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Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease (HARPS1)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01036139
First Posted: December 21, 2009
Last Update Posted: April 12, 2013
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.
Information provided by (Responsible Party):
Bioprojet
  Purpose
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 Intervention Phase
Parkinson's Disease Drug: BF2.649 (pitolisant) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, 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

Resource links provided by NLM:


Further study details as provided by Bioprojet:

Primary Outcome Measures:
  • ESS change (Epworth Sleepiness Scale) [ Time Frame: at week 12 / 52 versus baseline ]

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


Enrollment: 268
Study Start Date: December 2009
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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,fluctuating and non-fluctuating 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
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): NCT01036139


Locations
France
Pr Arnulf
Paris, France
Sponsors and Collaborators
Bioprojet
Investigators
Study Director: Kati Gutierrez, PharmD Bioprojet
  More Information

Responsible Party: Bioprojet
ClinicalTrials.gov Identifier: NCT01036139     History of Changes
Other Study ID Numbers: P06-10 / BF 2.649
Eudract number ( Other Identifier: 2009-013885-14 )
First Submitted: December 11, 2009
First Posted: December 21, 2009
Last Update Posted: April 12, 2013
Last Verified: April 2013

Keywords provided by Bioprojet:
EDS in 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