Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug aims to keep night shift workers awake and safe

NCT ID NCT06568367

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 24, 2026 · Updated 3 times

Summary

This Phase 3 trial tests whether the drug solriamfetol can reduce excessive sleepiness in people with shift work disorder. About 520 adults who work night shifts will take either solriamfetol or a placebo daily for 12 weeks. The study measures how well they stay awake and their overall sleepiness levels.

What this could mean

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

Active substance
Solriamfetol (a medication that promotes wakefulness)
What this could lead to
If successful, this could provide a new treatment option to help people with shift work disorder stay awake and alert during night shifts.
What could go wrong
This is a Phase 3 trial, but solriamfetol is already approved for other sleep conditions. However, it may not work for everyone, and side effects like headache or nausea are possible.

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 520 people

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

Started

Aug 2024

Expected to finish

Dec 2026

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

18 to 65 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: * Meets International Classification of Sleep Disorders, Third Edition (ICSD-3) criteria for Shift Work Disorder (SWD) * Provides written informed consent to participate in the study before the conduct of any study procedures. * Male or female, aged 18 to 65 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Excessive sleepiness are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

circadian rhythm sleep disorder circadian rhythm sleep disorder, shift work type Disorders of Excessive Somnolence hypersomnia insomnia

As listed by the trial registrant

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

Excessive sleepiness Shift work disorder

How to take part

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

  1. The places running it

    46 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

  • Clinical Research Site

    RECRUITING

    Auburn, Alabama, 36832, United States

  • Clinical Research Site

    RECRUITING

    Cullman, Alabama, 35055, United States

  • Clinical Research Site

    RECRUITING

    Chandler, Arizona, 85224, United States

  • Clinical Research Site

    WITHDRAWN

    Tucson, Arizona, 85704, United States

  • Clinical Research Site

    RECRUITING

    Little Rock, Arkansas, 72211, United States

  • Clinical Research Site

    RECRUITING

    Anaheim, California, 92801, United States

  • Clinical Research Site

    RECRUITING

    Cerritos, California, 90703, United States

  • Clinical Research Site

    TERMINATED

    Chula Vista, California, 91910, United States

  • Clinical Research Site

    RECRUITING

    Huntington Beach, California, 92647, United States

  • Clinical Research Site

    RECRUITING

    Long Beach, California, 90805, United States

  • Clinical Research Site

    RECRUITING

    Santa Ana, California, 92705, United States

  • Clinical Research Site

    RECRUITING

    Colorado Springs, Colorado, 80918, United States

  • Clinical Research Site

    RECRUITING

    Brandon, Florida, 33511, United States

  • Clinical Research Site

    RECRUITING

    Hialeah, Florida, 33016, United States

  • Clinical Research Site

    RECRUITING

    Miami, Florida, 33135, United States

  • Clinical Research Site

    WITHDRAWN

    Miami, Florida, 33144, United States

  • Clinical Research Site

    RECRUITING

    Miami, Florida, 33176, United States

  • Clinical Research Site

    RECRUITING

    Miami Lakes, Florida, 33016, United States

  • Clinical Research Site

    RECRUITING

    Atlanta, Georgia, 30238, United States

  • Clinical Research Site

    RECRUITING

    Stockbridge, Georgia, 30281, United States

  • Clinical Research Site

    RECRUITING

    Chicago, Illinois, 60634, United States

  • Clinical Research Site

    RECRUITING

    Kenner, Louisiana, 70065, United States

  • Clinical Research Site

    RECRUITING

    Towson, Maryland, 21286, United States

  • Clinical Research Site

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Clinical Research Site

    RECRUITING

    Lansing, Michigan, 48911, United States

  • Clinical Research Site

    RECRUITING

    Novi, Michigan, 48377, United States

  • Clinical Research Site

    RECRUITING

    Southfield, Michigan, 48075, United States

  • Clinical Research Site

    RECRUITING

    Chesterfield, Missouri, 63017, United States

  • Clinical Research Site

    RECRUITING

    St Louis, Missouri, 63123, United States

  • Clinical Research Site

    RECRUITING

    Henderson, Nevada, 89052, United States

  • Clinical Research Site

    RECRUITING

    Middletown, New Jersey, 07748, United States

  • Clinical Research Site

    RECRUITING

    Denver, North Carolina, 28037, United States

  • Clinical Research Site

    RECRUITING

    Fayetteville, North Carolina, 28304, United States

  • Clinical Research Site

    RECRUITING

    Huntersville, North Carolina, 28078, United States

  • Clinical Research Site

    RECRUITING

    Cincinnati, Ohio, 45212, United States

  • Clinical Research Site

    RECRUITING

    Cincinnati, Ohio, 45245, United States

  • Clinical Research Site

    RECRUITING

    Wyomissing, Pennsylvania, 19610, United States

  • Clinical Research Site

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Clinical Research Site

    RECRUITING

    Columbia, South Carolina, 29201, United States

  • Clinical Research Site

    RECRUITING

    Houston, Texas, 77058, United States

  • Clinical Research Site

    RECRUITING

    Houston, Texas, 77070, United States

  • Clinical Research Site

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Clinical Research Site

    RECRUITING

    Sugar Land, Texas, 77478, United States

  • Clinical Research Site

    RECRUITING

    Spokane, Washington, 99204, United States

  • Clinical Research Site

    RECRUITING

    Calgary, Alberta, T2Z 3A6, Canada

  • Clinical Research Site

    RECRUITING

    Markham, Ontario, L3R 1A3, Canada

  • Clinical Research Site

    RECRUITING

    Ottawa, Ontario, K2C 0P7, Canada

  • Clinical Research Site

    RECRUITING

    Toronto, Ontario, M4N 4M5, Canada

  • Clinical Research Site

    RECRUITING

    Toronto, Ontario, M5S 3A3, Canada

More trials for these conditions

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