A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects with Narcolepsy Type 1 (ALKS 2680-201)

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

Phase

2

Condition

Narcolepsy

Treatment

Placebo

ALKS 2680

Clinical Study ID

NCT06358950
ALKS 2860-201
  • Ages 18-70
  • All Genders

Study Summary

The purpose of this research study is to assess the safety and efficacy of ALKS 2680 compared to placebo, including whether participants taking ALKS 2680 experience a greater decrease in sleepiness and a decrease in cataplexy ("sudden loss of muscle control"), compared to participants taking placebo alone.

Eligibility Criteria

Inclusion

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-TRguidelines. 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 ofnarcolepsy symptoms for at least 14 days and for the duration of study

  • Is willing to adhere to additional protocol requirements

Exclusion

Exclusion Criteria:

  • Significant comorbid medical conditions, including other sleep, cardiovascular,psychiatric, hepatic or other disorders may be exclusionary; eligibility will bedetermined on an individual basis by the study investigator

  • 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: 80
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
March 28, 2024
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • Alkermes Investigator Site

    Macquarie Park, New South Wales 2113
    Australia

    Active - Recruiting

  • Alkermes Investigator Site

    Bedford Park, South Australia 5042
    Australia

    Active - Recruiting

  • Alkermes Investigational Site

    Alken, 3570
    Belgium

    Active - Recruiting

  • Alkermes Investigational Site

    Brugge, 8000
    Belgium

    Active - Recruiting

  • Alkermes Investigational Site

    Namur, 5101
    Belgium

    Active - Recruiting

  • Alkermes Investigational Site

    Praha, 128 21
    Czechia

    Active - Recruiting

  • Alkermes Investigational Site

    Bordeaux, 33000
    France

    Active - Recruiting

  • Alkermes Investigational Site

    Montpellier, 34295
    France

    Active - Recruiting

  • Alkermes Investigational Site

    Bologna, 40139
    Italy

    Active - Recruiting

  • Alkermes Investigational Site

    Milano, 20127
    Italy

    Active - Recruiting

  • Alkermes Investigational Site

    Verona, 37134
    Italy

    Active - Recruiting

  • Alkermes Investigational Site

    Heemstede, 2103 SW
    Netherlands

    Active - Recruiting

  • Alkermes Investigational Site

    Zwolle, 8025 BV
    Netherlands

    Active - Recruiting

  • Alkermes Investigational Site

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Alkermes Investigational Site

    Madrid, 28043
    Spain

    Active - Recruiting

  • Alkermes Investigational Site

    Los Angeles, California 90025
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Redwood City, California 94063
    United States

    Active - Recruiting

  • Alkermes Investigator Site

    San Francisco, California 94107
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Santa Ana, California 92705
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Colorado Springs, Colorado 80918
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Brandon, Florida 33511
    United States

    Active - Recruiting

  • Alkermes Investigator Site

    Brandon, Florida 33511
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Miami, Florida 33176
    United States

    Active - Recruiting

  • Alkermes Investigator 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 Investigator Site

    Peoria, Illinois 61637
    United States

    Active - Recruiting

  • Alkermes Investigator Site

    Lansing, Michigan 48911
    United States

    Active - Recruiting

  • Alkermes Investigator Site

    Sterling Heights, Michigan 48314
    United States

    Active - Recruiting

  • Alkermes Investigator Site

    Lincoln, Nebraska 68506
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Middletown, New Jersey 07748
    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 Investigator Site

    Canton, Ohio 44718
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Cincinnati, Ohio 45245
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Dublin, Ohio 43017
    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

    Cordova, Tennessee 38108
    United States

    Site Not Available

  • Alkermes Investigator Site

    Cordova, Tennessee 38018
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    Austin, Texas 78731
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Alkermes Investigational Site

    The Woodlands, Texas 77380
    United States

    Active - Recruiting

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