A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia
NCT ID: NCT06767683
Last Updated: 2025-10-14
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/PHASE3
256 participants
INTERVENTIONAL
2025-01-27
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Narcolepsy Type 1 (NT1)
ALKS 2680, 4mg
Oral tablet containing 4 mg of ALKS 2680 for once daily administration
ALKS 2680, 6mg
Oral tablet containing 6 mg of ALKS 2680 for once daily administration
ALKS 2680, 8mg
Oral tablet containing 8 mg of ALKS 2680 for once daily administration
Narcolepsy Type 2 (NT2)
ALKS 2680, 10mg
Oral tablet containing 10 mg of ALKS 2680 for once daily administration
ALKS 2680, 14mg
Oral tablet containing 14 mg of ALKS 2680 for once daily administration
ALKS 2680, 18mg
Oral tablet containing 18 mg of ALKS 2680 for once daily administration
Idiopathic Hypersomnia (IH)
ALKS 2680, 10mg
Oral tablet containing 10 mg of ALKS 2680 for once daily administration
ALKS 2680, 14mg
Oral tablet containing 14 mg of ALKS 2680 for once daily administration
ALKS 2680, 18mg
Oral tablet containing 18 mg of ALKS 2680 for once daily administration
Interventions
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ALKS 2680, 4mg
Oral tablet containing 4 mg of ALKS 2680 for once daily administration
ALKS 2680, 6mg
Oral tablet containing 6 mg of ALKS 2680 for once daily administration
ALKS 2680, 8mg
Oral tablet containing 8 mg of ALKS 2680 for once daily administration
ALKS 2680, 10mg
Oral tablet containing 10 mg of ALKS 2680 for once daily administration
ALKS 2680, 14mg
Oral tablet containing 14 mg of ALKS 2680 for once daily administration
ALKS 2680, 18mg
Oral tablet containing 18 mg of ALKS 2680 for once daily administration
Eligibility Criteria
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Inclusion Criteria
* Is willing and able, and in the opinion of the treating physician can safely discontinue any medications prescribed for the management of narcolepsy symptoms, as applicable, for 5 half-lives prior to Day 1 (for re-entry subjects), and for the duration of study (for all subjects)
Exclusion Criteria
* Is currently pregnant, breastfeeding, or planning to become pregnant during the study
* 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
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
Phoenix, Arizona, United States
Alkermes Investigational Site
Little Rock, Arkansas, United States
Alkermes Investigational Site
Los Angeles, California, United States
Alkermes Investigator Site
San Francisco, California, United States
Alkermes Investigational Site
Stanford, California, United States
Alkermes Investigational Site
Colorado Springs, Colorado, United States
Alkermes Investigational Site
Brandon, Florida, United States
Alkermes Investigational Site
Miami, Florida, United States
Alkermes Investigational Site
Winter Park, Florida, United States
Alkermes Investigational Site
Atlanta, Georgia, United States
Alkermes Investigational Site
Macon, Georgia, United States
Alkermes Investigational Site
Stockbridge, Georgia, United States
Alkermes Investigational Site
Peoria, Illinois, United States
Alkermes Investigational Site
Lansing, Michigan, United States
Alkermes Investigational Site
Sterling Heights, Michigan, United States
Alkermes Investigational Site
Lincoln, Nebraska, United States
Alkermes Investigational Site
Middletown, New Jersey, United States
Alkermes Investigational Site
Denver, North Carolina, United States
Alkermes Investigational Site
Huntersville, North Carolina, United States
Alkermes Investigational Site
Canton, Ohio, United States
Alkermes Investigational Site
Cincinnati, Ohio, United States
Alkermes Investigational Site
Cincinnati, Ohio, United States
Alkermes Investigational Site
Dublin, Ohio, United States
Alkermes Investigational Site
Abington, Pennsylvania, United States
Alkermes Investigational Site
Wyomissing, Pennsylvania, United States
Alkermes Investigational Site
Columbia, South Carolina, United States
Alkermes Investigational Site
Austin, Texas, United States
Alkermes Investigational Site
San Antonio, Texas, United States
Alkermes Investigational Site
Sugar Land, Texas, United States
Alkermes Investigational Site
Sydney, New South Wales, Australia
Alkermes Investigational Site
Bedford Park, South Australia, Australia
Alkermes Investigational Site
Bruges, Brugge, Belgium
Alkermes Investigational Site
Alken, , Belgium
Alkermes Investigational Site
Namur, , Belgium
Alkermes Investigational Site
Prague, , Czechia
Alkermes Investigational Site
Montpellier, Herault, France
Alkermes Investigational Site
Bordeaux, , France
Alkermes Investigational Site
Bologna, , Italy
Alkermes Investigational Site
Milan, , Italy
Alkermes Investigational Site
Verona, , Italy
Alkermes Investigational Site
Zwolle, , Netherlands
Alkermes Investigational Site
Madrid, Madrid, Spain
Alkermes Investigational Site
Barcelona, , Spain
Alkermes Investigational Site
Madrid, , Spain
Countries
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Central Contacts
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Other Identifiers
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ALKS 2680-301
Identifier Type: -
Identifier Source: org_study_id
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