Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia

June 30, 2026 updated by: Karuna Therapeutics, Inc., a Bristol Myers Squibb company

A Phase 3 Double-blind, Placebo-controlled Randomized Withdrawal Maintenance Trial of KarXT Treatment in Participants With Schizophrenia

The purpose of the study is to evaluate the relapse prevention of KarXT in the treatment of participants with Schizophrenia

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet 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.
Interventional

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.
472

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

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

  • Argentina
      • Buenos Aires, Argentina, C1199ABB
        • Local Institution - 0143
        • Contact:
          • Site 0143
      • Córdoba, Argentina, 5000
        • Local Institution - 0002
        • Contact:
          • Site 0002
      • Santiago del Estero, Argentina, 4200
        • Local Institution - 0144
        • Contact:
          • Site 0144
    • Córdoba Province
      • Río Cuarto, Córdoba Province, Argentina, 5800
        • Local Institution - 0175
        • Contact:
          • Site 0175
  • Bulgaria
      • Novi Iskar, Bulgaria, 1282
        • Local Institution - 0191
        • Contact:
          • Site 0191
  • Czechia
      • Brno, Czechia, 625 00
        • Local Institution - 0162
        • Contact:
          • Site 0162
      • Klecany, Czechia, 25067
        • Local Institution - 0014
        • Contact:
          • Site 0014
  • Denmark
      • Aalborg, Denmark, 9000
        • Local Institution - 0158
        • Contact:
          • Site 0158
    • Central Jutland
      • Aarhus, Central Jutland, Denmark, 8200
        • Local Institution - 0159
        • Contact:
          • Site 0159
    • Frederiksberg
      • Hovedvejen 19, Frederiksberg, Denmark, 2000
        • Local Institution - 0182
        • Contact:
          • Site 0182
    • Region Sjælland
      • Glostrup, Region Sjælland, Denmark, 2600
        • Local Institution - 0157
        • Contact:
          • Site 0157
  • Poland
      • Poznan, Poland, 60-744
        • Local Institution - 0001
        • Contact:
          • Site 0001
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-957
        • Local Institution - 0123
        • Contact:
          • Site 0123
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-272
        • Local Institution - 0122
        • Contact:
          • Site 0122
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-214
        • Local Institution - 0120
        • Contact:
          • Site 0120
  • Romania
      • Bucharest, Romania, 011241
        • Local Institution - 0174
        • Contact:
          • Site 0174
      • Bucharest, Romania, 41914
        • Local Institution - 0106
        • Contact:
          • Site 0106
      • Bucharest, Romania, 41914
        • Local Institution - 0109
        • Contact:
          • Site 0109
      • Iași, Romania, 700282
        • Local Institution - 0055
        • Contact:
          • Site 0055
    • Bucharest
      • Bucharest, Bucharest, Romania, 041914
        • Local Institution - 0103
        • Contact:
          • Site 0103
      • Bucharest, Bucharest, Romania, 041914
        • Local Institution - 0105
        • Contact:
          • Site 0105
      • Bucharest, Bucharest, Romania, 041914
        • Local Institution - 0107
        • Contact:
          • Site 0107
      • Bucharest, Bucharest, Romania, 041914
        • Local Institution - 0110
        • Contact:
          • Site 0110
  • Spain
      • Valladolid, Spain, 47012
        • Local Institution - 0167
        • Contact:
          • Site 0167
      • Zamora, Spain, 49021
        • Local Institution - 0181
        • Contact:
          • Site 0181
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08003
        • Local Institution - 0112
        • Contact:
          • Site 0112
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Local Institution - 0101
  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7JX
        • Local Institution - 0177
        • Contact:
          • Site 0177
  • United States
    • Arkansas
      • Bentonville, Arkansas, United States, 72712
        • Local Institution - 0133
        • Contact:
          • Site 0133
      • Bentonville, Arkansas, United States, 72712
        • Local Institution - 0154
        • Contact:
          • Site 0154
      • Little Rock, Arkansas, United States, 72204
        • Local Institution - 0139
        • Contact:
          • Site 0139
      • Little Rock, Arkansas, United States, 72211
        • Local Institution - 0021
        • Contact:
          • Site 0021
      • Rogers, Arkansas, United States, 72758
        • Local Institution - 0153
        • Contact:
          • Site 0153
    • California
      • Anaheim, California, United States, 92805
        • Local Institution - 0190
        • Contact:
          • Site 0190
      • Bellflower, California, United States, 90706
        • Local Institution - 0040
        • Contact:
          • Site 0040
      • Chino, California, United States, 91710
        • Local Institution - 0188
        • Contact:
          • Site 0188
      • Culver City, California, United States, 90230
        • Local Institution - 0032
        • Contact:
          • Site 0032
      • Garden Grove, California, United States, 92845
        • Local Institution - 0037
        • Contact:
          • Site 0037
      • La Habra, California, United States, 90631
        • Local Institution - 0068
        • Contact:
          • Site 0068
      • Lemon Grove, California, United States, 91945
        • Local Institution - 0128
        • Contact:
          • Site 0128
      • Montclair, California, United States, 91763
        • Local Institution - 0187
        • Contact:
          • Site 0187
      • Orange, California, United States, 92868
        • Local Institution - 0151
        • Contact:
          • Site 0151
      • Pico Rivera, California, United States, 90660
        • Local Institution - 0030
        • Contact:
          • Site 0030
      • Redlands, California, United States, 92373
        • Local Institution - 0185
        • Contact:
          • Site 0185
      • Riverside, California, United States, 92506
        • Local Institution - 0186
        • Contact:
          • Site 0186
    • Florida
      • Hollywood, Florida, United States, 33021
        • Local Institution - 0149
      • Hollywood, Florida, United States, 33024
        • Local Institution - 0145
        • Contact:
          • Site 0145
      • Miami, Florida, United States, 33135
        • Local Institution - 0075
      • Miami Lakes, Florida, United States, 33016
        • Local Institution - 0054
      • Miami Springs, Florida, United States, 33166
        • Local Institution - 0134
      • West Palm Beach, Florida, United States, 33407
        • Local Institution - 0044
        • Contact:
          • Site 0044
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Local Institution - 0166
        • Contact:
          • Site 0166
      • Sandy Springs, Georgia, United States, 30328
        • Local Institution - 0070
        • Contact:
          • Site 0070
      • Savannah, Georgia, United States, 31405
        • Local Institution - 0189
        • Contact:
          • Site 0189
    • Illinois
      • Chicago, Illinois, United States, 60640-5017
        • Local Institution - 0067
        • Contact:
          • Site 0067
      • Chicago, Illinois, United States, 60641
        • Local Institution - 0056
        • Contact:
          • Site 0056
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Local Institution - 0023
    • New York
      • Buffalo, New York, United States, 14215
        • Local Institution - 0135
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Local Institution - 0183
        • Contact:
          • Site 0183
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Local Institution - 0047
        • Contact:
          • Site 0047
    • Texas
      • Austin, Texas, United States, 78754
        • Local Institution - 0049
        • Contact:
          • Site 0049

