Dose Range Finding Study of BF2.649 Versus Placebo to Treat Excessive Daytime Sleepiness in Parkinson's Disease Patients

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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 patients

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bioprojet

Criteria

Inclusion Criteria:

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 Criteria:

• 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