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NCT07288567PHASE3Recruiting

A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (EMERGENT TEEN)

Bristol-Myers Squibb

Start Date

1/29/2026

Completion Date

12/18/2029

Summary

The purpose of this study is to evaluate the efficacy and safety of KarXT for treatment of Schizophrenia in adolescents.

Eligibility Criteria

Age Range: 13 years to 17 years

Inclusion Criteria: * Diagnosis of schizophrenia as defined by the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition,Text Revision (DSM-5-TR) criteria, confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-PL) and experiencing symptoms of psychosis at screening (Visit 1). * PANSS total score of at least 70 at screening (Visit 1) and randomization (Visit 2). * Participant has a CGI-S score of ≥ 4 at screening (Visit 1) and randomization (Visit 2). Exclusion Criteria: * Any primary DSM-5-TR disorder other than schizophrenia within 12 months before screening. * History or presence of clinically significant cardiovascular, pulmonary, hepatic impairment, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results. * All grades of hepatic impairment (mild \[Child-Pugh Class A\], moderate \[Child-Pugh Class B\], and severe \[Child-Pugh Class C\]). Participants with known intellectual disability defined as an IQ less than 70; or, either clinical evidence or known social or school history indicative of intellectual disability. * Any neurological disorder, except for Tourette's Syndrome. * Participants who have either a systolic blood pressure (sBP) or diastolic blood pressure (dBP) meeting criteria for stage 2 HTN, regardless of the presence or absence of symptoms. * Other protocol-defined Inclusion/Exclusion criteria apply.

Interventions

DRUG

KarXT

OTHER

KarXT Matching Placebo

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Conditions

Schizophrenia

Locations

Advanced Research Center Inc.

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 - 0083

Redlands, California 92373

United States

Local Institution - 0089

San Francisco, California 94158

United States

Local Institution - 0119

Hollywood, Florida 33024

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 - 0059

Worcester, Massachusetts 01608

United States

Local Institution - 0061

Great Neck, New York 11021

United States

University of Cincinnati Dept of Psychiatry and Behavioral Neuroscience

Cincinnati, Ohio 45219

United States

Local Institution - 0113

Nashville, Tennessee 37212

United States

VAST Clinical Research

Garland, Texas 75043

United States

Local Institution - 0120

Houston, Texas 77043

United States

Local Institution - 0118

Plano, Texas 75093

United States

Local Institution - 0066

Spring, Texas 77381

United States

Local Institution - 0050

Richmond, Virginia 23284

United States

Local Institution - 0109

Bello, Antioquia 051053

Colombia

Local Institution - 0009

Pereira, Risaralda Department 660003

Colombia

Local Institution - 0001

Barranquilla, 080020

Colombia

Local Institution - 0020

Bogotá, 111166

Colombia

Local Institution - 0075

Chikugo-Shi, 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 1438541

Japan

Local Institution - 0063

Yokohama, Kanagawa, 213-8507

Japan

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

Local Institution - 0030

Sibiu, 550082

Romania

Emergency Clinical Hospital For Children Louis Turcanu Timis

Timișoara, 300329

Romania