NCT07424404

A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Autism-Related Irritability in Adolescents, Respectively

A Phase 3 Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of KarXT in Adolescents (13 to 17 Years of Age) With Schizophrenia and KarXT+KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Industry
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the long-term safety and tolerability of KarXT and KarX-EC for the treatment of Schizophrenia and autism-related irritability in adolescents, respectively

Conditions

• Schizophrenia
• Autism-Related Irritability

Interventions

Type	Name	Description
DRUG	KarXT	Specified dose on specified days

Timeline

• Start date: 2026-03-31
• Primary completion: 2030-03-08
• Completion: 2030-03-08
• First posted: 2026-02-20
• Last updated: 2026-03-27

Locations

55 sites across 9 countries: United States, Canada, France, Germany, Hungary, Japan, Poland, Romania, Spain

Regulatory

• FDA-regulated drug study