sleep disturbances/sleep disorders in patients with Parkinson´s disease MedDRA version: 13.1 Level: LLT Classification code 10013113 Term: Disease Parkinson's System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Azilect
Pharmaceutical Form: Tablet
CAS Number: 161735-79-1
Other descriptive name: RASAGILINE MESILATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
Dresden University of Technology
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
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 30n/h) • Severe depression (MADRS >35) • Known history of cardiac arrhythmias and instable angina pectoris
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Reduction of sleep disturbances;Secondary Objective: 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 ;Primary end point(s): Change in sleep efficacy (TST/TIB %) and change in Parkinsons´s Disease Sleep Scale-2 ;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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) ;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) | — |
Countries
Germany
Contacts
Public ContactStudy Assistence
Department of Neurology
Outcome results
None listed