Treatment of Apomorphine-induced Skin Reactions: a Pilot Study

NCT02230930 | Terminated Phase 2

• 1 other identifier: 46934
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease; Apomorphine-induced Skin Reactions

Keywords

Parkinson's disease; Apomorphine; Infusion; Skin reactions; Subcutaneous nodules; Hydrocortisone; Massage; Dilution

Outcome Measures

Primary Outcomes (1)

• Changes on global perceived effect scale

  14 days

Secondary Outcomes (6)

• Changes in histological skin tissue characteristics

  14 days

• Changes in nodule size (diameter)

  14 days

• Changes in erythema size (diameter)

  14 days

• Eosinophilia

  14 days

• Personal or family history of atopic constellation

  14 days

Other Outcomes (1)

• Liver enzymes

  14 days

Study Arms (4)

Massage with a spiky ball

ACTIVE COMPARATOR

Subjects are instructed to massage the apomorphine-induced skin reactions with a spiky ball 3 times a day for 2 minutes for 14 days.

Device: Massage with a spiky ball

Hydrocortisone cream 1%

ACTIVE COMPARATOR

Subjects are instructed to apply hydrocortisone cream 1% once daily for 14 days.

Drug: Hydrocortisone cream 1%

Subcutaneous hydrocortisone 10mg

ACTIVE COMPARATOR

Subjects are instructed to administer subcutaneous hydrocortisone (Solu-Cortef 10mg) prior to apomorphine via the subcutaneous infusion line which is used for administration of apomorphine, for 14 days.

Drug: Subcutaneous hydrocortisone 10mg

Apomorphine 0.25% (2.5mg/ml)

ACTIVE COMPARATOR

Subjects are instructed to dilute apomorphine 0.5% (5mg/ml) with the same volume of physiologic saline (NaCl 0.9%) to 0.25% (2.5mg/ml). Apomorphine will be infused subcutaneously for 14 days.

Drug: Apomorphine 0.25% (2.5mg/ml)

Interventions

Apomorphine 0.25% (2.5mg/ml) DRUG

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%).

Apomorphine 0.25% (2.5mg/ml)

Massage with a spiky ball DEVICE

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

Massage with a spiky ball

Hydrocortisone cream 1% DRUG

Hydrocortisone cream 1% (1mg/g) will be administered on each nodule one time a day

Hydrocortisone cream 1%

Subcutaneous hydrocortisone 10mg DRUG

Subcutaneous hydrocortisone 10mg will be administered previous to apomorphine infusion making use of the apomorphine infusion system

Also known as: Solu-Cortef

Subcutaneous hydrocortisone 10mg

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

Department of Neurology

Groningen, 9713GZ, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 34218046 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Apomorphine; Massage; hydrocortisone hemisuccinate

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Aporphines; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 4 or More Rings; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Teus Van Laar, MD PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: September 3, 2014
• Study Start: June 1, 2015
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

NL (1)