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New drug ML-004 moves to safety testing in autism patients

NCT ID NCT05889273

Disease control 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 21, 2026 · Updated 2 times

Summary

This study is testing the safety of an experimental drug called ML-004 in 120 adolescents and adults with autism spectrum disorder who have already completed a previous study. Participants will take ML-004 once daily, and researchers will monitor for side effects. The goal is to see if the drug is safe enough for further testing.

What this could mean

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

Active substance
ML-004 tablet
What this could lead to
If it works, this could point toward a treatment to help manage core symptoms of autism spectrum disorder.
What could go wrong
This is an early-phase safety study, so it is not designed to prove effectiveness. The drug may cause side effects or not work better than a 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 2

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

Participants

About 120 people

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

Started

Jun 2023

Expected to finish

Dec 2027

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

12 to 46 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: * Has completed Study ML-004-002 within the past 90 days * Age 12 years to 46 years 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 kg/m² * Psychoactive medications and adjunctive therapies stable for 4 weeks prior to screening * Must be able to swallow study medication Exclusion Criteria: * Has Rett syndrome or Child Disintegrative Disorder * History of epilepsy without current adequate control, or any seizure in the 6 months preceding screening * Has a positive response to C-SSRS questions 4 and/or 5, or is a significant risk for suicidal behavior * Has 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

  • 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

  • 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

  • Richmond Behavioral Associates

    Staten Island, New York, 10314, United States

  • Road Runner Research, Ltd.

    San Antonio, Texas, 78249, United States

  • Southwest Autism Research and Resource Center

    Phoenix, Arizona, 85006, United States

  • Suburban Research Associates

    Media, Pennsylvania, 19063, United States

  • The Children's Research Institute

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

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

    Parkville, Victoria, 3052, Australia

  • University of Missouri, Thompson Center for Autism & Neurodevelopment

    Columbia, Missouri, 65211, United States

  • University of South Florida Psychiatry and Behavioral Neurosciences

    Tampa, Florida, 33613, United States

  • Yale Child Study Center

    New Haven, Connecticut, 06519, United States

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