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New drug aims to ease social struggles in autism

NCT ID NCT05081245

Symptom relief Sponsor: MapLight Therapeutics 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental drug called ML-004 in 168 adolescents and adults with autism spectrum disorder to see if it could improve social communication skills. Participants were randomly assigned to receive either the drug or a placebo for several weeks. The main goal was to measure changes in social communication using a caregiver questionnaire.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

168 people

The number who actually took part.

Started

Sep 2022

Finished

Apr 2026

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

12 to 45 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: * Age 12 to 45 at screening * Has a designated care/study partner who can reliably report on symptoms * Has a diagnosis of Autism Spectrum Disorder (ASD) * Has a body mass index (BMI) 18 through 34 kg/m², inclusive * Full scale IQ (or equivalent) ≥55 score, with adequate verbal fluency, as determined by the Principal Investigator. * Psychoactive medications and adjunctive therapies are stable for 4 weeks prior to screening * Must be able to swallow study medication Exclusion Criteria: * Has Rett syndrome or Child Disintegrative Disorder * Has participated in any other study and received any other investigational medication (other than COVID-19 vaccination) or device within 60 days prior to screening * History of epilepsy without current adequate control, or any seizure in the 6 months preceding screening * History of suicidal ideation or behavior in the past 12 months, or a positive response to C-SSRS questions 4 and/or 5 * Systolic blood pressure ≥140 mmHg (if adult) or \>135 mmHg (if adolescent), or diastolic blood pressure ≥90 (if adult) or \>85 mmHg (if adolescent), or a clinical history of uncontrolled or severe hypertension * If female, is pregnant or lactating

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Conditions

The condition(s) this trial relates to.

autism autism spectrum disorder Communication

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

  • Abba Medical Group

    Miami, Florida, 33176, United States

  • BioBehavioral Research of Austin

    Austin, Texas, 78759, United States

  • Brain and Mind Centre

    Camperdown, New South Wales, 2050, Australia

  • Cedar Clinical Research

    Draper, Utah, 84020, United States

  • Center for Autism and the Developing Brain, New York State Psychiatric Institute

    White Plains, New York, 10605, United States

  • Children's National Health System - The Children's Research Institute (CRI)

    Washington D.C., District of Columbia, 20010, United States

  • Cortica

    San Rafael, California, 94903, United States

  • Cortica Healthcare

    Glendale, California, 91203, United States

  • Family Psychiatry of The Woodlands

    The Woodlands, Texas, 77381, United States

  • Harmonex Neuroscience Research

    Dothan, Alabama, 36303, United States

  • Holland Bloorview Kids Rehabilitation Hospital

    Toronto, Ontario, M4G 1R8, Canada

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753, United States

  • Lawson Health Research Institute/ London Health Sciences Centre

    London, Ontario, N6A 5W9, Canada

  • NRC Research Institute

    Orange, California, 92868, United States

  • Nathan Kline Institute for Psychiatric Research

    Orangeburg, New York, 10962, United States

  • Neurobehavioral Medicine Group

    Bloomfield Hills, Michigan, 48302, United States

  • OCT Research ULC (dba Okanagan Clinical Trials)

    Kelowna, British Columbia, V1Y 1Z9, Canada

  • Ohio State University Nisonger Center

    Columbus, Ohio, 43210, United States

  • Red Oak Psychiatry Associates, PA

    Houston, Texas, 77090, United States

  • Richmond Behavioral Associates

    Staten Island, New York, 10314, United States

  • Road Runner Research, Ltd.

    San Antonio, Texas, 78249, United States

  • Southwest Autism Research & Resource Center, Clinical Research

    Phoenix, Arizona, 85006, United States

  • Suburban Research Associates

    Media, Pennsylvania, 19063, United States

  • The Royal Children's Hospital, Murdoch Children's Research Institute

    Parkville, Victoria, 3052, Australia

  • University of Missouri, Thompson Center for Autism & Neurodevelopmental Disorders

    Columbia, Missouri, 65211, United States

  • University of South Florida Psychiatry and Behavioral Neurosciences

    Tampa, Florida, 33613, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23220, United States

  • Yale Child Study Center

    New Haven, Connecticut, 06519, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.