A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism

August 21, 2026 updated by: Bristol-Myers Squibb

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of 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 assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.

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.
176

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

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Local Institution - 0010
        • Contact:
          • Site 0010
    • Queensland
      • Brisbane, Queensland, Australia, 4101
        • Local Institution - 0007
        • Contact:
          • Site 0007
    • Victoria
      • Melbourne, Victoria, Australia, 3052
        • Local Institution - 0045
        • Contact:
          • Site 0045
      • Melbourne, Victoria, Australia, 3168
        • Local Institution - 0286
        • Contact:
          • Site 0286
  • Canada
    • Alberta
      • Airdrie, Alberta, Canada, T4A 0K9
        • Local Institution - 0289
        • Contact:
          • Site 0289
      • Edmonton, Alberta, Canada, T6G 1Z1
        • Local Institution - 0136
        • Contact:
          • Site 0136
    • Ontario
      • Kingston, Ontario, Canada, K7L4X3
        • Local Institution - 0135
        • Contact:
          • Site 0135
      • Toronto, Ontario, Canada, M4G 1R8
        • Local Institution - 0205
        • Contact:
          • Site 0205
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • Local Institution - 0187
        • Contact:
          • Site 0187
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Local Institution - 0234
        • Contact:
          • Site 0234
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36303
        • Local Institution - 0036
        • Contact:
          • Site 0036
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Local Institution - 0236
        • Contact:
          • Site 0236
    • California
      • Anaheim, California, United States, 92805
        • Local Institution - 0031
        • Contact:
          • Site 0031
      • Glendale, California, United States, 91203
        • Local Institution - 0257
        • Contact:
          • Site 0257
      • Redlands, California, United States, 92373
        • Local Institution - 0233
        • Contact:
          • Site 0233
      • San Rafael, California, United States, 94903
        • Local Institution - 0181
        • Contact:
          • Site 0181
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • Local Institution - 0252
        • Contact:
          • Site 0252
    • Florida
      • Boca Raton, Florida, United States, 33428
        • Local Institution - 0264
        • Contact:
          • Site 0264
      • Gainesville, Florida, United States, 32607
        • Local Institution - 0099
        • Contact:
          • Site 0099
      • Gainesville, Florida, United States, 32607
        • Local Institution - 0278
        • Contact:
          • Site 0278
    • Georgia
      • Peachtree Corners, Georgia, United States, 30071
        • Local Institution - 0155
        • Contact:
          • Site 0155
    • Illinois
      • Chicago, Illinois, United States, 60622
        • Local Institution - 0266
        • Contact:
          • Site 0266
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Local Institution - 0242
        • Contact:
          • Site 0242
    • Michigan
      • Bloomfield Hills, Michigan, United States, 48302
        • Local Institution - 0160
        • Contact:
          • Site 0160
      • Detroit, Michigan, United States, 48203
        • Local Institution - 0220
        • Contact:
          • Site 0220
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Local Institution - 0110
        • Contact:
          • Site 0110
    • New York
      • Staten Island, New York, United States, 10312
        • Local Institution - 0246
        • Contact:
          • Site 0246
      • The Bronx, New York, United States, 10461
        • Local Institution - 0263
        • Contact:
          • Site 0263
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Local Institution - 0122
        • Contact:
          • Site 0122
      • West Chester, Ohio, United States, 45069
        • Local Institution - 0247
        • Contact:
          • Site 0247
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17821
        • Local Institution - 0269
        • Contact:
          • Site 0269
    • Texas
      • Dallas, Texas, United States, 75243
        • Local Institution - 0041
        • Contact:
          • Site 0041
      • Houston, Texas, United States, 77090
        • Local Institution - 0034
        • Contact:
          • Site 0034
      • Plano, Texas, United States, 75093
        • Local Institution - 0273
        • Contact:
          • Site 0273
      • San Antonio, Texas, United States, 78249
        • Local Institution - 0291
        • Contact:
          • Site 0291
      • Spring, Texas, United States, 77381
        • Local Institution - 0185
        • Contact:
          • Site 0185
    • Utah
      • Bountiful, Utah, United States, 84010
        • Local Institution - 0074
        • Contact:
          • Site 0074
      • Provo, Utah, United States, 84604
        • Local Institution - 0271
        • Contact:
          • Site 0271
    • Virginia
      • Richmond, Virginia, United States, 23220
        • Local Institution - 0260
        • Contact:
          • Site 0260

