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New pill shows promise for keeping people with narcolepsy awake longer

NCT ID NCT06767683

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This study is testing the long-term safety and how well ALKS 2680 works over time in people with narcolepsy type 1, type 2, or idiopathic hypersomnia. Participants take a once-daily tablet at different doses. The goal is to see if the drug remains safe and effective for staying awake during the day.

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 (a once-daily tablet)
What this could lead to
If successful, this could provide a long-term treatment option to help people with narcolepsy or idiopathic hypersomnia stay awake during the day.
What could go wrong
This is an extension study, so participants have already completed an earlier trial. It is still testing safety and durability, and side effects or lack of lasting benefit 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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 256 people

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

Started

Jan 2025

Expected to finish

Jun 2028

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: * Was eligible for and has completed end of treatment visit of ALKS 2680 eligible parent study in NT1, NT2 or IH. The current eligible studies are ALKS 2680-201 (Vibrance-1), ALKS 2680-202 (Vibrance-2) and ALKS 2680-203 (Vibrance-3) * Is willing and able, and in the opinion of the treating physician can safely discontinue any medications prescribed for the management of narcolepsy symptoms, as applicable, for 5 half-lives prior to Day 1 (for re-entry subjects), and for the duration of study (for all subjects) Exclusion Criteria: * Developed a new clinically significant health condition, ECG or laboratory abnormality, in the opinion of the Investigator or Sponsor, may impact the subject's participation in the study * Is currently pregnant, breastfeeding, or planning to become pregnant during the study * Is currently enrolled in another clinical study (other than the parent study) or used any investigational drug or device within 30 days prior to Screening

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Conditions

The condition(s) this trial relates to.

Disorders of Excessive Somnolence idiopathic hypersomnia narcolepsy narcolepsy without cataplexy narcolepsy-cataplexy syndrome sleep-wake disorder

As listed by the trial registrant

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

Idiopathic hypersomnia Narcolepsy type 1 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

    49 sites in 8 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

    Little Rock, Arkansas, 72211, United States

  • Alkermes Investigational Site

    RECRUITING

    Los Angeles, California, 90025, United States

  • Alkermes Investigational Site

    RECRUITING

    Stanford, California, 94305, United States

  • Alkermes Investigational Site

    RECRUITING

    Boulder, Colorado, 80309, United States

  • Alkermes Investigational Site

    RECRUITING

    Colorado Springs, Colorado, 80918, 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

    Atlanta, Georgia, 30328, United States

  • Alkermes Investigational Site

    RECRUITING

    Macon, Georgia, 31210, United States

  • Alkermes Investigational Site

    RECRUITING

    Stockbridge, Georgia, 30281, United States

  • Alkermes Investigational Site

    RECRUITING

    Peoria, Illinois, 61637, United States

  • Alkermes Investigational Site

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • Alkermes Investigational Site

    RECRUITING

    Lansing, Michigan, 48911, United States

  • Alkermes Investigational Site

    RECRUITING

    Sterling Heights, Michigan, 48314, United States

  • Alkermes Investigational Site

    RECRUITING

    Lincoln, Nebraska, 68506, United States

  • Alkermes Investigational Site

    RECRUITING

    Middletown, New Jersey, 07748, United States

  • Alkermes Investigational Site

    RECRUITING

    Denver, North Carolina, 28037, United States

  • Alkermes Investigational Site

    RECRUITING

    Huntersville, North Carolina, 28708, United States

  • Alkermes Investigational Site

    RECRUITING

    Canton, Ohio, 44718, United States

  • Alkermes Investigational Site

    RECRUITING

    Cincinnati, Ohio, 45212, United States

  • Alkermes Investigational Site

    RECRUITING

    Cincinnati, Ohio, 45245, United States

  • Alkermes Investigational Site

    RECRUITING

    Dublin, Ohio, 43017, United States

  • Alkermes Investigational Site

    RECRUITING

    Abington, Pennsylvania, 19001, 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, 53706, United States

  • Alkermes Investigational Site

    RECRUITING

    Sydney, New South Wales, 2113, Australia

  • Alkermes Investigational Site

    RECRUITING

    Bedford Park, South Australia, 5042, Australia

  • Alkermes Investigational Site

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • Alkermes Investigational Site

    RECRUITING

    Bruges, Brugge, 8000, Belgium

  • Alkermes Investigational Site

    RECRUITING

    Alken, 3570, Belgium

  • Alkermes Investigational Site

    RECRUITING

    Namur, 5101, Belgium

  • Alkermes Investigational Site

    RECRUITING

    Prague, 128 21, Czechia

  • Alkermes Investigational Site

    RECRUITING

    Montpellier, Herault, 34295, France

  • Alkermes Investigational Site

    RECRUITING

    Bordeaux, 33000, France

  • Alkermes Investigational Site

    RECRUITING

    Bologna, 40139, Italy

  • Alkermes Investigational Site

    RECRUITING

    Milan, 20127, Italy

  • Alkermes Investigational Site

    RECRUITING

    Verona, 37134, Italy

  • Alkermes Investigational Site

    RECRUITING

    Zwolle, 8025, Netherlands

  • Alkermes Investigational Site

    RECRUITING

    Madrid, Madrid, 28036, Spain

  • Alkermes Investigational Site

    RECRUITING

    Barcelona, 08036, Spain

  • Alkermes Investigational Site

    RECRUITING

    Madrid, 28043, Spain

  • Alkermes Investigator Site

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Alkermes Investigator Site

    RECRUITING

    San Francisco, California, 94158, United States

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