A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1

Last updated: May 12, 2026
Sponsor: Alkermes, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Narcolepsy

Pain (Pediatric)

Cataplexy

Treatment

ALKS 2680 Dose 2

Placebo

ALKS 2680 Dose 1

Clinical Study ID

NCT07455383
ALKS 2680-302
  • Ages 18-70
  • All Genders

Study Summary

The purpose of this study is to measure decreases in daytime sleepiness, cataplexy (sudden loss of muscle tone), and disease symptoms in participants with NT1 when taking ALKS 2680 tablets compared with placebo tablets.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Meets the diagnostic criteria of NT1 according to ICSD-3-TR guidelines, confirmed bydiagnostic evaluations (either PSG/MSLT* or CSF hypocretin-1 level).

Exclusion

Exclusion Criteria:

  • Has another comorbid sleep disorder or condition that may influence the sleep-wakecycle.

  • Has a history or presence at Visit 1 of other clinically significant (treated oruntreated) illness, disease, abnormality, or surgical procedure that, in the opinionof the Investigator, might compromise participant safety, interfere with any studyassessment, or affect the participant's ability to complete the study.

  • Is currently enrolled in another interventional clinical trial or has received anyinvestigational drug or used any interventional investigational device within 30days prior to Visit 1. Participants previously enrolled in Study ALKS 2680-201 arenot eligible for enrollment.

  • Is currently pregnant, breastfeeding, or is planning to become pregnant during thestudy

Study Design

Total Participants: 150
Treatment Group(s): 3
Primary Treatment: ALKS 2680 Dose 2
Phase: 3
Study Start date:
April 06, 2026
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • Alkermes Investigational Site

    Brandon, Florida 33511
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Macon, Georgia 31210
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Lansing, Michigan 48911
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    St Louis, Missouri 63123
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Cincinnati, Ohio 45245
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Wyomissing, Pennsylvania 19610
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Columbia, South Carolina 29201
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Austin, Texas 78731
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Sugar Land, Texas 77478
    United States

    Active - Recruiting

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