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)

Trial Profile

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)

Completed
Phase of Trial: Phase III

Latest Information Update: 02 Feb 2017

At a glance

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

    • 30 Jan 2017 Status changed from active, no longer recruiting to completed.
    • 01 Jul 2016 Planned End Date changed from 1 Dec 2015 to 1 Oct 2016.
    • 20 Nov 2015 According to European Medicines Agency media release, the European Medicines Agency (EMA) has recommended granting a marketing authorisation for Wakix (pitolisant) for the treatment of narcolepsy with or without cataplexy (sudden severe muscle weakness or loss of muscle control).
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