Status:
COMPLETED
Dose Range Finding Study of BF2.649 Versus Placebo to Treat Excessive Daytime Sleepiness in Parkinson's Disease Patients
Lead Sponsor:
Bioprojet
Conditions:
Excessive Daytime Sleepiness
Parkinson's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The objective of this trial is to define the minimum effective dose of BF 2.649 between 5 mg, 10 mg, 20 mg or 40 mg versus placebo in reducing the Excessive Daytime Sleepiness of Parkinson's disease p...
Detailed Description
Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by resting tremor, rigidity, bradykinesia and loss of postural reflexes that affects 1% of the North American populat...
Eligibility Criteria
Inclusion
- Idiopathic Parkinson disease
- Hoehn and Yahr \< 5
- Stable treatment of Parkinson disease for at least 4 weeks
- Excessive Daytime Sleepiness : Epworth scale superior or equal to 13
- None psychostimulant treatment intake for 2 weeks
Exclusion
- Other degenerative parkinsonian syndrome
- other condition than PD that is the primary cause of excessive daytime sleepiness
- Severe depression or suicidal risk
- 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. myocardial infarction,
- Electrocardiogram corrected QT interval 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 inferior or equal to 24
- Patients taking associated treatments which are not allowed during the study course and which cannot be stopped before the inclusion visit
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00642928
Start Date
October 1 2007
End Date
June 1 2009
Last Update
June 11 2012
Active Locations (1)
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1
Pitié-Salpêtrière Hospital
Paris, France, 75013