drugset / Trial / NCT01066442
Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease
RandomizedParallel-groupQuadruple-blindTreatment
Summary
To compare the efficacy of BF2.649 over placebo (12 week Double-Blind Phase) and assess the long term safety and the efficacy maintenance(9 months Open-Label Extension Phase) of BF2.649 in the improvement of excessive daytime sleepiness in patients diagnosed with Parkinson's Disease.
Timeline
- Start
- 2010-03
- Primary completion
- 2012-08
- Completion
- 2012-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pitolisant | Small molecule | 5 mg | — |
| Subject | Pitolisant | Small molecule | 10 mg | — |
| Subject | Pitolisant | Small molecule | 20 mg | — |