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Treatment of Apomorphine-induced Skin Reactions: a Pilot Study | Clinical Trials | Clareo Health

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Treatment of Apomorphine-induced Skin Reactions: a Pilot Study

Open-label Crossover Trial to Investigate the Efficacy of Treatments in Apomorphine-induced Skin Reactions

NCT02230930•University Medical Center Groningen

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

Age

30 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Department of Neurology

Groningen, Netherlands

Key Dates

Start Date

June 1, 2015

Primary Completion Date

December 31, 2018

Completion Date

December 31, 2018

Last Updated

March 13, 2024

Enrollment

ACTUAL participants

Conditions

Parkinson's DiseaseApomorphine-induced Skin Reactions

Interventions

Apomorphine 0.25% (2.5mg/ml)

DRUG

Massage with a spiky ball

DEVICE

Hydrocortisone cream 1%

DRUG

Subcutaneous hydrocortisone 10mg

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Treatment of Apomorphine-induced Skin Reactions: a Pilot Study

Inclusion Criteria

Exclusion Criteria

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

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Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

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