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

This study is looking into whether KarXT + KarX-EC can help reduce irritability in children and adolescents with autism spectrum disorder (ASD). You might be able to join if you are between 5 and 17 years old, have a confirmed diagnosis of ASD, and experience symptoms of irritability. The study will measure how much your irritability changes over 8 weeks using a specific rating scale called the Aberrant Behavior Checklist Irritability (ABC-I) Score. The study is currently unclear about its status and plans to enroll about 176 participants.

Study design
This study is testing KarXT + KarX-EC against a matching placebo. It plans to include about 176 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary measurement for the study is taken at Week 8.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07284745

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

Not Yet Recruiting
PHASE3Ages 5–17InterventionalTreatment
Bristol-Myers Squibb
~176 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:KarXTKarX-ECKarXT + KarX-EC Matching Placebo

At a glance

Recruiting sites
0 of 39 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change From Baseline in the Aberrant Behavior Checklist Irritability (ABC-I) Score at Week 8
Measured over Week 8

Conditions

Irritability Associated With Autism Spectrum Disorder

Explore related trials

Autism Spectrum DisorderIrritability Associated With Autism Spectrum Disorder

NCT07284745

Where you'd take part

This study runs at 39 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Local Institution - 0007

    Brisbane, Queensland, Australiano site contact published

  • Local Institution - 0010

    Westmead, New South Wales, Australiano site contact published

  • Local Institution - 0031

    Anaheim, Californiano site contact published

  • Local Institution - 0034

    Houston, Texasno site contact published

  • Local Institution - 0036

    Dothan, Alabamano site contact published

  • Local Institution - 0041

    Dallas, Texasno site contact published

  • Local Institution - 0045

    Melbourne, Victoria, Australiano site contact published

  • Local Institution - 0074

    Bountiful, Utahno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

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