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New pill aims to fight daytime sleepiness and sudden muscle collapse

NCT ID NCT07455383

Symptom relief Sponsor: Alkermes, 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 04, 2026 · Updated 6 times

Summary

This phase 3 trial tests whether a daily tablet called ALKS 2680 can reduce daytime sleepiness and cataplexy (sudden muscle weakness) in 150 adults with narcolepsy type 1. Participants will take the drug or a placebo for 12 weeks, and researchers will measure changes in sleep tests and symptom reports.

What this could mean

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

Active substance
ALKS 2680 (alixorexton) tablets
What this could lead to
If successful, this could provide a new daily medication to better control sleepiness and sudden muscle weakness in people with narcolepsy type 1.
What could go wrong
This is still an experimental drug; it may not work better than a placebo, and side effects are possible. The trial is relatively small (150 people) and lasts only 12 weeks.

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 150 people

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

Started

Apr 2026

Expected to finish

Jun 2027

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 70 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 the diagnostic criteria of NT1 according to ICSD-3-TR guidelines, confirmed by diagnostic evaluations (either PSG/MSLT\* or CSF hypocretin-1 level). Exclusion Criteria: * Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle. * Has a history or presence at Visit 1 of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure that, in the opinion of the Investigator, might compromise participant safety, interfere with any study assessment, or affect the participant's ability to complete the study. * Is currently enrolled in another interventional clinical trial or has received any investigational drug or used any interventional investigational device within 30 days prior to Visit 1. Participants previously enrolled in Study ALKS 2680-201 are not eligible for enrollment. * Is currently pregnant, breastfeeding, or is planning to become pregnant during the study

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Conditions

The condition(s) this trial relates to.

Cataplexy Disorders of Excessive Somnolence Fatigue narcolepsy narcolepsy-cataplexy syndrome sleep-wake disorder

As listed by the trial registrant

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

Narcolepsy type 1

How to take part

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

  1. The places running it

    42 sites in 9 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

  • Alkermes Investigational Site

    RECRUITING

    Cullman, Alabama, 35055, United States

  • Alkermes Investigational Site

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Alkermes Investigational Site

    RECRUITING

    Los Angeles, California, 90025, United States

  • Alkermes Investigational Site

    RECRUITING

    Boulder, Colorado, 80301, United States

  • Alkermes Investigational Site

    RECRUITING

    Brandon, Florida, 33511, United States

  • Alkermes Investigational Site

    RECRUITING

    Miami, Florida, 33176, United States

  • Alkermes Investigational Site

    RECRUITING

    Winter Park, Florida, 32789, United States

  • Alkermes Investigational Site

    RECRUITING

    Macon, Georgia, 31210, United States

  • Alkermes Investigational Site

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • Alkermes Investigational Site

    RECRUITING

    Newton, Massachusetts, 02459, United States

  • Alkermes Investigational Site

    RECRUITING

    Lansing, Michigan, 48911, United States

  • Alkermes Investigational Site

    RECRUITING

    Novi, Michigan, 48377, United States

  • Alkermes Investigational Site

    RECRUITING

    St Louis, Missouri, 63123, United States

  • Alkermes Investigational Site

    RECRUITING

    Middletown, New Jersey, 07748, United States

  • Alkermes Investigational Site

    RECRUITING

    Charlotte, North Carolina, 28210, United States

  • Alkermes Investigational Site

    RECRUITING

    Cincinnati, Ohio, 45245, United States

  • Alkermes Investigational Site

    RECRUITING

    Wyomissing, Pennsylvania, 19610, United States

  • Alkermes Investigational Site

    RECRUITING

    Columbia, South Carolina, 29201, United States

  • Alkermes Investigational Site

    RECRUITING

    Austin, Texas, 78731, United States

  • Alkermes Investigational Site

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Alkermes Investigational Site

    RECRUITING

    Sugar Land, Texas, 77478, United States

  • Alkermes Investigational Site

    RECRUITING

    Madison, Wisconsin, 53792, United States

  • Alkermes Investigational Site

    RECRUITING

    Macquarie Park, New South Wales, 2113, Australia

  • Alkermes Investigational Site

    RECRUITING

    Bruges, 8000, Belgium

  • Alkermes Investigational Site

    RECRUITING

    Edegem, 2650, Belgium

  • Alkermes Investigational Site

    RECRUITING

    Namur, Belgium

  • Alkermes Investigational Site

    RECRUITING

    Markham, Ontario, L3R 1A3, Canada

  • Alkermes Investigational Site

    RECRUITING

    Toronto, Ontario, M5S 3A3, Canada

  • Alkermes Investigational Site

    RECRUITING

    Bordeaux, France

  • Alkermes Investigational Site

    RECRUITING

    Lyon, France

  • Alkermes Investigational Site

    RECRUITING

    Montpellier, France

  • Alkermes Investigational Site

    RECRUITING

    Verona, 37134, Italy

  • Alkermes Investigational Site

    RECRUITING

    Kitakyushu-shi, Fukuoka, 802-0084, Japan

  • Alkermes Investigational Site

    RECRUITING

    Osaka, Osaka, 532-0003, Japan

  • Alkermes Investigational Site

    RECRUITING

    Shibuya-ku, Tokyo-To, 151-0053, Japan

  • Alkermes Investigational Site

    RECRUITING

    Shinjuku-Ku, Tokyo-To, 162-0851, Japan

  • Alkermes Investigational Site

    RECRUITING

    Kumamoto, 862-0954, Japan

  • Alkermes Investigational Site

    RECRUITING

    Zwolle, Overijssel, 8011, Netherlands

  • Alkermes Investigational Site

    RECRUITING

    Heeze, 5591 VE, Netherlands

  • Alkermes Investigational Site

    RECRUITING

    Vitoria-Gasteiz, Alava, 01004, Spain

  • Alkermes Investigational Site

    RECRUITING

    Barcelona, Barcelona, 08036, Spain

  • Alkermes Investigational Site

    RECRUITING

    Madrid, 28043, Spain

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