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

NCT07288567 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: CN012-00202025-523711-11-00U1111-1325-9936
• Study Type: interventional
• Target: 166
• Locations: 4 countries
• Sites: 39

Brief Summary

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

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score

  Week 5

Secondary Outcomes (7)

• Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score

  Week 5

• Change From Baseline in PANSS Positive Subscale Score

  Week 5

• Change From Baseline in PANSS Negative Subscale Score

  Week 5

• Change From Baseline in PANSS Marder Negative Factor Score

  Week 5

• Number of Participants With PANSS Response

  Week 5

Study Arms (2)

KarXT

EXPERIMENTAL

Drug: KarXT

Placebo

PLACEBO COMPARATOR

Other: KarXT Matching Placebo

Interventions

KarXT DRUG

Specified dose on specified days

Also known as: BMS-986510

KarXT

KarXT Matching Placebo OTHER

Specified dose on specified days

Placebo

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (39)

Advanced Research Center Inc.

Anaheim, California, 92805, United States

RECRUITING

Inland Psychiatric Medical Group.

Chino, California, 91710, United States

RECRUITING

Local Institution - 0024

Culver City, California, 90230, United States

NOT YET RECRUITING

Local Institution - 0083

Redlands, California, 92373, United States

NOT YET RECRUITING

Local Institution - 0089

San Francisco, California, 94158, United States

NOT YET RECRUITING

Local Institution - 0119

Hollywood, Florida, 33024, United States

NOT YET RECRUITING

Apg Research, Llc

Orlando, Florida, 32803, United States

RECRUITING

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

RECRUITING

Salveo Integrative Health - Lawrenceville

Lawrenceville, Georgia, 30046, United States

RECRUITING

Denali Health Atlanta, LLC

Stone Mountain, Georgia, 30083, United States

RECRUITING

EmVenio Research Center - Prime Healthcare

Chicago, Illinois, 60622, United States

RECRUITING

Local Institution - 0076

Boston, Massachusetts, 02115, United States

NOT YET RECRUITING

Local Institution - 0059

Worcester, Massachusetts, 01608, United States

NOT YET RECRUITING

Local Institution - 0061

Great Neck, New York, 11021, United States

NOT YET RECRUITING

University of Cincinnati Dept of Psychiatry and Behavioral Neuroscience

Cincinnati, Ohio, 45219, United States

RECRUITING

Local Institution - 0113

Nashville, Tennessee, 37212, United States

NOT YET RECRUITING

VAST Clinical Research

Garland, Texas, 75043, United States

RECRUITING

Local Institution - 0120

Houston, Texas, 77043, United States

NOT YET RECRUITING

Local Institution - 0118

Plano, Texas, 75093, United States

NOT YET RECRUITING

Local Institution - 0066

Spring, Texas, 77381, United States

NOT YET RECRUITING

Local Institution - 0050

Richmond, Virginia, 23284, United States

NOT YET RECRUITING

Local Institution - 0109

Bello, Antioquia, 051053, Colombia

NOT YET RECRUITING

Local Institution - 0009

Pereira, Risaralda Department, 660003, Colombia

NOT YET RECRUITING

Local Institution - 0001

Barranquilla, 080020, Colombia

NOT YET RECRUITING

Local Institution - 0020

Bogotá, 111166, Colombia

NOT YET RECRUITING

Local Institution - 0075

Chikugo-Shi, Fukuoka, 833-0041, Japan

NOT YET RECRUITING

Goryokai Medical Corporation - Goryokai Hospital

Sapporo, Hokkaido, 002-8029, Japan

RECRUITING

Local Institution - 0025

Zentsujichó, Kagawa-ken, 765-8507, Japan

NOT YET RECRUITING

Local Institution - 0062

Miyakonojō, Miyazaki, 885-0093, Japan

NOT YET RECRUITING

Local Institution - 0086

Bunkyo-ku, Tokyo, 113-8431, Japan

NOT YET RECRUITING

Local Institution - 0056

Ōta-ku, Tokyo, 1438541, Japan

NOT YET RECRUITING

Local Institution - 0063

Yokohama, Kanagawa, 213-8507, Japan

NOT YET RECRUITING

Local Institution - 0029

Bucharest, Bucharest, 041914, Romania

NOT YET RECRUITING

Local Institution - 0040

Bucharest, 021056, Romania

NOT YET RECRUITING

Local Institution - 0042

Bucharest, 031871, Romania

NOT YET RECRUITING

Cluj Napoca Emergency Hospital for Children, Department of Pediatric Psychiatry

Cluj-Napoca, 400370, Romania

RECRUITING

Local Institution - 0008

Iași, 700282, Romania

NOT YET RECRUITING

Local Institution - 0030

Sibiu, 550082, Romania

NOT YET RECRUITING

Emergency Clinical Hospital For Children Louis Turcanu Timis

Timișoara, 300329, Romania

RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 17, 2025
• Study Start: January 29, 2026
• Primary Completion (Estimated): December 18, 2029
• Study Completion (Estimated): December 18, 2029
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

JP (7); US (21); RO (7); CO (4)