Recruiting
Phase 3

KarXT & KarX-EC

Sponsor:

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Code:

NCT07424404

Conditions

Schizophrenia

Autism-Related Irritability

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

Interventions

KarXT

KarX-EC

Study Details

Brief summary:

The purpose of this study is to evaluate the long-term safety and tolerability of Xanomeline and Trospium Chloride for the treatment of psychiatric disorders in children and adolescents

Conditions

Schizophrenia

Autism-Related Irritability

Study ID

NCT07424404

Start date

Apr 7, 2026

Status verified date

Oct, 2026

Completion date

Mar 8, 2030

Anticipated

Primary completion date

Mar 8, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

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 opinion of the investigator, may indicate an unacceptable safety risk.
  • De-novo participants must have confirmed diagnosis of ASD with symptoms of irritability, as defined by 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).

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, or ECG at the end of treatment visit of Study CN0120020, CN0120044 or CN00120045 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.

Study Design

Enrollment

400 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Administration of KarXT for Schizophrenia

experimental: Administration of KarXT + KarX-EC for Autism Spectrum Disorder

Interventions

KarXT

Specified dose on specified days

KarX-EC

Specified dose on specified days

Primary outcome measure

  • Number of participants with treatment emergent adverse events (TEAEs) [ Time Frame: Up to 56 weeks ]
  • Number of participants with adverse events of special interest (AESIs) [ Time Frame: Up to 56 weeks ]
  • Number of participants with serious adverse events (SAEs) [ Time Frame: Up to 56 weeks ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

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

Locations

Advanced Research Center Inc.

Recruiting

Anaheim, California, United States, 92805

Contacts

Steven Macina, Site 0077

714-999-6688

Inland Psychiatric Medical Group.

Recruiting

Chino, California, United States, 91710

Contacts

Nandita Puchakayala, Site 0058

909-488-9116

Proscience Research Group

Recruiting

Culver City, California, United States, 90230

Contacts

Marina Bussel, Site 0024

424-227-8127

UCSF Neurosciences Clinical Research Unit (NCRU)

Recruiting

San Francisco, California, United States, 94158

Contacts

Danai Nyasha Chagwedera, Site 0089

415-746-9047

Apg Research, Llc

Recruiting

Orlando, Florida, United States, 32803

Contacts

Morteza Nadjafi, Site 0032

407-423-7149

Atlanta Center for Medical Research

Recruiting

Atlanta, Georgia, United States, 30331

Contacts

Elyssa Barron, Site 0057

404-881-5800

Salveo Integrative Health - Lawrenceville

Recruiting

Lawrenceville, Georgia, United States, 30046

Denali Health Atlanta, LLC

Recruiting

Stone Mountain, Georgia, United States, 30083

EmVenio Research Center - Prime Healthcare

Recruiting

Chicago, Illinois, United States, 60622

Contacts

Mitchell Glaser, Site 0044

773-620-2995

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02445

University of Cincinnati Cancer Institute

Recruiting

Cincinnati, Ohio, United States, 45219

VAST Clinical Research

Recruiting

Garland, Texas, United States, 75043

Evolution Research Group

Recruiting

Houston, Texas, United States, 77043

More Information

Sponsor

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Last update posted

Oct 15, 2026

Last verified

Oct, 2026

Keywords

  • KarXT
  • Adolescent schizophrenia
  • Autism
  • Children and adolescents
  • Irritability

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-22. This information was provided to ClinicalTrials.gov by Karuna Therapeutics, Inc., a Bristol Myers Squibb company on 2026-10-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.