Actively Recruiting
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1
Led by Alkermes, Inc. · Updated on 2026-06-04
150
Participants Needed
17
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of ALKS 2680 tablets on adults with Narcolepsy Type 1 (NT1), a condition marked by excessive daytime sleepiness and sudden muscle weakness called cataplexy. This Phase 3 study aims to compare ALKS 2680 with placebo tablets to measure improvements in these symptoms and overall disease severity. Participants will be randomly assigned to one of three groups: a placebo group or one of two different ALKS 2680 dose groups. Each participant will take the assigned oral tablet daily for 12 weeks. The study is double-blind, meaning neither participants nor researchers know who receives the active drug or placebo during the trial. During the study, participants will undergo assessments including the Maintenance of Wakefulness Test to measure sleep latency, the Epworth Sleepiness Scale, cataplexy frequency, cognitive tests, and patient-reported outcomes on fatigue and disease severity. Safety will be monitored throughout, and the primary measurements will focus on changes from baseline to week 12. The total study duration for participants is approximately 12 weeks with follow-up for adverse events up to 14 weeks.
CONDITIONS
Brief Title
A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years
- Diagnosed with Narcolepsy Type 1 according to ICSD-3-TR guidelines confirmed by PSG/MSLT or CSF hypocretin-1 level
You will not qualify if you...
- Presence of other sleep disorders or conditions affecting the sleep-wake cycle
- Clinically significant illness, disease, abnormality, or surgical history that may affect safety or study participation
- Participation in another interventional trial or use of investigational drugs/devices within 30 days prior to Visit 1
- Current pregnancy, breastfeeding, or plans to become pregnant during the study
- Previous enrollment in Study ALKS 2680-201
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 - 12 weeks
Participants receive oral tablets of ALKS 2680 or placebo daily for 12 weeks.
Weekly visits for up to 12 weeks
Duration - Up to 2 weeks
Participants are monitored for safety and treatment emergent adverse events after the treatment period.
1 to 2 visits depending on safety assessments
Trial Site Locations
Total: 17 locations
1
Alkermes Investigational Site
Los Angeles, California, United States, 90025
Actively Recruiting
2
Alkermes Investigational Site
Boulder, Colorado, United States, 80301
Actively Recruiting
3
Alkermes Investigational Site
Brandon, Florida, United States, 33511
Actively Recruiting
4
Alkermes Investigational Site
Miami, Florida, United States, 33176
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5
Alkermes Investigational Site
Winter Park, Florida, United States, 32789
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6
Alkermes Investigational Site
Macon, Georgia, United States, 31210
Actively Recruiting
7
Alkermes Investigational Site
Newton, Massachusetts, United States, 02459
Actively Recruiting
8
Alkermes Investigational Site
Lansing, Michigan, United States, 48911
Actively Recruiting
9
Alkermes Investigational Site
St Louis, Missouri, United States, 63123
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10
Alkermes Investigational Site
Cincinnati, Ohio, United States, 45245
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11
Alkermes Investigational Site
Wyomissing, Pennsylvania, United States, 19610
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12
Alkermes Investigational Site
Columbia, South Carolina, United States, 29201
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13
Alkermes Investigational Site
Austin, Texas, United States, 78731
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14
Alkermes Investigational Site
San Antonio, Texas, United States, 78229
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15
Alkermes Investigational Site
Sugar Land, Texas, United States, 77478
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16
Alkermes Investigational Site
Markham, Ontario, Canada, L3R 1A3
Actively Recruiting
17
Alkermes Investigational Site
Toronto, Ontario, Canada, M5S 3A3
Actively Recruiting
Research Team
D
Director, Clinical Trial Manager
D
Director, Clinical Trial Manager
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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