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Hope for families: new drug trial targets autism irritability in kids

NCT ID NCT07284745

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 6 times

Summary

This study tests whether a new medication, KarXT + KarX-EC, can reduce irritability in children and teens (ages 5 to 17) with autism. About 176 participants will receive either the drug or a placebo. The main goal is to see if the drug improves irritability scores after 8 weeks.

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 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

    39 sites in 4 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 - 0007

    Brisbane, Queensland, 4101, Australia

  • Local Institution - 0010

    Westmead, New South Wales, 2145, Australia

  • Local Institution - 0031

    Anaheim, California, 92805, United States

  • Local Institution - 0034

    Houston, Texas, 77090, United States

  • Local Institution - 0036

    Dothan, Alabama, 36303, United States

  • Local Institution - 0041

    Dallas, Texas, 75243, United States

  • Local Institution - 0045

    Melbourne, Victoria, 3052, Australia

  • Local Institution - 0074

    Bountiful, Utah, 84010, United States

  • Local Institution - 0099

    Gainesville, Florida, 32607, United States

  • Local Institution - 0110

    Las Vegas, Nevada, 89128, United States

  • Local Institution - 0122

    Cincinnati, Ohio, 45229, United States

  • Local Institution - 0135

    Kingston, Ontario, K7L4X3, Canada

  • Local Institution - 0136

    Edmonton, Alberta, T6G 1Z1, Canada

  • Local Institution - 0155

    Peachtree Corners, Georgia, 30071, United States

  • Local Institution - 0160

    Bloomfield Hills, Michigan, 48302, United States

  • Local Institution - 0181

    San Rafael, California, 94903, United States

  • Local Institution - 0185

    Spring, Texas, 77381, United States

  • Local Institution - 0187

    Montreal, Quebec, H3T 1C5, Canada

  • Local Institution - 0205

    Toronto, Ontario, M4G 1R8, Canada

  • Local Institution - 0220

    Detroit, Michigan, 48203, United States

  • Local Institution - 0233

    Redlands, California, 92373, United States

  • Local Institution - 0234

    San Juan, 00927, Puerto Rico

  • Local Institution - 0236

    Phoenix, Arizona, 85006, United States

  • Local Institution - 0242

    Louisville, Kentucky, 40202, United States

  • Local Institution - 0246

    Staten Island, New York, 10312, United States

  • Local Institution - 0247

    West Chester, Ohio, 45069, United States

  • Local Institution - 0252

    Colorado Springs, Colorado, 80910, United States

  • Local Institution - 0257

    Glendale, California, 91203, United States

  • Local Institution - 0260

    Richmond, Virginia, 23220, United States

  • Local Institution - 0263

    The Bronx, New York, 10461, United States

  • Local Institution - 0264

    Boca Raton, Florida, 33428, United States

  • Local Institution - 0266

    Chicago, Illinois, 60622, United States

  • Local Institution - 0269

    Danville, Pennsylvania, 17821, United States

  • Local Institution - 0271

    Provo, Utah, 84604, United States

  • Local Institution - 0273

    Plano, Texas, 75093, United States

  • Local Institution - 0278

    Gainesville, Florida, 32607, United States

  • Local Institution - 0286

    Melbourne, Victoria, 3168, Australia

  • Local Institution - 0289

    Airdrie, Alberta, T4A 0K9, Canada

  • Local Institution - 0291

    San Antonio, Texas, 78249, United States

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