A Phase 3 interventional study of KarXT and KarX-EC in Irritability Associated With Autism Spectrum Disorder, sponsored by Bristol-Myers Squibb. Not yet recruiting at 67 sites in 10 countries. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Bristol-Myers Squibb · Phase 3, Interventional, and Treatment
The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.
Exclusion Criteria
Drug: KarXT · Drug: KarX-EC
Drug: KarXT + KarX-EC Matching Placebo
Specified dose on specified days
Also known as: BMS-986510, Xanomeline/Trospium Chloride
Specified dose on specified days
Also known as: BMS-986519, Xanomeline Enteric-coated
Specified dose on specified days
Change From Baseline in the Aberrant Behavior Checklist Irritability (ABC-I) Score at Week 8
Time frame: Week 8
Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Week 8
Time frame: Week 8
Number of Participants With ABC-I response at Week 8
ABC-I response is determined by ≥ 25% reduction in ABC-I score from baseline.
Time frame: Week 8
Change From Baseline on the ABC Subscale for Social Withdrawal at Week 8
Time frame: Week 8
Change From Baseline on the Stereotypic Behavior Subscale at Week 8
Time frame: Week 8
Change From Baseline on the Hyperactivity/Noncompliance Subscale at Week 8
Time frame: Week 8
Change From Baseline on the Inappropriate Speech Subscale at Week 8
Time frame: Week 8
Clinical Global Impression-Improvement (CGI-I) Score at Week 8
Time frame: Week 8
Number of Participants With Procholinergic Symptoms
Time frame: Up to approximately 12 weeks
Number of Participants With Anticholinergic Symptoms
Time frame: Up to approximately 12 weeks
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 12 weeks
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to approximately 12 weeks
Number of Participants With Adverse Events of Special Interest (AESIs)
Time frame: Up to approximately 12 weeks
Number of Participants With AEs Leading to Discontinuation of Study Intervention
Time frame: Up to approximately 8 weeks
Plan to share: Yes — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Supporting information: Study protocol, Sap, Csr
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Bristol-Myers Squibb