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New drug shows promise for reducing narcolepsy attacks over the long term

NCT ID NCT05113745

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study looked at the long-term safety and effectiveness of a drug called AXS-12 for people with narcolepsy who also have sudden muscle weakness (cataplexy) and severe daytime sleepiness. 68 people who had already completed an earlier study took AXS-12 and were monitored for side effects and changes in how often they had cataplexy attacks. The goal was to see if the drug remains safe and helpful over time.

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

68 people

The number who actually took part.

Started

Oct 2021

Finished

Nov 2024

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

15 to 75 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: * Completed the treatment period of Study AXS-12-301 * Willing and able to comply with the study requirements Exclusion Criteria: * Significant change in medical history or concomitant medications since enrolling in the AXS-12-301 study which, in the opinion of the Investigator, would render the subject unsuitable to receive AXS-12

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Conditions

The condition(s) this trial relates to.

Cataplexy Disorders of Excessive Somnolence hypersomnia narcolepsy narcolepsy 1

As listed by the trial registrant

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

Cataplexy Excessive daytime sleepiness Narcolepsy

Contacts and locations

Locations

  • Clinical Research Site

    Phoenix, Arizona, 85054, United States

  • Clinical Research Site

    Boulder, Colorado, 80301, United States

  • Clinical Research Site

    Colorado Springs, Colorado, 80918, United States

  • Clinical Research Site

    Brandon, Florida, 33511, United States

  • Clinical Research Site

    Clearwater, Florida, 33765, United States

  • Clinical Research Site

    Doral, Florida, 33122, United States

  • Clinical Research Site

    Miami Lakes, Florida, 33016, United States

  • Clinical Research Site

    Winter Park, Florida, 32789, United States

  • Clinical Research Site

    Atlanta, Georgia, 30315, United States

  • Clinical Research Site

    Atlanta, Georgia, 30328, United States

  • Clinical Research Site

    Stockbridge, Georgia, 30281, United States

  • Clinical Research Site

    Chevy Chase, Maryland, 20815, United States

  • Clinical Research Site

    Kalamazoo, Michigan, 49008, United States

  • Clinical Research Site

    Novi, Michigan, 48377, United States

  • Clinical Research Site

    Neptune City, New Jersey, 07753, United States

  • Clinical Research Site

    Denver, North Carolina, 28037, United States

  • Clinical Research Site

    Gastonia, North Carolina, 28054, United States

  • Clinical Research Site

    Huntersville, North Carolina, 28078, United States

  • Clinical Research Site

    Cincinnati, Ohio, 45245, United States

  • Clinical Research Site

    Wyomissing, Pennsylvania, 19610, United States

  • Clinical Research Site

    Charleston, South Carolina, 29425, United States

  • Clinical Research Site

    Columbia, South Carolina, 29201, United States

  • Clinical Research Site

    Austin, Texas, 78731, United States

  • Clinical Research Site

    San Antonio, Texas, 78229, United States

  • Clinical Research Site

    Toronto, Ontario, M5S 3A3, Canada

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