Parkinson's disease
Conditions
Interventions
Trade Name: Hydrocortisone cream 10mg/g FNA Fagron
Product Name: Hydrocortisone cream
Pharmaceutical Form: Cream
Trade Name: Solu-Cortef, powder for so
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Changes in histological skin tissue characteristics • Changes in nodule size (diameter) • Changes in erythema size (diameter) • Eosinophilia (total eosinophils, complete full blood count with differential blood count) • Personal or family history of atopic constellation • Personal or family history of allergies ;Timepoint(s) of evaluation of this end point: After each treatment administered. Each treatment has a duration of 14 days. | — |
Countries
Netherlands
Contacts
Public ContactCoordinating Investigator
University Medical Center Groningen
Outcome results
None listed