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

    Phase 2
  • Study Type

  • Status

    Completed No Results Posted
  • Intervention/Treatment

    pitolisant ...
  • Study Participants

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
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.
Study Started
Oct 31
Primary Completion
Mar 31
Study Completion
Jun 30
Last Update
Jun 11

Drug Placebo

1 capsule per day during 4 weeks

Drug BF 2.649 5 mg

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

  • Other names: pitolisant

Drug BF 2.649 10 mg

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

  • Other names: pitolisant

Drug BF 2.649 20 mg

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

  • Other names: pitolisant

Drug BF 2.649 40 mg

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

  • Other names: pitolisant

Placebo Placebo Comparator

BF 2.649-5 mg Experimental

BF 2.649 10 mg Experimental

BF 2.649 20 mg Experimental

BF 2.649 40 mg Experimental


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
No Results Posted