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

An observational study of Schizophrenia, run by Bristol-Myers Squibb at 68 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Schizophrenia
What is being tested?: Xanomeline and trospium chloride (KarXT)
How many people: 1,500 participants
Where: 68 sitesUnited States
Study dates: 26 Feb 2026to 20 Jun 2028
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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)

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

68 sites in 1 country. Contact the study team or a site near you to ask about taking part.

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

City, postcode or hospital

Sites recruiting now only

68 sites in 1 country

United States68 sites, 68 recruiting

Pamoja Advanced Nursing Practice
Anaheim, California, 92801
Fines Shaw, Site 0047
Recruiting
Local Institution - 0003
Anaheim, California, 92805
Site 0003
Not yet recruiting
Local Institution - 0034
Apple Valley, Minnesota, 55124
Site 0034
Not yet recruiting
Emory University.
Atlanta, Georgia, 30303
Robert Cotes, Site 0025, 404-616-4752
Recruiting
Avant Psychiatry
Austell, Georgia, 30106
Okah Anyokwu, Site 0049, 573-999-0193
Recruiting
Local Institution - 0016
Austin, Texas, 78754
Site 0016
Not yet recruiting
Local Institution - 0014
Bloomfield Township, Michigan, 48302-1909
Site 0014
Not yet recruiting
Envision Trials LLC
Bonita Springs, Florida, 34134
Daniel Mandri, Site 0005, 305-819-2909
Recruiting
SanRo Clinical Research Group
Bryant, Arkansas, 72022
Robert Wooten, Site 0009
Recruiting
Local Institution - 0037
Buffalo, New York, 14215
Site 0037
Not yet recruiting
Magnolia Clinical Research, LLC
Cary, North Carolina, 27513
Michelle Maust, Site 0042, 984-345-3010
Recruiting
Local Institution - 0057
Charlotte, North Carolina, 28211-4849
Site 0057
Not yet recruiting
Inland Psychiatric Medical Group (IPMG)-Chino
Chino, California, 91710
Nandita Puchakayala, Site 0039
Recruiting
Local Institution - 0051
Cordova, Tennessee, 38018
Site 0051
Not yet recruiting
Local Institution - 0046
Crystal Lake, Illinois, 60523
Site 0046
Not yet recruiting
Local Institution - 0050
Dallas, Texas, 75390
Site 0050
Not yet recruiting
Local Institution - 0036
Detroit, Michigan, 48203
Site 0036
Not yet recruiting
Local Institution - 0054
Duluth, Minnesota, 55811
Site 0054
Not yet recruiting
SCLA Management- Psymed Solutions
Fort Worth, Texas, 76132
Satish Narayan, Site 0021, 888-888-8888
Recruiting
Psychiatric Consultants, Pc
Franklin, Tennessee, 37607
James Hart, Site 0002, 615-807-4025
Recruiting
Local Institution - 0067
Hagerstown, Maryland, 21740
Site 0067
Not yet recruiting
Local Institution - 0056
Hartford, Connecticut, 06106-3309
Site 0056
Not yet recruiting
Local Institution - 0059
Hartford, Connecticut, 06106-3309
Site 0059
Not yet recruiting
Galiz Research
Hialeah, Florida, 33016-1814
Jose Gamez, Site 0019, 305-805-0921
Recruiting
Local Institution - 0030
Homestead, Florida, 33030
Site 0030
Not yet recruiting
Local Institution - 0033
Houston, Texas, 77007-9015
Site 0033
Not yet recruiting
Local Institution - 0026
Houston, Texas, 77008-1758
Site 0026
Not yet recruiting
Local Institution - 0022
Houston, Texas, 77054-2852
Site 0022
Not yet recruiting
Local Institution - 0010
Houston, Texas, 77054
Site 0010
Not yet recruiting
Pioneer Research Solutions, Inc.
Houston, Texas, 77099
Ateka Zaki, Site 0024
Recruiting
Local Institution - 0017
