EUCTR2010-023756-82-DE进行中（未招募）不适用
Rasagiline treatment for Sleep disorders in Parkinson´s disease - RaSPar
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
- •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
研究者
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