E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Excessive daytime sleepiness in Parkinson’s Disease |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10015595 |
E.1.2 | Term | Excessive daytime sleepiness |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10034005 |
E.1.2 | Term | Parkinson's disease and parkinsonism |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 53, in patients diagnosed with Parkinson’s Disease |
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E.2.2 | Secondary objectives of the trial |
evaluate diurnal somnolence and sleep episodes number and duration as reported in the patients’ sleep diaries assess the evolution of the Fatigue Severity Scale Scores evaluate the evolution of the Unified Parkinson Disease Rating Scale assess the evolution of the Clinical Global Impression on EDS as measured by the CGI scale scores. assess patients’ depression as measured by the Beck Depression Inventory score assess Patients’ Apathy as measured by the Apathy Evaluation Scale assess patient´s sleep as measured by the Sudden Onset Sleep scale assess the product withdrawal effect at W13 and W54 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, SOS, BDI and sleep diary after one week of product withdrawal |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
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. |
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E.4 | Principal 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 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 / √[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
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E.5 End points |
E.5.1 | 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 53 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 25 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |