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

NCT ID: NCT00642928

Last Updated: 2012-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2009-06-30

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 patients

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.

Conditions

Excessive Daytime Sleepiness; Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

1 capsule per day during 4 weeks

BF 2.649-5 mg

Group Type: EXPERIMENTAL

BF 2.649 5 mg

Intervention Type: DRUG

one BF 2.649 capsule of 5 mg per day during 4 weeks

BF 2.649 10 mg

Group Type: EXPERIMENTAL

BF 2.649 10 mg

Intervention Type: DRUG

One BF 2.649 capsule of 10 mg per day during 4 weeks

BF 2.649 20 mg

Group Type: EXPERIMENTAL

BF 2.649 20 mg

Intervention Type: DRUG

One BF 2.649 capsule of 20 mg per day during 4 weeks

BF 2.649 40 mg

Group Type: EXPERIMENTAL

BF 2.649 40 mg

Intervention Type: DRUG

One BF 2.649 capsule of 40 mg per day during 4 weeks

Interventions

Placebo

1 capsule per day during 4 weeks

Intervention Type: DRUG

BF 2.649 5 mg

one BF 2.649 capsule of 5 mg per day during 4 weeks

Intervention Type: DRUG

BF 2.649 10 mg

One BF 2.649 capsule of 10 mg per day during 4 weeks

Intervention Type: DRUG

BF 2.649 20 mg

One BF 2.649 capsule of 20 mg per day during 4 weeks

Intervention Type: DRUG

BF 2.649 40 mg

One BF 2.649 capsule of 40 mg per day during 4 weeks

Intervention Type: DRUG

Other Intervention Names

pitolisant; pitolisant; pitolisant; pitolisant

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bioprojet

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ARNULF Isabelle

Role: PRINCIPAL_INVESTIGATOR

Pitié-Salpêtrière Hospital, Paris, France

Carsten Moeller

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Giessen und Marburg, Marburg, Germany

Locations

Pitié-Salpêtrière Hospital

Paris, , France

Countries

France

Other Identifiers

2007-003512-57

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P07-02 / BF 2.649

Identifier Type: -

Identifier Source: org_study_id