NCT07284745Not yet recruitingPhase 3
A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism
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
Source: ClinicalTrials.gov · Last updated 24 Aug 2026
Brief summary (registry, in English)
The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 176 (estimated)
- First submitted
- 9 Dec 2025
- Start date
- 11 Sept 2026
- Primary completion date
- 6 Aug 2029
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Autism
- NCT number
- NCT07284745
- EU CT number
- 2025-523189-26-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 176
- From 11 Sept 2026 to the primary completion date, 6 Aug 2029
- 39 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Lab values
- Participants must not have a risk for suicidal behavior, and any clinically significant abnormal laboratory test.
Other
- Other protocol-defined Inclusion/Exclusion criteria may apply.
Who the study is looking for
- 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).
Age in the registry: 5 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (39)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.