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

Narcolepsy Clinical Trial

Official title:
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

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01789398
Study type Interventional
Source Bioprojet
Contact
Status Completed
Phase Phase 3
Start date September 2012
Completion date August 2014
View Details
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