Excessive daytime sleepiness in Parkinson?s Disease Somnolencia diurna excesiva en la enfermedad de Parkinson. MedDRA version: 12.0 Level: LLT Classification code 10015595 Term: Excessive daytime sleepiness MedDRA version: 12.0 Level: HLT Classification code 10034005 Term: Parkinson's disease and parkinsonism
Conditions
Interventions
Product Name: Pitolisant
Product Code: BF2.649
Pharmaceutical Form: Capsule*
INN or Proposed INN: Pitolisant
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 5-20
Ph
Sponsors
BIOPROJET
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Outpatients, male or female, aged between 30 to 80 years 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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 9>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 / ?[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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of BF2.649 over placebo (Double-Blind Phase) and assess the long term efficacy (Open-Label Extension Phase) of BF2.649 in the improvement of excessive daytime sleepiness, as measured by the change from baseline in the Epworth Scale Scores (ESS) at Week 12 and confirm the long-term efficacy at Week 51, in patients diagnosed with Parkinson?s Disease;Secondary Objective: To evaluate diurnal somnolence and sleep episodes number and duration as reported in the patients? sleep diaries To assess the evolution of the Fatigue Severity Scale Scores (FSS) To evaluate the evolution of the Unified Parkinson Disease Rating Scale (UPDRS) To assess Quality of Life of Patients reported in Parkinson Disease Questionnaire (PDQ-39) To assess dopamine agonists dosage modification To assess the evolution of the Clinical Global Impression on EDS as measured by the CGI scale scores. To assess patients? depression as measured by the Beck Depression Inventory (BDI) score To assess Patients? Apathy as measured by the Apathy Evaluation Scale (AES) To assess the product withdrawal effect at W13 and W52 by collecting the changes in signs and symptoms (increased appetite, increased sleepiness, excitability, changes in mood)and by assessing the modification of ESS, AES, FSS, PDQ-39, CGI , BDI and sleep diary after one week of product withdrawal;Primary end point(s): Evolution of the Epworth Sleepiness Scale scores (ESS). Comparison between the ESS score baseline value and the ESS-score at week 12 and week 51 | — |
Countries
France, Spain
Outcome results
None listed