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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00642928
• Date of registration: 21/03/2008
• Prospective Registration: No
• Primary sponsor: Bioprojet
• Public title: Dose Range Finding Study of BF2.649 Versus Placebo to Treat Excessive Daytime Sleepiness in Parkinson's Disease Patients
• Scientific title: Randomized, Dose-finding Study of BF 2.649 5, 10 20 and 40 mg/d in Comparison to Placebo in Excessive Daytime Sleepiness in Parkinson's Disease Patients (PD)
• Date of first enrolment: October 2007
• Target sample size: 108
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00642928
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: ARNULF Isabelle
• Affiliation: Pitié-Salpêtrière Hospital, Paris, France

• Name: Carsten Moeller
• Affiliation: Universitätsklinikum Giessen und Marburg, Marburg, Germany

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Excessive Daytime Sleepiness

Intervention(s)

Drug: Placebo

Drug: BF 2.649 10 mg

Drug: BF 2.649 20 mg

Drug: BF 2.649 5 mg

Drug: BF 2.649 40 mg

Primary Outcome(s)

Epworth Sleepiness Scale scores (ESS) [Time Frame: At selection visit (Day-14 to Day-7)/Inclusion visit (Day0)/ Interim visit (Day14)/Final visit (Day28)]

Secondary Outcome(s)

frequency of sleep attacks [Time Frame: recorded at each visit]

Mean number of daytime sleep or sleepiness episodes and their duration [Time Frame: During 5 days before each visit]

Clinical global impression scale [Time Frame: at each visit]

UPDRS III for motor function [Time Frame: at each visit]

Secondary ID(s)

2007-003512-57

P07-02 / BF 2.649

Source(s) of Monetary Support

Please refer to primary and secondary sponsors