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Could a narcolepsy drug tame ADHD? phase 3 trial complete

NCT ID NCT05972044

Symptom relief 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tested whether solriamfetol, a drug already approved for sleep disorders, can reduce ADHD symptoms in adults. Over 500 participants took either a daily dose of solriamfetol or a placebo for six weeks. The study measured changes in attention and hyperactivity using a standard rating scale.

What this could mean

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

Active substance
Solriamfetol (Sunosi), a tablet taken once daily
What this could lead to
If successful, solriamfetol could offer a new medication option for adults with ADHD to help improve focus and reduce hyperactivity.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The drug may not work better than placebo, and side effects are possible. It is not a cure.

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

516 people

The number who actually took part.

Started

Jul 2023

Finished

Mar 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

18 to 55 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: * Primary diagnosis of ADHD according to DSM-5 criteria. * Provides written informed consent to participate in the study before the conduct of any study procedures. * Male or female, aged 18 to 55 inclusive. Exclusion Criteria: * Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription. * 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

Contacts and locations

Locations

  • Clinical Research Site

    Encino, California, 91316, United States

  • Clinical Research Site

    Garden Grove, California, 92845, United States

  • Clinical Research Site

    Newport Beach, California, 92660, United States

  • Clinical Research Site

    Riverside, California, 92506, United States

  • Clinical Research Site

    Santa Ana, California, 92705, United States

  • Clinical Research Site

    Sherman Oaks, California, 91403, United States

  • Clinical Research Site

    Torrance, California, 90504, United States

  • Clinical Research Site

    Walnut Creek, California, 94596, United States

  • Clinical Research Site

    Colorado Springs, Colorado, 80910, United States

  • Clinical Research Site

    Clermont, Florida, 34711, United States

  • Clinical Research Site

    Doral, Florida, 33122, United States

  • Clinical Research Site

    Gainesville, Florida, 32607, United States

  • Clinical Research Site

    Jacksonville, Florida, 32256, United States

  • Clinical Research Site

    Lauderhill, Florida, 33319, United States

  • Clinical Research Site

    Miami Lakes, Florida, 33016, United States

  • Clinical Research Site

    Orlando, Florida, 32801, United States

  • Clinical Research Site

    Marietta, Georgia, 30060, United States

  • Clinical Research Site

    Overland Park, Kansas, 66210, United States

  • Clinical Research Site

    Boston, Massachusetts, 02131, United States

  • Clinical Research Site

    Saint Charles, Missouri, 63304, United States

  • Clinical Research Site

    Lincoln, Nebraska, 68526, United States

  • Clinical Research Site

    Las Vegas, Nevada, 89102, United States

  • Clinical Research Site

    Las Vegas, Nevada, 89128, United States

  • Clinical Research Site

    Berlin, New Jersey, 08009, United States

  • Clinical Research Site

    Cherry Hill, New Jersey, 08002, United States

  • Clinical Research Site

    Princeton, New Jersey, 08540, United States

  • Clinical Research Site

    Mount Kisco, New York, 10549, United States

  • Clinical Research Site

    New York, New York, 10128, United States

  • Clinical Research Site

    Raleigh, North Carolina, 27609, United States

  • Clinical Research Site

    Cincinnati, Ohio, 45219, United States

  • Clinical Research Site

    Kettering, Ohio, 45439, United States

  • Clinical Research Site

    Oklahoma City, Oklahoma, 73116, United States

  • Clinical Research Site

    Media, Pennsylvania, 19063, United States

  • Clinical Research Site

    North Charleston, South Carolina, 29405, United States

  • Clinical Research Site

    Memphis, Tennessee, 38119, United States

  • Clinical Research Site

    Austin, Texas, 78737, United States

  • Clinical Research Site

    Bellaire, Texas, 77401, United States

  • Clinical Research Site

    Dallas, Texas, 75243, United States

  • Clinical Research Site

    Dallas, Texas, 75251, United States

  • Clinical Research Site

    San Antonio, Texas, 78229, United States

  • Clinical Research Site

    Draper, Utah, 84020, United States

  • Clinical Research Site

    Everett, Washington, 98201, United States

More trials for these conditions

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