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

NCT07424404 | Recruiting Phase 3 DMC FDA Drug

• 4 other identifiers: CN012-00212025-524062-16-00U1111-1325-99942025
• Study Type: interventional
• Target: 400
• Locations: 10 countries
• Sites: 94

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Number of participants with treatment emergent adverse events (TEAEs)

  Up to 56 weeks

• Number of participants with adverse events of special interest (AESIs)

  Up to 56 weeks

• Number of participants with serious adverse events (SAEs)

  Up to 56 weeks

Secondary Outcomes (6)

• Number or participants with cholinergic symptoms

  Up to 56 weeks

• Number of participants with anticholinergic symptoms

  Up to 56 weeks

• Number of participants with suicidal ideation and behavior assessed using the Columbia Suicide Severity Rating Scale (C-SSRS)

  Up to 56 weeks

• Change from baseline on the Simpson-Angus Scale (SAS)

  Up to 52 weeks

• Change from baseline on the Abnormal Involuntary Movement Scale (AIMS)

  Up to 52 weeks

Study Arms (2)

Administration of KarXT for Schizophrenia

EXPERIMENTAL

Drug: KarXT

Administration of KarXT + KarX-EC for Autism Spectrum Disorder

EXPERIMENTAL

Drug: KarXT; Drug: KarX-EC

Interventions

KarXT DRUG

Specified dose on specified days

Also known as: BMS-986510, Xanomeline/Trospium chloride

Administration of KarXT + KarX-EC for Autism Spectrum Disorder; Administration of KarXT for Schizophrenia

KarX-EC DRUG

Specified dose on specified days

Also known as: BMS-986519, Xanomeline Enteric-coated

Administration of KarXT + KarX-EC for Autism Spectrum Disorder

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karuna Therapeutics, Inc., a Bristol Myers Squibb company: lead

Study Sites (94)

Local Institution - 0054

Dothan, Alabama, 36303, United States

NOT YET RECRUITING

Local Institution - 0163

Phoenix, Arizona, 85006, United States

NOT YET RECRUITING

Advanced Research Center Inc.

Anaheim, California, 92805, United States

RECRUITING

Local Institution - 0159

Anaheim, California, 92805, United States

NOT YET RECRUITING

Inland Psychiatric Medical Group.

Chino, California, 91710, United States

RECRUITING

Proscience Research Group

Culver City, California, 90230, United States

RECRUITING

Local Institution - 0162

Glendale, California, 91203, United States

NOT YET RECRUITING

Local Institution - 0153

Los Angeles, California, 90095, United States

NOT YET RECRUITING

Local Institution - 0158

Orange, California, 92868, United States

NOT YET RECRUITING

Local Institution - 0174

San Diego, California, 92102, United States

NOT YET RECRUITING

UCSF Neurosciences Clinical Research Unit (NCRU)

