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Could a new daily pill help young children with ADHD?

NCT ID NCT07717879

Disease control Sponsor: Axsome Therapeutics, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 21, 2026 · Last updated Sep 09, 2026 · Updated 3 times

Summary

This phase 3 trial tests whether solriamfetol, taken once daily, can reduce ADHD symptoms in children aged 6 to under 12. Over 6 weeks, researchers compare the drug against a placebo using a standard rating scale. The goal is to see if solriamfetol is a safe and effective treatment option for this age group.

What this could mean

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

Active substance
solriamfetol capsules taken once daily
What this could lead to
If successful, this could provide a new daily medication option for managing ADHD symptoms in young children.
What could go wrong
This is a short 6-week trial, so long-term safety and effectiveness are not yet known. The drug may not work better than 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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 468 people

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

Started

Jul 2026

Expected to finish

Jun 2028

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

6 to 11 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, aged 6 to \<12 years. * Primary diagnosis of ADHD according to DSM-5 criteria. * Has parents/legal guardians provide written informed consent and has child provide written informed assent to participate in the study before the conduct of any study procedures. Exclusion Criteria: * Unable to comply with study procedures. * Medically inappropriate for study participation in the opinion of the investigator.

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Conditions

The condition(s) this trial relates to.

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

As listed by the trial registrant

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

ADHD

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    23 sites. 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

  • Clinical Research Site

    RECRUITING

    Dothan, Alabama, 36303, United States

  • Clinical Research Site

    RECRUITING

    Little Rock, Arkansas, 72211, United States

  • Clinical Research Site

    RECRUITING

    Irvine, California, 92604, United States

  • Clinical Research Site

    RECRUITING

    Long Beach, California, 90806, United States

  • Clinical Research Site

    RECRUITING

    Orange, California, 92868, United States

  • Clinical Research Site

    RECRUITING

    Walnut Creek, California, 94596, United States

  • Clinical Research Site

    RECRUITING

    Coral Gables, Florida, 33146, United States

  • Clinical Research Site

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • Clinical Research Site

    RECRUITING

    Maitland, Florida, 32751, United States

  • Clinical Research Site

    RECRUITING

    Orlando, Florida, 32801, United States

  • Clinical Research Site

    RECRUITING

    Atlanta, Georgia, 30318, United States

  • Clinical Research Site

    RECRUITING

    Bardstown, Kentucky, 40004, United States

  • Clinical Research Site

    RECRUITING

    Springfield, Massachusetts, 01103, United States

  • Clinical Research Site

    RECRUITING

    Worcester, Massachusetts, 01608, United States

  • Clinical Research Site

    RECRUITING

    Jackson, Mississippi, 39206, United States

  • Clinical Research Site

    RECRUITING

    Las Vegas, Nevada, 89128, United States

  • Clinical Research Site

    RECRUITING

    Staten Island, New York, 10314, United States

  • Clinical Research Site

    RECRUITING

    North Charleston, South Carolina, 29405, United States

  • Clinical Research Site

    RECRUITING

    Memphis, Tennessee, 38119, United States

  • Clinical Research Site

    RECRUITING

    Austin, Texas, 78759, United States

  • Clinical Research Site

    RECRUITING

    Friendswood, Texas, 77546, United States

  • Clinical Research Site

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Clinical Research Site

    RECRUITING

    Provo, Utah, 84604, United States

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