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
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
- 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.