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A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1
Sponsor: Alkermes, Inc.
Summary
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.
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 Study 302)
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2026-04-06
Completion Date
2027-06
Last Updated
2026-07-02
Healthy Volunteers
No
Conditions
Interventions
ALKS 2680 Dose 1
Participants will receive ALKS 2680 tablets, orally, daily, for 12 weeks
ALKS 2680 Dose 2
Participants will receive ALKS 2680 tablets, orally, daily, for 12 weeks
Placebo
Participants will receive ALKS 2680-matching placebo tablets, orally, for 12 weeks.
Locations (22)
Alkermes Investigational Site
Cullman, Alabama, United States
Alkermes Investigational Site
Los Angeles, California, United States
Alkermes Investigational Site
Boulder, Colorado, United States
Alkermes Investigational Site
Brandon, Florida, United States
Alkermes Investigational Site
Miami, Florida, United States
Alkermes Investigational Site
Winter Park, Florida, United States
Alkermes Investigational Site
Macon, Georgia, United States
Alkermes Investigational Site
Kansas City, Kansas, United States
Alkermes Investigational Site
Newton, Massachusetts, United States
Alkermes Investigational Site
Lansing, Michigan, United States
Alkermes Investigational Site
St Louis, Missouri, United States
Alkermes Investigational Site
Middletown, New Jersey, United States
Alkermes Investigational Site
Cincinnati, 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
Sugar Land, Texas, United States
Alkermes Investigational Site
Macquarie Park, New South Wales, Australia
Alkermes Investigational Site
Markham, Ontario, Canada
Alkermes Investigational Site
Toronto, Ontario, Canada
Alkermes Investigational Site
Zwolle, Overijssel, Netherlands