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Double Blind, Multicentre, Randomized, Placebo-controlled Trial to Evaluate Safety and Efficacy of Pitolisant in Children From 6 to Less Than 18 Years With Narcolepsy With/Without Cataplexy, Followed by a Prolonged Open-label Period

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Trial Profile

Double Blind, Multicentre, Randomized, Placebo-controlled Trial to Evaluate Safety and Efficacy of Pitolisant in Children From 6 to Less Than 18 Years With Narcolepsy With/Without Cataplexy, Followed by a Prolonged Open-label Period

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 28 Feb 2024

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At a glance

  • Drugs Pitolisant (Primary)
  • Indications Cataplexy; Narcolepsy
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Bioprojet

    • Most Recent Events

    • 22 Feb 2024 According to a Harmony Biosciences media release, FDA granted priority review of supplemental new drug application (sNDA) for WAKIX in pediatric narcolepsy; PDUFA date of June 21, 2024.
    • 31 Jan 2024 This trial is Discontinued at Germany location, According to European Clinical Trials Database record.
    • 01 Aug 2023 According to a Harmony Biosciences media release, the company is working with Bioprojet on the submission to FDA of a supplemental new drug application (sNDA) for pediatric narcolepsy. The company expect to submit the sNDA in the fourth quarter of 2023.
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