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

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bioprojet

Criteria

Inclusion Criteria:

• Patients with a documented history of Parkinson's disease according to UPDRS,fluctuator and non-fluctuator patients, Hoehn and Yahr score <5;

• stabilized on optimal antiparkinsonian treatments unmodified for 4 weeks prior to study entry;

• presenting an Excessive Daytime Sleepiness as indicated by an ESS>or=12

Exclusion Criteria:

• Patients with a known diagnosis of other degenerative parkinsonian syndromes (e.g. Progressive supra-nuclear palsy, multisystemic atrophy, corticobasal degenerescence, diffuse Lewy's Body dementia)

• Patients who have shift work, chronic or occasional sleep deprivation, circadian rhythm disorders

• Patients with a severe depression indicated by (BDI>= 16)or at suicidal risk (BDI item G>0) or depression treated for less than 8 weeks

• Patients with a cognitive impairment