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Multi-center, double-blind, randomized, placebo-controlled, parallel-group, polysomnography study to assess the efficacy and safety of ACT-541468 in adult and elderly subjects with insomnia disorder

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Trial Profile

Multi-center, double-blind, randomized, placebo-controlled, parallel-group, polysomnography study to assess the efficacy and safety of ACT-541468 in adult and elderly subjects with insomnia disorder

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Oct 2023

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At a glance

  • Drugs Daridorexant (Primary)
  • Indications Insomnia
  • Focus Registrational; Therapeutic Use
  • Sponsors Idorsia Pharmaceuticals

    • Most Recent Events

    • 23 Oct 2023 According to an Idorsia media release, data from this study will be presented at the 2023 World Sleep 2023, a global scientific congress.
    • 02 Oct 2023 Results from NCT02783729, NCT02952820, NCT03545191, NCT03575104; determining if there are differences in the number needed to treat (NNT), number needed to harm (NNH), and likelihood to be helped or harmed (LHH) between lemborexant and daridorexant and indirectly comparing lemborexant with daridorexant , published in the Journal of Clinical Psychiatry
    • 03 May 2023 According to an Idorsia media release, Health Canada has granted marketing authorization for QUVIVIQ™ (daridorexant) for the management of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance, on April 28, 2023.

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