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Clinical Trials in the USA / NCT07285798
Starting soon Phase 3

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

NCT07285798 · tracked via the Priya Life Science USA tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 3
Started
2026-09-11
Last updated
2026-08-24

Condition(s) studied

Irritability Associated With Autism Spectrum Disorder

Investigational drug(s) / intervention(s)

KarXTKarX-ECKarXT + KarX-EC Matching Placebo

KarXT: Specified dose on specified days

KarX-EC: Specified dose on specified days

KarXT + KarX-EC Matching Placebo: Specified dose on specified days

Study summary

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

Eligibility

Sex
ALL
Min age
5 Years
Max age
17 Years
Healthy volunteers
No
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 an 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.

Primary outcome measure(s)

Trial sites (63)

FacilityCityRegionStatus
Local Institution - 0062 Phoenix Arizona
Local Institution - 0013 Glendale California
Local Institution - 0117 Los Angeles California
Local Institution - 0126 Orange California
Local Institution - 0132 San Diego California
Local Institution - 0115 San Juan Capistrano California
Local Institution - 0116 San Rafael California
Local Institution - 0130 New Haven Connecticut
Local Institution - 0080 Orlando Florida
Local Institution - 0072 Decatur Georgia
Local Institution - 0014 Chicago Illinois
Local Institution - 0026 Chicago Illinois
Local Institution - 0051 Lexington Massachusetts
Local Institution - 0016 Columbia Missouri
Local Institution - 0036 Saint Charles Missouri
Local Institution - 0046 Lincoln Nebraska
Local Institution - 0114 Neptune City New Jersey
Local Institution - 0038 Staten Island New York
Local Institution - 0052 Cincinnati Ohio
Local Institution - 0003 Pittsburgh Pennsylvania
Local Institution - 0125 Spring Texas
Local Institution - 0009 Orem Utah
Local Institution - 0019 Everett Washington
Local Institution - 0088 Bordeaux France
Local Institution - 0102 Bron France
Local Institution - 0089 Paris France
Local Institution - 0103 Gdansk Germany
Local Institution - 0111 Budapest Hungary
Local Institution - 0127 Budapest Hungary
Local Institution - 0112 Siófok Hungary
Local Institution - 0110 Szeged Hungary
Local Institution - 0100 Belgavi Karnataka
Local Institution - 0096 Kozhikode Kerala
Local Institution - 0136 Nashik Maharashtra
Local Institution - 0101 Sakri Maharashtra
Local Institution - 0097 Kolkata West Bengal
Local Institution - 0099 Nagpur India
Local Institution - 0137 New Delhi India
Local Institution - 0094 Miyakonojō Miyazaki
Local Institution - 0090 Hirakata Osaka

+ 23 more sites — see the full list on the official registry below.

More Bristol-Myers Squibb trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07285798 on ClinicalTrials.gov ↗ ← All trials in the USA