San Francisco, California, 94158, United States

RECRUITING

Local Institution - 0157

San Rafael, California, 94903, United States

NOT YET RECRUITING

Local Institution - 0161

Colorado Springs, Colorado, 80910, United States

NOT YET RECRUITING

Local Institution - 0154

New Haven, Connecticut, 06520, United States

NOT YET RECRUITING

Local Institution - 0145

Boca Raton, Florida, 33428, United States

NOT YET RECRUITING

Local Institution - 0160

Gainesville, Florida, 32607, United States

NOT YET RECRUITING

Local Institution - 0164

Gainesville, Florida, 32607, United States

NOT YET RECRUITING

Local Institution - 0168

Hollywood, Florida, 33024, United States

NOT YET RECRUITING

Apg Research, Llc

Orlando, Florida, 32803, United States

RECRUITING

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

RECRUITING

Salveo Integrative Health - Lawrenceville

Lawrenceville, Georgia, 30046, United States

RECRUITING

Denali Health Atlanta, LLC

Stone Mountain, Georgia, 30083, United States

RECRUITING

Local Institution - 0175

Chicago, Illinois, 60611, United States

NOT YET RECRUITING

EmVenio Research Center - Prime Healthcare

Chicago, Illinois, 60622, United States

RECRUITING

Boston Children's Hospital

Boston, Massachusetts, 02445, United States

RECRUITING

Local Institution - 0132

Lexington, Massachusetts, 02421, United States

NOT YET RECRUITING

Local Institution - 0059

Worcester, Massachusetts, 01608, United States

NOT YET RECRUITING

Local Institution - 0152

Bloomfield Hills, Michigan, 48302, United States

NOT YET RECRUITING

Local Institution - 0142

Columbia, Missouri, 65201, United States

NOT YET RECRUITING

Local Institution - 0147

Lincoln, Nebraska, 68526, United States

NOT YET RECRUITING

Local Institution - 0144

Las Vegas, Nevada, 89128, United States

NOT YET RECRUITING

Local Institution - 0146

Neptune City, New Jersey, 07753-4859, United States

NOT YET RECRUITING

Local Institution - 0061

Great Neck, New York, 11021, United States

NOT YET RECRUITING

Local Institution - 0156

Staten Island, New York, 10314, United States

NOT YET RECRUITING

Local Institution - 0151

The Bronx, New York, 10461, United States

NOT YET RECRUITING

University of Cincinnati Cancer Institute

Cincinnati, Ohio, 45219, United States

RECRUITING

Local Institution - 0148

Cincinnati, Ohio, 45229, United States

NOT YET RECRUITING

Local Institution - 0139

West Chester, Ohio, 45069, United States

WITHDRAWN

Local Institution - 0143

Danville, Pennsylvania, 17821, United States

NOT YET RECRUITING

Local Institution - 0150

Pittsburgh, Pennsylvania, 15213-3403, United States

NOT YET RECRUITING

Local Institution - 0137

Nashville, Tennessee, 37212, United States

NOT YET RECRUITING

Local Institution - 0149

Dallas, Texas, 75243, United States

NOT YET RECRUITING

VAST Clinical Research

Garland, Texas, 75043, United States

RECRUITING

Local Institution - 0169

Houston, Texas, 77043, United States

NOT YET RECRUITING

Local Institution - 0165

Plano, Texas, 75093, United States

WITHDRAWN

Local Institution - 0176

Plano, Texas, 75093, United States

NOT YET RECRUITING

Local Institution - 0066

Spring, Texas, 77381, United States

NOT YET RECRUITING

Local Institution - 0141

Orem, Utah, 84097, United States

NOT YET RECRUITING

Local Institution - 0167

West Point, Utah, 84015, United States

NOT YET RECRUITING

Local Institution - 0050

Richmond, Virginia, 23284, United States

NOT YET RECRUITING

Local Institution - 0155

Everett, Washington, 98201, United States

NOT YET RECRUITING

Local Institution - 0107

Westmead, New South Wales, 2145, Australia

NOT YET RECRUITING

Local Institution - 0106

Brisbane, Queensland, 4101, Australia

NOT YET RECRUITING

Local Institution - 0108

