A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Autism-Related Irritability in Adolescents, Respectively

May 7, 2026 updated by: Karuna Therapeutics, Inc., a Bristol Myers Squibb company

A Phase 3 Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of KarXT in Adolescents (13 to 17 Years of Age) With Schizophrenia and KarXT+KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder

The purpose of this study is to evaluate the long-term safety and tolerability of KarXT and KarX-EC for the treatment of Schizophrenia and autism-related irritability in adolescents, respectively

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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.
400

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, C1405BOA
        • Not yet recruiting
        • Local Institution - 0036
        • Contact:
          • Site 0036
      • Córdoba, Argentina, X5003DCE
        • Not yet recruiting
        • Local Institution - 0035
        • Contact:
          • Site 0035
      • Santiago del Estero, Argentina, G4200DND
        • Not yet recruiting
        • Local Institution - 0116
        • Contact:
          • Site 0116
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1107
        • Not yet recruiting
        • Local Institution - 0084
        • Contact:
          • Site 0084
      • La Plata, Buenos Aires, Argentina, 1900
        • Not yet recruiting
        • Local Institution - 0085
        • Contact:
          • Site 0085
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z1
        • Not yet recruiting
        • Local Institution - 0111
        • Contact:
          • Site 0111
    • Ontario
      • Kingston, Ontario, Canada, K7L4X3
        • Not yet recruiting
        • Local Institution - 0110
        • Contact:
          • Site 0110
      • Toronto, Ontario, Canada, M4G 1R8
        • Not yet recruiting
        • Local Institution - 0113
        • Contact:
          • Site 0113
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • Not yet recruiting
        • Local Institution - 0112
        • Contact:
          • Site 0112
  • France
      • Bordeaux, France, 33076
        • Not yet recruiting
        • Local Institution - 0118
        • Contact:
          • Site 0118
      • Bron, France, 69678
        • Not yet recruiting
        • Local Institution - 0120
        • Contact:
          • Site 0120
      • Paris, France, 75019
        • Not yet recruiting
        • Local Institution - 0119
        • Contact:
          • Site 0119
  • Germany
      • Gdansk, Germany, 80-546
        • Not yet recruiting
        • Local Institution - 0121
        • Contact:
          • Site 0121
  • Hungary
      • Budapest, Hungary, 1143
        • Not yet recruiting
        • Local Institution - 0129
        • Contact:
          • Site 0129
      • Gyula, Hungary, 5700
        • Not yet recruiting
        • Local Institution - 0130
        • Contact:
          • Site 0130
      • Szeged, Hungary, 6720
        • Not yet recruiting
        • Local Institution - 0131
        • Contact:
          • Site 0131
  • Japan
      • Yokohama, Kanagawa, Japan, 213-8507
        • Not yet recruiting
        • Local Institution - 0063
        • Contact:
          • Site 0063
    • Fukuoka
      • Chikugo, Fukuoka, Japan, 833-0041
        • Not yet recruiting
        • Local Institution - 0075
        • Contact:
          • Site 0075
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 002-8029
        • Recruiting
        • Goryokai Medical Corporation - Goryokai Hospital
        • Contact:
          • Kimihiro Nakajima, Site 0073
          • Phone Number: +81-11-771-5660
    • Kagawa-ken
      • Zentsujichó, Kagawa-ken, Japan, 765-8507
        • Not yet recruiting
        • Local Institution - 0025
        • Contact:
          • Site 0025
    • Miyazaki
      • Miyakonojō, Miyazaki, Japan, 885-0093
        • Not yet recruiting
        • Local Institution - 0062
        • Contact:
          • Site 0062
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • Not yet recruiting
        • Local Institution - 0086
        • Contact:
          • Site 0086
      • Ōta-ku, Tokyo, Japan, 143-8541
        • Not yet recruiting
        • Local Institution - 0056
        • Contact:
          • Site 0056
  • Poland
      • Katowice, Poland, 40-146
        • Not yet recruiting
        • Local Institution - 0124
        • Contact:
          • Site 0124
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-744
        • Not yet recruiting
        • Local Institution - 0128
        • Contact:
          • Site 0128
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 54-234
        • Not yet recruiting
        • Local Institution - 0125
        • Contact:
          • Site 0125
    • Lublin Voivodeship
      • Kraśnik, Lublin Voivodeship, Poland, 23-210
        • Not yet recruiting
        • Local Institution - 0122
        • Contact:
          • Site 0122
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-957
        • Not yet recruiting
        • Local Institution - 0127
