Overview

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