NCT01036139

Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease

A Randomized, Multicenter 12-Week Double-blind Placebo-controlled Study to Assess the Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson's Disease Followed by a 38-Week Open-label Extension Phase

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 268 (actual)
• Sponsor: Bioprojet · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

As measured by the change from baseline in the Epworth Scale Scores (ESS) at Week 12 and at Week 51, in patients diagnosed with EDS in Parkinson's Disease.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	BF2.649 (pitolisant)	1 capsule of BF2.649 (5mg, 10mg , 20 mg) O.D

Timeline

• Start date: 2009-12-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2009-12-21
• Last updated: 2013-04-12

Locations

1 site across 1 country: France