KarXT	Drug: Xanomeline/trospium chloride; Specified dose on specified days; Other Names: KarXT; BMS-986510

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Number of participants with AEs of Special Interest (AESIs)	Up to 12 months
Number of participants with Serious AEs (SAEs)	Up to 12 months
Number of participants with suicidal ideation or behavior	Up to 12 months

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: October 13, 2025
• First Submitted That Met QC Criteria: October 24, 2025
• First Posted (Actual): October 28, 2025

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia; xanomeline; trospium chloride
• Other Study ID Numbers: CN012-0068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
• IPD Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No