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OpenTrials
Completed

NCT Number: NCT01066442

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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Disorders of Excessive Somnolence Dyssomnias Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Sleep Disorders, Intrinsic Sleep Wake Disorders Synucleinopathies

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Klinik für Neurologie Universitätsklinikum

Marburg, 35039, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BF2.649 (Pitolisant)

Drug

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

Other names: Pitolisant

Primary outcomes

  1. ESS change (Epworth Sleepiness Scale) versus baseline

    Time frame: at week 12 / 51 versus baseline

Secondary outcomes

  1. Safety

    Time frame: 12-week and 52-week

    Any AE observed and reported during the study

Sponsors and collaborators

Lead sponsor

Bioprojet

Other

Registry information

Official study 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

Acronym: HARPS2

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 10, 2010
Registry last updated
Apr 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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