A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201)
NCT ID: NCT06358950
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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COMPLETED
PHASE2
92 participants
INTERVENTIONAL
2024-03-28
2025-07-31
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
QUADRUPLE
Study Groups
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4 mg ALKS 2680
ALKS 2680
Oral tablet of ALKS 2680 for once daily administration
6 mg ALKS 2680
ALKS 2680
Oral tablet of ALKS 2680 for once daily administration
8 mg ALKS 2680
ALKS 2680
Oral tablet of ALKS 2680 for once daily administration
Placebo
Placebo
Oral tablet containing matching placebo for once daily administration
Interventions
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ALKS 2680
Oral tablet of ALKS 2680 for once daily administration
Placebo
Oral tablet containing matching placebo for once daily administration
Eligibility Criteria
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Inclusion Criteria
* Has a BMI ≥18 and ≤40 kg/m2
* Meets the diagnostic criteria of Narcolepsy type 1 according to ICSD-3-TR guidelines. Additionally, meets the following criteria:
* Is HLA-DQB1\*06:02-positive
* Has residual excessive daytime sleepiness and cataplexy
* Is willing and able to discontinue any medications prescribed for the management of narcolepsy symptoms for at least 14 days and for the duration of study
* Is willing to adhere to additional protocol requirements
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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Study Medical Director, MD
Role: STUDY_DIRECTOR
Alkermes, Inc.
Locations
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Alkermes Investigational Site
Los Angeles, California, United States
Alkermes Investigational Site
Redwood City, California, United States
Alkermes Investigator Site
San Francisco, California, United States
Alkermes Investigational Site
Santa Ana, California, United States
Alkermes Investigational Site
Aurora, Colorado, United States
Alkermes Investigational Site
Colorado Springs, Colorado, United States
Alkermes Investigational Site
Brandon, Florida, United States
Alkermes Investigator Site
Brandon, Florida, United States
Alkermes Investigational Site
Miami, Florida, United States
Alkermes Investigator 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 Investigator Site
Peoria, Illinois, United States
Alkermes Investigator Site
Lansing, Michigan, United States
Alkermes Investigator Site
Sterling Heights, Michigan, United States
Alkermes Investigator 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 Investigator 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
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
The Woodlands, Texas, United States
Alkermes Investigator Site
Macquarie Park, New South Wales, Australia
Alkermes Investigator Site
Bedford Park, South Australia, Australia
Alkermes Investigational Site
Alken, , Belgium
Alkermes Investigational Site
Bruges, , Belgium
Alkermes Investigational Site
Namur, , Belgium
Alkermes Investigational Site
Prague, , Czechia
Alkermes Investigational Site
Bordeaux, , France
Alkermes Investigational Site
Montpellier, , France
Alkermes Investigational Site
Bologna, , Italy
Alkermes Investigational Site
Milan, , Italy
Alkermes Investigational Site
Verona, , Italy
Alkermes Investigational Site
Heemstede, , Netherlands
Alkermes Investigational Site
Zwolle, , Netherlands
Alkermes Investigational Site
Barcelona, , Spain
Alkermes Investigational Site
Madrid, , Spain
Alkermes Investigational Site
Madrid, , Spain
Countries
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Related Links
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Other Identifiers
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ALKS 2860-201
Identifier Type: -
Identifier Source: org_study_id
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