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New pill aims to fight excessive daytime sleepiness

NCT ID NCT06843590

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests a new drug called ALKS 2680 to see if it can safely reduce daytime sleepiness in people with idiopathic hypersomnia, a condition causing excessive sleepiness without clear cause. About 126 participants will receive either the drug or a placebo daily for 8 weeks. Researchers will measure changes in sleepiness using standard questionnaires.

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
What this could lead to
If it works, this could lead to a new treatment option to reduce excessive daytime sleepiness in people with idiopathic hypersomnia.
What could go wrong
This is an early Phase 2 trial with only 126 participants, so results may not confirm effectiveness or safety. The drug may cause side effects or fail to improve sleepiness compared to placebo.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 126 people

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

Started

May 2025

Expected to finish

Nov 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 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: 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 Idiopathic Hypersomnia according to ICSD-3-TR guidelines, confirmed by the diagnostic evaluations (PSG/MSLT/actigraphy) within the previous 10 years 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 subject safety, interfere with any study assessment, or affect the subject's ability to complete the study * Is currently enrolled in another clinical study or used any investigational drug or device within 30 days prior to Visit 1 * 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 idiopathic hypersomnia sleep-wake disorder

As listed by the trial registrant

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

Idiopathic hypersomnia

How to take part

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

  1. The places running it

    50 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

    Boulder, Colorado, 80301, United States

  • Alkermes Investigational Site

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Alkermes Investigator Site

    RECRUITING

    Cullman, Alabama, 35055, United States

  • Alkermes Investigator Site

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Alkermes Investigator Site

    RECRUITING

    Little Rock, Arkansas, 72211, United States

  • Alkermes Investigator Site

    RECRUITING

    Los Angeles, California, 90025, United States

  • Alkermes Investigator Site

    RECRUITING

    Redwood City, California, 94063, United States

  • Alkermes Investigator Site

    RECRUITING

    San Francisco, California, 94143, United States

  • Alkermes Investigator Site

    RECRUITING

    Colorado Springs, Colorado, 80918, United States

  • Alkermes Investigator Site

    RECRUITING

    Brandon, Florida, 33511, United States

  • Alkermes Investigator Site

    RECRUITING

    Miami, Florida, 33176, United States

  • Alkermes Investigator Site

    RECRUITING

    Winter Park, Florida, 32789, United States

  • Alkermes Investigator Site

    RECRUITING

    Atlanta, Georgia, 30328, United States

  • Alkermes Investigator Site

    RECRUITING

    Macon, Georgia, 31210, United States

  • Alkermes Investigator Site

    RECRUITING

    Stockbridge, Georgia, 30281, United States

  • Alkermes Investigator Site

    RECRUITING

    Peoria, Illinois, 61637, United States

  • Alkermes Investigator Site

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • Alkermes Investigator Site

    RECRUITING

    Lansing, Michigan, 48911, United States

  • Alkermes Investigator Site

    RECRUITING

    Lincoln, Nebraska, 68506, United States

  • Alkermes Investigator Site

    RECRUITING

    Middletown, New Jersey, 07748, United States

  • Alkermes Investigator Site

    RECRUITING

    Denver, North Carolina, 28037, United States

  • Alkermes Investigator Site

    RECRUITING

    Huntersville, North Carolina, 28078, United States

  • Alkermes Investigator Site

    RECRUITING

    Canton, Ohio, 44718, United States

  • Alkermes Investigator Site

    RECRUITING

    Cincinnati, Ohio, 45245, United States

  • Alkermes Investigator Site

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Alkermes Investigator Site

    RECRUITING

    Danville, Pennsylvania, 17822, United States

  • Alkermes Investigator Site

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Alkermes Investigator Site

    RECRUITING

    Wyomissing, Pennsylvania, 19610, United States

  • Alkermes Investigator Site

    RECRUITING

    Columbia, South Carolina, 29201, United States

  • Alkermes Investigator Site

    RECRUITING

    Austin, Texas, 78731, United States

  • Alkermes Investigator Site

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Alkermes Investigator Site

    RECRUITING

    Sugar Land, Texas, 77478, United States

  • Alkermes Investigator Site

    RECRUITING

    Sugarland, Texas, 77478, United States

  • Alkermes Investigator Site

    RECRUITING

    Madison, Wisconsin, 53792, United States

  • Alkermes Investigator Site

    RECRUITING

    Sydney, New South Wales, 2113, Australia

  • Alkermes Investigator Site

    RECRUITING

    Bedford Park, South Australia, 5042, Australia

  • Alkermes Investigator Site

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • Alkermes Investigator Site

    RECRUITING

    Alken, 3570, Belgium

  • Alkermes Investigator Site

    RECRUITING

    Namur, 5101, Belgium

  • Alkermes Investigator Site

    RECRUITING

    Prague, 128 21, Czechia

  • Alkermes Investigator Site

    RECRUITING

    Bordeaux, Gironde, 33000, France

  • Alkermes Investigator Site

    RECRUITING

    Montpellier, Herault, 34295, France

  • Alkermes Investigator Site

    RECRUITING

    Grenoble, Isere, 38043, France

  • Alkermes Investigator Site

    RECRUITING

    Bologna, 40139, Italy

  • Alkermes Investigator Site

    RECRUITING

    Milan, 20127, Italy

  • Alkermes Investigator Site

    RECRUITING

    Verona, 37134, Italy

  • Alkermes Investigator Site

    RECRUITING

    Zwolle, 8025 BV, Netherlands

  • Alkermes Investigator Site

    RECRUITING

    Barcelona, 8036, Spain

  • Alkermes Investigator Site

    RECRUITING

    Madrid, 28036, Spain

  • Alkermes Investigator Site

    RECRUITING

    Madrid, 28043, Spain

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