Treatment of Apomorphine-induced Skin Reactions: a Pilot Study
Parkinson's Disease, Apomorphine-induced Skin Reactions
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Apomorphine, Infusion, Skin reactions, Subcutaneous nodules, Hydrocortisone, Massage, Dilution
Eligibility Criteria
Inclusion Criteria:
- Female and male subjects aged ≥30;
- Diagnosis of idiopathic Parkinson's disease of >3 years' duration, defined by the United Kingdom (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.
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;
- 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.
Sites / Locations
- Department of NeurologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Massage with a spiky ball
Hydrocortisone cream 1%
Subcutaneous hydrocortisone 10mg
Apomorphine 0.25% (2.5mg/ml)
Subjects are instructed to massage the apomorphine-induced skin reactions with a spiky ball 3 times a day for 2 minutes for 14 days.
Subjects are instructed to apply hydrocortisone cream 1% once daily for 14 days.
Subjects are instructed to administer subcutaneous hydrocortisone (Solu-Cortef 10mg) prior to apomorphine via the subcutaneous infusion line which is used for administration of apomorphine, for 14 days.
Subjects are instructed to dilute apomorphine 0.5% (5mg/ml) with the same volume of physiologic saline (NaCl 0.9%) to 0.25% (2.5mg/ml). Apomorphine will be infused subcutaneously for 14 days.