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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomised, 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

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: BF2.649 (Pitolisant)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BF2.649 ( Pitolisant)<br>BF2.649 (5mg, 10 mg, 20 mg) in capsules | Drug: BF2.649 (Pitolisant)<br>* 1 capsule of BF2.649 (5mg, 10mg , 20 mg) O.D<br>* Other names: Pitolisant;|
| Placebo Comparator: Placebo<br>Placebo of BF2.649 (5mg, 10mg, 20mg) in capsules | Drug: BF2.649 (Pitolisant)<br>* 1 capsule of BF2.649 (5mg, 10mg , 20 mg) O.D<br>* Other names: Pitolisant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ESS change (Epworth Sleepiness Scale) versus baseline |  | at week 12 / 51 versus baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Any AE observed and reported during the study | 12-week and 52-week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Excessive Daytime Sleepiness (EDS), Parkinson's Disease