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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study With Open-Label Extension Phase of the Efficacy and Safety of Lemborexant in Subjects With Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer's Disease Dementia

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Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study With Open-Label Extension Phase of the Efficacy and Safety of Lemborexant in Subjects With Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer's Disease Dementia

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 07 Dec 2021

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At a glance

  • Drugs Lemborexant (Primary)
  • Indications Circadian rhythm sleep disorders
  • Focus Proof of concept; Therapeutic Use
  • Sponsors Eisai Co Ltd; Eisai Inc

    • Most Recent Events

    • 31 Jul 2020 Results of Safety and efficacy Lemborexant of patients who entered in long term open label Extension Phases, presented at the Alzheimer's Association International Conference 2020
    • 14 Jul 2020 Results published in the Journal of Clinical Pharmacology
    • 28 May 2020 This trial has been completed in United Kingdom and global end of the trial is 2020-04-17 As per European Clinical Trials Database record.

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