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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:
Information provided by (Responsible Party):
Bioprojet
ClinicalTrials.gov Identifier:
NCT01036139
First received: December 11, 2009
Last updated: April 11, 2013
Last verified: April 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Bioprojet:

Primary Outcome Measures:
  • ESS change (Epworth Sleepiness Scale) [ Time Frame: at week 12 / 52 versus baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: 12-week and 52-week ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01036139

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

No publications provided

Responsible Party: Bioprojet
ClinicalTrials.gov Identifier: NCT01036139     History of Changes
Other Study ID Numbers: P06-10 / BF 2.649, Eudract number
Study First Received: December 11, 2009
Last Updated: April 11, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Spanish Agency of Medicines

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

ClinicalTrials.gov processed this record on May 19, 2013