A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia
NCT ID: NCT06843590
Last Updated: 2026-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
96 participants
INTERVENTIONAL
2025-05-22
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ALKS 2680, 10 mg
Oral tablet containing 10 mg of ALKS 2680 for once daily administration
ALKS 2680
Oral tablet containing ALKS 2680 for once daily administration
ALKS 2680, 14 mg
Oral tablet containing 14 mg of ALKS 2680 for once daily administration
ALKS 2680
Oral tablet containing ALKS 2680 for once daily administration
ALKS 2680, 18 mg
Oral tablet containing 18 mg of ALKS 2680 for once daily administration
ALKS 2680
Oral tablet containing ALKS 2680 for once daily administration
Placebo
Oral placebo tablet for once daily administration
Placebo
Oral placebo tablet for once daily administration
Interventions
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ALKS 2680
Oral tablet containing ALKS 2680 for once daily administration
Placebo
Oral placebo tablet for once daily administration
Eligibility Criteria
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Inclusion Criteria
* Meets the diagnostic criteria of Idiopathic Hypersomnia according to ICSD-3-TR guidelines, confirmed by the diagnostic evaluations (PSG/MSLT/actigraphy) within the previous 10 years
Exclusion Criteria
* Has a history or presence at Visit 1 of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure that, in the opinion of the Investigator, might compromise subject safety, interfere with any study assessment, or affect the subject's ability to complete the study
* Is currently enrolled in another clinical study or used any investigational drug or device within 30 days prior to Visit 1
* Is currently pregnant, breastfeeding, or is planning to become pregnant during the study
18 Years
70 Years
ALL
No
Sponsors
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Alkermes, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Alkermes, Inc.
Locations
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Alkermes Investigator Site
Cullman, Alabama, United States
Alkermes Investigator Site
Phoenix, Arizona, United States
Alkermes Investigator Site
Little Rock, Arkansas, United States
Alkermes Investigator Site
Los Angeles, California, United States
Alkermes Investigator Site
Redwood City, California, United States
Alkermes Investigator Site
San Francisco, California, United States
Alkermes Investigator Site
Colorado Springs, Colorado, United States
Alkermes Investigator Site
Brandon, Florida, United States
Alkermes Investigator Site
Miami, Florida, United States
Alkermes Investigator Site
Winter Park, Florida, United States
Alkermes Investigator Site
Atlanta, Georgia, United States
Alkermes Investigator Site
Macon, Georgia, United States
Alkermes Investigator Site
Stockbridge, Georgia, United States
Alkermes Investigator Site
Peoria, Illinois, United States
Alkermes Investigator Site
Kansas City, Kansas, United States
Alkermes Investigator Site
Lansing, Michigan, United States
Alkermes Investigator Site
Lincoln, Nebraska, United States
Alkermes Investigator Site
Middletown, New Jersey, United States
Alkermes Investigator Site
Denver, North Carolina, United States
Alkermes Investigator Site
Huntersville, North Carolina, United States
Alkermes Investigator Site
Canton, Ohio, United States
Alkermes Investigator Site
Cincinnati, Ohio, United States
Alkermes Investigator Site
Cleveland, Ohio, United States
Alkermes Investigator Site
Danville, Pennsylvania, United States
Alkermes Investigator Site
Philadelphia, Pennsylvania, United States
Alkermes Investigator Site
Wyomissing, Pennsylvania, United States
Alkermes Investigator Site
Columbia, South Carolina, United States
Alkermes Investigator Site
Austin, Texas, United States
Alkermes Investigator Site
San Antonio, Texas, United States
Alkermes Investigator Site
Sugar Land, Texas, United States
Alkermes Investigator Site
Sugarland, Texas, United States
Alkermes Investigator Site
Madison, Wisconsin, United States
Alkermes Investigator Site
Sydney, New South Wales, Australia
Alkermes Investigator Site
Bedford Park, South Australia, Australia
Alkermes Investigator Site
Clayton, Victoria, Australia
Alkermes Investigator Site
Alken, , Belgium
Alkermes Investigator Site
Namur, , Belgium
Alkermes Investigator Site
Prague, , Czechia
Alkermes Investigator Site
Bordeaux, Gironde, France
Alkermes Investigator Site
Montpellier, Herault, France
Alkermes Investigator Site
Grenoble, Isere, France
Alkermes Investigator Site
Bologna, , Italy
Alkermes Investigator Site
Milan, , Italy
Alkermes Investigator Site
Verona, , Italy
Alkermes Investigator Site
Zwolle, , Netherlands
Alkermes Investigator Site
Barcelona, , Spain
Alkermes Investigator Site
Madrid, , Spain
Alkermes Investigator Site
Madrid, , Spain
Countries
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Central Contacts
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Other Identifiers
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ALKS 2680-203
Identifier Type: -
Identifier Source: org_study_id
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