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NCT07424404PHASE3Recruiting

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

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Start Date

4/7/2026

Completion Date

3/8/2030

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 Criteria

Age Range: 5 years to 17 years

Inclusion Criteria \- Participants must have completed the double-blind treatment period (ie, Visit 8) of Study CN0120020 or the double-blind treatment period (ie, Week 8) of Study CN0120044 or CN0120045, without an adverse event (AE) that, in the investigator's opinion, may indicate an unacceptable safety risk. Exclusion Criteria * Participants must not have a significant risk of committing violent acts, serious self-harm, or attempting suicide based on history or routine psychiatric status examination, or those who are homicidal or are considered to be a high risk to others, or who have an answer of "Yes" on Questions 4 or 5 on the suicidal ideation section of the "Since Last Visit" version of the C-SSRS at baseline (Visit 1). Nonsuicidal, self-injurious behavior is not exclusionary. * Participants must not have any clinically significant abnormality including any finding(s) from the physical examination, vital signs, ECG at the end of treatment visit of Study CN0120020, CN0120044, or CN0120045 that the investigator, in consultation with the Sponsor Medical Monitor, would jeopardize the safety of the participant. * Participants must not have either a systolic blood pressure (sBP) or diastolic blood pressure (dBP) meeting criteria for stage 2 hypertension (HTN), regardless of the presence or absence of symptoms. * Other protocol-defined Inclusion/Exclusion criteria apply.

Interventions

DRUG

KarXT

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Conditions

SchizophreniaAutism-Related Irritability

Locations

Local Institution - 0054

Dothan, Alabama 36303

United States

Local Institution - 0163

Phoenix, Arizona 85006

United States

Advanced Research Center Inc.

Anaheim, California 92805

United States

Local Institution - 0159

Anaheim, California 92805

United States

Inland Psychiatric Medical Group.

