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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01066442

Acronym

HARPS2

Enrollment

273

Registered

2010-02-10

Start date

2010-03-31

Completion date

2012-08-31

Last updated

2013-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

Excessive Daytime Sleepiness (EDS), Parkinson's Disease

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.

Interventions

DRUGBF2.649 (Pitolisant)

1 capsule of BF2.649 (5mg, 10mg , 20 mg) O.D

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
ESS change (Epworth Sleepiness Scale) versus baseline	at week 12 / 51 versus baseline

Secondary

Measure	Time frame	Description
Safety	12-week and 52-week	Any AE observed and reported during the study

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026