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)
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
- 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).