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

August 18, 2026 updated by: Bristol-Myers Squibb

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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
        • Recruiting
        • SanRo Clinical Research Group
        • Contact:
          • Robert Wooten, Site 0009
    • California
      • Anaheim, California, United States, 92805
        • Not yet recruiting
        • Local Institution - 0003
        • Contact:
          • Site 0003
      • Anaheim, California, United States, 92801
        • Recruiting
        • Pamoja Advanced Nursing Practice
        • Contact:
          • Fines Shaw, Site 0047
      • Chino, California, United States, 91710
        • Recruiting
        • Inland Psychiatric Medical Group (IPMG)-Chino
        • Contact:
          • Nandita Puchakayala, 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
        • Recruiting
        • Envision Trials LLC
        • Contact:
          • Daniel Mandri, Site 0005
          • Phone Number: 305-819-2909
      • Hialeah, Florida, United States, 33016-1814
        • Recruiting
        • Galiz Research
        • Contact:
          • Jose Gamez, Site 0019
          • Phone Number: 305-805-0921
      • Homestead, Florida, United States, 33030
        • Not yet recruiting
        • Local Institution - 0030
        • Contact:
          • Site 0030
      • Kendall, Florida, United States, 33186
        • Recruiting
        • New Access Research & Medical Services Inc - Kendall
        • Contact:
          • Ana Maria Tous, 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, 33134
        • Recruiting
        • Banyan Behavioal Care Program - CSU
        • Contact:
          • Moraima Trujillo, Site 0011
          • Phone Number: 305-246-0001
      • Miami, Florida, United States, 33175
        • Recruiting
        • BioResearch Partner - Miami
        • Contact:
          • Fenton Lebon, Site 0006
      • Orange City, Florida, United States, 32763
        • Recruiting
        • Medical Research of Central Florida
        • Contact:
          • Adly Thebaud, Site 0023
          • Phone Number: 386-775-7627
      • Orlando, Florida, United States, 32803
        • Not yet recruiting
        • Local Institution - 0040
        • Contact:
          • Site 0040
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Emory University.
        • Contact:
          • Robert Cotes, Site 0025
          • Phone Number: 404-616-4752
      • Austell, Georgia, United States, 30106
        • Not yet recruiting
        • Local Institution - 0049
        • Contact:
          • Site 0049
      • Marietta, Georgia, United States, 30060
        • Not yet recruiting
        • Local Institution - 0044
        • Contact:
          • Site 0044
    • Illinois
      • Crystal Lake, Illinois, United States, 60523
        • Not yet recruiting
        • Local Institution - 0046
        • Contact:
          • Site 0046
      • Warrenville, Illinois, United States, 60555
        • Recruiting
        • Amr Conventions Research - Illinois
        • Contact:
          • Sandeep Gaonkar, Site 0048
          • Phone Number: 630-416-8289
    • 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
      • Duluth, Minnesota, United States, 55811
        • Not yet recruiting
        • Local Institution - 0054
        • Contact:
          • Site 0054
    • Nebraska
      • Lincoln, Nebraska, United States, 68526-9474
        • Not yet recruiting
        • Local Institution - 0041
        • Contact:
          • Site 0041
    • Nevada
      • Las Vegas, Nevada, United States, 89146
        • Not yet recruiting
        • Local Institution - 0055
        • Contact:
          • Site 0055
    • 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
        • Recruiting
        • Magnolia Clinical Research, LLC
        • Contact:
          • Michelle Maust, Site 0042
          • Phone Number: 984-345-3010
      • 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
        • Recruiting
        • The Rivus Wellness & Research Institute
        • Contact:
          • Marvin Peyton, Site 0027
          • Phone Number: 405-317-5783
      • Tulsa, Oklahoma, United States, 74135
        • Not yet recruiting
        • Local Institution - 0052
        • Contact:
          • Site 0052
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-4238
        • Recruiting
        • Perelman School of Medicine at the University of Pennsylvania
        • Contact:
          • Christian Kohler, Site 0015
          • Phone Number: 215-614-0161
      • State College, Pennsylvania, United States, 16801
        • Not yet recruiting
        • Local Institution - 0053
        • Contact:
          • Site 0053
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Not yet recruiting
        • Local Institution - 0051
        • Contact:
          • Site 0051
      • 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
      • Dallas, Texas, United States, 75390
        • Not yet recruiting
        • Local Institution - 0050
        • Contact:
          • Site 0050
      • Fort Worth, Texas, United States, 76132
        • Not yet recruiting
        • Local Institution - 0021
        • Contact:
          • Site 0021
      • Houston, Texas, United States, 77099
        • Recruiting
        • Pioneer Research Solutions, Inc.
        • Contact:
          • Ateka Zaki, Site 0024
      • 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, 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
        • Recruiting
        • Perceptive Pharma Research
        • Contact:
          • Adeeb Masood, Site 0008
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • UT Health San Antonio - Behavioral Health and Wellness Center
        • Contact:
          • Mady Stovall, 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Treatment titration and switch regimens as described by the prescribing clinician
Time Frame: Baseline and up to 20 weeks
Baseline and up to 20 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Participant age
Time Frame: Baseline
Baseline
Participant sex
Time Frame: Baseline
Baseline
Participant height
Time Frame: Baseline
Baseline
Participant race
Time Frame: Baseline
Baseline
Participant ethnicity
Time Frame: Baseline
Baseline
Adverse events (AEs)
Time Frame: Baseline and up to 20 weeks
Baseline and up to 20 weeks
Change in participant weight
Time Frame: Baseline and up to 20 weeks
Baseline and up to 20 weeks
Clinical Global Impressions - Improvement (CGI-I) score
Time Frame: Baseline and up to 20 weeks
Baseline and up to 20 weeks
Number of schizophrenia-related relapses (defined as schizophrenia-related emergency department visits and/or hospitalizations and symptoms
Time Frame: Baseline and up to 20 weeks
Baseline and up to 20 weeks
Continuation of treatment with xanomeline and trospium chloride (KarXT) at End of Study
Time Frame: Baseline and up to 20 weeks
Baseline and up to 20 weeks
Number of participants who discontinue treatment, time to discontinuation, and reasons for discontinuation
Time Frame: Baseline and up to 20 weeks
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
Time Frame: Baseline and up to 20 weeks
Baseline and up to 20 weeks
Date of first xanomeline and trospium chloride (KarXT) treatment
Time Frame: Baseline
Baseline
Participant's family history of schizophrenia
Time Frame: Baseline
Baseline
Duration since diagnosis of schizophrenia
Time Frame: Baseline
Baseline
Previous treatment(s) received for schizophrenia
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 26, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 20, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 20, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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