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

NCT07379827 | Recruiting FDA Drug

• 1 other identifier: CN012-0134
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 45

Brief Summary

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

Conditions

Schizophrenia

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Treatment titration and switch regimens as described by the prescribing clinician

  Baseline and up to 20 weeks

Secondary Outcomes (16)

• 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

Study Arms (1)

Group 1

Participants diagnosed with schizophrenia receiving xanomeline and trospium chloride (KarXT)

Drug: Xanomeline and trospium chloride (KarXT)

Interventions

Xanomeline and trospium chloride (KarXT) DRUG

According to the product label

Group 1

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (45)

Local Institution - 0009

Bryant, Arkansas, 72022, United States

NOT YET RECRUITING

Local Institution - 0003

Anaheim, California, 92805, United States

NOT YET RECRUITING

Local Institution - 0039

Chino, California, 91710, United States

NOT YET RECRUITING

Local Institution - 0012

La Palma, California, 90623, United States

NOT YET RECRUITING

Local Institution - 0043

Oceanside, California, 92056-4509, United States

NOT YET RECRUITING

Local Institution - 0028

Stanford, California, 94304, United States

NOT YET RECRUITING

Local Institution - 0005

Bonita Springs, Florida, 34134, United States

NOT YET RECRUITING

Local Institution - 0019

Hialeah, Florida, 33016-1814, United States

NOT YET RECRUITING

Local Institution - 0030

Homestead, Florida, 33030, United States

NOT YET RECRUITING

Local Institution - 0029

Kendall, Florida, 33186, United States

NOT YET RECRUITING

Local Institution - 0032

Miami, Florida, 33015, United States

NOT YET RECRUITING

Banyan Behavioal Care Program - CSU

Miami, Florida, 33134, United States

RECRUITING

Local Institution - 0007

Miami, Florida, 33155, United States

NOT YET RECRUITING

Local Institution - 0006

Miami, Florida, 33175, United States

NOT YET RECRUITING

Local Institution - 0023

Orange City, Florida, 32763, United States

NOT YET RECRUITING

Local Institution - 0040

Orlando, Florida, 32803, United States

NOT YET RECRUITING

Local Institution - 0025

Atlanta, Georgia, 30303, United States

NOT YET RECRUITING

Local Institution - 0044

Marietta, Georgia, 30060, United States

NOT YET RECRUITING

Local Institution - 0014

Bloomfield Township, Michigan, 48302-1909, United States

NOT YET RECRUITING

Local Institution - 0036

Detroit, Michigan, 48203, United States

NOT YET RECRUITING

Local Institution - 0034

Apple Valley, Minnesota, 55124, United States

NOT YET RECRUITING

Local Institution - 0041

Lincoln, Nebraska, 68526-9474, United States

NOT YET RECRUITING

Local Institution - 0037

Buffalo, New York, 14215, United States

NOT YET RECRUITING

Local Institution - 0004

Monsey, New York, 10952, United States

NOT YET RECRUITING

Local Institution - 0038

Rochester, New York, 14623, United States

NOT YET RECRUITING

Local Institution - 0020

White Plains, New York, 10601, United States

NOT YET RECRUITING

Local Institution - 0042

Cary, North Carolina, 27513, United States

NOT YET RECRUITING

PPD Virtual - PPD - US

Wilmington, North Carolina, 28401-3331, United States

RECRUITING

Local Institution - 0031

Mason, Ohio, 45040-7846, United States

NOT YET RECRUITING

Local Institution - 0027

Oklahoma City, Oklahoma, 73112-8729, United States

NOT YET RECRUITING

Local Institution - 0015

Philadelphia, Pennsylvania, 19104-4238, United States

NOT YET RECRUITING

Psychiatric Consultants, Pc

Franklin, Tennessee, 37607, United States

RECRUITING

Local Institution - 0016

Austin, Texas, 78754, United States

NOT YET RECRUITING

Local Institution - 0021

Fort Worth, Texas, 76132, United States

NOT YET RECRUITING

Local Institution - 0033

Houston, Texas, 77007-9015, United States

NOT YET RECRUITING

Local Institution - 0026

Houston, Texas, 77008-1758, United States

NOT YET RECRUITING

Local Institution - 0022

Houston, Texas, 77054-2852, United States

NOT YET RECRUITING

Local Institution - 0010

Houston, Texas, 77054, United States

NOT YET RECRUITING

Local Institution - 0024

Houston, Texas, 77099, United States

NOT YET RECRUITING

Local Institution - 0017

Irving, Texas, 75062-2757, United States

NOT YET RECRUITING

Local Institution - 0013

McKinney, Texas, 75092, United States

NOT YET RECRUITING

Local Institution - 0008

Richmond, Texas, 77407-3498, United States

NOT YET RECRUITING

Local Institution - 0035

San Antonio, Texas, 78240, United States

NOT YET RECRUITING

Local Institution - 0018

Stafford, Texas, 77477-3954, United States

NOT YET RECRUITING

Local Institution - 0045

Petersburg, Virginia, 23805, United States

NOT YET RECRUITING

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

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: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: February 2, 2026
• Study Start: February 26, 2026
• Primary Completion (Estimated): June 20, 2028
• Study Completion (Estimated): June 20, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (45)