RecruitingPhase 3NCT07424404

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

Sponsor

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Enrollment

400 participants

Start Date

Apr 7, 2026

Study Type

INTERVENTIONAL

Conditions

Schizophrenia Autism-Related Irritability

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

Eligibility

Min Age: 5 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called KarXT for people with autism-related irritability and schizophrenia. The study is currently recruiting participants at 59 locations. People eligible for this study include aged 5 Years to 17 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKarXT

Specified dose on specified days

Locations(95)

Local Institution - 0054

Dothan, Alabama, United States

Local Institution - 0163

Phoenix, Arizona, United States

Advanced Research Center Inc.

Anaheim, California, United States

Local Institution - 0159

Anaheim, California, United States

Inland Psychiatric Medical Group.

Chino, California, United States

Local Institution - 0024

Culver City, California, United States

Local Institution - 0162

Glendale, California, United States

Local Institution - 0153

Los Angeles, California, United States

Local Institution - 0158

Orange, California, United States

Local Institution - 0083

Redlands, California, United States

Local Institution - 0089

San Francisco, California, United States

Local Institution - 0157

San Rafael, California, United States

Local Institution - 0161

Colorado Springs, Colorado, United States

Local Institution - 0154

New Haven, Connecticut, United States

Local Institution - 0145

Boca Raton, Florida, United States

Local Institution - 0160

Gainesville, Florida, United States

Local Institution - 0164

Gainesville, Florida, United States

Local Institution - 0168

Hollywood, Florida, United States

Local Institution - 0166

Orange City, Florida, United States

Apg Research, Llc

Orlando, Florida, United States

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Salveo Integrative Health - Lawrenceville

Lawrenceville, Georgia, United States

Denali Health Atlanta, LLC

Stone Mountain, Georgia, United States

EmVenio Research Center - Prime Healthcare

Chicago, Illinois, United States

Local Institution - 0076

Boston, Massachusetts, United States

Local Institution - 0132

Lexington, Massachusetts, United States

Local Institution - 0059

Worcester, Massachusetts, United States

Local Institution - 0152

Bloomfield Hills, Michigan, United States

Local Institution - 0142

Columbia, Missouri, United States

Local Institution - 0147

Lincoln, Nebraska, United States

Local Institution - 0144

Las Vegas, Nevada, United States

Local Institution - 0146

Neptune City, New Jersey, United States

Local Institution - 0061

Great Neck, New York, United States

Local Institution - 0156

Staten Island, New York, United States

Local Institution - 0151

The Bronx, New York, United States

University of Cincinnati Cancer Institute

Cincinnati, Ohio, United States

Local Institution - 0148

Cincinnati, Ohio, United States

Local Institution - 0139

West Chester, Ohio, United States

Local Institution - 0143

Danville, Pennsylvania, United States

Local Institution - 0150

Pittsburgh, Pennsylvania, United States

Local Institution - 0137

Nashville, Tennessee, United States

Local Institution - 0149

Dallas, Texas, United States

VAST Clinical Research

Garland, Texas, United States

Local Institution - 0169

Houston, Texas, United States

Local Institution - 0165

Plano, Texas, United States

Local Institution - 0066

Spring, Texas, United States

Local Institution - 0141

Orem, Utah, United States

Local Institution - 0140

Provo, Utah, United States

Local Institution - 0167

West Point, Utah, United States

Local Institution - 0050

Richmond, Virginia, United States

Local Institution - 0155

Everett, Washington, United States

Local Institution - 0084

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0085

La Plata, Buenos Aires, Argentina

Local Institution - 0036

Buenos Aires, Argentina

Local Institution - 0035

Córdoba, Argentina

Local Institution - 0116

Santiago del Estero, Argentina

Local Institution - 0107

Westmead, New South Wales, Australia

Local Institution - 0106

Brisbane, Queensland, Australia

Local Institution - 0108

Melbourne, Victoria, Australia

Local Institution - 0109

Melbourne, Victoria, Australia

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

Goryokai Medical Corporation - Goryokai Hospital

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, Bucharest, Romania

Local Institution - 0040

Bucharest, Romania

Local Institution - 0042

Bucharest, Romania

Cluj Napoca Emergency Hospital for Children, Department of Pediatric Psychiatry

Cluj-Napoca, Romania

Local Institution - 0008

Iași, Romania

Emergency Clinical Hospital For Children Louis Turcanu Timis

Timișoara, Romania

Local Institution - 0101

Barcelona, Spain

Local Institution - 0099

Barcelona, Spain

Local Institution - 0098

Madrid, Spain

Local Institution - 0100

Madrid, Spain

View Full Details on ClinicalTrials.gov

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NCT07424404

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