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

March 30, 2026 updated by: Bristol-Myers Squibb

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability 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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

176

Phase

  • 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

  • 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

  • France
      • Bron, France, 69678
        • Local Institution - 0102
        • Contact:
          • Site 0102
      • Eysines, France, 33320
        • Local Institution - 0088
        • Contact:
          • Site 0088
      • Paris, France, 75019
        • Local Institution - 0089
        • Contact:
          • Site 0089
  • Germany
      • Gdansk, Germany, 80-546
        • Local Institution - 0103
        • Contact:
          • Site 0103
  • Hungary
      • Budapest, Hungary, 1021
        • Local Institution - 0111
        • Contact:
          • Site 0111
      • Budapest, Hungary, 1143
        • Local Institution - 0127
        • Contact:
          • Site 0127
      • Siófok, Hungary, 8600
        • Local Institution - 0112
        • Contact:
          • Site 0112
      • Szeged, Hungary, 6720
        • Local Institution - 0110
        • Contact:
          • Site 0110
  • India
    • Kerala
      • Kozhikode, Kerala, India, 673009
        • Local Institution - 0096
        • Contact:
          • Site 0096
    • Maharashtra
      • Sakri, Maharashtra, India, 441108
        • Local Institution - 0101
        • Contact:
          • Site 0101
    • West Bengal
      • Kolkata, West Bengal, India, 700020
        • Local Institution - 0097
        • Contact:
          • Site 0097
  • Japan
      • Saga, Japan, 840-0801
        • Local Institution - 0092
        • Contact:
          • Site 0092
      • Yokohama, Kanagawa, Japan, 213-8507
        • Local Institution - 0093
        • Contact:
          • Site 0093
    • Miyazaki
      • Miyakonojō, Miyazaki, Japan, 885-0093
        • Local Institution - 0094
        • Contact:
          • Site 0094
    • Osaka
      • Hirakata, Osaka, Japan, 573-0022
        • Local Institution - 0090
        • Contact:
          • Site 0090
    • Saga-ken
      • Yoshinogari-cho, Kanzaki-gun, Saga-ken, Japan, 842-0192
        • Local Institution - 0095
        • Contact:
          • Site 0095
    • Tokyo
      • Ōta-ku, Tokyo, Japan, 146-0095
        • Local Institution - 0091
        • Contact:
          • Site 0091
  • Poland
      • Katowice, Poland, 40-146
        • Local Institution - 0104
        • Contact:
          • Site 0104
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-744
        • Local Institution - 0108
        • Contact:
          • Site 0108
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 54-234
        • Local Institution - 0105
        • Contact:
          • Site 0105
    • Lublin Voivodeship
      • Kraśnik, Lublin Voivodeship, Poland, 23-210
        • Local Institution - 0109
        • Contact:
          • Site 0109
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-957
        • Local Institution - 0107
        • Contact:
          • Site 0107
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-542
        • Local Institution - 0106
        • Contact:
          • Site 0106
    • West Pomeranian Voivodeship
      • Szczecin, West Pomeranian Voivodeship, Poland, 70-419
        • Local Institution - 0113
        • Contact:
          • Site 0113
      • Szczecin, West Pomeranian Voivodeship, Poland, 70-419
        • Local Institution - 0129
        • Contact:
          • Site 0129
  • Romania
      • Bucharest, Romania, 031871
        • Local Institution - 0124
        • Contact:
          • Site 0124
      • Cluj-Napoca, Romania
        • Local Institution - 0123
        • Contact:
          • Site 0123
      • Iași, Romania, 700282
        • Local Institution - 0121
        • Contact:
          • Site 0121
      • Sibiu, Romania, 550082
        • Local Institution - 0119
        • Contact:
          • Site 0119
      • Timișoara, Romania, 300011
        • Local Institution - 0122
        • Contact:
          • Site 0122
    • București
      • Bucharest, București, Romania, 030167
        • Local Institution - 0118
        • Contact:
          • Site 0118
      • Bucharest, București, Romania, 041914
        • Local Institution - 0120
        • Contact:
          • Site 0120
  • Spain
      • Madrid, Spain, 28007
        • Local Institution - 0084
        • Contact:
          • Site 0084
      • Madrid, Spain, 28031
        • Local Institution - 0086
        • Contact:
          • Site 0086
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Local Institution - 0085
        • Contact:
          • Site 0085
    • Catalunya [Cataluña]
      • Barcelona, Catalunya [Cataluña], Spain, 08036
        • Local Institution - 0087
        • Contact:
          • Site 0087
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Local Institution - 0062
        • Contact:
          • Site 0062
    • Arkansas
      • Bentonville, Arkansas, United States, 72712
        • Local Institution - 0001
    • California
      • Glendale, California, United States, 91203
        • Local Institution - 0013
        • Contact:
          • Site 0013
      • Los Angeles, California, United States, 90095
        • Local Institution - 0117
        • Contact:
          • Site 0117
      • Orange, California, United States, 92868
        • Local Institution - 0126
        • Contact:
          • Site 0126
      • San Juan Capistrano, California, United States, 92675
        • Local Institution - 0115
        • Contact:
          • Site 0115
      • San Rafael, California, United States, 94903
        • Local Institution - 0116
        • Contact:
          • Site 0116
    • Florida
      • Orlando, Florida, United States, 32803
        • Local Institution - 0080
        • Contact:
          • Site 0080
    • Illinois
      • Chicago, Illinois, United States, 60622
        • Local Institution - 0014
        • Contact:
          • Site 0014
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Local Institution - 0006
        • Contact:
          • Site 0006
    • Massachusetts
      • Lexington, Massachusetts, United States, 02421
        • Local Institution - 0051
        • Contact:
          • Site 0051
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Local Institution - 0016
        • Contact:
          • Site 0016
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Local Institution - 0046
        • Contact:
          • Site 0046
    • New Jersey
      • Neptune City, New Jersey, United States, 07753-4859
        • Local Institution - 0114
        • Contact:
          • Site 0114
    • New York
      • Staten Island, New York, United States, 10312
        • Local Institution - 0038
        • Contact:
          • Site 0038
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Local Institution - 0052
        • Contact:
          • Site 0052
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Local Institution - 0003
        • Contact:
          • Site 0003
    • Utah
      • Orem, Utah, United States, 84097
        • Local Institution - 0009
        • Contact:
          • Site 0009
    • Washington
      • Everett, Washington, United States, 98201
        • Local Institution - 0019
        • Contact:
          • Site 0019

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

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 (C18 on the Irritability subscale of the ABC-I) 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
Intervention / Treatment
Experimental: 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

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

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
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
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 Procholinergic Symptoms
Time Frame: Up to approximately 10 weeks
Up to approximately 10 weeks
Number of Participants With Anticholinergic Symptoms
Time Frame: Up to approximately 10 weeks
Up to approximately 10 weeks
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to approximately 10 weeks
Up to approximately 10 weeks
Number of Participants With Serious Adverse Events (SAEs)
Time Frame: Up to approximately 10 weeks
Up to approximately 10 weeks
Number of Participants With Adverse Events of Special Interest (AESIs)
Time Frame: Up to approximately 10 weeks
Up to approximately 10 weeks
Number of Participants With AEs Leading to Discontinuation of Study Intervention
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

Bristol-Myers Squibb

Investigators

  • 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)

September 11, 2026

Primary Completion (Estimated)

August 4, 2029

Study Completion (Estimated)

August 4, 2029

Study Registration Dates

First Submitted

December 10, 2025

First Submitted That Met QC Criteria

December 10, 2025

First Posted (Actual)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN012-0045

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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