Irving, Texas, 75062-2757
Site 0017
Not yet recruiting
New Access Research & Medical Services Inc - Kendall
Kendall, Florida, 33186
Ana Maria Tous, Site 0029
Recruiting
Local Institution - 0012
La Palma, California, 90623
Site 0012
Not yet recruiting
Local Institution - 0055
Las Vegas, Nevada, 89146
Site 0055
Not yet recruiting
Alivation Research, LLC
Lincoln, Nebraska, 68526
Walter Duffy, Site 0041, 402-817-2236
Recruiting
Local Institution - 0044
Marietta, Georgia, 30060
Site 0044
Not yet recruiting
Local Institution - 0031
Mason, Ohio, 45040-7846
Site 0031
Not yet recruiting
Local Institution - 0013
McKinney, Texas, 75092
Site 0013
Not yet recruiting
Local Institution - 0032
Miami, Florida, 33015
Site 0032
Not yet recruiting
Banyan Behavioal Care Program - CSU
Miami, Florida, 33134
Moraima Trujillo, Site 0011, 305-246-0001
Recruiting
Local Institution - 0007
Miami, Florida, 33155
Site 0007
Not yet recruiting
BioResearch Partner - Miami
Miami, Florida, 33175
Fenton Lebon, Site 0006
Recruiting
Local Institution - 0062
Mission Viejo, California, 92691
Site 0062
Not yet recruiting
Local Institution - 0004
Monsey, New York, 10952
Site 0004
Not yet recruiting
Local Institution - 0066
Nashville, Tennessee, 37212
Site 0066
Not yet recruiting
Local Institution - 0043
Oceanside, California, 92054
Site 0043
Not yet recruiting
The Rivus Wellness & Research Institute
Oklahoma City, Oklahoma, 73112-8729
Marvin Peyton, Site 0027, 405-317-5783
Recruiting
Medical Research of Central Florida
Orange City, Florida, 32763
Adly Thebaud, Site 0023, 386-775-7627
Recruiting
Local Institution - 0061
Orland Park, Illinois, 60467
Site 0061
Not yet recruiting
Local Institution - 0040
Orlando, Florida, 32803
Site 0040
Not yet recruiting
Local Institution - 0045
Petersburg, Virginia, 23805
Site 0045
Not yet recruiting
Perelman School of Medicine at the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4238
Christian Kohler, Site 0015, 215-614-0161
Recruiting
Local Institution - 0068
Redlands, California, 92373
Site 0068
Not yet recruiting
Perceptive Pharma Research
Richmond, Texas, 77407-3498
Adeeb Masood, Site 0008
Recruiting
Local Institution - 0038
Rochester, New York, 14623
Site 0038
Not yet recruiting
UT Health San Antonio - Behavioral Health and Wellness Center
San Antonio, Texas, 78240
Mady Stovall, Site 0035
Recruiting
Local Institution - 0060
San Diego, California, 92103
Site 0060
Not yet recruiting
Local Institution - 0063
Seal Beach, California, 90740
Site 0063
Not yet recruiting
R & H Clinical Research-3727 Greenbriar Dr
Stafford, Texas, 77477-3954
Syed Zaidi, Site 0018, 713-904-3329
Recruiting
Local Institution - 0028
Stanford, California, 94304
Site 0028
Not yet recruiting
Local Institution - 0053
State College, Pennsylvania, 16801
Site 0053
Not yet recruiting
Local Institution - 0052
Tulsa, Oklahoma, 74135
Site 0052
Not yet recruiting
Amr Conventions Research - Illinois
Warrenville, Illinois, 60555
Sandeep Gaonkar, Site 0048, 630-416-8289
Recruiting
Phillips Medical Services PLLC
White Plains, New York, 10601
Parinda Parikh, Site 0020
Recruiting
PPD Virtual - PPD - US
Wilmington, North Carolina, 28401-3331
Ghazaleh Bahrami, Site 0001, 866-609-3139
Recruiting
Local Institution - 0065
Worcester, Massachusetts, 01655-0002
Site 0065
Not yet recruiting
Local Institution - 0058
Worcester, Massachusetts, 01655
Site 0058
Not yet recruiting
Local Institution - 0064
Wyomissing, Pennsylvania, 19610
Site 0064
Not yet recruiting

