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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bioprojet
ClinicalTrials.gov Identifier:
NCT00642928
First received: March 21, 2008
Last updated: June 8, 2012
Last verified: June 2012
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


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 ]

Enrollment: 108
Study Start Date: October 2007
Study Completion Date: June 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
1 capsule per day during 4 weeks
Other Name: placebo
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Pitié-Salpêtrière Hospital
Paris, France, 75013
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
ClinicalTrials.gov Identifier: NCT00642928     History of Changes
Other Study ID Numbers: P07-02 / BF 2.649, 2007-003512-57
Study First Received: March 21, 2008
Last Updated: June 8, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bioprojet:
Excessive Daytime Sleepiness
Parkinson's disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on October 19, 2014