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

This study is looking at how well a combination of two drugs, KarXT and KarX-EC, works to treat irritability in children and adolescents with Autism Spectrum Disorder (ASD). You may be able to join if you are between 5 and 17 years old, have a confirmed ASD diagnosis, and are experiencing significant irritability. The study will measure success by looking at changes in irritability scores after 8 weeks. Some participants will receive KarXT + KarX-EC, while others will receive a matching placebo (an inactive substance that looks like the study drug). The current status of this study is unclear, but it plans to enroll 176 participants.

Study design
This interventional study plans to enroll 176 participants. It compares KarXT + KarX-EC to a matching placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at Week 8, indicating follow-up for at least this duration.

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

NCT07285798

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

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 63 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 Disorder

NCT07285798

Where you'd take part

This study runs at 63 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Local Institution - 0003

    Pittsburgh, Pennsylvaniano site contact published

  • Local Institution - 0009

    Orem, Utahno site contact published

  • Local Institution - 0013

    Glendale, Californiano site contact published

  • Local Institution - 0014

    Chicago, Illinoisno site contact published

  • Local Institution - 0016

    Columbia, Missourino site contact published

  • Local Institution - 0019

    Everett, Washingtonno site contact published

  • Local Institution - 0026

    Chicago, Illinoisno site contact published

  • Local Institution - 0036

    Saint Charles, Missourino 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 an 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