A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism

NCT07284745 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: CN012-0044
• Study Type: interventional
• Target: 176
• Locations: 5 countries
• Sites: 45

Brief Summary

The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.

Conditions

Irritability Associated With Autism Spectrum Disorder

Keywords

Cobenfy; Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Aberrant Behavior Checklist Irritability (ABC-I) Score at Week 8

  Week 8

Secondary Outcomes (13)

• Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Week 8

  Week 8

• Number of Participants With ABC-I Response at Week 8

  Week 8

• Change From Baseline on the ABC Subscale for Social Withdrawal at Week 8

  Week 8

• Change From Baseline on the Stereotypic Behavior Subscale at Week 8

  Week 8

• Change From Baseline on the Hyperactivity/Noncompliance Subscale at Week 8

  Week 8

Study Arms (2)

KarXT + KarX-EC Arm

EXPERIMENTAL

Drug: KarXT; Drug: KarX-EC

Placebo

PLACEBO COMPARATOR

Drug: KarXT + KarX-EC Matching Placebo

Interventions

KarXT DRUG

Specified dose on specified days

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

KarXT + KarX-EC Arm

KarX-EC DRUG

Specified dose on specified days

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

KarXT + KarX-EC Arm

KarXT + KarX-EC Matching Placebo DRUG

Specified dose on specified days

Placebo

Eligibility Criteria

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

You may qualify if:

• Participants must have a confirmed diagnosis of ASD, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria, confirmed by the K-SADS-PL and must be experiencing symptoms of irritability.
• Participants must have ABC-I ≥18 (C18 on the Irritability subscale of the ABC-I) and CGIS specific to irritability ≥4, at screening and baseline (Day 1).

You may not qualify if:

• Participants must not have a current primary DSM-5 diagnosis of bipolar disorder, including bipolar II disorder, schizophrenia, schizoaffective disorder, major depressive episode as determined by clinical instrument, or post-traumatic stress disorder (PTSD).
• Exception Include: Participants with comorbid ADHD, provided that attention deficit/hyperactivity disorder (ADHD) is not the primary disorder, the participant is adequately treated and based on the investigator judgment the disorder is clinically stable.
• Participants must not have history/presence of clinically significant disease or disorder that would jeopardize participant safety or validity of study results.
• Participants must not have a risk for suicidal behavior, and any clinically significant abnormal laboratory test.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (45)

Local Institution - 0036

Dothan, Alabama, 36303, United States

Location

Local Institution - 0236

Phoenix, Arizona, 85006, United States

Location

Local Institution - 0031

Anaheim, California, 92805, United States

Location

Local Institution - 0092

Chino, California, 91710, United States

Location

Local Institution - 0257

Glendale, California, 91203, United States

Location

Local Institution - 0181

San Rafael, California, 94903, United States

Location

Local Institution - 0252

Colorado Springs, Colorado, 80910, United States

Location

Local Institution - 0256

Hartford, Connecticut, 06106, United States

Location

Local Institution - 0264

Boca Raton, Florida, 33428, United States

Location

Local Institution - 0099

Gainesville, Florida, 32607, United States

Location

Local Institution - 0278

Gainesville, Florida, 32607, United States

Location

Local Institution - 0155

Peachtree Corners, Georgia, 30071, United States

Location

Local Institution - 0266

Chicago, Illinois, 60622, United States

Location

Local Institution - 0160

Bloomfield Hills, Michigan, 48302, United States

Location

Local Institution - 0220

Detroit, Michigan, 48203, United States

Location

Local Institution - 0110

Las Vegas, Nevada, 89128, United States

Location

Local Institution - 0246

Staten Island, New York, 10312, United States

Location

Local Institution - 0263

The Bronx, New York, 10461, United States

Location

Local Institution - 0247

West Chester, Ohio, 45069, United States

Location

Local Institution - 0269

Danville, Pennsylvania, 17821, United States

Location

Local Institution - 0105

Pittsburgh, Pennsylvania, 15213, United States

Location

Local Institution - 0041

Dallas, Texas, 75243, United States

Location

Local Institution - 0273

Fort Worth, Texas, 76104, United States

Location

Local Institution - 0185

Spring, Texas, 77381, United States

Location

Local Institution - 0074

Bountiful, Utah, 84010, United States

Location

Local Institution - 0271

Provo, Utah, 84604, United States

Location

Local Institution - 0260

Richmond, Virginia, 23298-0341, United States

Location

Local Institution - 0046

La Plata, Buenos Aires, 1900, Argentina

Location

Local Institution - 0048

Buenos Aires, Buenos Aires F.D., 1133, Argentina

Location

Local Institution - 0047

Córdoba, X5003DCE, Argentina

Location

Local Institution - 0288

Córdoba, X5004AOA, Argentina

Location

Local Institution - 0049

Mendoza, 5502, Argentina

Location

Local Institution - 0140

Santiago del Estero, G4200DND, Argentina

Location

Local Institution - 0010

Westmead, New South Wales, 2145, Australia

Location

Local Institution - 0007

Brisbane, Queensland, 4101, Australia

Location

Local Institution - 0045

Melbourne, Victoria, 3052, Australia

Location

Local Institution - 0286

Melbourne, Victoria, 3168, Australia

Location

Local Institution - 0136

Edmonton, Alberta, T6G 1Z1, Canada

Location

Local Institution - 0134

Hamilton, Ontario, L8L 2X2, Canada

Location

Local Institution - 0135

Kingston, Ontario, K7L4X3, Canada

Location

Local Institution - 0205

Toronto, Ontario, M4G 1R8, Canada

Location

Local Institution - 0187

Montreal, Quebec, H3T 1C5, Canada

Location

Local Institution - 0056

Kozhikode, Kerala, 673009, India

Location

Local Institution - 0061

Nagpur, Maharashtra, 441108, India

Location

Local Institution - 0218

Kolkata, West Bengal, 700020, India

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

xanomeline; trospium chloride

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental 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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 16, 2025
• Study Start (Estimated): September 11, 2026
• Primary Completion (Estimated): July 5, 2029
• Study Completion (Estimated): July 5, 2029
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

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

Locations

AU (4); AR (6); US (27); IN (3); CA (5)