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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
RecruitingPhase 3
A Phase 3 Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride in Children and Adolescents With Psychiatric Disorders
Who can join
Ages 5 to 17 · All sexes
Full eligibility 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.
About the study
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
What is being tested
- KarXT (drug)
- KarX-EC (drug)
Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Participants: 400 · Started: Apr 7, 2026
Contact the study team
- BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · Phone: 855-907-3286
Official record on ClinicalTrials.gov — NCT07424404
Locations in the U.S.
| Alabama | Local Institution - 0054, Dothan (Not yet recruiting) |
| Arizona | Local Institution - 0163, Phoenix (Not yet recruiting) |
| California | Advanced Research Center Inc., Anaheim Local Institution - 0159, Anaheim (Not yet recruiting) Inland Psychiatric Medical Group., Chino Proscience Research Group, Culver City Local Institution - 0162, Glendale (Not yet recruiting) Local Institution - 0153, Los Angeles (Not yet recruiting) Local Institution - 0158, Orange (Not yet recruiting) Local Institution - 0174, San Diego (Not yet recruiting) UCSF Neurosciences Clinical Research Unit (NCRU), San Francisco Local Institution - 0157, San Rafael (Not yet recruiting) |
| Connecticut | Local Institution - 0154, New Haven (Not yet recruiting) |
| Florida | Local Institution - 0145, Boca Raton (Not yet recruiting) Local Institution - 0160, Gainesville (Not yet recruiting) Local Institution - 0164, Gainesville (Not yet recruiting) Research Centers of America - Hollywood - CenExel - PPDS, Hollywood Apg Research, Llc, Orlando Local Institution - 0182, Virginia Gardens (Not yet recruiting) |
| Georgia | Atlanta Center for Medical Research, Atlanta Local Institution - 0173, Decatur (Not yet recruiting) Salveo Integrative Health - Lawrenceville, Lawrenceville Denali Health Atlanta, LLC, Stone Mountain |
| Illinois | EmVenio Research Center - Prime Healthcare, Chicago |
| Kentucky | Local Institution - 0170, Louisville (Not yet recruiting) |
| Massachusetts | Boston Children's Hospital, Boston Local Institution - 0132, Lexington (Not yet recruiting) Local Institution - 0059, Worcester (Not yet recruiting) |
| Michigan | Local Institution - 0152, Bloomfield Hills (Not yet recruiting) |
| Missouri | Local Institution - 0142, Columbia (Not yet recruiting) Local Institution - 0172, Saint Charles (Not yet recruiting) |
| Nebraska | Local Institution - 0147, Lincoln (Not yet recruiting) |
| Nevada | Local Institution - 0144, Las Vegas (Not yet recruiting) |
| New Jersey | Local Institution - 0146, Neptune City (Not yet recruiting) |
| New York | Local Institution - 0061, Great Neck (Not yet recruiting) Local Institution - 0171, Orangeburg (Not yet recruiting) Local Institution - 0156, Staten Island (Not yet recruiting) Local Institution - 0151, The Bronx (Not yet recruiting) |
| Ohio | Local Institution - 0148, Cincinnati (Not yet recruiting) University of Cincinnati Cancer Institute, Cincinnati |
| Pennsylvania | Local Institution - 0143, Danville (Not yet recruiting) Local Institution - 0150, Pittsburgh (Not yet recruiting) |
| Tennessee | Local Institution - 0137, Nashville (Not yet recruiting) |
| Texas | Local Institution - 0149, Dallas (Not yet recruiting) VAST Clinical Research, Garland Evolution Research Group, Houston Local Institution - 0047, Houston (Not yet recruiting) Local Institution - 0176, Plano (Not yet recruiting) Local Institution - 0181, San Antonio (Not yet recruiting) Local Institution - 0066, Spring (Not yet recruiting) |
| Utah | Local Institution - 0141, Orem (Not yet recruiting) Local Institution - 0167, West Point (Not yet recruiting) |
| Virginia | Local Institution - 0050, Richmond (Not yet recruiting) |
| Washington | Local Institution - 0155, Everett (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.