Actively Recruiting
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
Eligibility Criteria
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
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
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
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3
Alkermes Investigator Site
Little Rock, Arkansas, United States, 72211
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4
Alkermes Investigator Site
Los Angeles, California, United States, 90025
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5
Alkermes Investigator Site
Redwood City, California, United States, 94063
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6
Alkermes Investigator Site
San Francisco, California, United States, 94143
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7
Alkermes Investigator Site
Colorado Springs, Colorado, United States, 80918
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8
Alkermes Investigator Site
Brandon, Florida, United States, 33511
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9
Alkermes Investigator Site
Miami, Florida, United States, 33176
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10
Alkermes Investigator Site
Winter Park, Florida, United States, 32789
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11
Alkermes Investigator Site
Atlanta, Georgia, United States, 30328
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12
Alkermes Investigator Site
Macon, Georgia, United States, 31210
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13
Alkermes Investigator Site
Stockbridge, Georgia, United States, 30281
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14
Alkermes Investigator Site
Peoria, Illinois, United States, 61637
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15
Alkermes Investigator Site
Kansas City, Kansas, United States, 66160
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16
Alkermes Investigator Site
Lansing, Michigan, United States, 48911
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17
Alkermes Investigator Site
Lincoln, Nebraska, United States, 68506
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18
Alkermes Investigator Site
Middletown, New Jersey, United States, 07748
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19
Alkermes Investigator Site
Denver, North Carolina, United States, 28037
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20
Alkermes Investigator Site
Huntersville, North Carolina, United States, 28078
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21
Alkermes Investigator Site
Canton, Ohio, United States, 44718
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22
Alkermes Investigator Site
Cincinnati, Ohio, United States, 45245
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23
Alkermes Investigator Site
Cleveland, Ohio, United States, 44195
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24
Alkermes Investigator Site
Danville, Pennsylvania, United States, 17822
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25
Alkermes Investigator Site
Philadelphia, Pennsylvania, United States, 19107
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26
Alkermes Investigator Site
Wyomissing, Pennsylvania, United States, 19610
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27
Alkermes Investigator Site
Columbia, South Carolina, United States, 29201
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28
Alkermes Investigator Site
Austin, Texas, United States, 78731
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29
Alkermes Investigator Site
San Antonio, Texas, United States, 78229
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30
Alkermes Investigator Site
Sugar Land, Texas, United States, 77478
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31
Alkermes Investigator Site
Sugarland, Texas, United States, 77478
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32
Alkermes Investigator Site
Madison, Wisconsin, United States, 53792
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33
Alkermes Investigator Site
Sydney, New South Wales, Australia, 2113
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34
Alkermes Investigator Site
Bedford Park, South Australia, Australia, 5042
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35
Alkermes Investigator Site
Clayton, Victoria, Australia, 3168
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36
Alkermes Investigator Site
Alken, Belgium, 3570
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37
Alkermes Investigator Site
Namur, Belgium, 5101
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38
Alkermes Investigator Site
Prague, Czechia, 128 21
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39
Alkermes Investigator Site
Bordeaux, Gironde, France, 33000
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40
Alkermes Investigator Site
Montpellier, Herault, France, 34295
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41
Alkermes Investigator Site
Grenoble, Isere, France, 38043
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42
Alkermes Investigator Site
Bologna, Italy, 40139
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43
Alkermes Investigator Site
Milan, Italy, 20127
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44
Alkermes Investigator Site
Verona, Italy, 37134
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45
Alkermes Investigator Site
Zwolle, Netherlands, 8025 BV
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46
Alkermes Investigator Site
Barcelona, Spain, 8036
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47
Alkermes Investigator Site
Madrid, Spain, 28036
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48
Alkermes Investigator Site
Madrid, Spain, 28043
Actively Recruiting
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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