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
- San Juan, Puerto RicoSee the site
- Phase
- Phase 3
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 Puerto Rico
- San JuanSan Juan, Puerto RicoNot 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.