A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of E2086 in Adults With Narcolepsy
Eisai Inc.
Summary
The primary purpose of this study is to evaluate the optimal doses of E2086 compared to placebo in participants with narcolepsy for reduction of excessive daytime sleepiness (EDS) as assessed by Mean Sleep Latency (MSL) (measured from the first 4 maintenance of wakefulness tests \[MWTs\]).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Participants must meet all of the following criteria to be included in this study: 1. Male or female, age greater than or equal to (\>=) 18 years (or as regionally appropriate) at the time of informed consent 2. NT1 Cohort: Must fulfill Inclusion Criteria 2a and 2b 1. Diagnosis of NT1 within the last 10 years of screening, as confirmed by at least one of the following: * Polysomnography (PSG) and Multiple Sleep Latency Test (MSLT) results, and clinical history, consistent with the 2023 International Classification of Sleep Disorders, 3rd edition, text revision…