Melbourne, Victoria, 3052, Australia

NOT YET RECRUITING

Local Institution - 0109

Melbourne, Victoria, 3168, Australia

NOT YET RECRUITING

Local Institution - 0138

Calgary, Alberta, T2N 4Z6, Canada

NOT YET RECRUITING

Local Institution - 0111

Edmonton, Alberta, T6G 1Z1, Canada

NOT YET RECRUITING

Local Institution - 0110

Kingston, Ontario, K7L4X3, Canada

NOT YET RECRUITING

Local Institution - 0113

Toronto, Ontario, M4G 1R8, Canada

NOT YET RECRUITING

Local Institution - 0112

Montreal, Quebec, H3T 1C5, Canada

NOT YET RECRUITING

Local Institution - 0118

Bordeaux, 33076, France

NOT YET RECRUITING

Local Institution - 0120

Bron, 69678, France

NOT YET RECRUITING

Local Institution - 0119

Paris, 75019, France

NOT YET RECRUITING

Local Institution - 0129

Budapest, 1143, Hungary

NOT YET RECRUITING

Local Institution - 0130

Gyula, 5700, Hungary

NOT YET RECRUITING

Local Institution - 0131

Szeged, 6720, Hungary

NOT YET RECRUITING

Local Institution - 0075

Chikugo, Fukuoka, 833-0041, Japan

NOT YET RECRUITING

Goryokai Medical Corporation - Goryokai Hospital

Sapporo, Hokkaido, 002-8029, Japan

RECRUITING

Local Institution - 0025

Zentsujichó, Kagawa-ken, 765-8507, Japan

NOT YET RECRUITING

Local Institution - 0062

Miyakonojō, Miyazaki, 885-0093, Japan

NOT YET RECRUITING

Local Institution - 0086

Bunkyo-ku, Tokyo, 113-8431, Japan

NOT YET RECRUITING

Local Institution - 0056

Ōta-ku, Tokyo, 143-8541, Japan

NOT YET RECRUITING

Local Institution - 0063

Yokohama, Kanagawa, 213-8507, Japan

NOT YET RECRUITING

Local Institution - 0128

Poznan, Greater Poland Voivodeship, 60-744, Poland

NOT YET RECRUITING

Local Institution - 0125

Wroclaw, Lower Silesian Voivodeship, 54-234, Poland

WITHDRAWN

Local Institution - 0127

Warsaw, Masovian Voivodeship, 02-957, Poland

WITHDRAWN

Local Institution - 0126

Gdansk, Pomeranian Voivodeship, 80-542, Poland

NOT YET RECRUITING

Local Institution - 0123

Szczecin, West Pomeranian Voivodeship, 70-419, Poland

NOT YET RECRUITING

Local Institution - 0121

Gdansk, 80-546, Poland

NOT YET RECRUITING

Local Institution - 0124

Katowice, 40-146, Poland

WITHDRAWN

Local Institution - 0122

Lublin, 20-059, Poland

WITHDRAWN

Local Institution - 0177

Lublin, 20-701, Poland

NOT YET RECRUITING

Local Institution - 0178

Zabrze, 41-807, Poland

NOT YET RECRUITING

Local Institution - 0180

San Juan, 00927, Puerto Rico

NOT YET RECRUITING

Local Institution - 0029

Bucharest, Bucharest, 041914, Romania

NOT YET RECRUITING

Local Institution - 0040

Bucharest, 021056, Romania

NOT YET RECRUITING

Cabinet Medical Individual Dr Gheorghita Karina Lidia

Bucharest, 031871, Romania

RECRUITING

Cluj Napoca Emergency Hospital for Children, Department of Pediatric Psychiatry

Cluj-Napoca, 400370, Romania

RECRUITING

Local Institution - 0008

Iași, 700282, Romania

NOT YET RECRUITING

Emergency Clinical Hospital For Children Louis Turcanu Timis

Timișoara, 300329, Romania

RECRUITING

Local Institution - 0101

Barcelona, 08036, Spain

NOT YET RECRUITING

Local Institution - 0099

Barcelona, 8035, Spain

NOT YET RECRUITING

Local Institution - 0098

Madrid, 28007, Spain

NOT YET RECRUITING

Local Institution - 0100

Madrid, 28031, Spain

NOT YET RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Schizophrenia; Autistic Disorder

Interventions

xanomeline; trospium chloride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

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

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 20, 2026
• Study Start: April 7, 2026
• Primary Completion (Estimated): March 8, 2030
• Study Completion (Estimated): March 8, 2030
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (51); PL (10); HU (3); CA (5); FR (3); ES (4); JP (7); AU (4); RO (6); PR (1)