        • Contact:
          • Site 0127
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-542
        • Not yet recruiting
        • Local Institution - 0126
        • Contact:
          • Site 0126
    • West Pomeranian Voivodeship
      • Szczecin, West Pomeranian Voivodeship, Poland, 70-419
        • Not yet recruiting
        • Local Institution - 0123
        • Contact:
          • Site 0123
  • Romania
      • Bucharest, Romania, 021056
        • Not yet recruiting
        • Local Institution - 0040
        • Contact:
          • Site 0040
      • Bucharest, Romania, 031871
        • Not yet recruiting
        • Local Institution - 0042
        • Contact:
          • Site 0042
      • Iași, Romania, 700282
        • Not yet recruiting
        • Local Institution - 0008
        • Contact:
          • Site 0008
      • Timișoara, Romania, 300011
        • Not yet recruiting
        • Local Institution - 0038
        • Contact:
          • Site 0038
    • Bucharest
      • Bucharest, Bucharest, Romania, 041914
        • Not yet recruiting
        • Local Institution - 0029
        • Contact:
          • Site 0029
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400370
        • Not yet recruiting
        • Local Institution - 0031
        • Contact:
          • Site 0031
  • Spain
      • Barcelona, Spain, 08036
        • Not yet recruiting
        • Local Institution - 0101
        • Contact:
          • Site 0101
      • Barcelona, Spain, 8035
        • Not yet recruiting
        • Local Institution - 0099
        • Contact:
          • Site 0099
      • Madrid, Spain, 28007
        • Not yet recruiting
        • Local Institution - 0098
        • Contact:
          • Site 0098
      • Madrid, Spain, 28031
        • Not yet recruiting
        • Local Institution - 0100
        • Contact:
          • Site 0100
  • United States
    • California
      • Anaheim, California, United States, 92805
        • Not yet recruiting
        • Local Institution - 0077
        • Contact:
          • Site 0077
      • Chino, California, United States, 91710
        • Not yet recruiting
        • Local Institution - 0058
        • Contact:
          • Site 0058
      • Culver City, California, United States, 90230
        • Not yet recruiting
        • Local Institution - 0024
        • Contact:
          • Site 0024
      • Redlands, California, United States, 92373
        • Not yet recruiting
        • Local Institution - 0083
        • Contact:
          • Site 0083
      • San Francisco, California, United States, 94158
        • Not yet recruiting
        • Local Institution - 0089
        • Contact:
          • Site 0089
    • Florida
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Apg Research, Llc
        • Contact:
          • Morteza Nadjafi, Site 0032
          • Phone Number: 407-423-7149
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Recruiting
        • Atlanta Center for Medical Research
        • Contact:
          • Elyssa Barron, Site 0057
          • Phone Number: 404-881-5800
      • Lawrenceville, Georgia, United States, 30046
        • Recruiting
        • Salveo Integrative Health - Lawrenceville
        • Contact:
          • Shahzad Hashmi, Site 0103
      • Stone Mountain, Georgia, United States, 30083
        • Not yet recruiting
        • Local Institution - 0039
        • Contact:
          • Site 0039
    • Illinois
      • Chicago, Illinois, United States, 60622
        • Recruiting
        • EmVenio Research Center - Prime Healthcare
        • Contact:
          • Mitchell Glaser, Site 0044
          • Phone Number: 773-620-2995
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Not yet recruiting
        • Local Institution - 0076
        • Contact:
          • Site 0076
      • Worcester, Massachusetts, United States, 01608
        • Not yet recruiting
        • Local Institution - 0059
        • Contact:
          • Site 0059
    • New York
      • Great Neck, New York, United States, 11021
        • Not yet recruiting
        • Local Institution - 0061
        • Contact:
          • Site 0061
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Cancer Institute
        • Contact:
          • Melissa DelBello, Site 0051
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19139
        • Not yet recruiting
        • Local Institution - 0097
        • Contact:
          • Site 0097
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Not yet recruiting
        • Local Institution - 0137
        • Contact:
          • Site 0137
    • Texas
      • Garland, Texas, United States, 75043
        • Not yet recruiting
        • Local Institution - 0046
        • Contact:
          • Site 0046
      • Spring, Texas, United States, 77381
        • Not yet recruiting
        • Local Institution - 0066
        • Contact:
          • Site 0066
    • Virginia
      • Richmond, Virginia, United States, 23284
        • Not yet recruiting
        • Local Institution - 0050
        • Contact:
          • Site 0050

