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New drug combo tested for long-term safety in teens with schizophrenia and kids with autism

NCT ID NCT07424404

Disease control Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 5 times

Summary

This study is checking the long-term safety of a drug called KarXT in teenagers (13-17) with schizophrenia, and a combination of KarXT and KarX-EC in children (5-17) with irritability linked to autism. About 400 participants who completed earlier studies will take the drug for up to 2 years. The main goal is to see what side effects occur, not to measure how well the drug works.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria \- 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. Exclusion Criteria * 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.

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autism-related irritability Schizophrenia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    86 sites in 9 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advanced Research Center Inc.

    RECRUITING

    Anaheim, California, 92805, United States

  • Apg Research, Llc

    RECRUITING

    Orlando, Florida, 32803, United States

  • Atlanta Center for Medical Research

    RECRUITING

    Atlanta, Georgia, 30331, United States

  • Boston Children's Hospital

    RECRUITING

    Boston, Massachusetts, 02445, United States

  • Cabinet Medical Individual Dr Gheorghita Karina Lidia

    RECRUITING

    Bucharest, 031871, Romania

  • Cluj Napoca Emergency Hospital for Children, Department of Pediatric Psychiatry

    RECRUITING

    Cluj-Napoca, 400370, Romania

  • Denali Health Atlanta, LLC

    RECRUITING

    Stone Mountain, Georgia, 30083, United States

  • EmVenio Research Center - Prime Healthcare

    RECRUITING

    Chicago, Illinois, 60622, United States

  • Emergency Clinical Hospital For Children Louis Turcanu Timis

    RECRUITING

    Timișoara, 300329, Romania

  • Goryokai Medical Corporation - Goryokai Hospital

    RECRUITING

    Sapporo, Hokkaido, 002-8029, Japan

  • Inland Psychiatric Medical Group.

