A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia

Last updated: October 10, 2025
Sponsor: Alkermes, Inc.
Overall Status: Active - Recruiting

Phase

2/3

Condition

Sleep Disorders

Idiopathic Hypersomnia

Narcolepsy

Treatment

ALKS 2680, 14mg

ALKS 2680, 4mg

ALKS 2680, 8mg

Clinical Study ID

NCT06767683
ALKS 2680-301
  • Ages 18-70
  • All Genders

Study Summary

The purpose of this study is to continue to measure the safety, tolerability, and durability of treatment effect in subjects with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), or Idiopathic Hypersomnia (IH) when taking ALKS 2680 tablets.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Was eligible for and has completed end of treatment visit of ALKS 2680 eligibleparent 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 safelydiscontinue any medications prescribed for the management of narcolepsy symptoms, asapplicable, for 5 half-lives prior to Day 1 (for re-entry subjects), and for theduration of study (for all subjects)

Exclusion

Exclusion Criteria:

  • Developed a new clinically significant health condition, ECG or laboratoryabnormality, in the opinion of the Investigator or Sponsor, may impact the subject'sparticipation in the study

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

  • Is currently enrolled in another clinical study (other than the parent study) orused any investigational drug or device within 30 days prior to Screening

Study Design

Total Participants: 256
Treatment Group(s): 6
Primary Treatment: ALKS 2680, 14mg
Phase: 2/3
Study Start date:
January 27, 2025
Estimated Completion Date:
June 30, 2028

Connect with a study center

  • Alkermes Investigational Site

    Sydney, New South Wales 2113
    Australia

    Site Not Available

  • Alkermes Investigational Site

    Sydney 2147714, New South Wales 2155400 2113
    Australia

    Active - Recruiting

  • Alkermes Investigational Site

    Bedford Park, South Australia 5042
    Australia

    Site Not Available

  • Alkermes Investigational Site

    Bedford Park 2076918, South Australia 2061327 5042
    Australia

    Active - Recruiting

  • Alkermes Investigational Site

    Bruges 2800931, Brugge 8000
    Belgium

    Active - Recruiting

  • Alkermes Investigational Site

    Alken, 3570
    Belgium

    Site Not Available

  • Alkermes Investigational Site

    Alken 2803285, 3570
    Belgium

    Active - Recruiting

  • Alkermes Investigational Site

    Namur, 5101
    Belgium

    Site Not Available

  • Alkermes Investigational Site

    Namur 2790471, 5101
    Belgium

    Active - Recruiting

  • Alkermes Investigational Site

    Prague 3067696, 128 21
    Czechia

    Active - Recruiting

  • Alkermes Investigational Site

    Praha, 128 21
    Czechia

    Site Not Available

  • Alkermes Investigational Site

    Montpellier, Herault 34295
    France

    Site Not Available

  • Alkermes Investigational Site

    Montpellier 2992166, Herault 34295
    France

    Active - Recruiting

  • Alkermes Investigational Site

    Bordeaux, 33000
    France

    Site Not Available

  • Alkermes Investigational Site

    Bordeaux 3031582, 33000
    France

    Active - Recruiting

  • Alkermes Investigational Site

    Bologna, 40139
    Italy

    Site Not Available

  • Alkermes Investigational Site

    Bologna 3181928, 40139
    Italy

    Active - Recruiting

  • Alkermes Investigational Site

    Milan 6951411, 20127
    Italy

    Active - Recruiting

  • Alkermes Investigational Site

    Milano, 20127
    Italy

    Site Not Available

  • Alkermes Investigational Site

    Verona, 37134
    Italy

    Site Not Available

  • Alkermes Investigational Site

    Verona 3164527, 37134
    Italy

    Active - Recruiting

  • Alkermes Investigational Site

    Zwolle, 8025
    Netherlands

    Site Not Available

  • Alkermes Investigational Site

    Zwolle 2743477, 8025
    Netherlands

    Active - Recruiting

  • Alkermes Investigational Site

    Barcelona, 08036
    Spain

    Site Not Available

  • Alkermes Investigational Site

    Barcelona 3128760, 08036
    Spain

    Active - Recruiting

  • Alkermes Investigational Site

    Madrid, 28043
    Spain

    Site Not Available

  • Alkermes Investigational Site

    Madrid 3117735, 28043
    Spain

    Active - Recruiting

  • Alkermes Investigator Site

    Phoenix 5308655, Arizona 5551752 85054
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • Alkermes Investigational Site

