Excessive daytime sleepiness associated to Parkinson disease MedDRA version: 9.1 Level: LLT Classification code 10041014 Term: Sleepiness MedDRA version: 9.1 Level: LLT Classification code 10061536 Term: Parkinson's disease
Conditions
Interventions
Product Name: BF 2.649
Product Code: BF 2.649
Pharmaceutical Form: Capsule*
Current Sponsor code: BF 2.649
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharm
Sponsors
Bioprojet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult outpatients of both sex with confirmed diagnosis of idiopathic PD defined by : - UKPD Society Brain Bank clinical diagnostic criteria - Historical knowledge of positive response to Levodopa or dopamine agonist test - Severity of PD - Hoehn and Yahr =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Other degenerative parkinsonian syndromes (supra nuclear paralysis, multisystemic atrophy, corticobasal degenerescence, diffuse Lewy’s Body dementia) - Other condition than PD that can be considered the primary cause of excessive daytime sleepiness as: •Previous diagnostic of severe OSAS requiring CPAP according to the investigator •Idiopathic narcolepsy and narcolepsy secondary to structural brain lesion •Severe chronic alcohol consumption, shift work, chronic or occasional sleep deprivation, - Severe depression (BDI = 16 ) or with suicidal risk (item G BDI > 0) or depression treated for less than 8 weeks - Pregnant or breast-feeding women - Patients having an occupation that requires night shift - History of drugs, alcohol, narcotic or other substance abuse or dependence - Refusal from the patient to stop any current therapy for excessive daytime sleepiness or predictable risks for the patient to stop the therapy - Any significant abnormality in the physical examination or clinical laboratory results e.g. liver or kidney function deficiency, - Any significant serious abnormality of the ECG e.g. recent myocardial infarction, - Electrocardiogram Bazett’s corrected QT interval (QT x ?Racine carrée? [60/HR]) higher than 450 ms - Other active clinically significant illness which could interfere with the study conduct or contra-indicate the study treatments or put patients at risk - Dementia with MMS = 24 - Patients taking associated treatments which are not allowed during the study course and which cannot be stopped before the inclusion visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the minimum effective dose of BF 2.649 between 5 mg, 10 mg, 20 mg and 40 mg versus placebo in reducing the effects of BF 2.649 on the excessive daytime sleepiness and unintended sleep in Parkinson disease (PD);Secondary Objective: Mean number of daytime sleep or sleepiness episodes and their duration, motor function;Primary end point(s): Epworth Sleepiness Scale scores (ESS) on the 4-week treatment period | — |
Countries
France
Outcome results
None listed