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New narcolepsy pill aims to banish daytime drowsiness

NCT ID NCT07502443

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 04, 2026 · Updated 4 times

Summary

This study tests a new tablet called ALKS 2680 to see if it can reduce daytime sleepiness in adults with narcolepsy type 2. About 176 participants will receive either the study drug or a placebo for 12 weeks. The main goal is to measure how well they can stay awake using a standard wakefulness test.

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 176 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: * Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including the following: lifestyle considerations and restrictions, adherence to contraception guidance, adherence to actigraphy and diary requirements, if receiving treatment for OSA, adherence to primary OSA therapy over the 30 days prior to Visit 1, and throughout the study, including during overnight visits. * Meets the diagnostic criteria of NT2 according to ICSD-3-TR guidelines, confirmed by diagnostic evaluations (either PSG/MSLT). Exclusion Criteria: * Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle. * Has a history or presence 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 2680-202 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.

Disorders of Excessive Somnolence narcolepsy without cataplexy sleep-wake disorder

As listed by the trial registrant

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

Narcolepsy type 2

How to take part

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

  1. The places running it

    38 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

    Maimi, 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

    Stockbridge, Georgia, 30281, United States

  • Alkermes Investigational Site

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • Alkermes Investigational Site

    RECRUITING

    Newton, Massachusetts, 02459, United States

  • Alkermes Investigational Site

    NOT_YET_RECRUITING

    Lansing, Michigan, 48911, United States

  • Alkermes Investigational Site

    RECRUITING

    Novi, Michigan, 48377, United States

  • Alkermes Investigational Site

    RECRUITING

    Charlotte, North Carolina, 28210, United States

  • Alkermes Investigational Site

    RECRUITING

    Huntersville, North Carolina, 28078, 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

    Frisco, Texas, 75033, 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

    Sydney, New Sout, 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

    Bologna, 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

    Heeze, Netherlands

  • Alkermes Investigational Site

    RECRUITING

    Barcelona, Spain

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