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 a confirmed diagnosis of ASD, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria, confirmed by the K-SADS-PL and must be experiencing symptoms of irritability.
  • Participants must have ABC-I ≥18 (Irritability subscale of the ABC) and CGIS specific to irritability ≥4, at screening and baseline (Day 1).

Exclusion Criteria

  • Participants must not have a current primary DSM-5 diagnosis of bipolar disorder, including bipolar II disorder, schizophrenia, schizoaffective disorder, major depressive episode as determined by clinical instrument, or post-traumatic stress disorder (PTSD).
  • Exception Include: Participants with comorbid ADHD, provided that attention deficit/hyperactivity disorder (ADHD) is not the primary disorder, the participant is adequately treated and based on the investigator judgment the disorder is clinically stable.
  • Participants must not have history/presence of clinically significant disease or disorder that would jeopardize participant safety or validity of study results.
  • Participants must not have a risk for suicidal behavior, and any clinically significant abnormal laboratory test.
  • Other protocol-defined Inclusion/Exclusion criteria may 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: KarXT + KarX-EC Matching Placebo
Specified dose on specified days
Experimental: KarXT + KarX-EC Arm
Drug: KarXT
Specified dose on specified days
Other Names:
  • BMS-986510
  • Xanomeline/Trospium Chloride
Drug: KarX-EC
Specified dose on specified days
Other Names:
  • BMS-986519
  • Xanomeline Enteric-coated

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
Change From Baseline in the Aberrant Behavior Checklist Irritability (ABC-I) Score at Week 8
Time Frame: Week 8
Week 8

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
Measure Description
Time Frame
Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Week 8
Time Frame: Week 8
Week 8
Change From Baseline on the ABC Subscale for Social Withdrawal at Week 8
Time Frame: Week 8
Week 8
Change From Baseline on the Stereotypic Behavior Subscale at Week 8
Time Frame: Week 8
Week 8
Change From Baseline on the Hyperactivity/Noncompliance Subscale at Week 8
Time Frame: Week 8
Week 8
Change From Baseline on the Inappropriate Speech Subscale at Week 8
Time Frame: Week 8
Week 8
Clinical Global Impression-Improvement (CGI-I) Score at Week 8
Time Frame: Week 8
Week 8
Number of Participants With AEs Leading to Discontinuation of Study Intervention
Time Frame: Up to approximately 8 weeks
Up to approximately 8 weeks
Number of Participants With ABC-I Response at Week 8
Time Frame: Week 8
ABC-I response is determined by ≥ 25% reduction in ABC-I score from baseline.
Week 8
Number of Participants With Procholinergic Symptoms
Time Frame: Up to approximately 12 weeks
Up to approximately 12 weeks
Number of Participants With Anticholinergic Symptoms
Time Frame: Up to approximately 12 weeks
Up to approximately 12 weeks
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to approximately 12 weeks
Up to approximately 12 weeks
Number of Participants With Serious Adverse Events (SAEs)
Time Frame: Up to approximately 12 weeks
Up to approximately 12 weeks
Number of Participants With Adverse Events of Special Interest (AESIs)
Time Frame: Up to approximately 12 weeks
Up to approximately 12 weeks
Plasma concentrations of KarXT
Time Frame: Up to approximately 8 weeks
Up to approximately 8 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.
Bristol-Myers Squibb

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 11, 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.
August 6, 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.
August 6, 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).
December 9, 2025

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.
December 9, 2025

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.
December 16, 2025

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.
August 24, 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.
August 21, 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.
August 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.
  • CN012-0044
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-523189-26-00 (Other Identifier: EU CTR)
  • U1111-1325-4950 (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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