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

Parkinson's Disease Clinical Trial

— HARPS2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01066442
• Other study ID #: P06-11 / BF2.649
• Secondary ID: 2009-013886-24
• Status: Completed
• Phase: Phase 3
• First received: February 9, 2010
• Last updated: April 11, 2013
• Start date: March 2010
• Est. completion date: August 2012

Study information

• Verified date: April 2013
• Source: Bioprojet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesCzech Republic: State Institute for Drug ControlSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 273
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• BF2.649 (Pitolisant)
1 capsule of BF2.649 (5mg, 10mg , 20 mg) O.D

Locations

Country	Name	City	State
Germany	Klinik für Neurologie Universitätsklinikum	Marburg

Sponsors (1)

Lead Sponsor	Collaborator
Bioprojet

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ESS change (Epworth Sleepiness Scale) versus baseline		at week 12 / 51 versus baseline	No
Secondary	Safety	Any AE observed and reported during the study	12-week and 52-week	Yes