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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
2026-03
Completion Date
2027-06
Last Updated
2026-03-09
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.