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An Open-label Naturalistic Pragmatic Study to Assess the Long Term Safety of BF2.649 (Pitolisant) in the Treatment of Excessive Daytime Sleepiness (EDS) in Narcolepsy (12 Months Follow-up, Followed by a Prolonged Follow up)

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An Open-label Naturalistic Pragmatic Study to Assess the Long Term Safety of BF2.649 (Pitolisant) in the Treatment of Excessive Daytime Sleepiness (EDS) in Narcolepsy (12 Months Follow-up, Followed by a Prolonged Follow up)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Nov 2021

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At a glance

  • Drugs Pitolisant (Primary)
  • Indications Cataplexy; Narcolepsy
  • Focus Adverse reactions
  • Acronyms HARMONY-III
  • Sponsors Bioprojet

    • Most Recent Events

    • 27 Apr 2021 According to a Harmony Biosciences media release, data from three analyses; two featuring analyses of efficacy and safety data from the clinical development program for WAKIX in adult patients with narcolepsy and the third a post hoc analysis evaluating the time to onset of clinical response for WAKIX will be presented at the 2021 American Psychiatric Association (APA) Annual Meeting.
    • 12 Apr 2021 According to a Harmony Biopharm media release, pooled data from HARMONY-1, HARMONY-CTP and HARMONY-III will be presented at the American Academy of Neurology (AAN) Annual Meeting.
    • 28 Aug 2020 According to a Harmony Biosciences media release, results of a post-hoc analysis assessing the cardiac safety events associated with pitolisant based on a pooled analysis of the HARMONY 1 (8-week) and HARMONY CTP (7-week) clinical trials, and from the 12-month, open-label HARMONY 3 trial, were presented at the 34th Annual Meeting of the Associated Professional Sleep Societies (APSS), known as "SLEEP 2020." The meeting is being held virtually from 27th to 30th Aug 2020.

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