Actively Recruiting
A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1
Led by Alkermes, Inc. · Updated on 2026-05-14
150
Participants Needed
9
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to measure decreases in daytime sleepiness, cataplexy (sudden loss of muscle tone), and disease symptoms in participants with NT1 when taking ALKS 2680 tablets compared with placebo tablets.
CONDITIONS
Official 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
- Diagnosis of 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 procedure that may affect safety or study participation
- Participation in another interventional clinical trial or use of investigational drugs or devices within 30 days prior to Visit 1
- Previous enrollment in Study ALKS 2680-201
- Currently pregnant, breastfeeding, or planning pregnancy during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Alkermes Investigational Site
Brandon, Florida, United States, 33511
Actively Recruiting
2
Alkermes Investigational Site
Macon, Georgia, United States, 31210
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3
Alkermes Investigational Site
Lansing, Michigan, United States, 48911
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4
Alkermes Investigational Site
St Louis, Missouri, United States, 63123
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5
Alkermes Investigational Site
Cincinnati, Ohio, United States, 45245
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6
Alkermes Investigational Site
Wyomissing, Pennsylvania, United States, 19610
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7
Alkermes Investigational Site
Columbia, South Carolina, United States, 29201
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8
Alkermes Investigational Site
Austin, Texas, United States, 78731
Actively Recruiting
9
Alkermes Investigational Site
Sugar Land, Texas, United States, 77478
Actively Recruiting
Research Team
D
Director, Clinical Trial Manager
CONTACT
D
Director, Clinical Trial Manager
CONTACT
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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