Prospective, Randomized, Double-blind Study, Placebo-controlled, Parallel-group, Multi-center Trial Assessing the Effects of BF2.649 in Treatment of Excessive Daytime Sleepiness in Narcolepsy.

Trial Profile

Prospective, Randomized, Double-blind Study, Placebo-controlled, Parallel-group, Multi-center Trial Assessing the Effects of BF2.649 in Treatment of Excessive Daytime Sleepiness in Narcolepsy.

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Nov 2013

At a glance

  • Drugs Pitolisant (Primary) ; Modafinil
  • Indications Narcolepsy
  • Focus Registrational; Therapeutic Use
  • Acronyms Harmony-I; Harmony1
  • Sponsors Bioprojet
  • Most Recent Events

    • 01 Nov 2013 Primary endpoint 'Epworth-Sleepiness-Scale' has not been met according to results published in the Lancet.
    • 01 Nov 2013 Results published in the Lancet.
    • 09 Oct 2013 Data published in Lancet Neurology, according to a Bioprojet media release.
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