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RECRUITING
NCT07424404
PHASE3

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

Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

5 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2026-03-31

Completion Date

2030-03-08

Last Updated

2026-03-27

Healthy Volunteers

No

Interventions

DRUG

KarXT

Specified dose on specified days

Locations (55)

Local Institution - 0077

Anaheim, California, United States

Local Institution - 0058

Chino, California, United States

Local Institution - 0083

Redlands, California, United States

Local Institution - 0089

San Francisco, California, United States

Local Institution - 0032

Orlando, Florida, United States

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Local Institution - 0103

Lawrenceville, Georgia, United States

Local Institution - 0039

Stone Mountain, Georgia, United States

Local Institution - 0044

Chicago, Illinois, United States

Local Institution - 0105

Evanston, Illinois, United States

Local Institution - 0076

Boston, Massachusetts, United States

Local Institution - 0104

Brookline, Massachusetts, United States

Local Institution - 0059

Worcester, Massachusetts, United States

Local Institution - 0061

Great Neck, New York, United States

Local Institution - 0051

Cincinnati, Ohio, United States

Local Institution - 0097

Philadelphia, Pennsylvania, United States

Local Institution - 0046

Garland, Texas, United States

Local Institution - 0090

McAllen, Texas, United States

Local Institution - 0066

Spring, Texas, United States

Local Institution - 0050

Richmond, Virginia, United States

Local Institution - 0111

Edmonton, Alberta, Canada

Local Institution - 0110

Kingston, Ontario, Canada

Local Institution - 0113

Toronto, Ontario, Canada

Local Institution - 0112

Montreal, Quebec, Canada

Local Institution - 0118

Bordeaux, France

Local Institution - 0120

Bron, France

Local Institution - 0119

Paris, France

Local Institution - 0121

Gdansk, Germany

Local Institution - 0129

Budapest, Hungary

Local Institution - 0130

Gyula, Hungary

Local Institution - 0131

Szeged, Hungary

Local Institution - 0075

Chikugo, Fukuoka, Japan

Local Institution - 0073

Sapporo, Hokkaido, Japan

Local Institution - 0025

Zentsujichó, Kagawa-ken, Japan

Local Institution - 0062

Miyakonojō, Miyazaki, Japan

Local Institution - 0086

Bunkyo-ku, Tokyo, Japan

Local Institution - 0056

Ōta-ku, Tokyo, Japan

Local Institution - 0063

Yokohama, Kanagawa, Japan

Local Institution - 0128

Poznan, Greater Poland Voivodeship, Poland

Local Institution - 0125

Wroclaw, Lower Silesian Voivodeship, Poland

Local Institution - 0122

Kraśnik, Lublin Voivodeship, Poland

Local Institution - 0127

Warsaw, Masovian Voivodeship, Poland

Local Institution - 0126

Gdansk, Pomeranian Voivodeship, Poland

Local Institution - 0123

Szczecin, West Pomeranian Voivodeship, Poland

Local Institution - 0124

Katowice, Poland

Local Institution - 0029

Bucharest, București, Romania

Local Institution - 0031

Cluj-Napoca, Cluj, Romania

Local Institution - 0040

Bucharest, Romania

Local Institution - 0042

Bucharest, Romania

Local Institution - 0008

Iași, Romania

Local Institution - 0038

Timișoara, Romania

Local Institution - 0101

Barcelona, Spain

Local Institution - 0099

Barcelona, Spain

Local Institution - 0098

Madrid, Spain

Local Institution - 0100

Madrid, Spain