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

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Irritability Associated With Autism Spectrum Disorder

In brief

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

Key facts

Study ID

NCT07285798

Run by

Bristol-Myers Squibb

People needed

176

Starts

2026-09-11

Expected to finish

2029-08-04

Last updated by the study team

2026-06-30

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Local Institution - 0013 — Glendale, California, United States
• Local Institution - 0117 — Los Angeles, California, United States
• Local Institution - 0126 — Orange, California, United States
• Local Institution - 0115 — San Juan Capistrano, California, United States
• Local Institution - 0116 — San Rafael, California, United States
• Local Institution - 0130 — New Haven, Connecticut, United States
• Local Institution - 0080 — Orlando, Florida, United States
• Local Institution - 0014 — Chicago, Illinois, United States
• Local Institution - 0051 — Lexington, Massachusetts, United States
• Local Institution - 0016 — Columbia, Missouri, United States
• Local Institution - 0046 — Lincoln, Nebraska, United States
• Local Institution - 0114 — Neptune City, New Jersey, United States
• Local Institution - 0038 — Staten Island, New York, United States
• Local Institution - 0052 — Cincinnati, Ohio, United States
• Local Institution - 0003 — Pittsburgh, Pennsylvania, United States
• Local Institution - 0125 — Spring, Texas, United States
• Local Institution - 0009 — Orem, Utah, United States
• Local Institution - 0019 — Everett, Washington, United States
• Local Institution - 0102 — Bron, France
• Local Institution - 0088 — Eysines, France
• Local Institution - 0089 — Paris, France
• Local Institution - 0103 — Gdansk, Germany
• Local Institution - 0111 — Budapest, Hungary
• Local Institution - 0127 — Budapest, Hungary
• Local Institution - 0062 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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