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RECRUITING

NCT07379827

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

Sponsor: Bristol-Myers Squibb

View on ClinicalTrials.gov

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

Official title: Effectiveness and Adverse-effect Switch Evaluation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1500

Start Date

2026-02-26

Completion Date

2028-06-20

Last Updated

2026-08-19

Healthy Volunteers

Conditions

Schizophrenia

Interventions

DRUG

Xanomeline and trospium chloride (KarXT)

According to the product label

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.

Locations (55)

SanRo Clinical Research Group

Bryant, Arkansas, United States

Pamoja Advanced Nursing Practice

Anaheim, California, United States

Local Institution - 0003

Anaheim, California, United States

Inland Psychiatric Medical Group (IPMG)-Chino

Chino, California, United States

Local Institution - 0012

La Palma, California, United States

Local Institution - 0043

Oceanside, California, United States

Local Institution - 0028

Stanford, California, United States

Envision Trials LLC

Bonita Springs, Florida, United States

Galiz Research

Hialeah, Florida, United States

Local Institution - 0030

Homestead, Florida, United States

New Access Research & Medical Services Inc - Kendall

Kendall, Florida, United States

Local Institution - 0032

Miami, Florida, United States

Banyan Behavioal Care Program - CSU

Miami, Florida, United States

Local Institution - 0007

Miami, Florida, United States

BioResearch Partner - Miami

Miami, Florida, United States

Medical Research of Central Florida

Orange City, Florida, United States

Local Institution - 0040

Orlando, Florida, United States

Emory University.

Atlanta, Georgia, United States

Local Institution - 0049

Austell, Georgia, United States

Local Institution - 0044

Marietta, Georgia, United States

Local Institution - 0046

Crystal Lake, Illinois, United States

Amr Conventions Research - Illinois

Warrenville, Illinois, United States

Local Institution - 0014

Bloomfield Township, Michigan, United States

Local Institution - 0036

Detroit, Michigan, United States

Local Institution - 0034

Apple Valley, Minnesota, United States

Local Institution - 0054

Duluth, Minnesota, United States

Local Institution - 0041

Lincoln, Nebraska, United States

Local Institution - 0055

Las Vegas, Nevada, United States

Local Institution - 0037

Buffalo, New York, United States

Local Institution - 0004

Monsey, New York, United States

Local Institution - 0038

Rochester, New York, United States

Local Institution - 0020

White Plains, New York, United States

Magnolia Clinical Research, LLC

Cary, North Carolina, United States

PPD Virtual - PPD - US

Wilmington, North Carolina, United States

Local Institution - 0031

Mason, Ohio, United States

The Rivus Wellness & Research Institute

Oklahoma City, Oklahoma, United States

Local Institution - 0052

Tulsa, Oklahoma, United States

Perelman School of Medicine at the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Local Institution - 0053

State College, Pennsylvania, United States

Local Institution - 0051

Cordova, Tennessee, United States

Psychiatric Consultants, Pc

Franklin, Tennessee, United States

Local Institution - 0016

Austin, Texas, United States

Local Institution - 0050

Dallas, Texas, United States

Local Institution - 0021

Fort Worth, Texas, United States

Local Institution - 0033

Houston, Texas, United States

Local Institution - 0026

Houston, Texas, United States

Local Institution - 0022

Houston, Texas, United States

Local Institution - 0010

Houston, Texas, United States

Pioneer Research Solutions, Inc.

Houston, Texas, United States

Local Institution - 0017

Irving, Texas, United States

Local Institution - 0013

McKinney, Texas, United States

Perceptive Pharma Research

Richmond, Texas, United States

UT Health San Antonio - Behavioral Health and Wellness Center

San Antonio, Texas, United States

Local Institution - 0018

Stafford, Texas, United States

Local Institution - 0045

Petersburg, Virginia, United States

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (55)