    Little Rock 4119403, Arkansas 4099753 72211
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Los Angeles, California 90025
    United States

    Site Not Available

  • Alkermes Investigational Site

    Stanford, California 94305
    United States

    Site Not Available

  • Alkermes Investigational Site

    Los Angeles 5368361, California 5332921 90025
    United States

    Active - Recruiting

  • Alkermes Investigator Site

    San Francisco 5391959, California 5332921 94158
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Stanford 5398563, California 5332921 94305
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Colorado Springs, Colorado 80918
    United States

    Site Not Available

  • Alkermes Investigational Site

    Colorado Springs 5417598, Colorado 5417618 80918
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Brandon, Florida 33511
    United States

    Site Not Available

  • Alkermes Investigational Site

    Miami, Florida 33176
    United States

    Site Not Available

  • Alkermes Investigational Site

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Alkermes Investigational Site

    Brandon 4148757, Florida 4155751 33511
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Miami 4164138, Florida 4155751 33176
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Winter Park 4178560, Florida 4155751 32789
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • Alkermes Investigational Site

    Macon, Georgia 31210
    United States

    Site Not Available

  • Alkermes Investigational Site

    Stockbridge, Georgia 30281
    United States

    Site Not Available

  • Alkermes Investigational Site

    Atlanta 4180439, Georgia 4197000 30328
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Macon 4207400, Georgia 4197000 31210
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Stockbridge 4224681, Georgia 4197000 30281
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Peoria, Illinois 61637
    United States

    Site Not Available

  • Alkermes Investigational Site

    Peoria 4905687, Illinois 4896861 61637
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Lansing, Michigan 48911
    United States

    Site Not Available

  • Alkermes Investigational Site

    Sterling Heights, Michigan 48314
    United States

    Site Not Available

  • Alkermes Investigational Site

    Lansing 4998830, Michigan 5001836 48911
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Sterling Heights 5011148, Michigan 5001836 48314
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Lincoln, Nebraska 68506
    United States

    Site Not Available

  • Alkermes Investigational Site

    Lincoln 5072006, Nebraska 5073708 68506
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Middletown, New Jersey 07748
    United States

    Site Not Available

  • Alkermes Investigational Site

    Middletown 5101170, New Jersey 5101760 07748
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Denver, North Carolina 28037
    United States

    Site Not Available

  • Alkermes Investigational Site

    Huntersville, North Carolina 28708
    United States

    Site Not Available

  • Alkermes Investigational Site

    Denver 4463523, North Carolina 4482348 28037
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Huntersville 4472370, North Carolina 4482348 28708
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Canton, Ohio 44718
    United States

    Site Not Available

  • Alkermes Investigational Site

    Cincinnati, Ohio 45212
    United States

    Site Not Available

  • Alkermes Investigational Site

    Dublin, Ohio 43017
    United States

    Site Not Available

  • Alkermes Investigational Site

    Canton 5149222, Ohio 5165418 44718
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Cincinnati 4508722, Ohio 5165418 45245
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Dublin 5152333, Ohio 5165418 43017
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Abington, Pennsylvania 19001
    United States

    Site Not Available

  • Alkermes Investigational Site

    Wyomissing, Pennsylvania 19610
    United States

    Site Not Available

  • Alkermes Investigational Site

    Abington 5177773, Pennsylvania 6254927 19001
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Wyomissing 5220248, Pennsylvania 6254927 19610
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Columbia, South Carolina 29201
    United States

    Site Not Available

  • Alkermes Investigational Site

    Columbia 4575352, South Carolina 4597040 29201
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Austin, Texas 78731
    United States

    Site Not Available

  • Alkermes Investigational Site

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Alkermes Investigational Site

    Sugar Land, Texas 77478
    United States

    Site Not Available

  • Alkermes Investigational Site

    Austin 4671654, Texas 4736286 78731
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    San Antonio 4726206, Texas 4736286 78229
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Sugar Land 4734825, Texas 4736286 77478
    United States

    Active - Recruiting

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