Double Blind Randomized Study to Assess the Efficacy of BF2.649 Compared to Placebo in add-on to Sodium Oxybate in the Treatment of Narcoleptic Patients With Residual Excessive Daytime Sleepiness (EDS) During 8 Weeks

Trial Profile

Double Blind Randomized Study to Assess the Efficacy of BF2.649 Compared to Placebo in add-on to Sodium Oxybate in the Treatment of Narcoleptic Patients With Residual Excessive Daytime Sleepiness (EDS) During 8 Weeks

Completed
Phase of Trial: Phase III

Latest Information Update: 20 Nov 2015

At a glance

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

    • 20 Jan 2015 Status changed from active, no longer recruiting to completed, according to ClinicalTrials.gov record.
    • 03 Sep 2014 According to ClinicalTrials.gov record, status changed from recruiting to active, no longer recruiting.
    • 02 Mar 2013 Planned number of patients changed from 50 to 60 as reported by European Clinical Trials Database.
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