A Randomized, Multicenter, 12-Week, Double-blind, Placebo-Controlled, Study to Assess the Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson Disease, followed by a 9-months Open-Label Extension Phase - HARPS-2
- Conditions
- Excessive daytime sleepiness in Parkinson’s DiseaseMedDRA version: 12.0Level: LLTClassification code 10015595Term: Excessive daytime sleepinessMedDRA version: 12.0Level: HLTClassification code 10034005Term: Parkinson's disease and parkinsonism
- Registration Number
- EUCTR2009-013886-24-CZ
- Lead Sponsor
- BIOPROJET
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 246
Outpatients, male or female, aged between 30 years and older
Patients with a documented history of Parkinson’s disease according to UPDRS (Unified Parkinson Disease Rating Scale), fluctuator and non-fluctuator patients, Hoehn and Yahr score <5
Patients stabilized on optimal antiparkinsonian treatments unmodified for 4 weeks prior to study entry
Patients presenting an Excessive Daytime Sleepiness as indicated by an Epworth Scale Score ³12
Patients having a health Insurance Coverage (according to local regulatory requirements)
Patients having signed an informed consent before any specific study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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
Severe depression indicated by Beck’s Depression Inventory (BDI ³16) or at suicidal risk (BDI item G>0) or depression treated for less than 8 weeks
Cognitive impairment as indicated by a Minimental Status Examination (MMSE) score less than 25 or with mental conditions rendering them unable to understand the nature, scope, and possible consequences of the study
Females who have not been using an adequate contraceptive method for the last 2 months, or is pregnant or breastfeeding, or not at least one year post-menopausal or unwilling or unable to continue contraceptive use during the study
Recent history of alcohol or drug abuse within the last three years prior to study entry
Concomitant condition (including clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease) making either implementation of the protocol or interpretation of the study results
difficult or which could interfere with the study conduct or contra-indicate the study treatments or put patients at risk
Progressively fatal disease, or life expectancy = one year
Known history of long QTc syndrome (e.g., personal or family history of syncope or arrhythmia) or presenting any significant serious abnormality of the ECG (e.g. recent myocardial infarction), QTc strictly higher than 450 ms (electrocardiogram Bazett’s corrected QT interval ( QT / v[60/HR])
Patients who have received any other investigational drug (including BF2.649) within 1 month prior to study entry, or have such treatment planned during the study period
Patients unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and are unlikely to complete the study
Suspected or known hypersensitivity to, or suspected serious adverse reaction to the study medication
Galactose intolerance, lactase deficiency or glucose-galactose malabsorption
Associated treatments which are not allowed during the study course and which cannot be stopped at least 2weeks prior to study entry
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method