Treatment of Apomorphine-induced Skin Reactions: a Pilot Study

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02230930
• Other study ID #: 46934
• Status: Terminated
• Phase: Phase 2
• Start date: June 2015
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2024
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apomorphine-induced Skin Reactions
• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• 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%).

Device:
• Massage with a spiky ball
Each patient will massage skin reactions with a spiky ball 3 times a day for 2 minutes.

Drug:
• Hydrocortisone cream 1%
Hydrocortisone cream 1% (1mg/g) will be administered on each nodule one time a day
• Subcutaneous hydrocortisone 10mg
Subcutaneous hydrocortisone 10mg will be administered previous to apomorphine infusion making use of the apomorphine infusion system

Locations

Country	Name	City	State
Netherlands	Department of Neurology	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Liver enzymes	aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), alkaline phosphatase (AF), lactate dehydrogenase (LDH), gamma-glutamyl transpeptidase (gGT)	14 days
Primary	Changes on global perceived effect scale		14 days
Secondary	Changes in histological skin tissue characteristics	Histological skin tissue characteristics are presence of eosinophils, melanin-like pigment, fibrosis, lymphocytes and histiocytes.	14 days
Secondary	Changes in nodule size (diameter)		14 days
Secondary	Changes in erythema size (diameter)		14 days
Secondary	Eosinophilia	Defined as increased absolute eosinophil count	14 days
Secondary	Personal or family history of atopic constellation	Assessed with a questionnaire	14 days
Secondary	Personal or family history of allergies	Assessed with a questionnaire	14 days