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

NCT07285798 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: CN012-0045
• Study Type: interventional
• Target: 176
• Locations: 9 countries
• Sites: 55

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

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

EXPERIMENTAL

Drug: KarXT + KarX-EC Matching Placebo

Interventions

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

KarXT DRUG

Specified dose on specified days

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

KarXT + KarX-EC Arm

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 (55)

Local Institution - 0062

Phoenix, Arizona, 85006, United States

Location

Local Institution - 0001

Bentonville, Arkansas, 72712, United States

Location

Local Institution - 0013

Glendale, California, 91203, United States

Location

Local Institution - 0117

Los Angeles, California, 90095, United States

Location

Local Institution - 0126

Orange, California, 92868, United States

Location

Local Institution - 0115

San Juan Capistrano, California, 92675, United States

Location

Local Institution - 0116

San Rafael, California, 94903, United States

Location

Local Institution - 0080

Orlando, Florida, 32803, United States

Location

Local Institution - 0014

Chicago, Illinois, 60622, United States

Location

Local Institution - 0006

Lexington, Kentucky, 40536, United States

Location

Local Institution - 0051

Lexington, Massachusetts, 02421, United States

Location

Local Institution - 0016

Columbia, Missouri, 65201, United States

Location

Local Institution - 0046

Lincoln, Nebraska, 68526, United States

Location

Local Institution - 0114

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

Location

Local Institution - 0038

Staten Island, New York, 10312, United States

Location

Local Institution - 0052

Cincinnati, Ohio, 45229, United States

Location

Local Institution - 0003

Pittsburgh, Pennsylvania, 15213, United States

Location

Local Institution - 0009

Orem, Utah, 84097, United States

Location

Local Institution - 0019

Everett, Washington, 98201, United States

Location

Local Institution - 0102

Bron, 69678, France

Location

Local Institution - 0088

Eysines, 33320, France

Location

Local Institution - 0089

Paris, 75019, France

Location

Local Institution - 0103

Gdansk, 80-546, Germany

Location

Local Institution - 0111

Budapest, 1021, Hungary

Location

Local Institution - 0127

Budapest, 1143, Hungary

Location

Local Institution - 0112

Siófok, 8600, Hungary

Location

Local Institution - 0110

Szeged, 6720, Hungary

Location

Local Institution - 0096

Kozhikode, Kerala, 673009, India

Location

Local Institution - 0101

Sakri, Maharashtra, 441108, India

Location

Local Institution - 0097

Kolkata, West Bengal, 700020, India

Location

Local Institution - 0094

Miyakonojō, Miyazaki, 885-0093, Japan

Location

Local Institution - 0090

Hirakata, Osaka, 573-0022, Japan

Location

Local Institution - 0095

Yoshinogari-cho, Kanzaki-gun, Saga-ken, 842-0192, Japan

Location

Local Institution - 0091

Ōta-ku, Tokyo, 146-0095, Japan

Location

Local Institution - 0092

Saga, 840-0801, Japan

Location

Local Institution - 0093

Yokohama, Kanagawa, 213-8507, Japan

Location

Local Institution - 0108

Poznan, Greater Poland Voivodeship, 60-744, Poland

Location

Local Institution - 0105

Wroclaw, Lower Silesian Voivodeship, 54-234, Poland

Location

Local Institution - 0109

Kraśnik, Lublin Voivodeship, 23-210, Poland

Location

Local Institution - 0107

Warsaw, Masovian Voivodeship, 02-957, Poland

Location

Local Institution - 0106

Gdansk, Pomeranian Voivodeship, 80-542, Poland

Location

Local Institution - 0113

Szczecin, West Pomeranian Voivodeship, 70-419, Poland

Location

Local Institution - 0129

Szczecin, West Pomeranian Voivodeship, 70-419, Poland

Location

Local Institution - 0104

Katowice, 40-146, Poland

Location

Local Institution - 0118

Bucharest, București, 030167, Romania

Location

Local Institution - 0120

Bucharest, București, 041914, Romania

Location

Local Institution - 0124

Bucharest, 031871, Romania

Location

Local Institution - 0123

Cluj-Napoca, 0, Romania

Location

Local Institution - 0121

Iași, 700282, Romania

Location

Local Institution - 0119

Sibiu, 550082, Romania

Location

Local Institution - 0122

Timișoara, 300011, Romania

Location

Local Institution - 0085

Barcelona, Barcelona [Barcelona], 08035, Spain

Location

Local Institution - 0087

Barcelona, Catalunya [Cataluña], 08036, Spain

Location

Local Institution - 0084

Madrid, 28007, Spain

Location

Local Institution - 0086

Madrid, 28031, Spain

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 10, 2025
• First Posted: December 16, 2025
• Study Start (Estimated): September 11, 2026
• Primary Completion (Estimated): August 4, 2029
• Study Completion (Estimated): August 4, 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

IN (3); DE (1); JP (6); US (19); ES (4); FR (3); RO (7); HU (4); PL (8)