Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease
HARPS2
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
2 other identifiers
interventional
273
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2010
CompletedFirst Posted
Study publicly available on registry
February 10, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedApril 12, 2013
April 1, 2013
2.4 years
February 9, 2010
April 11, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ESS change (Epworth Sleepiness Scale) versus baseline
at week 12 / 51 versus baseline
Secondary Outcomes (1)
Safety
12-week and 52-week
Study Arms (2)
BF2.649 ( Pitolisant)
EXPERIMENTALBF2.649 (5mg, 10 mg, 20 mg) in capsules
Placebo
PLACEBO COMPARATORPlacebo of BF2.649 (5mg, 10mg, 20mg) in capsules
Interventions
1 capsule of BF2.649 (5mg, 10mg , 20 mg) O.D
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bioprojetlead
Study Sites (1)
Klinik für Neurologie Universitätsklinikum
Marburg, 35039, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kati Gutierrez, PharmD
Bioprojet
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2010
First Posted
February 10, 2010
Study Start
March 1, 2010
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
April 12, 2013
Record last verified: 2013-04