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A Randomized, Double Blind Study Comparing Pitolisant (BF2.649) to Placebo in Two Parallel Groups on the Weekly Frequency of Cataplexy Attacks and Excessive Daytime Sleepiness in Narcoleptic Patients With Cataplexy.

Trial Profile

A Randomized, Double Blind Study Comparing Pitolisant (BF2.649) to Placebo in Two Parallel Groups on the Weekly Frequency of Cataplexy Attacks and Excessive Daytime Sleepiness in Narcoleptic Patients With Cataplexy.

Completed
Phase of Trial: Phase III

Latest Information Update: 29 Apr 2019

At a glance

  • Drugs Pitolisant (Primary)
  • Indications Cataplexy; Narcolepsy
  • Focus Registrational; Therapeutic Use
  • Acronyms HARMONY-CTP
  • Sponsors Bioprojet
  • Most Recent Events

    • 29 Apr 2019 According to a Harmony Biosciences media release, the data from this trial and Harmony CTP will be presented at the upcoming 2019 American Academy of Neurology (AAN) annual meeting in Philadelphia, May 4-10.
    • 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).
    • 02 Jul 2015 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
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