    RECRUITING

    Chino, California, 91710, United States

  • Local Institution - 0008

    NOT_YET_RECRUITING

    Iași, 700282, Romania

  • Local Institution - 0025

    NOT_YET_RECRUITING

    Zentsujichó, Kagawa-ken, 765-8507, Japan

  • Local Institution - 0029

    NOT_YET_RECRUITING

    Bucharest, Bucharest, 041914, Romania

  • Local Institution - 0040

    NOT_YET_RECRUITING

    Bucharest, 021056, Romania

  • Local Institution - 0050

    NOT_YET_RECRUITING

    Richmond, Virginia, 23284, United States

  • Local Institution - 0054

    NOT_YET_RECRUITING

    Dothan, Alabama, 36303, United States

  • Local Institution - 0056

    NOT_YET_RECRUITING

    Ōta-ku, Tokyo, 143-8541, Japan

  • Local Institution - 0059

    NOT_YET_RECRUITING

    Worcester, Massachusetts, 01608, United States

  • Local Institution - 0061

    NOT_YET_RECRUITING

    Great Neck, New York, 11021, United States

  • Local Institution - 0062

    NOT_YET_RECRUITING

    Miyakonojō, Miyazaki, 885-0093, Japan

  • Local Institution - 0063

    NOT_YET_RECRUITING

    Yokohama, Kanagawa, 213-8507, Japan

  • Local Institution - 0066

    NOT_YET_RECRUITING

    Spring, Texas, 77381, United States

  • Local Institution - 0075

    NOT_YET_RECRUITING

    Chikugo, Fukuoka, 833-0041, Japan

  • Local Institution - 0086

    NOT_YET_RECRUITING

    Bunkyo-ku, Tokyo, 113-8431, Japan

  • Local Institution - 0089

    NOT_YET_RECRUITING

    San Francisco, California, 94158, United States

  • Local Institution - 0098

    NOT_YET_RECRUITING

    Madrid, 28007, Spain

  • Local Institution - 0099

    NOT_YET_RECRUITING

    Barcelona, 8035, Spain

  • Local Institution - 0100

    NOT_YET_RECRUITING

    Madrid, 28031, Spain

  • Local Institution - 0101

    NOT_YET_RECRUITING

    Barcelona, 08036, Spain

  • Local Institution - 0106

    NOT_YET_RECRUITING

    Brisbane, Queensland, 4101, Australia

  • Local Institution - 0107

    NOT_YET_RECRUITING

    Westmead, New South Wales, 2145, Australia

  • Local Institution - 0108

    NOT_YET_RECRUITING

    Melbourne, Victoria, 3052, Australia

  • Local Institution - 0109

    NOT_YET_RECRUITING

    Melbourne, Victoria, 3168, Australia

  • Local Institution - 0110

    NOT_YET_RECRUITING

    Kingston, Ontario, K7L4X3, Canada

  • Local Institution - 0111

    NOT_YET_RECRUITING

    Edmonton, Alberta, T6G 1Z1, Canada

  • Local Institution - 0112

    NOT_YET_RECRUITING

    Montreal, Quebec, H3T 1C5, Canada

  • Local Institution - 0113

    NOT_YET_RECRUITING

    Toronto, Ontario, M4G 1R8, Canada

  • Local Institution - 0118

    NOT_YET_RECRUITING

    Bordeaux, 33076, France

  • Local Institution - 0119

    NOT_YET_RECRUITING

    Paris, 75019, France

  • Local Institution - 0120

    NOT_YET_RECRUITING

    Bron, 69678, France

  • Local Institution - 0121

    NOT_YET_RECRUITING

    Gdansk, 80-546, Poland

  • Local Institution - 0122

    WITHDRAWN

    Lublin, 20-059, Poland

  • Local Institution - 0123

    NOT_YET_RECRUITING

    Szczecin, West Pomeranian Voivodeship, 70-419, Poland

  • Local Institution - 0124

    WITHDRAWN

    Katowice, 40-146, Poland

  • Local Institution - 0125

    NOT_YET_RECRUITING

    Wroclaw, Lower Silesian Voivodeship, 54-234, Poland

  • Local Institution - 0126

    NOT_YET_RECRUITING

    Gdansk, Pomeranian Voivodeship, 80-542, Poland

  • Local Institution - 0127

    WITHDRAWN

    Warsaw, Masovian Voivodeship, 02-957, Poland

  • Local Institution - 0128

    NOT_YET_RECRUITING

    Poznan, Greater Poland Voivodeship, 60-744, Poland

  • Local Institution - 0129

    NOT_YET_RECRUITING

    Budapest, 1143, Hungary

  • Local Institution - 0130

    NOT_YET_RECRUITING

    Gyula, 5700, Hungary

  • Local Institution - 0131

    NOT_YET_RECRUITING

    Szeged, 6720, Hungary

  • Local Institution - 0132

    NOT_YET_RECRUITING

    Lexington, Massachusetts, 02421, United States

  • Local Institution - 0137

    NOT_YET_RECRUITING

    Nashville, Tennessee, 37212, United States

  • Local Institution - 0138

    NOT_YET_RECRUITING

    Calgary, Alberta, T2N 4Z6, Canada

  • Local Institution - 0139

    WITHDRAWN

    West Chester, Ohio, 45069, United States

  • Local Institution - 0141

    NOT_YET_RECRUITING

    Orem, Utah, 84097, United States

  • Local Institution - 0142

    NOT_YET_RECRUITING

    Columbia, Missouri, 65201, United States

  • Local Institution - 0143

    NOT_YET_RECRUITING

    Danville, Pennsylvania, 17821, United States

  • Local Institution - 0144

    NOT_YET_RECRUITING

    Las Vegas, Nevada, 89128, United States

  • Local Institution - 0145

    NOT_YET_RECRUITING

    Boca Raton, Florida, 33428, United States

  • Local Institution - 0146

    NOT_YET_RECRUITING

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

  • Local Institution - 0147

    NOT_YET_RECRUITING

    Lincoln, Nebraska, 68526, United States

  • Local Institution - 0148

    NOT_YET_RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Local Institution - 0149

    NOT_YET_RECRUITING

    Dallas, Texas, 75243, United States

  • Local Institution - 0150

    NOT_YET_RECRUITING

    Pittsburgh, Pennsylvania, 15213-3403, United States

  • Local Institution - 0151

    NOT_YET_RECRUITING

    The Bronx, New York, 10461, United States

  • Local Institution - 0152

    NOT_YET_RECRUITING

    Bloomfield Hills, Michigan, 48302, United States

  • Local Institution - 0153

    NOT_YET_RECRUITING

    Los Angeles, California, 90095, United States

  • Local Institution - 0154

    NOT_YET_RECRUITING

    New Haven, Connecticut, 06520, United States

  • Local Institution - 0155

    NOT_YET_RECRUITING

    Everett, Washington, 98201, United States

  • Local Institution - 0156

    NOT_YET_RECRUITING

    Staten Island, New York, 10314, United States

  • Local Institution - 0157

    NOT_YET_RECRUITING

    San Rafael, California, 94903, United States

  • Local Institution - 0158

    NOT_YET_RECRUITING

    Orange, California, 92868, United States

  • Local Institution - 0159

    NOT_YET_RECRUITING

    Anaheim, California, 92805, United States

  • Local Institution - 0160

    NOT_YET_RECRUITING

    Gainesville, Florida, 32607, United States

  • Local Institution - 0161

    NOT_YET_RECRUITING

    Colorado Springs, Colorado, 80910, United States

  • Local Institution - 0162

    NOT_YET_RECRUITING

    Glendale, California, 91203, United States

  • Local Institution - 0163

    NOT_YET_RECRUITING

    Phoenix, Arizona, 85006, United States

  • Local Institution - 0164

    NOT_YET_RECRUITING

    Gainesville, Florida, 32607, United States

  • Local Institution - 0165

    WITHDRAWN

    Plano, Texas, 75093, United States

  • Local Institution - 0167

    NOT_YET_RECRUITING

    West Point, Utah, 84015, United States

  • Local Institution - 0168

    NOT_YET_RECRUITING

    Hollywood, Florida, 33024, United States

  • Local Institution - 0169

    NOT_YET_RECRUITING

    Houston, Texas, 77043, United States

  • Local Institution - 0174

    NOT_YET_RECRUITING

    San Diego, California, 92102, United States

  • Local Institution - 0175

    NOT_YET_RECRUITING

    Chicago, Illinois, 60611, United States

  • Local Institution - 0176

    NOT_YET_RECRUITING

    Plano, Texas, 75093, United States

  • Proscience Research Group

    RECRUITING

    Culver City, California, 90230, United States

  • Salveo Integrative Health - Lawrenceville

    RECRUITING

    Lawrenceville, Georgia, 30046, United States

  • University of Cincinnati Cancer Institute

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • VAST Clinical Research

    RECRUITING

    Garland, Texas, 75043, United States

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