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Which ADHD drug works best for kids with autism? major trial aims to end guesswork

NCT ID NCT05916339

Disease control Sponsor: Daniel Coury Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two common stimulant classes (amphetamine and methylphenidate) and alpha-2 agonists to treat ADHD in 500 children aged 4-17 with autism. The goal is to find which medication works best and reduce the trial-and-error process. Parents and doctors will track symptoms using standard rating scales over the course of treatment.

What this could mean

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

Active substance
Amphetamine (e.g., Adderall) or Methylphenidate (e.g., Ritalin) or Alpha-2 agonists (e.g., guanfacine)
What this could lead to
If successful, this could help doctors choose the right ADHD medication for children with autism more quickly, reducing the need for multiple failed trials.
What could go wrong
This is a Phase 4 pragmatic trial, so results may vary in real-world settings. The study is large but still observational in design, and individual responses to medication can differ widely.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 500 people

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

Started

Oct 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

4 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: 1. Participant and/or legal caregiver must be willing and able to give informed consent/assent for participation in this study. 2. Participant and/or legal caregiver must be willing and able (in the Investigator's opinion) to comply with all study requirements. 3. Participant must be between 4 and 17 years of age (inclusive) at time of enrollment. 4. Participant must have a confirmed diagnosis of ASD based on supportive evidence (e.g. referring physician's report, medical records, such as ADOS or CARS, etc.). 5. Participant must have the ability to consistently take medication (via pill, liquid or mixed with food/liquid). 6. Participant must have a confirmed diagnosis of ADHD (based upon DSM-5 criteria and supportive evidence). 7. Participant must have a consistent reporter (e.g., parent) who spends regular time with the child. 8. Participant can be on other psychotropic medications (selective serotonin reuptake inhibitor (SSRI), atypical antipsychotic, anticonvulsant) if dose has been stable for \> 4 weeks prior to consent with no plans for a dose change during the study. 9. It has been at least 7 days since the participant last took an ADHD medication and the presiding clinician believes this to be a sufficient amount of time. 10. Caregiver must be sufficiently fluent in English or Spanish to be able to complete questionnaires relevant to this study. Exclusion Criteria: 1. Participant has taken ADHD medication within the past 7 days. 2. Participant is not stable on other medications (\< 4 weeks). 3. Any other risk factor that might prevent patient from safely taking the study medications. * There are no inclusion/exclusion criteria based upon participant IQ. We will include individuals across the entire range of cognition, just as practitioners are asked to treat ADHD in children with ASD across the entire IQ range.

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Conditions

The condition(s) this trial relates to.

attention deficit hyperactivity disorder, inattentive type attention deficit-hyperactivity disorder autism autism spectrum disorder

As listed by the trial registrant

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

ADHD 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

    12 sites in 2 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

  • Children's Hospital Los Angeles

    RECRUITING

    Los Angeles, California, 90027, United States

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19178, United States

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Holland Bloorview Kids Rehabilitation Hospital

    RECRUITING

    Toronto, Canada

  • Maine Medical Center

    RECRUITING

    Portland, Maine, 04102, United States

  • Massachusetts General Hospital Lurie Center for Autism

    RECRUITING

    Boston, Massachusetts, 02421, United States

  • Nationwide Children's Hospital

    RECRUITING

    Columbus, Ohio, 43205, United States

  • University of Alberta, Glenrose Rehabilitation Hospital

    RECRUITING

    Edmonton, Canada

  • University of California, Irvine

    RECRUITING

    Irvine, California, 92697, United States

  • University of Pittsburgh

    RECRUITING

    Pittsburgh, Pennsylvania, 15262, United States

  • University of Rochester

    RECRUITING

    Rochester, New York, 14642, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22903, United States

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