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Could a new pill tame Autism-Related irritability in kids?

NCT ID NCT07285798

Symptom relief Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Updated 4 times

Summary

This Phase 3 study tests whether a combination of two drugs, KarXT and KarX-EC, can safely reduce irritability in children and adolescents aged 5 to 17 with autism spectrum disorder. About 176 participants will receive either the drug combo or a placebo for 8 weeks. The main goal is to see if the treatment lowers scores on a standard irritability checklist.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
KarXT (xanomeline/trospium chloride) and KarX-EC (xanomeline enteric-coated)
What this could lead to
If successful, this could provide a new medication option to reduce irritability in children and teens with autism, potentially improving daily functioning and quality of life.
What could go wrong
This is an early-stage Phase 3 trial with only 176 participants, so results may not apply to everyone. The drug may cause side effects or prove no better than placebo.

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 176 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2029

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 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 an ABC-I ≥18 (Irritability subscale of the ABC) and CGIS specific to irritability ≥4, at screening and baseline (Day 1). Exclusion Criteria * 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. * Other protocol-defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder

As listed by the trial registrant

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

Irritability associated with autism spectrum disorder

How to take part

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

  1. The places running it

    63 sites in 10 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

  • Local Institution - 0003

    Pittsburgh, Pennsylvania, 15213, United States

  • Local Institution - 0009

    Orem, Utah, 84097, United States

  • Local Institution - 0013

    Glendale, California, 91203, United States

  • Local Institution - 0014

    Chicago, Illinois, 60622, United States

  • Local Institution - 0016

    Columbia, Missouri, 65201, United States

  • Local Institution - 0019

    Everett, Washington, 98201, United States

  • Local Institution - 0026

    Chicago, Illinois, 60622, United States

  • Local Institution - 0036

    Saint Charles, Missouri, 63304, United States

  • Local Institution - 0038

    Staten Island, New York, 10312, United States

  • Local Institution - 0039

    San Juan, 917, Puerto Rico

  • Local Institution - 0046

    Lincoln, Nebraska, 68526, United States

  • Local Institution - 0051

    Lexington, Massachusetts, 02421, United States

  • Local Institution - 0052

    Cincinnati, Ohio, 45229, United States

  • Local Institution - 0062

    Phoenix, Arizona, 85006, United States

  • Local Institution - 0072

    Decatur, Georgia, 30030, United States

  • Local Institution - 0080

    Orlando, Florida, 32803, United States

  • Local Institution - 0084

    Madrid, 28007, Spain

  • Local Institution - 0085

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Local Institution - 0086

    Madrid, 28031, Spain

  • Local Institution - 0087

    Barcelona, Catalunya [Cataluña], 08036, Spain

  • Local Institution - 0088

    Bordeaux, 33076, France

  • Local Institution - 0089

    Paris, 75019, France

  • Local Institution - 0090

    Hirakata, Osaka, 573-0022, Japan

  • Local Institution - 0091

    Ōta-ku, Tokyo, 146-0095, Japan

  • Local Institution - 0093

    Yokohama, Kanagawa, 213-8507, Japan

  • Local Institution - 0094

    Miyakonojō, Miyazaki, 885-0093, Japan

  • Local Institution - 0095

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

  • Local Institution - 0096

    Kozhikode, Kerala, 673009, India

  • Local Institution - 0097

    Kolkata, West Bengal, 700020, India

  • Local Institution - 0099

    Nagpur, 440010, India

  • Local Institution - 0100

    Belgavi, Karnataka, 590001, India

  • Local Institution - 0101

    Sakri, Maharashtra, 441108, India

  • Local Institution - 0102

    Bron, 69678, France

  • Local Institution - 0103

    Gdansk, 80-546, Germany

  • Local Institution - 0104

    Katowice, 40-146, Poland

  • Local Institution - 0105

    Wroclaw, Lower Silesian Voivodeship, 54-234, Poland

  • Local Institution - 0106

    Gdansk, Pomeranian Voivodeship, 80-542, Poland

  • Local Institution - 0107

    Warsaw, Masovian Voivodeship, 02-957, Poland

  • Local Institution - 0108

    Poznan, Greater Poland Voivodeship, 60-744, Poland

  • Local Institution - 0109

    Lublin, 20-059, Poland

  • Local Institution - 0110

    Szeged, 6720, Hungary

  • Local Institution - 0111

    Budapest, 1021, Hungary

  • Local Institution - 0112

    Siófok, 8600, Hungary

  • Local Institution - 0113

    Szczecin, West Pomeranian Voivodeship, 70-419, Poland

  • Local Institution - 0114

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

  • Local Institution - 0115

    San Juan Capistrano, California, 92675, United States

  • Local Institution - 0116

    San Rafael, California, 94903, United States

  • Local Institution - 0117

    Los Angeles, California, 90095, United States

  • Local Institution - 0118

    Bucharest, Bucharest, 030167, Romania

  • Local Institution - 0119

    Sibiu, 550082, Romania

  • Local Institution - 0120

    Bucharest, Bucharest, 041914, Romania

  • Local Institution - 0121

    Iași, 700282, Romania

  • Local Institution - 0122

    Timișoara, 300329, Romania

  • Local Institution - 0123

    Cluj-Napoca, 0, Romania

  • Local Institution - 0124

    Bucharest, 031871, Romania

  • Local Institution - 0125

    Spring, Texas, 77381, United States

  • Local Institution - 0126

    Orange, California, 92868, United States

  • Local Institution - 0127

    Budapest, 1143, Hungary

  • Local Institution - 0129

    Szczecin, West Pomeranian Voivodeship, 70-419, Poland

  • Local Institution - 0130

    New Haven, Connecticut, 06519, United States

  • Local Institution - 0132

    San Diego, California, 92102, United States

  • Local Institution - 0136

    Nashik, Maharashtra, 422005, India

  • Local Institution - 0137

    New Delhi, 110075, India

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