drugset / Trial / NCT01789398
Patient Narcoleptic Treated With BF2.649 (Pitolisant) in add-on to Sodium Oxybate (HARMONY IV)
RandomizedParallel-groupDouble-blindTreatment
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
Timeline
- Start
- 2012-09
- Primary completion
- 2014-08
- Completion
- 2014-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pitolisant | Small molecule | 5 mg | Oral |
| Subject | Pitolisant | Small molecule | 10 mg | Oral |
| Subject | Pitolisant | Small molecule | 20 mg | Oral |
| Subject | Pitolisant | Small molecule | 40 mg | Oral |