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New narcolepsy drug shows promise in reducing sudden sleep attacks and muscle collapse

NCT ID NCT06358950

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a new medicine called ALKS 2680 in 92 adults with narcolepsy type 1, a condition that causes severe daytime sleepiness and sudden muscle weakness (cataplexy). Participants stopped their usual narcolepsy medications and received either ALKS 2680 or a placebo for several weeks. The goal was to see if the drug helps people stay awake longer and have fewer cataplexy episodes.

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

92 people

The number who actually took part.

Started

Mar 2024

Finished

Jul 2025

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: * 18-70 years of age * Has a BMI ≥18 and ≤40 kg/m2 * Meets the diagnostic criteria of Narcolepsy type 1 according to ICSD-3-TR guidelines. Additionally, meets the following criteria: * Is HLA-DQB1\*06:02-positive * Has residual excessive daytime sleepiness and cataplexy * Is willing and able to discontinue any medications prescribed for the management of narcolepsy symptoms for at least 14 days and for the duration of study * Is willing to adhere to additional protocol requirements Exclusion Criteria: * Significant comorbid medical conditions, including other sleep, cardiovascular, psychiatric, hepatic or other disorders may be exclusionary; eligibility will be determined on an individual basis by the study investigator * 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.

Cataplexy narcolepsy narcolepsy-cataplexy syndrome

As listed by the trial registrant

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

Narcolepsy type 1

Contacts and locations

Locations

  • Alkermes Investigational Site

    Los Angeles, California, 90025, United States

  • Alkermes Investigational Site

    Redwood City, California, 94063, United States

  • Alkermes Investigational Site

    Santa Ana, California, 92705, United States

  • Alkermes Investigational Site

    Aurora, Colorado, 80045, United States

  • Alkermes Investigational Site

    Colorado Springs, Colorado, 80918, United States

  • Alkermes Investigational Site

    Brandon, Florida, 33511, United States

  • Alkermes Investigational Site

    Miami, Florida, 33176, United States

  • Alkermes Investigational Site

    Atlanta, Georgia, 30328, United States

  • Alkermes Investigational Site

    Macon, Georgia, 31210, United States

  • Alkermes Investigational Site

    Stockbridge, Georgia, 30281, United States

  • Alkermes Investigational Site

    Middletown, New Jersey, 07748, United States

  • Alkermes Investigational Site

    Denver, North Carolina, 28037, United States

  • Alkermes Investigational Site

    Huntersville, North Carolina, 28708, United States

  • Alkermes Investigational Site

    Cincinnati, Ohio, 45227, United States

  • Alkermes Investigational Site

    Cincinnati, Ohio, 45245, United States

  • Alkermes Investigational Site

    Dublin, Ohio, 43017, United States

  • Alkermes Investigational Site

    Wyomissing, Pennsylvania, 19610, United States

  • Alkermes Investigational Site

    Columbia, South Carolina, 29201, United States

  • Alkermes Investigational Site

    Austin, Texas, 78731, United States

  • Alkermes Investigational Site

    San Antonio, Texas, 78229, United States

  • Alkermes Investigational Site

    The Woodlands, Texas, 77380, United States

  • Alkermes Investigational Site

    Alken, 3570, Belgium

  • Alkermes Investigational Site

    Bruges, 8000, Belgium

  • Alkermes Investigational Site

    Namur, 5101, Belgium

  • Alkermes Investigational Site

    Prague, 128 21, Czechia

  • Alkermes Investigational Site

    Bordeaux, 33000, France

  • Alkermes Investigational Site

    Montpellier, 34295, France

  • Alkermes Investigational Site

    Bologna, 40139, Italy

  • Alkermes Investigational Site

    Milan, 20127, Italy

  • Alkermes Investigational Site

    Verona, 37134, Italy

  • Alkermes Investigational Site

    Heemstede, 2103 SW, Netherlands

  • Alkermes Investigational Site

    Zwolle, 8025 BV, Netherlands

  • Alkermes Investigational Site

    Barcelona, 08036, Spain

  • Alkermes Investigational Site

    Madrid, 28036, Spain

  • Alkermes Investigational Site

    Madrid, 28043, Spain

  • Alkermes Investigator Site

    San Francisco, California, 94107, United States

  • Alkermes Investigator Site

    Brandon, Florida, 33511, United States

  • Alkermes Investigator Site

    Winter Park, Florida, 32789, United States

  • Alkermes Investigator Site

    Peoria, Illinois, 61637, United States

  • Alkermes Investigator Site

    Lansing, Michigan, 48911, United States

  • Alkermes Investigator Site

    Sterling Heights, Michigan, 48314, United States

  • Alkermes Investigator Site

    Lincoln, Nebraska, 68506, United States

  • Alkermes Investigator Site

    Canton, Ohio, 44718, United States

  • Alkermes Investigator Site

    Macquarie Park, New South Wales, 2113, Australia

  • Alkermes Investigator Site

    Bedford Park, South Australia, 5042, Australia

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