Recruiting

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

Sponsor:

Bristol-Myers Squibb

Code:

NCT07379827

Conditions

Schizophrenia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Xanomeline and trospium chloride (KarXT)

Study Details

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

Study ID

NCT07379827

Start date

Feb 26, 2026

Status verified date

Aug, 2026

Completion date

Jun 20, 2028

Anticipated

Primary completion date

Jun 20, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Arms

Group 1

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

Interventions

Xanomeline and trospium chloride (KarXT)

According to the product label

Primary outcome measure

Treatment titration and switch regimens as described by the prescribing clinician [ Time Frame: Baseline and up to 20 weeks ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

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

Locations

SanRo Clinical Research Group

Recruiting

Bryant, Arkansas, United States, 72022

Pamoja Advanced Nursing Practice

Recruiting

Anaheim, California, United States, 92801

Inland Psychiatric Medical Group (IPMG)-Chino

Recruiting

Chino, California, United States, 91710

Envision Trials LLC

Recruiting

Bonita Springs, Florida, United States, 34134

Contacts

Daniel Mandri, Site 0005

305-819-2909

Galiz Research

Recruiting

Hialeah, Florida, United States, 33016-1814

Contacts

Jose Gamez, Site 0019

305-805-0921

New Access Research & Medical Services Inc - Kendall

Recruiting

Kendall, Florida, United States, 33186

Banyan Behavioal Care Program - CSU

Recruiting

Miami, Florida, United States, 33134

Contacts

Moraima Trujillo, Site 0011

305-246-0001

BioResearch Partner - Miami

Recruiting

Miami, Florida, United States, 33175

Medical Research of Central Florida

Recruiting

Orange City, Florida, United States, 32763

Contacts

Adly Thebaud, Site 0023

386-775-7627

Emory University.

Recruiting

Atlanta, Georgia, United States, 30303

Contacts

Robert Cotes, Site 0025

404-616-4752

Amr Conventions Research - Illinois

Recruiting

Warrenville, Illinois, United States, 60555

Contacts

Sandeep Gaonkar, Site 0048

630-416-8289

Magnolia Clinical Research, LLC

Recruiting

Cary, North Carolina, United States, 27513

Contacts

Michelle Maust, Site 0042

984-345-3010

PPD Virtual - PPD - US

Recruiting

Wilmington, North Carolina, United States, 28401-3331

Contacts

Ghazaleh Bahrami, Site 0001

866-609-3139

The Rivus Wellness & Research Institute

Recruiting

Oklahoma City, Oklahoma, United States, 73112-8729

Contacts

Marvin Peyton, Site 0027

405-317-5783

Perelman School of Medicine at the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104-4238

Contacts

Christian Kohler, Site 0015

215-614-0161

Psychiatric Consultants, Pc

Recruiting

Franklin, Tennessee, United States, 37607

Contacts

James Hart, Site 0002

615-807-4025

Pioneer Research Solutions, Inc.

Recruiting

Houston, Texas, United States, 77099

Perceptive Pharma Research

Recruiting

Richmond, Texas, United States, 77407-3498

UT Health San Antonio - Behavioral Health and Wellness Center

Recruiting

San Antonio, Texas, United States, 78240

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

Schizophrenia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-08-19.