Clinical trial NCT02230930: Treatment of Apomorphine-induced Skin Reactions: a Pilot Study
Official title: Open-label Crossover Trial to Investigate the Efficacy of Treatments in Apomorphine-induced Skin Reactions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Parkinson's Disease
Apomorphine-induced Skin Reactions
Keywords: Parkinson's disease
Apomorphine
Infusion
Skin reactions
Subcutaneous nodules
Hydrocortisone
Massage
Dilution
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2014-09-03
Enrollment: 13
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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.


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.

Primary outcomes:
measure: Changes on global perceived effect scale
timeFrame: 14 days
Secondary outcomes:
measure: Changes in histological skin tissue characteristics
timeFrame: 14 days
measure: Changes in nodule size (diameter)
timeFrame: 14 days
measure: Changes in erythema size (diameter)
timeFrame: 14 days
measure: Eosinophilia
timeFrame: 14 days
measure: Personal or family history of atopic constellation
timeFrame: 14 days
measure: Personal or family history of allergies
timeFrame: 14 days
Other outcomes:
measure: Liver enzymes
timeFrame: 14 days
Locations:
city: Groningen
country: Netherlands
facility: Department of Neurology
Study officials:
affiliation: University Medical Center Groningen
name: Teus Van Laar, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Borgemeester RWK, Diercks GFH, van Laar T. Treatment of subcutaneous nodules after infusion of apomorphine; a biopsy-controlled study comparing 4 frequently used therapies. Parkinsonism Relat Disord. 2021 Aug;89:38-40. doi: 10.1016/j.parkreldis.2021.06.024. Epub 2021 Jun 29.