Trial to investigate the efficacy of treatments in apomorphine-induced skin reactions
- Conditions
- Parkinson's diseaseTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2014-000657-36-NL
- Lead Sponsor
- niversity Medical Center Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
•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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this pilot study is to investigate the effectiveness of treatment used in the treatment of skin reactions induced by continuous subcutaneous apomorphine infusion. ;Secondary Objective: The secondary objective is to investigate the role of allergy in apomorphine-induced skin reactions.;Primary end point(s): Changes on global perceived effect (GPE) scale;Timepoint(s) of evaluation of this end point: After each treatment administered. Each treatment has a duration of 14 days.
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): •Changes in histological skin tissue characteristics<br> •Changes in nodule size (diameter)<br> •Changes in erythema size (diameter)<br> •Eosinophilia (total eosinophils, complete full blood count with differential blood count)<br> •Personal or family history of atopic constellation<br> •Personal or family history of allergies<br> ;Timepoint(s) of evaluation of this end point: After each treatment administered. Each treatment has a duration of 14 days.