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A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents

Karuna Therapeutics, Inc., a Bristol Myers Squibb company · NCT07424404

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 5–17 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
400
US sites recruiting
13
Study start
April 7, 2026
Record last updated
October 15, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: KarXT; KarX-EC

Conditions: Schizophrenia; Autism-Related Irritability

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • Advanced Research Center Inc.

    Anaheim, CA 92805

    Site contact: Steven Macina, Site 0077 · 714-999-6688

  • Inland Psychiatric Medical Group.

    Chino, CA 91710

    Site contact: Nandita Puchakayala, Site 0058 · 909-488-9116

  • Proscience Research Group

    Culver City, CA 90230

    Site contact: Marina Bussel, Site 0024 · 424-227-8127

  • UCSF Neurosciences Clinical Research Unit (NCRU)

    San Francisco, CA 94158

    Site contact: Danai Nyasha Chagwedera, Site 0089 · 415-746-9047

  • Apg Research, Llc

    Orlando, FL 32803

    Site contact: Morteza Nadjafi, Site 0032 · 407-423-7149

  • Atlanta Center for Medical Research

    Atlanta, GA 30331

    Site contact: Elyssa Barron, Site 0057 · 404-881-5800

  • Salveo Integrative Health - Lawrenceville

    Lawrenceville, GA 30046

    Site contact: Shahzad Hashmi, Site 0103

  • Denali Health Atlanta, LLC

    Stone Mountain, GA 30083

    Site contact: Maria Johnson, Site 0039

  • EmVenio Research Center - Prime Healthcare

    Chicago, IL 60622

    Site contact: Mitchell Glaser, Site 0044 · 773-620-2995

  • Boston Children's Hospital

    Boston, MA 02445

    Site contact: Joseph Gonzalez-Heydrich, Site 0076

  • University of Cincinnati Cancer Institute

    Cincinnati, OH 45219

    Site contact: Melissa DelBello, Site 0051

  • VAST Clinical Research

    Garland, TX 75043

    Site contact: Asikaiwe Chima, Site 0046

  • Evolution Research Group

    Houston, TX 77043

    Site contact: Carlin Barnes, Site 0169

Study contacts (from the official record)

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · 855-907-3286 · Clinical.Trials@bms.com
  • First line of the email MUST contain NCT # and Site #.
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A Study to Evaluate the Long-term Safety and Tolerability of… (NCT07424404) | Bored Studies