NCT01789398

Patient Narcoleptic Treated With BF2.649 (Pitolisant) in add-on to Sodium Oxybate (HARMONY IV)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Bioprojet · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicentric international phase III, double blind randomized study assessing efficacy and safety in parallel group of BF2.649 (pitolisant) compared to placebo in add-on to sodium oxybate of narcoleptic patients with residual Excessive Daytime Sleepiness (EDS) during 8 weeks

Conditions

• Narcolepsy

Interventions

Type	Name	Description
DRUG	BF2.649	BF2.649 is provided in capsules. Patients should take 1 capsules per day with a glass of water. They will be instructed to take 1 capsule in the morning (after waking up, before breakfast).

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2013-02-12
• Last updated: 2015-11-18

Locations

1 site across 1 country: France