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Recruiting Phase 3

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

NCT07288567 · tracked via the Priya Life Science Japan tracker
Phase
Phase 3
Started
2026-01-29
Last updated
2026-10-06

Condition(s) studied

Schizophrenia

Investigational drug(s) / intervention(s)

KarXT →KarXT Matching Placebo

KarXT: Specified dose on specified days

KarXT Matching Placebo: Specified dose on specified days

Study summary

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

Eligibility

Sex
ALL
Min age
13 Years
Max age
17 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score — Week 5

Trial sites (37)

FacilityCityRegionStatus
Advanced Research Center Inc. Anaheim California Recruiting
Inland Psychiatric Medical Group. Chino California Recruiting
Proscience Research Group Culver City California Recruiting
UCSF Neurosciences Clinical Research Unit (NCRU) San Francisco California Recruiting
Local Institution - 0119 Hollywood Florida Not Yet Recruiting
Apg Research, Llc Orlando Florida Recruiting
Atlanta Center for Medical Research Atlanta Georgia Recruiting
Salveo Integrative Health - Lawrenceville Lawrenceville Georgia Recruiting
Denali Health Atlanta, LLC Stone Mountain Georgia Recruiting
Local Institution - 0122 Chicago Illinois Not Yet Recruiting
EmVenio Research Center - Prime Healthcare Chicago Illinois Recruiting
Boston Children's Hospital Boston Massachusetts Recruiting
Local Institution - 0059 Worcester Massachusetts Not Yet Recruiting
Local Institution - 0061 Great Neck New York Not Yet Recruiting
University of Cincinnati Dept of Psychiatry and Behavioral Neuroscience Cincinnati Ohio Recruiting
Local Institution - 0113 Nashville Tennessee Not Yet Recruiting
VAST Clinical Research Garland Texas Recruiting
Memorial Hermann Houston Texas Recruiting
Local Institution - 0066 Spring Texas Not Yet Recruiting
Local Institution - 0050 Richmond Virginia Not Yet Recruiting
Local Institution - 0109 Bello Antioquia Not Yet Recruiting
Local Institution - 0009 Pereira Risaralda Department Not Yet Recruiting
Local Institution - 0001 Barranquilla Colombia Not Yet Recruiting
Local Institution - 0075 Chikugo-Shi Fukuoka Not Yet Recruiting
Goryokai Medical Corporation - Goryokai Hospital Sapporo Hokkaido Recruiting
Local Institution - 0025 Zentsujichó Kagawa-ken Not Yet Recruiting
Local Institution - 0062 Miyakonojō Miyazaki Not Yet Recruiting
Local Institution - 0086 Bunkyo-ku Tokyo Not Yet Recruiting
Local Institution - 0056 Ōta-ku Tokyo Not Yet Recruiting
Local Institution - 0063 Yokohama, Kanagawa Japan Not Yet Recruiting
Local Institution - 0029 Bucharest Bucharest Not Yet Recruiting
Clinica Animedica Bucuresti Bucharest Romania Recruiting
Cabinet Medical Individual Dr Gheorghita Karina Lidia Bucharest Romania Recruiting
Cluj Napoca Emergency Hospital for Children, Department of Pediatric Psychiatry Cluj-Napoca Romania Recruiting
Local Institution - 0008 Iași Romania Not Yet Recruiting
Local Institution - 0030 Sibiu Romania Not Yet Recruiting
Emergency Clinical Hospital For Children Louis Turcanu Timis Timișoara Romania Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07288567 on ClinicalTrials.gov ↗ ← All trials in Japan