drugset / Trial / NCT01399606

Long Term Open Label Study in Narcolepsy With BF2.649 (Pitolisant)

NCT01399606

Phase 3 Completed 102 enrolled Bioprojet
NaSingle-groupOpen-labelTreatment

Summary

This is a multicentric International Phase III,Long term open label study(12 months)assessing the long-term safety and efficacy of BF2.649 (Pitolisant)in the treatment of Excessive Daytime Sleepiness (EDS) in narcoleptic patients with or without cataplexy.

Timeline

Start
2011-05
Primary completion
2013-10
Completion
2016-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Pitolisant Small molecule 5 mg
Subject Pitolisant Small molecule 10 mg
Subject Pitolisant Small molecule 20 mg
Subject Pitolisant Small molecule 40 mg