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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 Phase 3 400 Adolescent

Recruiting
Clinical Trial NCT07424404 is designed to study Treatment for Schizophrenia, Autism-Related Irritability. It is a Phase 3 interventional study that is recruiting, having started on March 31, 2026, with plans to enroll 400 participants. Led by Karuna Therapeutics, Inc., a Bristol Myers Squibb company, it is expected to complete by March 8, 2030. The latest data from ClinicalTrials.gov was last updated on March 27, 2026.
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
Official Title

A Phase 3 Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of KarXT in Adolescents (13 to 17 Years of Age) With Schizophrenia and KarXT+KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder

Conditions
SchizophreniaAutism-Related Irritability
Other Study IDs
  • CN012-0021
  • 2025-524062-16-00 (Other Identifier) (EU CT Number)
  • U1111-1325-9994 (Other Identifier) (UTN)
NCT ID Number
NCT07424404
Start Date (Actual)
2026-03-31
Last Update Posted
2026-03-27
Completion Date (Estimated)
2030-03-08
Enrollment (Estimated)
400
Study Type
Interventional
PHASE
Phase 3
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalAdministration of KarXT for Schizophrenia
KarXT
Specified dose on specified days
ExperimentalAdministration of KarXT for Autism-related Irritability
KarXT
Specified dose on specified days
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
Change from baseline on the Barnes-Akathisia Rating Scale (BARS)
Up to 52 weeks
Participation Assistant
Eligibility Criteria

Eligible Ages
Child
Minimum Age
5 Years
Eligible Sexes
All

- 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.

  • 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, 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.
  • Other protocol-defined Inclusion/Exclusion criteria apply.
Karuna Therapeutics, Inc., a Bristol Myers Squibb company logoKaruna Therapeutics, Inc., a Bristol Myers Squibb company9 active studies to explore
Study Central Contact
Contact: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, 855-907-3286, [email protected]
Contact: First line of the email MUST contain NCT # and Site #.
55 Study Locations in 9 Countries

California

Local Institution - 0077, Anaheim, California, 92805, United States
Site 0077, Contact
Not yet recruiting
Local Institution - 0058, Chino, California, 91710, United States
Site 0058, Contact
Not yet recruiting
Local Institution - 0083, Redlands, California, 92373, United States
Site 0083, Contact
Not yet recruiting
Local Institution - 0089, San Francisco, California, 94158, United States
Site 0089, Contact
Not yet recruiting

Florida

Local Institution - 0032, Orlando, Florida, 32803, United States
Site 0032, Contact
Not yet recruiting

Georgia

Atlanta Center for Medical Research, Atlanta, Georgia, 30331, United States
Elyssa Barron, Site 0057, Contact, 404-881-5800
Recruiting
Local Institution - 0103, Lawrenceville, Georgia, 30046, United States
Site 0103, Contact
Not yet recruiting
Local Institution - 0039, Stone Mountain, Georgia, 30083, United States
Site 0039, Contact
Not yet recruiting

Illinois

Local Institution - 0044, Chicago, Illinois, 60622, United States
Site 0044, Contact
Not yet recruiting
Local Institution - 0105, Evanston, Illinois, 60201, United States
Site 0105, Contact
Not yet recruiting

Massachusetts

Local Institution - 0076, Boston, Massachusetts, 02115, United States
Site 0076, Contact
Not yet recruiting
Local Institution - 0104, Brookline, Massachusetts, 02446, United States
Site 0104, Contact
Not yet recruiting
Local Institution - 0059, Worcester, Massachusetts, 01608, United States
Site 0059, Contact
Not yet recruiting

New York

Local Institution - 0061, Great Neck, New York, 11021, United States
Site 0061, Contact
Not yet recruiting

Ohio

Local Institution - 0051, Cincinnati, Ohio, 45219, United States
Site 0051, Contact
Not yet recruiting

Pennsylvania

Local Institution - 0097, Philadelphia, Pennsylvania, 19139, United States
Site 0097, Contact
Not yet recruiting

Texas

Local Institution - 0046, Garland, Texas, 75043, United States
Site 0046, Contact
Not yet recruiting
Local Institution - 0090, McAllen, Texas, 78501, United States
Site 0090, Contact
Not yet recruiting
Local Institution - 0066, Spring, Texas, 77381, United States
Site 0066, Contact
Not yet recruiting

Virginia

Local Institution - 0050, Richmond, Virginia, 23284, United States
Site 0050, Contact
Not yet recruiting

