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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT07424404

Public ClinicalTrials.gov record NCT07424404. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 8, 2026, 3:40 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT07424404
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Enrollment
400 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
5 Years to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 6, 2026
Primary completion
Mar 7, 2030
Completion
Mar 7, 2030
Last update posted
Aug 27, 2026

2026 – 2030

United States locations

U.S. sites
51
U.S. states
22
U.S. cities
46
Facility City State ZIP Site status
Local Institution - 0054 Dothan Alabama 36303 Not yet recruiting
Local Institution - 0163 Phoenix Arizona 85006 Not yet recruiting
Advanced Research Center Inc. Anaheim California 92805 Recruiting
Local Institution - 0159 Anaheim California 92805 Not yet recruiting
Inland Psychiatric Medical Group. Chino California 91710 Recruiting
Proscience Research Group Culver City California 90230 Recruiting
Local Institution - 0162 Glendale California 91203 Not yet recruiting
Local Institution - 0153 Los Angeles California 90095 Not yet recruiting
Local Institution - 0158 Orange California 92868 Not yet recruiting
Local Institution - 0174 San Diego California 92102 Not yet recruiting
Local Institution - 0089 San Francisco California 94158 Not yet recruiting
Local Institution - 0157 San Rafael California 94903 Not yet recruiting
Local Institution - 0161 Colorado Springs Colorado 80910 Not yet recruiting
Local Institution - 0154 New Haven Connecticut 06520 Not yet recruiting
Local Institution - 0145 Boca Raton Florida 33428 Not yet recruiting
Local Institution - 0160 Gainesville Florida 32607 Not yet recruiting
Local Institution - 0164 Gainesville Florida 32607 Not yet recruiting
Local Institution - 0168 Hollywood Florida 33024 Not yet recruiting
Apg Research, Llc Orlando Florida 32803 Recruiting
Atlanta Center for Medical Research Atlanta Georgia 30331 Recruiting
Salveo Integrative Health - Lawrenceville Lawrenceville Georgia 30046 Recruiting
Denali Health Atlanta, LLC Stone Mountain Georgia 30083 Recruiting
Local Institution - 0175 Chicago Illinois 60611 Not yet recruiting
EmVenio Research Center - Prime Healthcare Chicago Illinois 60622 Recruiting
Boston Children's Hospital Boston Massachusetts 02445 Recruiting
Local Institution - 0132 Lexington Massachusetts 02421 Not yet recruiting
Local Institution - 0059 Worcester Massachusetts 01608 Not yet recruiting
Local Institution - 0152 Bloomfield Hills Michigan 48302 Not yet recruiting
Local Institution - 0142 Columbia Missouri 65201 Not yet recruiting
Local Institution - 0147 Lincoln Nebraska 68526 Not yet recruiting
Local Institution - 0144 Las Vegas Nevada 89128 Not yet recruiting
Local Institution - 0146 Neptune City New Jersey 07753-4859 Not yet recruiting
Local Institution - 0061 Great Neck New York 11021 Not yet recruiting
Local Institution - 0156 Staten Island New York 10314 Not yet recruiting
Local Institution - 0151 The Bronx New York 10461 Not yet recruiting
University of Cincinnati Cancer Institute Cincinnati Ohio 45219 Recruiting
Local Institution - 0148 Cincinnati Ohio 45229 Not yet recruiting
Local Institution - 0139 West Chester Ohio 45069 Withdrawn
Local Institution - 0143 Danville Pennsylvania 17821 Not yet recruiting
Local Institution - 0150 Pittsburgh Pennsylvania 15213-3403 Not yet recruiting
Local Institution - 0137 Nashville Tennessee 37212 Not yet recruiting
Local Institution - 0149 Dallas Texas 75243 Not yet recruiting
VAST Clinical Research Garland Texas 75043 Recruiting
Local Institution - 0169 Houston Texas 77043 Not yet recruiting
Local Institution - 0165 Plano Texas 75093 Withdrawn
Local Institution - 0176 Plano Texas 75093 Not yet recruiting
Local Institution - 0066 Spring Texas 77381 Not yet recruiting
Local Institution - 0141 Orem Utah 84097 Not yet recruiting
Local Institution - 0167 West Point Utah 84015 Not yet recruiting
Local Institution - 0050 Richmond Virginia 23284 Not yet recruiting
Local Institution - 0155 Everett Washington 98201 Not yet recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 40 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07424404, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 27, 2026 · Synced Sep 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07424404 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →