2025-521172-64-00招募中2 期
Comparative, randomized, open, crossover clinical trial to investigate adhesiveness of a newly developed Rotigotine 12 mg/24 h transdermal patch in patients with Parkinson’s disease
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 6
- 主要终点
- Mean adhesion of Test at 23 h 55 min
研究概览
简要总结
Assessment of skin adhesion properties of Test product at the end of the dosing interval Comparative assessment of skin adhesion properties of the Test and Reference product at the end of the dosing interval
研究设计
- 分配方式
- Randomized
- 主要目的
- Period 4
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Ethnic group: Caucasian
- •Age: 18 years or older
- •Diagnosis of idiopathic Parkinson’s disease
- •Administration of a stable dose of at least 12 mg/24 h rotigotine for at least 2 weeks prior to enrolment
- •Agreement to refrain from swimming, bathing or using a sauna on the assessment days
- •Written informed consent, 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 participants participating in the clinical trial
排除标准
- •Existing and/or history of significant skin hypersensitivity to adhesives or other transdermal products
- •History of severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator
- •Administration of any investigational medicinal product during the last 2 months prior to individual enrolment of the participant
- •Simultaneous participation in another clinical trial with active ingredients
- •Positive pregnancy test at screening examination
- •Pregnant or lactating women
- •Female participants who do not agree to apply highly effective contraceptive methods (highly effective contraceptive methods are defined in chapter 13.2.1 of the clinical trial protocol)
- •Participant is vulnerable such as detained or committed to an institution by a court of law or by legal authorities or close affiliation with the sponsor or the investigational site; e.g. a close relative of the investigator, dependent person (e.g. employee of or student at the investigational site), employee of sponsor`s affiliates)
- •Participants suspected or known not to follow instructions
- •Participants 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
- •Existing and/or history of dermatitis (eczema; excluding seborrheic skin by Parkinson’s disease)
- •Existing and/or history of psoriasis
- •Existing and/or history of an active skin disease which interferes with the rotigotine patch application according to the investigator’s assessment
- •History of or current drug or alcohol dependence
- •Existing medical condition or psychiatric condition which, in the opinion of the investigator, could jeopardize or compromise the participant’s well-being or ability to participate in this study
- •Lifetime history of suicide attempt
- •Suicidal ideation in the past 6 months
- •Known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparations
结局指标
主要结局
Mean adhesion of Test at 23 h 55 min
Mean adhesion of Test at 23 h 55 min
Difference of adhesiveness (Test – Reference) at 23 h 55 min
Difference of adhesiveness (Test – Reference) at 23 h 55 min
次要结局
- Frequency of AESIs
- Frequency of AEs
研究者
Director R&D
Scientific
Luye Pharma Switzerland AG
研究点 (6)
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