Treatment of apomorphine-induced skin reactions: a pilot study
- Conditions
- Parkinson's disease1000131610028037
- Registration Number
- NL-OMON41221
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- 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;
• Presence of apomorphine-induced skin reactions (i.e. erythema, swelling and/or subcutaneous 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 should be able and capable of adhering to the protocol, visit schedule, and medication intake according to the judgement of the investigator.
• 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;
• Presence of 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The effect of each treatment option will be evaluated by changes in global<br /><br>perceived effect (GPE). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Changes in nodule size;<br /><br>Changes in erythema size;<br /><br>Changes in histologic skin tissue characteristics;<br /><br><br /><br>Other study parameters:<br /><br>Eosinophilia will be measured to investigate a systemic allergic reaction.<br /><br>Allergic predisposition in the development of skin reactions, personal and<br /><br>family history of allergies and atopic constellation will be questioned. </p><br>