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

Phase 3

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: BF2.649 (pitolisant)

• Registration Number: NCT01036139
• Lead Sponsor: Bioprojet

Brief 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.

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.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-11
• Study First Submitted QC: 2009-12-18
• Study First Posted: 2009-12-21
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-11
• Last Update Posted: 2013-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 268

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BF2.649 (pitolisant)	BF2.649 (pitolisant)	BF2.649 (5mg, 10 mg, 20 mg) in capsules
Placebo	BF2.649 (pitolisant)	Placebo of BF2.649 (5mg, 10mg, 20mg) in capsules

Primary Outcome Measures

Name	Time	Method
ESS change (Epworth Sleepiness Scale)	at week 12 / 52 versus baseline

Secondary Outcome Measures

Name	Time	Method
Safety	12-week and 52-week	Any AE observed and reported during the study

Trial Locations

Locations (1)

Pr Arnulf; 🇫🇷 Paris, France