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Clinical Trials in the USA / NCT07424404
Recruiting Phase 3

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

NCT07424404 · tracked via the Priya Life Science USA tracker
Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Phase
Phase 3
Started
2026-04-07
Last updated
2026-08-28

Condition(s) studied

SchizophreniaAutism-Related Irritability

Investigational drug(s) / intervention(s)

KarXT

KarXT: Specified dose on specified days

Study 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

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

Primary outcome measure(s)

Trial sites (91)

FacilityCityRegionStatus
Local Institution - 0054 Dothan Alabama Not Yet Recruiting
Local Institution - 0163 Phoenix Arizona Not Yet Recruiting
Advanced Research Center Inc. Anaheim California Recruiting
Local Institution - 0159 Anaheim California Not Yet Recruiting
Inland Psychiatric Medical Group. Chino California Recruiting
Proscience Research Group Culver City California Recruiting
Local Institution - 0162 Glendale California Not Yet Recruiting
Local Institution - 0153 Los Angeles California Not Yet Recruiting
Local Institution - 0158 Orange California Not Yet Recruiting
Local Institution - 0174 San Diego California Not Yet Recruiting
Local Institution - 0089 San Francisco California Not Yet Recruiting
Local Institution - 0157 San Rafael California Not Yet Recruiting
Local Institution - 0161 Colorado Springs Colorado Not Yet Recruiting
Local Institution - 0154 New Haven Connecticut Not Yet Recruiting
Local Institution - 0145 Boca Raton Florida Not Yet Recruiting
Local Institution - 0160 Gainesville Florida Not Yet Recruiting
Local Institution - 0164 Gainesville Florida Not Yet Recruiting
Local Institution - 0168 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 - 0175 Chicago Illinois Not Yet Recruiting
EmVenio Research Center - Prime Healthcare Chicago Illinois Recruiting
Boston Children's Hospital Boston Massachusetts Recruiting
Local Institution - 0132 Lexington Massachusetts Not Yet Recruiting
Local Institution - 0059 Worcester Massachusetts Not Yet Recruiting
Local Institution - 0152 Bloomfield Hills Michigan Not Yet Recruiting
Local Institution - 0142 Columbia Missouri Not Yet Recruiting
Local Institution - 0147 Lincoln Nebraska Not Yet Recruiting
Local Institution - 0144 Las Vegas Nevada Not Yet Recruiting
Local Institution - 0146 Neptune City New Jersey Not Yet Recruiting
Local Institution - 0061 Great Neck New York Not Yet Recruiting
Local Institution - 0156 Staten Island New York Not Yet Recruiting
Local Institution - 0151 The Bronx New York Not Yet Recruiting
University of Cincinnati Cancer Institute Cincinnati Ohio Recruiting
Local Institution - 0148 Cincinnati Ohio Not Yet Recruiting
Local Institution - 0139 West Chester Ohio Withdrawn
Local Institution - 0143 Danville Pennsylvania Not Yet Recruiting
Local Institution - 0150 Pittsburgh Pennsylvania Not Yet Recruiting

+ 51 more sites — see the full list on the official registry below.

More Karuna Therapeutics, Inc., a Bristol Myers Squibb company trials in the USA

Other trials for the same condition

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 NCT07424404 on ClinicalTrials.gov ↗ ← All trials in the USA