Chino, California 91710

United States

Local Institution - 0024

Culver City, California 90230

United States

Local Institution - 0162

Glendale, California 91203

United States

Local Institution - 0153

Los Angeles, California 90095

United States

Local Institution - 0158

Orange, California 92868

United States

Local Institution - 0083

Redlands, California 92373

United States

Local Institution - 0089

San Francisco, California 94158

United States

Local Institution - 0157

San Rafael, California 94903

United States

Local Institution - 0161

Colorado Springs, Colorado 80910

United States

Local Institution - 0154

New Haven, Connecticut 06520

United States

Local Institution - 0145

Boca Raton, Florida 33428

United States

Local Institution - 0160

Gainesville, Florida 32607

United States

Local Institution - 0164

Gainesville, Florida 32607

United States

Local Institution - 0168

Hollywood, Florida 33024

United States

Local Institution - 0166

Orange City, Florida 32763

United States

Apg Research, Llc

Orlando, Florida 32803

United States

Atlanta Center for Medical Research

Atlanta, Georgia 30331

United States

Salveo Integrative Health - Lawrenceville

Lawrenceville, Georgia 30046

United States

Denali Health Atlanta, LLC

Stone Mountain, Georgia 30083

United States

EmVenio Research Center - Prime Healthcare

Chicago, Illinois 60622

United States

Local Institution - 0076

Boston, Massachusetts 02115

United States

Local Institution - 0132

Lexington, Massachusetts 02421

United States

Local Institution - 0059

Worcester, Massachusetts 01608

United States

Local Institution - 0152

Bloomfield Hills, Michigan 48302

United States

Local Institution - 0142

Columbia, Missouri 65201

United States

Local Institution - 0147

Lincoln, Nebraska 68526

United States

Local Institution - 0144

Las Vegas, Nevada 89128

United States

Local Institution - 0146

Neptune City, New Jersey 07753-4859

United States

Local Institution - 0061

Great Neck, New York 11021

United States

Local Institution - 0156

Staten Island, New York 10314

United States

Local Institution - 0151

The Bronx, New York 10461

United States

University of Cincinnati Cancer Institute

Cincinnati, Ohio 45219

United States

Local Institution - 0148

Cincinnati, Ohio 45229

United States

Local Institution - 0139

West Chester, Ohio 45069

United States

Local Institution - 0143

Danville, Pennsylvania 17821

United States

Local Institution - 0150

Pittsburgh, Pennsylvania 15213-3403

United States

Local Institution - 0137

Nashville, Tennessee 37212

United States

Local Institution - 0149

Dallas, Texas 75243

United States

VAST Clinical Research

Garland, Texas 75043

United States

Local Institution - 0169

Houston, Texas 77043

United States

Local Institution - 0165

Plano, Texas 75093

United States

Local Institution - 0066

Spring, Texas 77381

United States

Local Institution - 0141

Orem, Utah 84097

United States

Local Institution - 0140

Provo, Utah 84604

United States

Local Institution - 0167

West Point, Utah 84015

United States

Local Institution - 0050

Richmond, Virginia 23284

United States

Local Institution - 0155

Everett, Washington 98201

United States

Local Institution - 0084

Ciudad Autónoma de Buenos Aires, Buenos Aires C1107

Argentina

Local Institution - 0085

La Plata, Buenos Aires 1900

Argentina

Local Institution - 0036

Buenos Aires, C1405BOA

Argentina

Local Institution - 0035

Córdoba, X5003DCE

Argentina

Local Institution - 0116

Santiago del Estero, G4200DND

Argentina

Local Institution - 0107

Westmead, New South Wales 2145

Australia

Local Institution - 0106

Brisbane, Queensland 4101

Australia

Local Institution - 0108

Melbourne, Victoria 3052

Australia

Local Institution - 0109

Melbourne, Victoria 3168

Australia

Local Institution - 0111

Edmonton, Alberta T6G 1Z1

Canada

Local Institution - 0110

Kingston, Ontario K7L4X3

Canada

Local Institution - 0113

Toronto, Ontario M4G 1R8

Canada

Local Institution - 0112

Montreal, Quebec H3T 1C5

Canada

Local Institution - 0118

Bordeaux, 33076

France

Local Institution - 0120

Bron, 69678

France

Local Institution - 0119

Paris, 75019

France

Local Institution - 0121

Gdansk, 80-546

Germany

Local Institution - 0129

Budapest, 1143

Hungary

Local Institution - 0130

Gyula, 5700

Hungary

Local Institution - 0131

Szeged, 6720

Hungary

Local Institution - 0075

Chikugo, Fukuoka 833-0041

Japan

Goryokai Medical Corporation - Goryokai Hospital

Sapporo, Hokkaido 002-8029

Japan

Local Institution - 0025

Zentsujichó, Kagawa-ken 765-8507

Japan

Local Institution - 0062

Miyakonojō, Miyazaki 885-0093

Japan

Local Institution - 0086

Bunkyo-ku, Tokyo 113-8431

Japan

Local Institution - 0056

Ōta-ku, Tokyo 143-8541

Japan

Local Institution - 0063

Yokohama, Kanagawa, 213-8507

Japan

Local Institution - 0128

Poznan, Greater Poland Voivodeship 60-744

Poland

Local Institution - 0125

Wroclaw, Lower Silesian Voivodeship 54-234

Poland

Local Institution - 0122

Kraśnik, Lublin Voivodeship 23-210

Poland

Local Institution - 0127

Warsaw, Masovian Voivodeship 02-957

Poland

Local Institution - 0126

Gdansk, Pomeranian Voivodeship 80-542

Poland

Local Institution - 0123

Szczecin, West Pomeranian Voivodeship 70-419

Poland

Local Institution - 0124

Katowice, 40-146

Poland

Local Institution - 0029

Bucharest, Bucharest 041914

Romania

Local Institution - 0040

Bucharest, 021056

Romania

Local Institution - 0042

Bucharest, 031871

Romania

Cluj Napoca Emergency Hospital for Children, Department of Pediatric Psychiatry

Cluj-Napoca, 400370

Romania

Local Institution - 0008

Iași, 700282

Romania

Emergency Clinical Hospital For Children Louis Turcanu Timis

Timișoara, 300329

Romania

Local Institution - 0101

Barcelona, 08036

Spain

Local Institution - 0099

Barcelona, 8035

Spain

Local Institution - 0098

Madrid, 28007

Spain

Local Institution - 0100

Madrid, 28031

Spain