Tests KarXT with KarX-EC for irritability in children with autism
Tests KarXT and KarX-EC against placebo in children and teens with autism-related irritability.
Plain-language title generated from the registry record
Registry title: A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism
Key facts
- Where
- Brisbane, Melbourne, and Westmead, AustraliaSee the 4 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teenagers aged 5 to 17 with autism who have irritability. It tests KarXT + KarX-EC against a placebo.
- Age
- 5 to 17 years
- Sex
- All sexes can join.
- Disease stage
- Confirmed autism spectrum disorder (ASD) with irritability. Irritability scores must be ABC-I 18 or higher and CGIS for irritability 4 or higher, at screening and on Day 1.
Main reasons for not taking part
- Current main diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, major depressive episode or PTSD
- ADHD as the main disorder (ADHD alongside autism can be allowed if it is treated and stable)
- Serious illness or disorder that could put safety or the study results at risk
- Risk of suicidal behavior
- Clinically significant abnormal laboratory test
Read by machine on 11 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 5 and 17 years old?
Source: NCT07284745, who can take part
Where in Australia
- BrisbaneBrisbane, AustraliaNot yet recruiting
- MelbourneMelbourne, AustraliaNot yet recruiting
- MelbourneMelbourne, AustraliaNot yet recruiting
- WestmeadWestmead, AustraliaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT07284745EU 2025-523189-26-00
- Record updated
- 10 November 2026
- Original description
The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.Read full original descriptionShow less
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
The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.
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; Other protocol-defined Inclusion/Exclusion criteria may apply.