Treatment of Apomorphine-induced Skin Reactions: a Pilot Study

Condition(s) targeted: Parkinson's Disease; Apomorphine-induced Skin Reactions

Intervention: Apomorphine 0.25% (2.5mg/ml) (Drug); Massage with a spiky ball (Device); Hydrocortisone cream 1% (Drug); Subcutaneous hydrocortisone 10mg (Drug)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: University Medical Center Groningen

Official(s) and/or principal investigator(s):
Teus van Laar, MD PhD, Principal Investigator, Affiliation: University Medical Center Groningen

Overall contact:
Robbert Borgemeester, MD, Phone: +31 (0) 50-3611519, Email: r.w.k.borgemeester@umcg.nl

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.

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Changes on global perceived effect scale

Secondary outcome:

Changes in histological skin tissue characteristics

Changes in nodule size (diameter)

Changes in erythema size (diameter)

Eosinophilia

Personal or family history of atopic constellation

Personal or family history of allergies

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Both.

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.

Robbert Borgemeester, MD, Phone: +31 (0) 50-3611519, Email: r.w.k.borgemeester@umcg.nl

Department of Neurology, Groningen 9713GZ, Netherlands; Not yet recruiting
Robbert Borgemeester, MD, Phone: +31 (0) 50-3611519, Email: r.w.k.borgemeester@umcg.nl
Robbert Borgemeester, MD, Sub-Investigator
Teus van Laar, MD PhD, Principal Investigator

Starting date: October 2014
Last updated: August 29, 2014