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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
Sponsor:
Information provided by (Responsible Party):
Bioprojet

Tracking Information
First Submitted Date  ICMJE March 21, 2008
First Posted Date  ICMJE March 25, 2008
Last Update Posted Date June 11, 2012
Study Start Date  ICMJE October 2007
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2008)
Epworth Sleepiness Scale scores (ESS) [ Time Frame: At selection visit (Day-14 to Day-7)/Inclusion visit (Day0)/ Interim visit (Day14)/Final visit (Day28) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2008)
  • Mean number of daytime sleep or sleepiness episodes and their duration [ Time Frame: During 5 days before each visit ]
  • frequency of sleep attacks [ Time Frame: recorded at each visit ]
  • UPDRS III for motor function [ Time Frame: at each visit ]
  • Clinical global impression scale [ Time Frame: at each visit ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose Range Finding Study of BF2.649 Versus Placebo to Treat Excessive Daytime Sleepiness in Parkinson's Disease Patients
Official Title  ICMJE 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)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Excessive Daytime Sleepiness
  • Parkinson's Disease
Intervention  ICMJE
  • 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 Name: pitolisant
  • Drug: BF 2.649 10 mg
    One BF 2.649 capsule of 10 mg per day during 4 weeks
    Other Name: pitolisant
  • Drug: BF 2.649 20 mg
    One BF 2.649 capsule of 20 mg per day during 4 weeks
    Other Name: pitolisant
  • Drug: BF 2.649 40 mg
    One BF 2.649 capsule of 40 mg per day during 4 weeks
    Other Name: pitolisant
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: BF 2.649-5 mg
    Intervention: Drug: BF 2.649 5 mg
  • Experimental: BF 2.649 10 mg
    Intervention: Drug: BF 2.649 10 mg
  • Experimental: BF 2.649 20 mg
    Intervention: Drug: BF 2.649 20 mg
  • Experimental: BF 2.649 40 mg
    Intervention: Drug: BF 2.649 40 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 6, 2009)
108
Original Estimated Enrollment  ICMJE
 (submitted: March 21, 2008)
130
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00642928
Other Study ID Numbers  ICMJE P07-02 / BF 2.649
2007-003512-57 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Bioprojet
Original Responsible Party Dr Geneviève Giret-d'Orsay, Bioprojet
Current Study Sponsor  ICMJE Bioprojet
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: ARNULF Isabelle Pitié-Salpêtrière Hospital, Paris, France
Principal Investigator: Carsten Moeller Universitätsklinikum Giessen und Marburg, Marburg, Germany
PRS Account Bioprojet
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP