drugset / Trial / NCT01399606
Long Term Open Label Study in Narcolepsy With BF2.649 (Pitolisant)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pitolisant | Small molecule | 5 mg | — |
| Subject | Pitolisant | Small molecule | 10 mg | — |
| Subject | Pitolisant | Small molecule | 20 mg | — |
| Subject | Pitolisant | Small molecule | 40 mg | — |