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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
Led by Alkermes, Inc. · Updated on 2026-03-04
256
Participants Needed
46
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety, tolerability, and lasting effects of ALKS 2680 tablets in adults with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia. This open-label, long-term extension study builds on previous ALKS 2680 parent studies and aims to understand how well the treatment works over time and how safe it is for participants living with these sleep disorders. Participants will take oral tablets of ALKS 2680 once daily, with doses ranging from 4 mg to 18 mg. The study is non-randomized and includes groups of people with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia. Those joining the study may need to stop other narcolepsy medications before starting ALKS 2680 and continue taking ALKS 2680 throughout the trial. During the study, participants will be monitored for treatment side effects and changes in sleepiness using tests like the Maintenance of Wakefulness Test and the Epworth Sleepiness Scale. Researchers will track adverse events for up to 100 weeks and evaluate changes in sleep latency and sleepiness over several months. The study supports close safety monitoring and long-term follow-up from the start in early 2025 until mid-2028.
CONDITIONS
Brief Title
A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Completed end of treatment visit of ALKS 2680 eligible parent study in Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia
- Willing and able to safely stop any narcolepsy medications for 5 half-lives prior to Day 1 (for re-entry subjects) and for the duration of the study
- Aged between 18 and 70 years
- Able to provide informed consent and comply with study procedures
You will not qualify if you...
- Developed a new clinically significant health condition, ECG or laboratory abnormality that may impact participation
- Currently pregnant, breastfeeding, or planning to become pregnant during the study
- Currently enrolled in another clinical study (other than the parent study) or used any investigational drug or device within 30 days prior to screening
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.
1 visit (in-person)
Duration - Up to 100 weeks
Participants take ALKS 2680 once daily to investigate safety, tolerability, and treatment effects over time.
Regular visits for safety and efficacy assessments during treatment
Trial Site Locations
Total: 46 locations
1
Alkermes Investigator Site
Phoenix, Arizona, United States, 85054
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2
Alkermes Investigational Site
Little Rock, Arkansas, United States, 72211
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3
Alkermes Investigational Site
Los Angeles, California, United States, 90025
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4
Alkermes Investigator Site
San Francisco, California, United States, 94158
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5
Alkermes Investigational Site
Stanford, California, United States, 94305
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6
Alkermes Investigational Site
Colorado Springs, Colorado, United States, 80918
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7
Alkermes Investigational Site
Brandon, Florida, United States, 33511
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8
Alkermes Investigational Site
Miami, Florida, United States, 33176
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9
Alkermes Investigational Site
Winter Park, Florida, United States, 32789
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10
Alkermes Investigational Site
Atlanta, Georgia, United States, 30328
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11
Alkermes Investigational Site
Macon, Georgia, United States, 31210
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12
Alkermes Investigational Site
Stockbridge, Georgia, United States, 30281
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13
Alkermes Investigational Site
Peoria, Illinois, United States, 61637
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14
Alkermes Investigational Site
Lansing, Michigan, United States, 48911
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15
Alkermes Investigational Site
Sterling Heights, Michigan, United States, 48314
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16
Alkermes Investigational Site
Lincoln, Nebraska, United States, 68506
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17
Alkermes Investigational Site
Middletown, New Jersey, United States, 07748
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18
Alkermes Investigational Site
Denver, North Carolina, United States, 28037
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19
Alkermes Investigational Site
Huntersville, North Carolina, United States, 28708
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20
Alkermes Investigational Site
Canton, Ohio, United States, 44718
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21
Alkermes Investigational Site
Cincinnati, Ohio, United States, 45212
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22
Alkermes Investigational Site
Cincinnati, Ohio, United States, 45245
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23
Alkermes Investigational Site
Dublin, Ohio, United States, 43017
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24
Alkermes Investigational Site
Abington, Pennsylvania, United States, 19001
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25
Alkermes Investigational Site
Wyomissing, Pennsylvania, United States, 19610
Actively Recruiting
26
Alkermes Investigational Site
Columbia, South Carolina, United States, 29201
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27
Alkermes Investigational Site
Austin, Texas, United States, 78731
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28
Alkermes Investigational Site
San Antonio, Texas, United States, 78229
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29
Alkermes Investigational Site
Sugar Land, Texas, United States, 77478
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30
Alkermes Investigational Site
Madison, Wisconsin, United States, 53706
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31
Alkermes Investigational Site
Sydney, New South Wales, Australia, 2113
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32
Alkermes Investigational Site
Bedford Park, South Australia, Australia, 5042
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33
Alkermes Investigational Site
Clayton, Victoria, Australia, 3168
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34
Alkermes Investigational Site
Bruges, Brugge, Belgium, 8000
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35
Alkermes Investigational Site
Alken, Belgium, 3570
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36
Alkermes Investigational Site
Namur, Belgium, 5101
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37
Alkermes Investigational Site
Prague, Czechia, 128 21
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38
Alkermes Investigational Site
Montpellier, Herault, France, 34295
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39
Alkermes Investigational Site
Bordeaux, France, 33000
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40
Alkermes Investigational Site
Bologna, Italy, 40139
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41
Alkermes Investigational Site
Milan, Italy, 20127
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42
Alkermes Investigational Site
Verona, Italy, 37134
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43
Alkermes Investigational Site
Zwolle, Netherlands, 8025
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44
Alkermes Investigational Site
Madrid, Madrid, Spain, 28036
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45
Alkermes Investigational Site
Barcelona, Spain, 08036
Actively Recruiting
46
Alkermes Investigational Site
Madrid, Spain, 28043
Actively Recruiting
Research Team
D
Director, Global Clinical Services
D
Director, Global Clinical Services
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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