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Can a new drug calm irritability in kids with autism?

NCT ID NCT06557902

Symptom relief Sponsor: Intra-Cellular Therapies, Inc. 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 24, 2026 · Last updated Jul 24, 2026

Summary

This early-stage trial is testing an experimental drug called lumateperone in children aged 5 to 12 who have autism spectrum disorder and symptoms of irritability. The study aims to see how the body processes the drug and whether it is safe and tolerable at different doses. It is a first step toward possibly finding a new treatment option for irritability in this population.

What this could mean

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

Active substance
an experimental drug called lumateperone, given as capsules or orally disintegrating tablets
What this could lead to
If safe and well-tolerated, this could pave the way for larger studies testing whether lumateperone helps ease irritability in children with autism.
What could go wrong
This is a very early, small phase 1 trial focused on safety and drug levels, not on whether the drug works. Side effects are possible, and the drug may not prove effective in later studies.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

33 people

The number who actually took part.

Started

May 2024

Finished

Nov 2025

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 12 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: * Male or female patients between 5 to less than 13 years of age * Primary clinical diagnosis of ASD with symptoms of irritability * ABC-I subscale score of ≥12 at Screening * CGI-S score of ≥3 at Screening * Body mass index (BMI) greater than the 5th percentile according to age- and gender-specific CDC Clinical Growth Charts (2000) at Screening * Ability to swallow capsules Exclusion Criteria: * Has a primary psychiatric diagnosis other than ASD * Reports suicidal ideation (Type 3, 4 or 5 on the Baseline/Screening version of the C-SSRS) within 6 months prior to Screening, or any suicidal behavior within 2 years prior to Screening, and/or the Investigator assesses the patient to be a safety risk to him/herself or others * Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the patient at risk or interfere with study outcome variables * History of a clinically significant cardiac disorder and/or abnormal screening ECG or a QT interval corrected for heart rate using Fridericia formula (QTcF) \> 460 msec at Screening * Patients with a history of orthostatic hypotension or who have orthostatic hypotension at Screening * Has a history of uncontrolled/disruptive behavior in the past 30 days that, in the Investigator's opinion, would preclude the ability to participate in study procedures

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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.

Autism spectrum disorder

Contacts and locations

Locations

  • APG Research LLC

    Orlando, Florida, 32803, United States

  • Alivation Research LLC

    Lincoln, Nebraska, 68526, United States

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30331, United States

  • CenExeli Research LLC

    Atlanta, Georgia, 30030, United States

  • CenExeli Research LLC 1

    Savannah, Georgia, 31405, United States

  • Core Clinical Research

    Everett, Washington, 98201, United States

  • Midwest Research Group

    Saint Charles, Missouri, 63304, United States

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