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Efficacy and safety of BF2.649 in the treatment of Excessive Daytime Sleepiness in patients with Obstructive Sleep Apnoea syndrome (OSA), refusing the nasal continuous positive airway pressure (nCPAP) therapy

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Trial Profile

Efficacy and safety of BF2.649 in the treatment of Excessive Daytime Sleepiness in patients with Obstructive Sleep Apnoea syndrome (OSA), refusing the nasal continuous positive airway pressure (nCPAP) therapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Nov 2023

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At a glance

  • Drugs Pitolisant (Primary)
  • Indications Hypersomnia; Sleep apnoea syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms HAROSA II
  • Sponsors Bioprojet

Most Recent Events

  • 16 Nov 2023 Results assessing long-term efficacy and safety of pitolisant for residual sleepiness due to obstructive sleep apnea in HAROSA-1 & HAROSA-2 trials, published in the Chest.
  • 02 Dec 2021 Results of meta-analysis of individual patient data from two studies (HAROSA-1 & HAROSA-2) assessing efficacy and safety of pitolisant 20 mg in patients with OSA, published in the Clinical Drug Investigation.
  • 03 Sep 2021 According to a Renovacor media release, The European Medicines Agency has issued a marketing authorisation for OZAWADE (pitolisant), indicated in the treatment of excessive daytime sleepiness (EDS) associated with obstructive sleep apnoea in adults.

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