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

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ClinicalTrials.gov Identifier: NCT00642928
Recruitment Status : Completed
First Posted : March 25, 2008
Last Update Posted : June 11, 2012
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment 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 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Study Start Date : October 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
1 capsule per day during 4 weeks

Experimental: BF 2.649-5 mg Drug: BF 2.649 5 mg
one BF 2.649 capsule of 5 mg per day during 4 weeks
Other Name: pitolisant

Experimental: BF 2.649 10 mg Drug: BF 2.649 10 mg
One BF 2.649 capsule of 10 mg per day during 4 weeks
Other Name: pitolisant

Experimental: BF 2.649 20 mg Drug: BF 2.649 20 mg
One BF 2.649 capsule of 20 mg per day during 4 weeks
Other Name: pitolisant

Experimental: BF 2.649 40 mg Drug: BF 2.649 40 mg
One BF 2.649 capsule of 40 mg per day during 4 weeks
Other Name: pitolisant

Primary Outcome Measures :
  1. 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 Measures :
  1. Mean number of daytime sleep or sleepiness episodes and their duration [ Time Frame: During 5 days before each visit ]
  2. frequency of sleep attacks [ Time Frame: recorded at each visit ]
  3. UPDRS III for motor function [ Time Frame: at each visit ]
  4. Clinical global impression scale [ Time Frame: at each visit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00642928

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Pitié-Salpêtrière Hospital
Paris, France, 75013
Sponsors and Collaborators
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Principal Investigator: ARNULF Isabelle Pitié-Salpêtrière Hospital, Paris, France
Principal Investigator: Carsten Moeller Universitätsklinikum Giessen und Marburg, Marburg, Germany
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Responsible Party: Bioprojet
ClinicalTrials.gov Identifier: NCT00642928    
Other Study ID Numbers: P07-02 / BF 2.649
2007-003512-57 ( EudraCT Number )
First Posted: March 25, 2008    Key Record Dates
Last Update Posted: June 11, 2012
Last Verified: June 2012
Keywords provided by Bioprojet:
Excessive Daytime Sleepiness
Parkinson's disease
Additional relevant MeSH terms:
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Parkinson Disease
Disorders of Excessive Somnolence
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Mental Disorders