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NCT Number: NCT07284745

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

The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.

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Key information

Conditions

Irritability Associated With Autism Spectrum Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution - 0046, La Plata, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

KarXT

Drug

Specified dose on specified days

Other names: BMS-986510, Xanomeline/Trospium Chloride

KarX-EC

Drug

Specified dose on specified days

Other names: BMS-986519, Xanomeline Enteric-coated

KarXT + KarX-EC Matching Placebo

Drug

Specified dose on specified days

Primary outcomes

  1. Change From Baseline in the Aberrant Behavior Checklist Irritability (ABC-I) Score at Week 8

    Time frame: Week 8

Secondary outcomes

  1. Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Week 8

    Time frame: Week 8

  2. 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.

  3. Change From Baseline on the ABC Subscale for Social Withdrawal at Week 8

    Time frame: Week 8

  4. Change From Baseline on the Stereotypic Behavior Subscale at Week 8

    Time frame: Week 8

  5. Change From Baseline on the Hyperactivity/Noncompliance Subscale at Week 8

    Time frame: Week 8

  6. Change From Baseline on the Inappropriate Speech Subscale at Week 8

    Time frame: Week 8

  7. Clinical Global Impression-Improvement (CGI-I) Score at Week 8

    Time frame: Week 8

  8. Number of Participants With Procholinergic Symptoms

    Time frame: Up to approximately 12 weeks

  9. Number of Participants With Anticholinergic Symptoms

    Time frame: Up to approximately 12 weeks

  10. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Time frame: Up to approximately 12 weeks

  11. Number of Participants With Serious Adverse Events (SAEs)

    Time frame: Up to approximately 12 weeks

  12. Number of Participants With Adverse Events of Special Interest (AESIs)

    Time frame: Up to approximately 12 weeks

  13. Number of Participants With AEs Leading to Discontinuation of Study Intervention

    Time frame: Up to approximately 8 weeks

  14. Plasma concentrations of KarXT

    Time frame: Up to approximately 8 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Dec 16, 2025
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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