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: 22 Jul 2017

At a glance

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

    • 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.
    • 20 Jan 2015 Planned End Date changed from 1 Sep 2014 to 1 Jan 2015, according to ClinicalTrials.gov record.
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