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Multi-center, Double-blind, Parallel-group, Randomized, Placebo-controlled, Three Doses, 40-week Extension to Studies ID-078A301 and ID-078A302 to Assess the Long Term Safety and Tolerability of ACT-541468 in Adult and Elderly Subjects With Insomnia Disorder

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Trial Profile

Multi-center, Double-blind, Parallel-group, Randomized, Placebo-controlled, Three Doses, 40-week Extension to Studies ID-078A301 and ID-078A302 to Assess the Long Term Safety and Tolerability of ACT-541468 in Adult and Elderly Subjects With Insomnia Disorder

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 May 2023

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At a glance

  • Drugs Daridorexant (Primary)
  • Indications Insomnia
  • Focus Adverse reactions; Registrational
  • Sponsors Idorsia Pharmaceuticals

    • Most Recent Events

    • 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.
    • 09 Dec 2022 Results assessing Long-Term Safety and Tolerability of Daridorexant in Patients with Insomnia Disorderpublished in the CNS Drugs
    • 03 May 2022 According to an Idorsia Pharmaceuticals media release, the European Commission (EC) has granted marketing authorization for QUVIVIQ (daridorexant) for the treatment of adult patients with insomnia characterized by symptoms present for at least three months and considerable impact on daytime functioning.

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