E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
sleep disturbances/sleep disorders in patients with Parkinson´s disease |
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E.1.1.1 | Medical condition in easily understood language |
insomnia in parkinson patients |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10013113 |
E.1.2 | Term | Disease Parkinson's |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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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 |
Reduction of sleep disturbances |
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E.2.2 | Secondary objectives of the trial |
a) Changes in different sleep variables measured by PSG and clinical assessment b) Changes in sleep quality and daytime sleepiness assessed by standardized scales as well as cognitive function, depression indices and Quality of Life indices are measured. c) Rasagiline Safety assessment
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Idiopathic Morbus Parkinson according United Kingdom BBB-Criterias • Male or female patients 50 to 85 years old • Hoehn and Yahr Stadium I-III • Relevant sleep disorder (> 5 PSQI) • Well adjusted antiparkinsonian medication about 4 weeks before inclusion • Patients, who are able and willing to complete questionaries • Patients who are able and willing to unterstand the relevance of the trial • Signed informed consent
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E.4 | Principal exclusion criteria |
• Known hypersensitivity to Rasagiline or other componets of Azilect or drugs with similar chemical structure • Atypical Parkinson syndrome • Pregnant or breastfeeding females • Females of childbearing potential (FCBP) except those fulfilling the following criterias: - post-menopausal (12 months of natural amenorrhea or 6 months of amenorrhea with serum FSH > 40 U/ml); - post-surgery (6 weeks after bilateral ovarectomy with or without hysterectomy); - regular and correct use of contraceptives with a PEARL Index of < 1% (e.g. implants, depot formulations of hormones, oral contraceptives, intra uterine device – IUD); - sexual abstinence; - partner, who had vasectomy • Intake, within the last 2 weeks before treatment, of: Amantadin, Monoaminoxidase- (MAO) inhibitors, SSRI, SNRI, trizyclical and tetrazyclical antidepressants, all neuroleptics except Clozapin and Quetiapin • Intake, within 4 weeks before inclusion, of: CYP P450 1A2 Inhibitors (e.g. Ciprofloxacin, Cimetidin, Clarithromycin, Erythromycin, systemic Estrogene, Fluvoxamin, Isoniazid, Ketokonazol, Levofloxacin, Norfloxacin, Mexiletin, Paroxetin, Propafenon, Zileuton, Disulfiram, Ginseng, Grapefruitjuice, Ephedrin, Pseudoephedrin) • Ongoing or terminated treatment within the last 2 weeks before inclusion with Opiates like Pethidin • Patients with a history of chronic drug abuse or another illness which does not allow the patient to assess the nature and/or possible consequences of the study • Neurological (other than PD) or psychiatric disorders which affect the patient´s functional status and/or judgement or ability to agree • Patients who are not likely to follow the trial protocol (lack of willigness to Cooperate) • Legal incapacity or limited legal incapacity • Epilepsy or epileptic seizure in the history • Known or ongoing alcohol or drug abuse • Deep brain stimulation (DBS), condition after deep brain stimulation • Significant renal or hepatic impairment • Participation in other clinical trial during this trial and within 4 weeks before inclusion • History of sleep related breathing disorder or severe OSAS as characterized by PSG (AHI >30n/h) • Severe depression (MADRS >35) • Known history of cardiac arrhythmias and instable angina pectoris
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in sleep efficacy (TST/TIB %) and change in Parkinsons´s Disease Sleep Scale-2 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
between evaluation at V2 (end of placebo run-in-phase) and V3 (end of 8 weeks Rasagiline treatment phase) |
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E.5.2 | Secondary end point(s) |
Measured by PSG as: frequency of slow wave sleep (SWS) and REM sleep, sleep latency, REM latency, total sleep time (TST), total wake time (WASO), sleep fragmentation, arousal index, percentage of light sleep (stage 1,2) periodic limb movements in sleep (PLMS), Apnoe-Hypopnoe-Index (AHI), Respiratory-Distress Index (RDI) and nocturnal mobility assed by PSG video recording. Sleep quality and daytime sleepiness assessed by standardized scales (ESS, PSQI, number of diurnal naps) as well as cognitive function (PANDA, TAP), depression indices (MADRS) and QoL index (PDQ-39) are measured. Motor symptoms (full version of new Unified Parkinson’s Disease Rating Scale (UPDRS)) Modified Hoehn&Yahr Scale Schwab and England ADL Scale Global Clinical Impression (GCI) ECG changes Safety laboratory values (Liver and renal function, electrolytes, WBC, RBC)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
between evaluation at V2 (end of placebo run-in-phase) and V3 (end of 8 weeks Rasagiline treatment phase) |
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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.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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 | No |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |