Status:
TERMINATED
Treatment of Apomorphine-induced Skin Reactions: a Pilot Study
Lead Sponsor:
University Medical Center Groningen
Conditions:
Parkinson's Disease
Apomorphine-induced Skin Reactions
Eligibility:
All Genders
30+ years
Phase:
PHASE2
Brief Summary
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 i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT02230930
Start Date
June 1 2015
End Date
December 31 2018
Last Update
March 13 2024
Active Locations (1)
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1
Department of Neurology
Groningen, Netherlands, 9713GZ