Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT)

Effectiveness and Adverse-effect Switch Evaluation

The purpose of this study is to describe real-world treatment patterns, effectiveness and adverse events of adults diagnosed with schizophrenia that have initiated xanomeline and trospium chloride (KarXT) treatment in the United States

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Xanomeline and trospium chloride (KarXT)

• Study Type: Observational
• Enrollment (Estimated): 1500

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
    • Bryant, Arkansas, United States, 72022
      • Not yet recruiting
      • Local Institution - 0009
      • Contact: Site 0009
  • California
    • Anaheim, California, United States, 92805
      • Not yet recruiting
      • Local Institution - 0003
      • Contact: Site 0003
    • Chino, California, United States, 91710
      • Not yet recruiting
      • Local Institution - 0039
      • Contact: Site 0039
    • La Palma, California, United States, 90623
      • Not yet recruiting
      • Local Institution - 0012
      • Contact: Site 0012
    • Oceanside, California, United States, 92056-4509
      • Not yet recruiting
      • Local Institution - 0043
      • Contact: Site 0043
    • Stanford, California, United States, 94304
      • Not yet recruiting
      • Local Institution - 0028
      • Contact: Site 0028
  • Florida
    • Bonita Springs, Florida, United States, 34134
      • Not yet recruiting
      • Local Institution - 0005
      • Contact: Site 0005
    • Hialeah, Florida, United States, 33016-1814
      • Not yet recruiting
      • Local Institution - 0019
      • Contact: Site 0019
    • Homestead, Florida, United States, 33030
      • Not yet recruiting
      • Local Institution - 0030
      • Contact: Site 0030
    • Kendall, Florida, United States, 33186
      • Not yet recruiting
      • Local Institution - 0029
      • Contact: Site 0029
    • Miami, Florida, United States, 33015
      • Not yet recruiting
      • Local Institution - 0032
      • Contact: Site 0032
    • Miami, Florida, United States, 33155
      • Not yet recruiting
      • Local Institution - 0007
      • Contact: Site 0007
    • Miami, Florida, United States, 33175
      • Not yet recruiting
      • Local Institution - 0006
      • Contact: Site 0006
    • Miami, Florida, United States, 33134
      • Recruiting
      • Banyan Behavioal Care Program - CSU
      • Contact: Moraima Trujillo, Site 0011; Phone Number: 305-246-0001
    • Orange City, Florida, United States, 32763
      • Not yet recruiting
      • Local Institution - 0023
      • Contact: Site 0023
    • Orlando, Florida, United States, 32803
      • Not yet recruiting
      • Local Institution - 0040
      • Contact: Site 0040
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Not yet recruiting
      • Local Institution - 0025
      • Contact: Site 0025
    • Marietta, Georgia, United States, 30060
      • Not yet recruiting
      • Local Institution - 0044
      • Contact: Site 0044
  • Michigan
    • Bloomfield Township, Michigan, United States, 48302-1909
      • Not yet recruiting
      • Local Institution - 0014
      • Contact: Site 0014
    • Detroit, Michigan, United States, 48203
      • Not yet recruiting
      • Local Institution - 0036
      • Contact: Site 0036
  • Minnesota
    • Apple Valley, Minnesota, United States, 55124
      • Not yet recruiting
      • Local Institution - 0034
      • Contact: Site 0034
  • Nebraska
    • Lincoln, Nebraska, United States, 68526-9474
      • Not yet recruiting
      • Local Institution - 0041
      • Contact: Site 0041
  • New York
    • Buffalo, New York, United States, 14215
      • Not yet recruiting
      • Local Institution - 0037
      • Contact: Site 0037
    • Monsey, New York, United States, 10952
      • Not yet recruiting
      • Local Institution - 0004
      • Contact: Site 0004
    • Rochester, New York, United States, 14623
      • Not yet recruiting
      • Local Institution - 0038
      • Contact: Site 0038
    • White Plains, New York, United States, 10601
      • Not yet recruiting
      • Local Institution - 0020
      • Contact: Site 0020
  • North Carolina
    • Cary, North Carolina, United States, 27513
      • Not yet recruiting
      • Local Institution - 0042
      • Contact: Site 0042
    • Wilmington, North Carolina, United States, 28401-3331
      • Recruiting
      • PPD Virtual - PPD - US
      • Contact: Ghazaleh Bahrami, Site 0001; Phone Number: 866-609-3139
  • Ohio
    • Mason, Ohio, United States, 45040-7846
      • Not yet recruiting
      • Local Institution - 0031
      • Contact: Site 0031
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112-8729
      • Not yet recruiting
      • Local Institution - 0027
      • Contact: Site 0027
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-4238
      • Not yet recruiting
      • Local Institution - 0015
      • Contact: Site 0015
  • Tennessee
    • Franklin, Tennessee, United States, 37607
      • Recruiting
      • Psychiatric Consultants, PC
      • Contact: James Hart, Site 0002; Phone Number: 615-807-4025
  • Texas
    • Austin, Texas, United States, 78754
      • Not yet recruiting
      • Local Institution - 0016
      • Contact: Site 0016
    • Fort Worth, Texas, United States, 76132
      • Not yet recruiting
      • Local Institution - 0021
      • Contact: Site 0021
    • Houston, Texas, United States, 77054-2852
      • Not yet recruiting
      • Local Institution - 0022
      • Contact: Site 0022
    • Houston, Texas, United States, 77054
      • Not yet recruiting
      • Local Institution - 0010
      • Contact: Site 0010
    • Houston, Texas, United States, 77099
      • Not yet recruiting
      • Local Institution - 0024
      • Contact: Site 0024
    • Houston, Texas, United States, 77007-9015
      • Not yet recruiting
      • Local Institution - 0033
      • Contact: Site 0033
    • Houston, Texas, United States, 77008-1758
      • Not yet recruiting
      • Local Institution - 0026
      • Contact: Site 0026
    • Irving, Texas, United States, 75062-2757
      • Not yet recruiting
      • Local Institution - 0017
      • Contact: Site 0017
    • McKinney, Texas, United States, 75092
      • Not yet recruiting
      • Local Institution - 0013
      • Contact: Site 0013
    • Richmond, Texas, United States, 77407-3498
      • Not yet recruiting
      • Local Institution - 0008
      • Contact: Site 0008
    • San Antonio, Texas, United States, 78240
      • Not yet recruiting
      • Local Institution - 0035
      • Contact: Site 0035
    • Stafford, Texas, United States, 77477-3954
      • Not yet recruiting
      • Local Institution - 0018
      • Contact: Site 0018
  • Virginia
    • Petersburg, Virginia, United States, 23805
      • Not yet recruiting
      • Local Institution - 0045
      • Contact: Site 0045

