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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
273
1 capsule of BF2.649 (5mg, 10mg , 20 mg) O.D
Klinik für Neurologie Universitätsklinikum
Marburg, Germany
ESS change (Epworth Sleepiness Scale) versus baseline
Time frame: at week 12 / 51 versus baseline
Safety
Any AE observed and reported during the study
Time frame: 12-week and 52-week
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