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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

- Participants must have completed the double-blind treatment period (ie, Visit 8) of Study CN0120020 or the double-blind treatment period (ie, Week 8) of Study CN0120044 or CN0120045, without an adverse event (AE) that, in the investigator's opinion, may indicate an unacceptable safety risk.

Exclusion Criteria

  • Participants must not have a significant risk of committing violent acts, serious self-harm, or attempting suicide based on history or routine psychiatric status examination, or those who are homicidal or are considered to be a high risk to others, or who have an answer of "Yes" on Questions 4 or 5 on the suicidal ideation section of the "Since Last Visit" version of the C-SSRS at baseline (Visit 1). Nonsuicidal, self-injurious behavior is not exclusionary.
  • Participants must not have any clinically significant abnormality including any finding(s) from the physical examination, vital signs, ECG at the end of treatment visit of Study CN0120020, CN0120044, or CN0120045 that the investigator, in consultation with the Sponsor Medical Monitor, would jeopardize the safety of the participant.
  • Participants must not have either a systolic blood pressure (sBP) or diastolic blood pressure (dBP) meeting criteria for stage 2 hypertension (HTN), regardless of the presence or absence of symptoms.
  • 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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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.
Experimental: Administration of KarXT for Schizophrenia
Drug: KarXT
Specified dose on specified days
Experimental: Administration of KarXT for Autism-related Irritability
Drug: KarXT
Specified dose on specified days

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
Number of participants with treatment emergent adverse events (TEAEs)
Time Frame: Up to 54 weeks
Up to 54 weeks
Number of participants with adverse events of special interest (AESIs)
Time Frame: Up to 54 weeks
Up to 54 weeks
Number of participants with serious adverse events (SAEs)
Time Frame: Up to 54 weeks
Up to 54 weeks

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
Number or participants with procholinergic symptoms
Time Frame: Up to 54 weeks
Up to 54 weeks
Number of participants with anticholinergic symptoms
Time Frame: Up to 54 weeks
Up to 54 weeks
Number of participants with suicidal ideation and behavior assessed using the Columbia Suicide Severity Rating Scale (C-SSRS)
Time Frame: Up to 54 weeks
Up to 54 weeks
Change from baseline on the Simpson-Angus Scale (SAS)
Time Frame: Up to 52 weeks
Up to 52 weeks
Change from baseline on the Abnormal Involuntary Movement Scale (AIMS)
Time Frame: Up to 52 weeks
Up to 52 weeks
Change from baseline on the Barnes-Akathisia Rating Scale (BARS)
Time Frame: Up to 52 weeks
Up to 52 weeks

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

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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 (Actual)

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.
April 7, 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 8, 2030

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 8, 2030

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).
February 13, 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.
February 13, 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.
February 20, 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.
May 11, 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.
May 7, 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.
May 1, 2026

More Information

Terms related to this study

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.
  • CN012-0021
  • 2025-524062-16-00 (Other Identifier: EU CT Number)
  • U1111-1325-9994 (Other Identifier: UTN)

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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