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

Last updated: April 3, 2025
Sponsor: Alkermes, Inc.
Overall Status: Active - Recruiting

Phase

2/3

Condition

Sleep Disorders

Narcolepsy

Idiopathic Hypersomnia

Treatment

ALKS 2680, 14mg

ALKS 2680, 4mg

ALKS 2680, 10mg

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) or Narcolepsy Type 2 (NT2) 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:
November 30, 2027

Connect with a study center

  • Alkermes Investigational Site

    Brandon, Florida 33511
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Winter Park, Florida 32789
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Atlanta, Georgia 30328
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Macon, Georgia 31210
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Stockbridge, Georgia 30281
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Denver, North Carolina 28037
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Huntersville, North Carolina 28708
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Cincinnati, Ohio 45212
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Dublin, Ohio 43017
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Columbia, South Carolina 29201
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    San Antonio, Texas 78229
    United States

    Active - Recruiting

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