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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01066442
• Date of registration: 09/02/2010
• Prospective Registration: Yes
• Primary sponsor: Bioprojet
• Public title: Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease HARPS2
• Scientific 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
• Date of first enrolment: March 2010
• Target sample size: 273
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01066442
• 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
• Phase: Phase 3

Countries of recruitment

Germany

Contacts

• Name: Kati Gutierrez, PharmD
• Affiliation: Bioprojet

Key inclusion & exclusion 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



Age minimum: 30 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: BF2.649 (Pitolisant)

Primary Outcome(s)

ESS change (Epworth Sleepiness Scale) versus baseline [Time Frame: at week 12 / 51 versus baseline]

Secondary Outcome(s)

Safety [Time Frame: 12-week and 52-week]

Secondary ID(s)

P06-11 / BF2.649

2009-013886-24

Source(s) of Monetary Support

Please refer to primary and secondary sponsors