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Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease (HARPS2)

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ClinicalTrials.gov Identifier: NCT01066442
Recruitment Status : Completed
First Posted : February 10, 2010
Last Update Posted : April 12, 2013
Sponsor:
Information provided by (Responsible Party):
Bioprojet

Study Description
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Brief Summary:
To compare the efficacy of BF2.649 over placebo (12 week Double-Blind Phase) and assess the long term safety and the efficacy maintenance(9 months Open-Label Extension Phase) of BF2.649 in the improvement of excessive daytime sleepiness in patients diagnosed with Parkinson's Disease.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: BF2.649 (Pitolisant) Phase 3

Detailed Description:
As measured by the change from baseline in the Epworth Scale Scores (ESS) at Week 12 and at Week 51, in patients diagnosed with EDS in Parkinson's Disease.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 273 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Multicenter 12-Week Double-blind Placebo-controlled Study to Assess the Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson's Disease Followed by a 38 Week Open Label Extension Phase
Study Start Date : March 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: BF2.649 ( Pitolisant)
BF2.649 (5mg, 10 mg, 20 mg) in capsules
 Drug: BF2.649 (Pitolisant)
1 capsule of BF2.649 (5mg, 10mg , 20 mg) O.D
Other Name: Pitolisant
Placebo Comparator: Placebo
Placebo of BF2.649 (5mg, 10mg, 20mg) in capsules
 Drug: BF2.649 (Pitolisant)
1 capsule of BF2.649 (5mg, 10mg , 20 mg) O.D
Other Name: Pitolisant


Outcome Measures
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Primary Outcome Measures :
  1. ESS change (Epworth Sleepiness Scale) versus baseline [ Time Frame: at week 12 / 51 versus baseline ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: 12-week and 52-week ]
    Any AE observed and reported during the study


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a documented history of Parkinson's disease according to UPDRS,fluctuator and non-fluctuator patients, Hoehn and Yahr score <5;
  • stabilized on optimal antiparkinsonian treatments unmodified for 4 weeks prior to study entry;
  • presenting an Excessive Daytime Sleepiness as indicated by an ESS>or=12

Exclusion Criteria:

  • Patients with a known diagnosis of other degenerative parkinsonian syndromes (e.g. Progressive supra-nuclear palsy, multisystemic atrophy, corticobasal degenerescence, diffuse Lewy's Body dementia)
  • Patients who have shift work, chronic or occasional sleep deprivation, circadian rhythm disorders
  • Patients with a severe depression indicated by (BDI>= 16)or at suicidal risk (BDI item G>0) or depression treated for less than 8 weeks
  • Patients with a cognitive impairment
Contacts and Locations
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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): NCT01066442


Locations
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Germany
Klinik für Neurologie Universitätsklinikum
Marburg, Germany, 35039
Sponsors and Collaborators
Bioprojet
Investigators
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Study Director: Kati Gutierrez, PharmD Bioprojet
More Information
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Responsible Party: Bioprojet
ClinicalTrials.gov Identifier: NCT01066442    
Other Study ID Numbers: P06-11 / BF2.649
2009-013886-24 ( EudraCT Number )
First Posted: February 10, 2010    Key Record Dates
Last Update Posted: April 12, 2013
Last Verified: April 2013
Keywords provided by Bioprojet:
Excessive Daytime Sleepiness (EDS)
Parkinson's Disease
Additional relevant MeSH terms:
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Parkinson Disease
Disorders of Excessive Somnolence
Sleepiness
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Mental Disorders