Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New pill aims to keep narcolepsy patients awake and steady

NCT ID NCT07540897

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 5 times

Summary

This phase 3 trial tests whether a daily tablet called ALKS 2680 can reduce severe daytime sleepiness and sudden muscle weakness (cataplexy) in adults with narcolepsy type 1. About 150 participants will receive either the drug or a placebo for 12 weeks. The study measures improvements in staying awake and overall symptom severity.

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 excessive daytime sleepiness and sudden muscle weakness in people with narcolepsy type 1.
What could go wrong
This is a phase 3 trial, but it is still experimental. The drug may not work better than a placebo, and side effects are possible. It is not a cure, and long-term safety is not yet known.

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

Aug 2026

Expected to finish

Jul 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Narcolepsy type 1 are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Disorders of Excessive Somnolence narcolepsy-cataplexy syndrome sleep-wake disorder Sleepiness

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

    17 sites in 3 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

    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

    Lansing, Michigan, 48911, United States

  • Alkermes Investigational Site

    RECRUITING

    St Louis, Missouri, 63123, 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

    Colombia, South Carolina, 29201, United States

  • Alkermes Investigational Site

    RECRUITING

    Dallas, Texas, 75251, 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

    Markham, Ontario, L3R 1A3, Canada

  • Alkermes Investigational Site

    RECRUITING

    Toronto, Ontario, M5S 3A3, Canada

  • Alkermes Investigational Site

    RECRUITING

    Krakow, 30-105, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.