Treatment of Apomorphine-induced Skin Reactions: a Pilot Study

• Register: ClinicalTrials.gov
• Last refreshed on: 25 March 2024
• Main ID: NCT02230930
• Date of registration: 29/08/2014
• Prospective Registration: Yes
• Primary sponsor: University Medical Center Groningen
• Public title: Treatment of Apomorphine-induced Skin Reactions: a Pilot Study
• Scientific title: Open-label Crossover Trial to Investigate the Efficacy of Treatments in Apomorphine-induced Skin Reactions
• Date of first enrolment: June 2015
• Target sample size: 13
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT02230930
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Netherlands

Contacts

• Name: Teus Van Laar, MD PhD
• Affiliation: University Medical Center Groningen

Key inclusion & exclusion 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.



Age minimum: 30 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Apomorphine-induced Skin Reactions

Parkinson's Disease

Intervention(s)

Device: Massage with a spiky ball

Drug: Subcutaneous hydrocortisone 10mg

Drug: Apomorphine 0.25% (2.5mg/ml)

Drug: Hydrocortisone cream 1%

Primary Outcome(s)

Changes on global perceived effect scale [Time Frame: 14 days]

Secondary Outcome(s)

Changes in histological skin tissue characteristics [Time Frame: 14 days]

Eosinophilia [Time Frame: 14 days]

Personal or family history of allergies [Time Frame: 14 days]

Changes in erythema size (diameter) [Time Frame: 14 days]

Personal or family history of atopic constellation [Time Frame: 14 days]

Changes in nodule size (diameter) [Time Frame: 14 days]

Secondary ID(s)

46934

Source(s) of Monetary Support

Please refer to primary and secondary sponsors