Under construction – not a live service
Sign in
CompletedPhase 2

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

Key facts

Who runs it
Alkermes, Inc.
Where
Atlanta, Aurora, Austin, Brandon, Canton, Cincinnati, Colorado Springs, Columbia, Denver, Dublin, Huntersville, Lansing, Lincoln, Los Angeles, Macon, Miami, Middletown, Peoria, Redwood City, San Antonio, San Francisco, Santa Ana, Sterling Heights, Stockbridge, The Woodlands, Winter Park, and Wyomissing, United StatesSee the 28 sitesAlso in 7 other countries, 17 sites
Status
Completed
Phase
Phase 2
People taking part
92 people enrolled
Started
24 Mar 2024
Ended
31 Jul 2025
Type of study
Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • ALKS 2680
  • Placebo
Record updated
10 June 2026

Who can take part

Age
18 years to 70 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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

Where in United States

Also in 7 other countries, 17 sites

  • Atlanta, GeorgiaHospital not named in the registryNo longer taking part
  • Aurora, ColoradoHospital not named in the registryNo longer taking part
  • Austin, TexasHospital not named in the registryNo longer taking part
  • Brandon, FloridaHospital not named in the registryNo longer taking part
  • Brandon, FloridaHospital not named in the registryNo longer taking part
  • Canton, OhioHospital not named in the registryNo longer taking part
  • Cincinnati, OhioHospital not named in the registryNo longer taking part
  • Colorado Springs, ColoradoHospital not named in the registryNo longer taking part
  • Columbia, South CarolinaHospital not named in the registryNo longer taking part
  • Denver, North CarolinaHospital not named in the registryNo longer taking part
  • Dublin, OhioHospital not named in the registryNo longer taking part
  • Huntersville, North CarolinaHospital not named in the registryNo longer taking part
  • Lansing, MichiganHospital not named in the registryNo longer taking part
  • Lincoln, NebraskaHospital not named in the registryNo longer taking part
  • Los Angeles, CaliforniaHospital not named in the registryNo longer taking part
  • Macon, GeorgiaHospital not named in the registryNo longer taking part
  • Miami, FloridaHospital not named in the registryNo longer taking part
  • Middletown, New JerseyHospital not named in the registryNo longer taking part
  • Peoria, IllinoisHospital not named in the registryNo longer taking part
  • Redwood City, CaliforniaHospital not named in the registryNo longer taking part
  • San Antonio, TexasHospital not named in the registryNo longer taking part
  • San Francisco, CaliforniaHospital not named in the registryNo longer taking part
  • Santa Ana, CaliforniaHospital not named in the registryNo longer taking part
  • Sterling Heights, MichiganHospital not named in the registryNo longer taking part
  • Stockbridge, GeorgiaHospital not named in the registryNo longer taking part
  • The Woodlands, TexasHospital not named in the registryNo longer taking part
  • Winter Park, FloridaHospital not named in the registryNo longer taking part
  • Wyomissing, PennsylvaniaHospital not named in the registryNo longer taking part

About the trial

What the trial wants to find out

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.

The 4 groups in the trial

  • 4 mg ALKS 2680Treatment being tested

    Treatment: ALKS 2680

  • 6 mg ALKS 2680Treatment being tested

    Treatment: ALKS 2680

  • 8 mg ALKS 2680Treatment being tested

    Treatment: ALKS 2680

  • PlaceboPlacebo, for comparison

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 2, Parallel-Group, Dose-Range-Finding Study With Randomized Double-Blind Treatment and Open-Label Periods to Evaluate the Safety and Efficacy of ALKS 2680 in Subjects With Narcolepsy Type 1
Publications
Record updated
10 June 2026