Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT06843590

A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia

Led by Alkermes, Inc. · Updated on 2026-02-12

96

Participants Needed

48

Research Sites

53 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to measure the safety and decrease in daytime sleepiness in subjects with Idiopathic Hypersomnia when taking ALKS 2680 tablets compared with placebo tablets

CONDITIONS

Official Title

A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing and able to understand and follow study requirements including lifestyle, contraception, actigraphy, and diary use
  • If treated for obstructive sleep apnea (OSA), adherent to primary OSA therapy for 30 days before and during the study
  • Meets diagnostic criteria for Idiopathic Hypersomnia per ICSD-3-TR guidelines, confirmed by PSG/MSLT/actigraphy within the past 10 years
Not Eligible

You will not qualify if you...

  • Has another sleep disorder or condition affecting the sleep-wake cycle
  • Has other significant illness, disease, abnormality, or recent surgery that might affect safety or study completion
  • Currently enrolled in another clinical study or used investigational drugs/devices within 30 days before Visit 1
  • Pregnant, breastfeeding, or planning pregnancy during the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 48 locations

1

Alkermes Investigator Site

Cullman, Alabama, United States, 35055

Actively Recruiting

2

Alkermes Investigator Site

Phoenix, Arizona, United States, 85054

Actively Recruiting

3

Alkermes Investigator Site

Little Rock, Arkansas, United States, 72211

Actively Recruiting

4

Alkermes Investigator Site

Los Angeles, California, United States, 90025

Actively Recruiting

5

Alkermes Investigator Site

Redwood City, California, United States, 94063

Actively Recruiting

6

Alkermes Investigator Site

San Francisco, California, United States, 94143

Actively Recruiting

7

Alkermes Investigator Site

Colorado Springs, Colorado, United States, 80918

Actively Recruiting

8

Alkermes Investigator Site

Brandon, Florida, United States, 33511

Actively Recruiting

9

Alkermes Investigator Site

Miami, Florida, United States, 33176

Actively Recruiting

10

Alkermes Investigator Site

Winter Park, Florida, United States, 32789

Actively Recruiting

11

Alkermes Investigator Site

Atlanta, Georgia, United States, 30328

Actively Recruiting

12

Alkermes Investigator Site

Macon, Georgia, United States, 31210

Actively Recruiting

13

Alkermes Investigator Site

Stockbridge, Georgia, United States, 30281

Actively Recruiting

14

Alkermes Investigator Site

Peoria, Illinois, United States, 61637

Actively Recruiting

15

Alkermes Investigator Site

Kansas City, Kansas, United States, 66160

Actively Recruiting

16

Alkermes Investigator Site

Lansing, Michigan, United States, 48911

Actively Recruiting

17

Alkermes Investigator Site

Lincoln, Nebraska, United States, 68506

Actively Recruiting

18

Alkermes Investigator Site

Middletown, New Jersey, United States, 07748

Actively Recruiting

19

Alkermes Investigator Site

Denver, North Carolina, United States, 28037

Actively Recruiting

20

Alkermes Investigator Site

Huntersville, North Carolina, United States, 28078

Actively Recruiting

21

Alkermes Investigator Site

Canton, Ohio, United States, 44718

Actively Recruiting

22

Alkermes Investigator Site

Cincinnati, Ohio, United States, 45245

Actively Recruiting

23

Alkermes Investigator Site

Cleveland, Ohio, United States, 44195

Actively Recruiting

24

Alkermes Investigator Site

Danville, Pennsylvania, United States, 17822

Actively Recruiting

25

Alkermes Investigator Site

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

26

Alkermes Investigator Site

Wyomissing, Pennsylvania, United States, 19610

Actively Recruiting

27

Alkermes Investigator Site

Columbia, South Carolina, United States, 29201

Actively Recruiting

28

Alkermes Investigator Site

Austin, Texas, United States, 78731

Actively Recruiting

29

Alkermes Investigator Site

San Antonio, Texas, United States, 78229

Actively Recruiting

30

Alkermes Investigator Site

Sugar Land, Texas, United States, 77478

Actively Recruiting

31

Alkermes Investigator Site

Sugarland, Texas, United States, 77478

Actively Recruiting

32

Alkermes Investigator Site

Madison, Wisconsin, United States, 53792

Actively Recruiting

33

Alkermes Investigator Site

Sydney, New South Wales, Australia, 2113

Actively Recruiting

34

Alkermes Investigator Site

Bedford Park, South Australia, Australia, 5042

Actively Recruiting

35

Alkermes Investigator Site

Clayton, Victoria, Australia, 3168

Actively Recruiting

36

Alkermes Investigator Site

Alken, Belgium, 3570

Actively Recruiting

37

Alkermes Investigator Site

Namur, Belgium, 5101

Actively Recruiting

38

Alkermes Investigator Site

Prague, Czechia, 128 21

Actively Recruiting

39

Alkermes Investigator Site

Bordeaux, Gironde, France, 33000

Actively Recruiting

40

Alkermes Investigator Site

Montpellier, Herault, France, 34295

Actively Recruiting

41

Alkermes Investigator Site

Grenoble, Isere, France, 38043

Actively Recruiting

42

Alkermes Investigator Site

Bologna, Italy, 40139

Actively Recruiting

43

Alkermes Investigator Site

Milan, Italy, 20127

Actively Recruiting

44

Alkermes Investigator Site

Verona, Italy, 37134

Actively Recruiting

45

Alkermes Investigator Site

Zwolle, Netherlands, 8025 BV

Actively Recruiting

46

Alkermes Investigator Site

Barcelona, Spain, 8036

Actively Recruiting

47

Alkermes Investigator Site

Madrid, Spain, 28036

Actively Recruiting

48

Alkermes Investigator Site

Madrid, Spain, 28043

Actively Recruiting

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Research Team

D

Director, Global Clinical Services

CONTACT

D

Director, Global Clinical Services

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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