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A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia

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Trial Profile

A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Sep 2024

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At a glance

  • Drugs Pitolisant (Primary)
  • Indications Idiopathic hypersomnia
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms INTUNE
  • Sponsors Harmony Biosciences

    • Most Recent Events

    • 30 Apr 2024 According to a Harmony Biosciences media release, the company plans to submit supplemental new drug application (sNDA) for pitolisant in Idiopathic Hypersomnia in the second half of 2024
    • 02 Feb 2024 Status changed from active, no longer recruiting to completed.
    • 13 Oct 2023 Primary endpoint (Excessive Daytime Sleepiness) has not been met, according to a Harmony Biosciences media release.

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