Back to resultsEfficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease (HARPS2)
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
BF2.649 (Pitolisant)
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Excessive Daytime Sleepiness (EDS), Parkinson's Disease
Eligibility 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
Sites / Locations
- Klinik für Neurologie Universitätsklinikum
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BF2.649 ( Pitolisant)
Placebo
Arm Description
BF2.649 (5mg, 10 mg, 20 mg) in capsules
Placebo of BF2.649 (5mg, 10mg, 20mg) in capsules
Outcomes
Primary Outcome Measures
ESS change (Epworth Sleepiness Scale) versus baseline
Secondary Outcome Measures
Safety
Any AE observed and reported during the study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01066442
Brief Title
Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease
Acronym
HARPS2
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 Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bioprojet
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Excessive Daytime Sleepiness (EDS), Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
273 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BF2.649 ( Pitolisant)
Arm Type
Experimental
Arm Description
BF2.649 (5mg, 10 mg, 20 mg) in capsules
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo of BF2.649 (5mg, 10mg, 20mg) in capsules
Intervention Type
Drug
Intervention Name(s)
BF2.649 (Pitolisant)
Other Intervention Name(s)
Pitolisant
Intervention Description
1 capsule of BF2.649 (5mg, 10mg , 20 mg) O.D
Primary Outcome Measure Information:
Title
ESS change (Epworth Sleepiness Scale) versus baseline
Time Frame
at week 12 / 51 versus baseline
Secondary Outcome Measure Information:
Title
Safety
Description
Any AE observed and reported during the study
Time Frame
12-week and 52-week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kati Gutierrez, PharmD
Organizational Affiliation
Bioprojet
Official's Role
Study Director
Facility Information:
Facility Name
Klinik für Neurologie Universitätsklinikum
City
Marburg
ZIP/Postal Code
35039
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease
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