A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism
← catalyst calendarNCT07284745 · readout in 1,083 d
Sponsored by Bristol-Myers Squibb (industry) · BMY — their whole pipeline →.
Phase
Phase 3
Status
Not yet recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
176estimated
Sites
35
Countries
Australia, Canada, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-09-11 | estimated | When the study began enrolling |
| Primary completion | 2029-08-06 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2029-08-06 | estimated | The whole study's end, after follow-up |
| First posted | 2025-12-16 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-03 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Irritability Associated With Autism Spectrum Disorder
Interventions
- Drug: KarXT — also filed as BMS-986510, Xanomeline/Trospium Chloride
- Drug: KarX-EC — also filed as BMS-986519, Xanomeline Enteric-coated
- Drug: KarXT + KarX-EC Matching Placebo
Primary outcome
what the primary-completion date above is the date OFChange From Baseline in the Aberrant Behavior Checklist Irritability (ABC-I) Score at Week 8
measured Week 8
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