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

Description

Inclusion Criteria

  • Participant must have a primary diagnosis of schizophrenia for at least 1 year established by a comprehensive psychiatric evaluation based on the DSM-5-TR (American Psychiatric Association 2022) criteria and confirmed by MINI for Psychotic Disorder Studies version 7.0.2 at screening.
  • Participant must have experienced hospitalization for schizophrenia within 1 year from the screening date.
  • Participant must be experiencing residual schizophrenia symptoms and have a PANSS total score ≥70 to ≤ 110 at screening and Day -1.

  • Participant much have a PANSS Score of ≥ 4 (moderate or greater) on ≥ 2 of the following Positive Scale (P) items at screening and Day -1:

    1. Item 1 (P1; delusions)
    2. Item 2 (P2; conceptual disorganization)
    3. Item 3 (P3; hallucinatory behavior)
    4. Item 6 (P6; suspiciousness/persecution)
  • Participant must have a CGI-S score of ≥ 4 at screening and Day -1
  • Participant must have a BMI ≥ 18 and ≤ 40 kg/m2.

Exclusion Criteria

  • Participant must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening
  • Participants must not have a newly diagnosed or are experiencing their first treated episode of psychosis or schizophrenia.
  • Participant must not have a risk of suicidal behavior as determined by the Investigator's clinical assessment and/or Columbia-suicide Severity Rating Scale (C-SSRS).
  • Participant must not have had psychiatric hospitalization(s) for more than 30 days (cumulative) within the 6 months before screening.
  • Participant must not have a history of treatment resistance to schizophrenia medications
  • Participant must not have decrease in PANSS total score (floor adjusted) between screening and Day -1 of more than 20%.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Placebo Comparator: Placebo
Drug: Placebo
Specified dose on specified days
Experimental: KarXT
Drug: Xanomeline/Trospium Chloride
Specified dose on specified days
Other Names:
  • KarXT
  • BMS-986510

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
Time From Randomization to the First Relapse Event
Time Frame: Up to approximately Week 43
Up to approximately Week 43

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
Time to Discontinuation During Double-blind Treatment Period
Time Frame: Approximately From Week 18 to 43
Approximately From Week 18 to 43
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame: Up to approximately Week 45
Up to approximately Week 45
Number of Participants With Adverse Events of Special Interest (AESIs)
Time Frame: Up to approximately Week 45
Up to approximately Week 45
Number of Participants With Procholinergic Symptoms
Time Frame: Up to approximately Week 45
Up to approximately Week 45
Number of Participants With Anticholinergic Symptoms
Time Frame: Up to approximately Week 45
Up to approximately Week 45
Number of Participants With Serious Adverse Events (SAEs)
Time Frame: Up to approximately Week 45
Up to approximately Week 45

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.
Karuna Therapeutics, Inc., a Bristol Myers Squibb company

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 (Estimated)

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.
September 3, 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.
March 3, 2029

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.
March 3, 2029

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).
June 30, 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.
June 30, 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.
July 7, 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.
July 7, 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.
June 30, 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.
June 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.
  • CN012-0006
  • 2025-523664-20 (Other Identifier: EU CT Number)
  • U1111-1327-7599 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

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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