Alberta

Local Institution - 0111, Edmonton, Alberta, T6G 1Z1, Canada
Site 0111, Contact
Not yet recruiting

Ontario

Local Institution - 0110, Kingston, Ontario, K7L4X3, Canada
Site 0110, Contact
Not yet recruiting
Local Institution - 0113, Toronto, Ontario, M4G 1R8, Canada
Site 0113, Contact
Not yet recruiting

Quebec

Local Institution - 0112, Montreal, Quebec, H3T 1C5, Canada
Site 0112, Contact
Not yet recruiting
Local Institution - 0118, Bordeaux, 33076, France
Site 0118, Contact
Not yet recruiting
Local Institution - 0120, Bron, 69678, France
Site 0120, Contact
Not yet recruiting
Local Institution - 0119, Paris, 75019, France
Site 0119, Contact
Not yet recruiting
Local Institution - 0121, Gdansk, 80-546, Germany
Site 0121, Contact
Not yet recruiting
Local Institution - 0129, Budapest, 1143, Hungary
Site 0129, Contact
Not yet recruiting
Local Institution - 0130, Gyula, 5700, Hungary
Site 0130, Contact
Not yet recruiting
Local Institution - 0131, Szeged, 6720, Hungary
Site 0131, Contact
Not yet recruiting

Fukuoka

Local Institution - 0075, Chikugo, Fukuoka, 833-0041, Japan
Site 0075, Contact
Not yet recruiting

Hokkaido

Local Institution - 0073, Sapporo, Hokkaido, 002-8029, Japan
Site 0073, Contact
Not yet recruiting

Kagawa-ken

Local Institution - 0025, Zentsujichó, Kagawa-ken, 765-8507, Japan
Site 0025, Contact
Not yet recruiting

Miyazaki

Local Institution - 0062, Miyakonojō, Miyazaki, 885-0093, Japan
Site 0062, Contact
Not yet recruiting

Tokyo

Local Institution - 0086, Bunkyo-ku, Tokyo, 113-8431, Japan
Site 0086, Contact
Not yet recruiting
Local Institution - 0056, Ōta-ku, Tokyo, 143-8541, Japan
Site 0056, Contact
Not yet recruiting
Local Institution - 0063, Yokohama, Kanagawa, 213-8507, Japan
Site 0063, Contact
Not yet recruiting

Greater Poland Voivodeship

Local Institution - 0128, Poznan, Greater Poland Voivodeship, 60-744, Poland
Site 0128, Contact
Not yet recruiting

Lower Silesian Voivodeship

Local Institution - 0125, Wroclaw, Lower Silesian Voivodeship, 54-234, Poland
Site 0125, Contact
Not yet recruiting

Lublin Voivodeship

Local Institution - 0122, Kraśnik, Lublin Voivodeship, 23-210, Poland
Site 0122, Contact
Not yet recruiting

Masovian Voivodeship

Local Institution - 0127, Warsaw, Masovian Voivodeship, 02-957, Poland
Site 0127, Contact
Not yet recruiting

Pomeranian Voivodeship

Local Institution - 0126, Gdansk, Pomeranian Voivodeship, 80-542, Poland
Site 0126, Contact
Not yet recruiting

West Pomeranian Voivodeship

Local Institution - 0123, Szczecin, West Pomeranian Voivodeship, 70-419, Poland
Site 0123, Contact
Not yet recruiting
Local Institution - 0124, Katowice, 40-146, Poland
Site 0124, Contact
Not yet recruiting

București

Local Institution - 0029, Bucharest, București, 041914, Romania
Site 0029, Contact
Not yet recruiting

Cluj

Local Institution - 0031, Cluj-Napoca, Cluj, 400370, Romania
Site 0031, Contact
Not yet recruiting
Local Institution - 0040, Bucharest, 021056, Romania
Site 0040, Contact
Not yet recruiting
Local Institution - 0042, Bucharest, 031871, Romania
Site 0042, Contact
Not yet recruiting
Local Institution - 0008, Iași, 700282, Romania
Site 0008, Contact
Not yet recruiting
Local Institution - 0038, Timișoara, 300011, Romania
Site 0038, Contact
Not yet recruiting
Local Institution - 0101, Barcelona, 08036, Spain
Site 0101, Contact
Not yet recruiting
Local Institution - 0099, Barcelona, 8035, Spain
Site 0099, Contact
Not yet recruiting
Local Institution - 0098, Madrid, 28007, Spain
Site 0098, Contact
Not yet recruiting
Local Institution - 0100, Madrid, 28031, Spain
Site 0100, Contact
Not yet recruiting