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

The study population will include adults diagnosed with schizophrenia who have switched or plan to switch from prior antipsychotic treatment to xanomeline and trospium chloride (KarXT)

Description

Inclusion Criteria:

• Participants (or caregiver/legal guardian) must have signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written ICF or signed an electronic ICF in accordance with regulatory, local, and institutional guidelines.
• Adults ≥ 18 years of age at Baseline who are willing and able, in the judgement of the treating clinician, to participate in routine clinical care and follow up.

• Schizophrenia, confirmed by the treating clinician's judgement or physician decision to treat the patient with receiving xanomeline and trospium chloride (KarXT) for schizophrenia made prior to and independently of participation in this study. Current Antipsychotic Treatment: Participant must fall into one of the categories below:

  • Be within <16 weeks of initiating treatment with KarXT with intent to discontinue prior antipsychotic treatment(s) OR
  • On a stable regimen (dose and frequency consistent with the drug label and/or at a stable dose based on the judgement of the Investigator for at least 30 days prior to screening) of treatment with 1 or more antipsychotics with plan to discontinue and switch to treatment with KarXT from a prior antipsychotic treatments(s). NOTE: The decision to switch for reasons of safety, tolerability, and/or efficacy will be made independently by the treating clinician and/or the patient and is not dictated by the study. Participants can be enrolled during tapering/discontinuing process from prior antipsychotic treatment(s). Individuals who are not currently receiving treatment for schizophrenia are not eligible for the study. Any antipsychotic treatments must be recorded as concomitant medications.
• Concomitant psychiatric medications (eg, antidepressants, mood stabilizers, anxiolytics) are permitted and are recommended to remain at a stable dose during the study period.

Exclusion Criteria:

• Prior use of KarXT that has been discontinued for any reason prior to Baseline.
• Participation in an interventional study within the last 30 days or plans to participate in an interventional study at the time of eligibility or baseline through the study period.
• Known hypersensitivity to xanomeline or trospium chloride, or history or high risk of urinary retention, gastric retention, moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment, or narrow-angle glaucoma.
• In the opinion of the treating clinician, unstable psychiatric or medical conditions that would prevent the participant from safely switching to KarXT. Hospitalized individuals who have been switched to KarXT or are switching treatment to KarXT are permitted to be enrolled at discharge if they are < 16 weeks from initiation of KarXT.
• Participants who are pregnant, planning to become pregnant, or breastfeeding.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Participants diagnosed with schizophrenia receiving xanomeline and trospium chloride (KarXT)	Drug: Xanomeline and trospium chloride (KarXT); According to the product label

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Treatment titration and switch regimens as described by the prescribing clinician	Baseline and up to 20 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Participant age	Baseline
Participant sex	Baseline
Participant height	Baseline
Participant race	Baseline
Participant ethnicity	Baseline
Adverse events (AEs)	Baseline and up to 20 weeks
Change in participant weight	Baseline and up to 20 weeks
Clinical Global Impressions - Improvement (CGI-I) score	Baseline and up to 20 weeks
Number of schizophrenia-related relapses (defined as schizophrenia-related emergency department visits and/or hospitalizations and symptoms	Baseline and up to 20 weeks
Continuation of treatment with xanomeline and trospium chloride (KarXT) at End of Study	Baseline and up to 20 weeks
Number of participants who discontinue treatment, time to discontinuation, and reasons for discontinuation	Baseline and up to 20 weeks
Number of participants using antiemetic treatment by type, duration, and resolution of event for xanomeline and trospium chloride (KarXT) related gastro-intestinal (GI) symptoms	Baseline and up to 20 weeks
Date of first xanomeline and trospium chloride (KarXT) treatment	Baseline
Participant's family history of schizophrenia	Baseline
Duration since diagnosis of schizophrenia	Baseline
Previous treatment(s) received for schizophrenia	Baseline

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
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2026
• Primary Completion (Estimated): June 20, 2028
• Study Completion (Estimated): June 20, 2028

Study Registration Dates

• First Submitted: January 23, 2026
• First Submitted That Met QC Criteria: January 23, 2026
• First Posted (Actual): February 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Schizophrenia
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia; xanomeline; trospium chloride
• Other Study ID Numbers: CN012-0134

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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