Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease - Full Text View

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: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Genetics Home Reference related topics: Parkinson disease Perry syndrome

MedlinePlus related topics: Parkinson's Disease

U.S. FDA Resources

Further study details as provided by Bioprojet:

Primary Outcome Measures:

ESS change (Epworth Sleepiness Scale) versus baseline [ Time Frame: at week 12 / 51 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:	273
Study Start Date:	March 2010
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 (Adult, Senior)
Genders Eligible for Study:	Both
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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01066442

Locations


Germany
Klinik für Neurologie Universitätsklinikum
Marburg, Germany, 35039

Sponsors and Collaborators

Bioprojet

Investigators


Study Director:	Kati Gutierrez, PharmD	Bioprojet

More Information


Responsible Party:	Bioprojet
ClinicalTrials.gov Identifier:	NCT01066442 History of Changes
Other Study ID Numbers:	P06-11 / BF2.649 2009-013886-24
Study First Received:	February 9, 2010
Last Updated:	April 11, 2013
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices Czech Republic: State Institute for Drug Control Sweden: Medical Products Agency

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

ClinicalTrials.gov processed this record on September 29, 2016

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