ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Germany
Klinik für Neurologie Universitätsklinikum
Marburg, Germany, 35039
Sponsors and Collaborators
Bioprojet
Investigators
Study Director: Kati Gutierrez, PharmD Bioprojet
More Information
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Bioprojet
ClinicalTrials.gov Identifier: NCT01066442     History of Changes
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:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases