Clinical trial
Open-label Crossover Trial to Investigate the Efficacy of Treatments in Apomorphine-induced Skin Reactions
Name
46934
Description
Skin reactions as a result of continuous subcutaneous apomorphine infusion occur frequently and interfere with the absorption of apomorphine. The histopathology of apomorphine-induced skin reactions is poorly understood. Therefore treatment options are limited and suggestive.
Objective: to investigate the efficacy of four treatments including massage, dilution of apomorphine, treatment with topical hydrocortisone and pre-treatment with subcutaneous administered hydrocortisone, in Parkinson's disease patients with apomorphine-induced skin reactions.
Trial arms
Trial start
2015-06-01
Estimated PCD
2018-12-31
Trial end
2018-12-31
Status
Terminated
Phase
Early phase I
Treatment
Apomorphine 0.25% (2.5mg/ml)
Apomorphine 0.5% (5mg/ml) will be diluted to 0.25% (2.5mg/ml) by the addition of the same volume physiological saline (NaCl 0.9%).
Arms:
Apomorphine 0.25% (2.5mg/ml)
Massage with a spiky ball
Each patient will massage skin reactions with a spiky ball 3 times a day for 2 minutes.
Arms:
Massage with a spiky ball
Hydrocortisone cream 1%
Hydrocortisone cream 1% (1mg/g) will be administered on each nodule one time a day
Arms:
Hydrocortisone cream 1%
Subcutaneous hydrocortisone 10mg
Subcutaneous hydrocortisone 10mg will be administered previous to apomorphine infusion making use of the apomorphine infusion system
Arms:
Subcutaneous hydrocortisone 10mg
Other names:
Solu-Cortef
Size
13
Primary endpoint
Changes on global perceived effect scale
14 days
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 13, 'type': 'ACTUAL'}}
Updated at
2024-03-13
1 organization
3 products
2 indications
Organization
University Medical Center GroningenProduct
ApomorphineIndication
Parkinson's DiseaseIndication
Apomorphine-induced Skin ReactionsProduct
HydrocortisoneProduct
Subcutaneous hydrocortisone