EUCTR2021-000867-65-DE进行中（未招募）1 期
Comparative, randomized, open, crossover clinical trial to investigate adhesiveness of a newly developed rotigotine-containing transdermal patch in patients with Parkinson's disease
uye Pharma Switzerland AG0 个研究点目标入组 38 人开始时间: 2021年3月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 38
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
- •1. ethnic origin: Caucasian
- •2. age: 18 years or older
- •3. diagnosis of idiopathic Parkinson’s disease
- •4. administration of a stable dose of at least 8 mg/24 h rotigotine including use of an 8 mg/24 h patch for at least 2 weeks prior to enrolment
- •5. agreement to refrain from swimming, bathing or using a sauna on the assessment days
- •6. written informed consent obtained, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the patients participating in the clinical trial
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 19
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 19
排除标准
- •Safety concerns
- •1. existing and/or history of significant skin hypersensitivity to adhesives or other transdermal products
- •2. existing and/or history of dermatitis (eczema; excluding seborrheic skin by parkinson’s disease)
- •3. existing and/or history of psoriasis
- •4. existing and/or history of an active skin disease which interferes with the rotigotine patch application according to the investigator's assessment
- •5. history of or current drug or alcohol dependence
- •6. existing medical condition or psychiatric condition which, in the opinion of the investigator, could jeopardize or compromise the patient’s well-being or ability to participate in this study
- •7. lifetime history of suicide attempt
- •8. suicidal ideation in the past 6 months
- •9. administration of any investigational medicinal product during the last 2 months prior to individual enrolment of the patient
- •10. diagnosis of COVID-19 within the last 14 days prior to individual enrolment of the patient
- •11. contact to persons in foreign risk regions as defined by the Robert Koch Institute within the last 14 days prior to individual enrolment of the patient
- •12. known direct contact with insufficient protection to persons with diagnosis of COVID-19 within the last 14 days prior to individual enrolment upon reporting of the patient
- •For female patients with childbearing potential only:
- •13. positive pregnancy test at screening examination
- •14. pregnant or lactating women
- •15. female patients who do not agree to apply highly effective contraceptive methods (see chapter 13.2.1 of the trial protocol)
- •Administrative reasons
- •16. patients suspected or known not to follow instructions
- •17. patients who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical trial
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