A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Autism-Related Irritability in Adolescents, Respectively

NCT07424404 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: CN012-00212025-524062-16-00U1111-1325-9994
• Study Type: interventional
• Target: 400
• Locations: 10 countries
• Sites: 59

Brief Summary

The purpose of this study is to evaluate the long-term safety and tolerability of KarXT and KarX-EC for the treatment of Schizophrenia and autism-related irritability in adolescents, respectively

Conditions

Schizophrenia; Autism-Related Irritability

Outcome Measures

Primary Outcomes (3)

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

  Up to 54 weeks

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

  Up to 54 weeks

• Number of participants with serious adverse events (SAEs)

  Up to 54 weeks

Secondary Outcomes (6)

• Number or participants with procholinergic symptoms

  Up to 54 weeks

• Number of participants with anticholinergic symptoms

  Up to 54 weeks

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

  Up to 54 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 for Autism-related Irritability

EXPERIMENTAL

Drug: KarXT

Interventions

KarXT DRUG

Specified dose on specified days

Administration of KarXT for Autism-related Irritability; Administration of KarXT for Schizophrenia

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 investigator's opinion, may indicate an unacceptable safety risk.

You may not qualify if:

• Participants must not have any clinically significant abnormality including any finding(s) from the physical examination, vital signs, ECG at the end of treatment visit of Study CN0120020, CN0120044, or CN0120045 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 (59)

Local Institution - 0077

Anaheim, California, 92805, United States

NOT YET RECRUITING

Local Institution - 0058

Chino, California, 91710, United States

NOT YET RECRUITING

Local Institution - 0024

Culver City, California, 90230, United States

NOT YET RECRUITING

Local Institution - 0083

Redlands, California, 92373, United States

NOT YET RECRUITING

Local Institution - 0089

San Francisco, California, 94158, 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

Local Institution - 0039

Stone Mountain, Georgia, 30083, United States

NOT YET RECRUITING

EmVenio Research Center - Prime Healthcare

Chicago, Illinois, 60622, United States

RECRUITING

Local Institution - 0076

Boston, Massachusetts, 02115, United States

NOT YET RECRUITING

Local Institution - 0059

Worcester, Massachusetts, 01608, United States

NOT YET RECRUITING

Local Institution - 0061

Great Neck, New York, 11021, United States

NOT YET RECRUITING

University of Cincinnati Cancer Institute

Cincinnati, Ohio, 45219, United States

RECRUITING

Local Institution - 0097

Philadelphia, Pennsylvania, 19139, United States

NOT YET RECRUITING

Local Institution - 0137

Nashville, Tennessee, 37212, United States

NOT YET RECRUITING

Local Institution - 0046

Garland, Texas, 75043, United States

NOT YET RECRUITING

Local Institution - 0066

Spring, Texas, 77381, United States

NOT YET RECRUITING

Local Institution - 0050

Richmond, Virginia, 23284, United States

NOT YET RECRUITING

Local Institution - 0084

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1107, Argentina

NOT YET RECRUITING

Local Institution - 0085

La Plata, Buenos Aires, 1900, Argentina

NOT YET RECRUITING

Local Institution - 0036

Buenos Aires, C1405BOA, Argentina

NOT YET RECRUITING

Local Institution - 0035

Córdoba, X5003DCE, Argentina

NOT YET RECRUITING

Local Institution - 0116

Santiago del Estero, G4200DND, Argentina

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 - 0121

Gdansk, 80-546, Germany

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

NOT YET RECRUITING

Local Institution - 0122

Kraśnik, Lublin Voivodeship, 23-210, Poland

NOT YET RECRUITING

Local Institution - 0127

Warsaw, Masovian Voivodeship, 02-957, Poland

NOT YET RECRUITING

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 - 0124

Katowice, 40-146, Poland

NOT YET RECRUITING

Local Institution - 0029

Bucharest, Bucharest, 041914, Romania

NOT YET RECRUITING

Local Institution - 0031

Cluj-Napoca, Cluj, 400370, Romania

NOT YET RECRUITING

Local Institution - 0040

Bucharest, 021056, Romania

NOT YET RECRUITING

Local Institution - 0042

Bucharest, 031871, Romania

NOT YET RECRUITING

Local Institution - 0008

Iași, 700282, Romania

NOT YET RECRUITING

Local Institution - 0038

Timișoara, 300011, Romania

NOT YET 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

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic 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: 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: May 11, 2026

Record last verified: 2026-05

Data Sharing

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

Locations

AR (5); US (19); RO (6); PL (7); HU (3); CA (4); FR (3); DE (1); ES (4); JP (7)