Open-label crossover trial to investigate the efficacy of treatments in apomorphine-induced skin reactions - Treatment of apomorphine-induced skin reactions: a pilot study

niversity Medical Center Groningen0 个研究点目标入组 20 人开始时间: 2015年6月3日最近更新: 2019年6月30日

适应症

试验速览

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•Female and male subjects aged =30;
•Diagnosis of idiopathic Parkinson’s disease of >3 years’ duration, defined by the UK Brain Bank criteria, with the exception of >1 affected relative being allowed, without any other known or suspected cause of Parkinsonism (Gibb & Lees, 1988);
•Treatment with continuous subcutaneous apomorphine infusion;
•Having apomorphine-induced skin reactions (i.e. erythema, swelling and/or nodule formation);
•Male and female patients must be compliant with a highly effective contraceptive method (oral hormonal contraception alone is not considered highly effective and must be used in combination with a barrier method) during the study, if sexually active;
•Subjects considered reliable and capable of adhering to the protocol, visit schedule, and medication intake according to the judgement of the investigator.
•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 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•High suspicion of other parkinsonian syndromes;
•History of respiratory depression;
•Hypersensitivity to hydrocortisone or any excipients of the medicinal product;
•Concomitant therapy with histamine antagonist or (gluco)corticosteroids;
•Known with Cushing’s disease or hypercortisolism
•Any medical condition that is likely to interfere with an adequate participation in the study including e.g. current diagnosis of unstable epilepsy; clinically relevant cardiac dysfunction and/or myocardial infarction or stroke within the last 12 months;
•Pregnant and breastfeeding women;
•Current infectious disease with fever at the time of investigation.

发起方