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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

Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Participants: 400 · Started: Apr 7, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07424404

Locations in the U.S.

AlabamaLocal Institution - 0054, Dothan (Not yet recruiting)
ArizonaLocal Institution - 0163, Phoenix (Not yet recruiting)
CaliforniaAdvanced 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)
ColoradoLocal Institution - 0161, Colorado Springs (Not yet recruiting)
ConnecticutLocal Institution - 0154, New Haven (Not yet recruiting)
FloridaLocal Institution - 0145, Boca Raton (Not yet recruiting)
Local Institution - 0160, Gainesville (Not yet recruiting)
Local Institution - 0164, Gainesville (Not yet recruiting)
Local Institution - 0168, Hollywood (Not yet recruiting)
Apg Research, Llc, Orlando
GeorgiaAtlanta Center for Medical Research, Atlanta
Salveo Integrative Health - Lawrenceville, Lawrenceville
Denali Health Atlanta, LLC, Stone Mountain
IllinoisEmVenio Research Center - Prime Healthcare, Chicago
Local Institution - 0175, Chicago (Not yet recruiting)
MassachusettsBoston Children's Hospital, Boston
Local Institution - 0132, Lexington (Not yet recruiting)
Local Institution - 0059, Worcester (Not yet recruiting)
MichiganLocal Institution - 0152, Bloomfield Hills (Not yet recruiting)
MissouriLocal Institution - 0142, Columbia (Not yet recruiting)
NebraskaLocal Institution - 0147, Lincoln (Not yet recruiting)
NevadaLocal Institution - 0144, Las Vegas (Not yet recruiting)
New JerseyLocal Institution - 0146, Neptune City (Not yet recruiting)
New YorkLocal Institution - 0061, Great Neck (Not yet recruiting)
Local Institution - 0156, Staten Island (Not yet recruiting)
Local Institution - 0151, The Bronx (Not yet recruiting)
OhioLocal Institution - 0148, Cincinnati (Not yet recruiting)
University of Cincinnati Cancer Institute, Cincinnati
PennsylvaniaLocal Institution - 0143, Danville (Not yet recruiting)
Local Institution - 0150, Pittsburgh (Not yet recruiting)
TennesseeLocal Institution - 0137, Nashville (Not yet recruiting)
TexasLocal Institution - 0149, Dallas (Not yet recruiting)
VAST Clinical Research, Garland
Local Institution - 0169, Houston (Not yet recruiting)
Local Institution - 0176, Plano (Not yet recruiting)
Local Institution - 0066, Spring (Not yet recruiting)
UtahLocal Institution - 0141, Orem (Not yet recruiting)
Local Institution - 0167, West Point (Not yet recruiting)
VirginiaLocal Institution - 0050, Richmond (Not yet recruiting)
WashingtonLocal Institution - 0155, Everett (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.