Sponsor Name: Alkermes, Inc.
Regulatory Agency Identifier Numbers: 165600 (IND); 2025-523912-35-00 (EU Trial Number)
Protocol Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2
Brief Summary: The purpose of this study is to measure decreases in daytime sleepiness, and disease symptoms in participants with NT2 when taking ALKS 2680 tablets compared with placebo tablets. This study aims also to measure the safety profile of ALKS 2680 compared with placebo. Study details include the following:
- Study duration: up to 20 weeks (approximately, including Screening and Safety Follow-Up Periods).
- Treatment duration: up to 12 weeks.
- Visit frequency: up to 17 visits, including 3 overnight visits, 7 in-clinic visits, and 7 telephone calls.
