A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia
An Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Durability of Treatment Effect of ALKS 2680 in Subjects With Narcolepsy Type 1 and Type 2 and Idiopathic Hypersomnia
1 other identifier
interventional
256
8 countries
46
Brief Summary
The purpose of this study is to continue to measure the safety, tolerability, and durability of treatment effect in subjects with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), or Idiopathic Hypersomnia (IH) when taking ALKS 2680 tablets.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2025
Typical duration for phase_2
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2025
CompletedFirst Posted
Study publicly available on registry
January 10, 2025
CompletedStudy Start
First participant enrolled
January 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
March 4, 2026
March 1, 2026
3.3 years
January 6, 2025
March 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Treatment-Emergent Adverse Events
Up to 100 Weeks
Secondary Outcomes (2)
Change in the mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT)
Baseline to Week 24
Change in Epworth Sleepiness Scale (ESS)
Baseline to 96 Weeks
Study Arms (3)
Narcolepsy Type 1 (NT1)
EXPERIMENTALNarcolepsy Type 2 (NT2)
EXPERIMENTALIdiopathic Hypersomnia (IH)
EXPERIMENTALInterventions
Oral tablet containing 4 mg of ALKS 2680 for once daily administration
Oral tablet containing 6 mg of ALKS 2680 for once daily administration
Oral tablet containing 8 mg of ALKS 2680 for once daily administration
Oral tablet containing 10 mg of ALKS 2680 for once daily administration
Oral tablet containing 14 mg of ALKS 2680 for once daily administration
Oral tablet containing 18 mg of ALKS 2680 for once daily administration
Eligibility Criteria
You may qualify if:
- Was eligible for and has completed end of treatment visit of ALKS 2680 eligible parent study in NT1, NT2 or IH. The current eligible studies are ALKS 2680-201 (Vibrance-1), ALKS 2680-202 (Vibrance-2) and ALKS 2680-203 (Vibrance-3)
- 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)
You may not qualify if:
- Developed a new clinically significant health condition, ECG or laboratory abnormality, in the opinion of the Investigator or Sponsor, may impact the subject's participation in the study
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alkermes, Inc.lead
Study Sites (46)
Alkermes Investigator Site
Phoenix, Arizona, 85054, United States
Alkermes Investigational Site
Little Rock, Arkansas, 72211, United States
Alkermes Investigational Site
Los Angeles, California, 90025, United States
Alkermes Investigator Site
San Francisco, California, 94158, United States
Alkermes Investigational Site
Stanford, California, 94305, United States
Alkermes Investigational Site
Colorado Springs, Colorado, 80918, United States
Alkermes Investigational Site
Brandon, Florida, 33511, United States
Alkermes Investigational Site
Miami, Florida, 33176, United States
Alkermes Investigational Site
Winter Park, Florida, 32789, United States
Alkermes Investigational Site
Atlanta, Georgia, 30328, United States
Alkermes Investigational Site
Macon, Georgia, 31210, United States
Alkermes Investigational Site
Stockbridge, Georgia, 30281, United States
Alkermes Investigational Site
Peoria, Illinois, 61637, United States
Alkermes Investigational Site
Lansing, Michigan, 48911, United States
Alkermes Investigational Site
Sterling Heights, Michigan, 48314, United States
Alkermes Investigational Site
Lincoln, Nebraska, 68506, United States
Alkermes Investigational Site
Middletown, New Jersey, 07748, United States
Alkermes Investigational Site
Denver, North Carolina, 28037, United States
Alkermes Investigational Site
Huntersville, North Carolina, 28708, United States
Alkermes Investigational Site
Canton, Ohio, 44718, United States
Alkermes Investigational Site
Cincinnati, Ohio, 45212, United States
Alkermes Investigational Site
Cincinnati, Ohio, 45245, United States
Alkermes Investigational Site
Dublin, Ohio, 43017, United States
Alkermes Investigational Site
Abington, Pennsylvania, 19001, United States
Alkermes Investigational Site
Wyomissing, Pennsylvania, 19610, United States
Alkermes Investigational Site
Columbia, South Carolina, 29201, United States
Alkermes Investigational Site
Austin, Texas, 78731, United States
Alkermes Investigational Site
San Antonio, Texas, 78229, United States
Alkermes Investigational Site
Sugar Land, Texas, 77478, United States
Alkermes Investigational Site
Madison, Wisconsin, 53706, United States
Alkermes Investigational Site
Sydney, New South Wales, 2113, Australia
Alkermes Investigational Site
Bedford Park, South Australia, 5042, Australia
Alkermes Investigational Site
Clayton, Victoria, 3168, Australia
Alkermes Investigational Site
Bruges, Brugge, 8000, Belgium
Alkermes Investigational Site
Alken, 3570, Belgium
Alkermes Investigational Site
Namur, 5101, Belgium
Alkermes Investigational Site
Prague, 128 21, Czechia
Alkermes Investigational Site
Montpellier, Herault, 34295, France
Alkermes Investigational Site
Bordeaux, 33000, France
Alkermes Investigational Site
Bologna, 40139, Italy
Alkermes Investigational Site
Milan, 20127, Italy
Alkermes Investigational Site
Verona, 37134, Italy
Alkermes Investigational Site
Zwolle, 8025, Netherlands
Alkermes Investigational Site
Madrid, Madrid, 28036, Spain
Alkermes Investigational Site
Barcelona, 08036, Spain
Alkermes Investigational Site
Madrid, 28043, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Alkermes, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2025
First Posted
January 10, 2025
Study Start
January 27, 2025
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
March 4, 2026
Record last verified: 2026-03