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

Sponsored by:	Bioprojet
Information provided by:	Bioprojet
ClinicalTrials.gov Identifier:	NCT00642928

Purpose

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

Condition	Intervention	Phase
Excessive Daytime Sleepiness Parkinson's Disease	Drug: Placebo Drug: BF 2.649 5 mg Drug: BF 2.649 10 mg Drug: BF 2.649 20 mg Drug: BF 2.649 40 mg	Phase II

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official 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)

Further study details as provided by Bioprojet:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Mean number of daytime sleep or sleepiness episodes and their duration [ Time Frame: During 5 days before each visit ] [ Designated as safety issue: Yes ]
frequency of sleep attacks [ Time Frame: recorded at each visit ] [ Designated as safety issue: No ]
UPDRS III for motor function [ Time Frame: at each visit ] [ Designated as safety issue: Yes ]
Clinical global impression scale [ Time Frame: at each visit ] [ Designated as safety issue: No ]

Estimated Enrollment:	130
Study Start Date:	October 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator	Drug: Placebo 1 capsule per day during 4 weeks
BF 2.649-5 mg: Experimental	Drug: BF 2.649 5 mg one BF 2.649 capsule of 5 mg per day during 4 weeks
BF 2.649 10 mg: Experimental	Drug: BF 2.649 10 mg One BF 2.649 capsule of 10 mg per day during 4 weeks
BF 2.649 20 mg: Experimental	Drug: BF 2.649 20 mg One BF 2.649 capsule of 20 mg per day during 4 weeks
BF 2.649 40 mg: Experimental	Drug: BF 2.649 40 mg One BF 2.649 capsule of 40 mg per day during 4 weeks

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 population. Besides these motor problems there are also so called non-motor problems.

Excessive daytime sleepiness (EDS) is a bothersome non-motor problem, which affects 20% to 50% of all PD patients and currently, there isn't any registered treatment for that trouble. The study medication BF2.649 tested here is a novel, highly potent, selective, orally active inverse agonist at the histamine H3 receptor, therefore strengthens histaminergic transmission in the brain and increases wakefulness EDS is characterized by daytime somnolence and sudden sleep episodes. This problem has several consequences, e.g., an impairment of quality of life, an interference with activities of daily living and other handicaps in the management of social and family affairs. The primary endpoint of this study will be measured by the change in the well-validated Epworth sleepiness scale (ESS). The ESS is a simple self-administered 8-item questionnaire. The outcome is to get an impression about the level of the daytime sleepiness in several real-life situations.

On the basis of this pharmacological and clinical rationale it is considered relevant to carry out a dose-finding study for this original, non-amphetamine molecule in PD patients affected by excessive daytime sleepiness. PD severity will be assessed by the routinely used UPDRS.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642928

Contacts

Contact: Genevieve d'Orsay	+33 1 47 03 66 51	g.dorsay@bioprojet.com
Contact: Julie Pharaboz	+33 1 47 03 66 25	j.pharaboz@bioprojet.com

Locations

France
Pitié-Salpêtirère Hospital	Recruiting
PARIS, France, 75013
Contact: ARNULF Isabelle 33 (1) 42 17 67 58 isabelle.arnulf@psl.aphp.fr
Principal Investigator: ARNULF Isabelle

Sponsors and Collaborators

Bioprojet

Investigators

Principal Investigator:	ARNULF Isabelle	Pitié-Salpêtrière Hospital, Paris, France
Principal Investigator:	Carsten Moeller	Universitätsklinikum Giessen und Marburg, Marburg, Germany

More Information

No publications provided

Responsible Party:	Bioprojet ( Dr Geneviève Giret-d'Orsay )
Study ID Numbers:	P07-02/BF 2.649, Eudract number:2007-003512-57
Study First Received:	March 21, 2008
Last Updated:	March 21, 2008
ClinicalTrials.gov Identifier:	NCT00642928 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bioprojet:

Excessive Daytime Sleepiness
Parkinson's disease

Study placed in the following topic categories:

Signs and Symptoms
Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:

Movement Disorders
Parkinson Disease
Nervous System Diseases
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

ClinicalTrials.gov processed this record on May 07, 2009