Actively Recruiting
A Phase 2, Randomized, Double-Blind Study to Evaluate the Safety and Effectiveness of ALKS 2680 Tablets for Idiopathic Hypersomnia
Led by Alkermes, Inc. · Updated on 2026-02-12
96
Participants Needed
48
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of ALKS 2680 tablets in adults with Idiopathic Hypersomnia, a condition characterized by excessive daytime sleepiness. This phase 2 trial aims to measure how ALKS 2680 affects daytime sleepiness compared with placebo tablets, providing important information about its impact on symptoms. Participants will be randomly assigned to take one of three doses of ALKS 2680 (10 mg, 14 mg, or 18 mg) or a placebo tablet once daily. The study is double-blinded, meaning neither participants nor researchers will know which treatment is given. The treatment period lasts up to 8 weeks, during which participants will take their assigned tablets daily. During the study, participants will be monitored for changes in daytime sleepiness using the Epworth Sleepiness Scale and the Idiopathic Hypersomnia Severity Scale from the start to Week 8. Researchers will also assess safety throughout the trial. The total duration of participation includes screening, treatment, and follow-up visits as scheduled by the study team.
CONDITIONS
Brief 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 and contraception guidelines
- Adherence to treatment for obstructive sleep apnea if applicable
- Diagnosis of Idiopathic Hypersomnia confirmed by appropriate tests within the past 10 years
- Age between 18 and 70 years
You will not qualify if you...
- Presence of other sleep disorders or conditions affecting the sleep-wake cycle
- Significant illness, disease, or medical history that might affect safety or study participation
- Current enrollment in another clinical study or use of investigational drugs/devices within 30 days
- Pregnant, breastfeeding, or planning pregnancy during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 8 weeks
Participants take ALKS 2680 or placebo tablets once daily to evaluate safety and effectiveness for idiopathic hypersomnia.
Weekly visits for up to 8 weeks
Trial Site Locations
Total: 48 locations
1
Alkermes Investigator Site
Cullman, Alabama, United States, 35055
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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
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Research Team
D
Director, Global Clinical Services
D
Director, Global Clinical Services
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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