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Clinical Trial Summary

This is a randomized, double-blind, placebo- and active-controlled, 4-period crossover study of lemborexant in healthy adult and elderly subjects to evaluate driving performance


Clinical Trial Description

The study will have 2 phases, Prerandomization and Randomization. The Prerandomization Phase will consist of 2 periods that will last up to a maximum of 21 days: Screening and Baseline. The Randomization Phase will comprise of four, 9-day treatment periods (Treatment Period 1 - Treatment Period 4) with a minimum 14-day washout between treatment periods, and a follow-up interval of at least 14 days after Treatment Period 4 before the end-of-study (EOS) visit. Participants will be randomized to 1 of 12 sequences in an incomplete blocks design. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02583451
Study type Interventional
Source Eisai Inc.
Contact
Status Completed
Phase Phase 1
Start date November 2015
Completion date February 2017

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