Other trials in United States

About this study

Official title: Effectiveness and Adverse-effect Switch Evaluation

Conditions: Schizophrenia
Being tested: Xanomeline and trospium chloride (KarXT)
Keywords: Schizophrenia
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Xanomeline and trospium chloride (KarXT)Drug
According to the product label

Study groups in NCT07379827
Study group	Role	What they receive
Group 1		Participants diagnosed with schizophrenia receiving xanomeline and trospium chloride (KarXT) Receives: Drug: Xanomeline and trospium chloride (KarXT)

What is being measured

The primary outcome is the main question the study is designed to answer.

Treatment titration and switch regimens as described by the prescribing clinician
Measured: Baseline and up to 20 weeks

Secondary outcomes (16)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Feb 202620 Jun 2028

First posted2 Feb 2026
Study start26 Feb 2026
Primary completion20 Jun 2028 (estimated)
Study completion20 Jun 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Other
Enrolment: 1,500 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07379827
Sponsor's protocol ID: CN012-0134
Status last verified: Oct 2026
First submitted: 23 Jan 2026
Last updated: 2 Nov 2026
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286

Clinical.Trials@bms.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion

All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness and Adverse-effect Switch Evaluation
ClinicalTrials.gov ID: NCT07379827
Acronym / sponsor ID: CN012-0134
Conditions: Schizophrenia
Keywords: Schizophrenia
Study type: Observational
Recruitment status: Recruiting
Enrolment: 1,500 participants (estimated)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 26 Feb 2026 (actual)
Primary completion: 20 Jun 2028 (estimated)
Study completion: 20 Jun 2028 (estimated)
First posted: 2 Feb 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Other
Number of arms: 1

Arm	Type	Receives
Group 1	–	Drug: Xanomeline and trospium chloride (KarXT)Participants diagnosed with schizophrenia receiving xanomeline and trospium chloride (KarXT)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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)

Key inclusion criteria (6 listed)

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:
Concomitant psychiatric medications (eg, antidepressants, mood stabilizers, anxiolytics) are permitted and are recommended to remain at a stable dose during the study period.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Xanomeline and trospium chloride (KarXT)According to the product label	Drug	Group 1

Primary outcome

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

16 secondary outcomes

Adverse events (AEs)
Time frame: Baseline and up to 20 weeks
Change in participant weight
Time frame: Baseline and up to 20 weeks
Clinical Global Impressions - Improvement (CGI-I) score
Time frame: 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
Continuation of treatment with xanomeline and trospium chloride (KarXT) at End of Study
Time frame: 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
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
Date of first xanomeline and trospium chloride (KarXT) treatment
Time frame: Baseline
Participant age
Time frame: Baseline
Participant sex
Time frame: Baseline
Participant race
Time frame: Baseline
Participant ethnicity
Time frame: Baseline
Participant height
Time frame: Baseline
Participant's family history of schizophrenia
Time frame: Baseline
Duration since diagnosis of schizophrenia
Time frame: Baseline
Previous treatment(s) received for schizophrenia
Time frame: Baseline

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
BMS Clinical Trial InformationLink provided by the sponsor.
FDA Safety Alerts and RecallsLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Schizophrenia

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

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

Bristol Myers Squibb study director

Bristol-Myers Squibb

68 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Schizophrenia, run by Bristol-Myers Squibb at 68 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment titration and switch regimens as described by the prescribing clinician (time frame: Baseline and up to 20 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07379827.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.