Study to test influence of parkinson drug of insomnia in parkinson patients

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

• 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