Trials / Not Yet Recruiting
Not Yet RecruitingNCT07284745
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, and Tolerability of KarXT + KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder
- Status
- Not Yet Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 176 (estimated)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 5 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KarXT | Specified dose on specified days |
| DRUG | KarX-EC | Specified dose on specified days |
| DRUG | KarXT + KarX-EC Matching Placebo | Specified dose on specified days |
Timeline
- Start date
- 2026-09-11
- Primary completion
- 2029-07-05
- Completion
- 2029-07-05
- First posted
- 2025-12-16
- Last updated
- 2026-04-02
Locations
45 sites across 5 countries: United States, Argentina, Australia, Canada, India
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07284745. Inclusion in this directory is not an endorsement.