A Randomized, Double-Blind, Single-Dose, 5-Period Crossover Study to Evaluate the Efficacy, Safety, and Tolerability of E2086 Compared to Placebo and Active Comparator in Adult Subjects With Narcolepsy Type 1
Abstract
The primary purpose of this study is to evaluate the efficacy of single oral doses of E2086 compared to placebo in the treatment of excessive daytime sleepiness (EDS) as assessed by the Maintenance of Wakefulness Test (MWT) in adult participants with narcolepsy type 1 (NT1).
Conditions: Narcolepsy Type 1 (NT1).
Primary outcome: Mean Sleep Latency (MSL) as Assessed by the 4 Maintenance of Wakefulness Tests (MWTs) for E2086 Versus Placebo at Day 1; MSL as Assessed by the 4 MWTs for E2086 Versus Placebo at Day 5; MSL as Assessed by the 4 MWTs for E2086 Versus Placebo at Day 9; MSL as Assessed by the 4 MWTs for E2086 Versus Placebo at Day 13; MSL as Assessed by the 4 MWTs for E2086 Versus Placebo at Day 17.
Enrollment: 22 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 22 participants or records.
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