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

Parkinson's Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00642928
• Other study ID #: P07-02 / BF 2.649
• Secondary ID: 2007-003512-57
• Status: Completed
• Phase: Phase 2
• First received: March 21, 2008
• Last updated: June 8, 2012
• Start date: October 2007
• Est. completion date: June 2009

Study information

• Verified date: June 2012
• Source: Bioprojet
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: June 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Excessive Daytime Sleepiness
• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Placebo
1 capsule per day during 4 weeks
• BF 2.649 5 mg
one BF 2.649 capsule of 5 mg per day during 4 weeks
• BF 2.649 10 mg
One BF 2.649 capsule of 10 mg per day during 4 weeks
• BF 2.649 20 mg
One BF 2.649 capsule of 20 mg per day during 4 weeks
• BF 2.649 40 mg
One BF 2.649 capsule of 40 mg per day during 4 weeks

Locations

Country	Name	City	State
France	Pitié-Salpêtrière Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Bioprojet

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epworth Sleepiness Scale scores (ESS)		At selection visit (Day-14 to Day-7)/Inclusion visit (Day0)/ Interim visit (Day14)/Final visit (Day28)	Yes
Secondary	Mean number of daytime sleep or sleepiness episodes and their duration		During 5 days before each visit	Yes
Secondary	frequency of sleep attacks		recorded at each visit	No
Secondary	UPDRS III for motor function		at each visit	Yes
Secondary	Clinical global impression scale		at each visit	No