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Treatment of Apomorphine-induced Skin Reactions: a Pilot Study

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ClinicalTrials.gov Identifier: NCT02230930
Recruitment Status : Unknown
Verified May 2017 by Teus van Laar, University Medical Center Groningen.
Recruitment status was:  Recruiting
First Posted : September 3, 2014
Last Update Posted : May 2, 2017
Sponsor:
Information provided by (Responsible Party):
Teus van Laar, University Medical Center Groningen

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.


Condition or disease Intervention/treatment Phase
Parkinson's Disease Apomorphine-induced Skin Reactions Drug: Apomorphine 0.25% (2.5mg/ml) Device: Massage with a spiky ball Drug: Hydrocortisone cream 1% Drug: Subcutaneous hydrocortisone 10mg Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label Crossover Trial to Investigate the Efficacy of Treatments in Apomorphine-induced Skin Reactions
Study Start Date : June 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : November 2017


Arm Intervention/treatment
Active Comparator: Massage with a spiky ball
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
Each patient will massage skin reactions with a spiky ball 3 times a day for 2 minutes.

Active Comparator: Hydrocortisone cream 1%
Subjects are instructed to apply hydrocortisone cream 1% once daily for 14 days.
Drug: Hydrocortisone cream 1%
Hydrocortisone cream 1% (1mg/g) will be administered on each nodule one time a day

Active Comparator: Subcutaneous hydrocortisone 10mg
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
Subcutaneous hydrocortisone 10mg will be administered previous to apomorphine infusion making use of the apomorphine infusion system
Other Name: Solu-Cortef

Active Comparator: Apomorphine 0.25% (2.5mg/ml)
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)
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%).




Primary Outcome Measures :
  1. Changes on global perceived effect scale [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Changes in histological skin tissue characteristics [ Time Frame: 14 days ]
    Histological skin tissue characteristics are presence of eosinophils, melanin-like pigment, fibrosis, lymphocytes and histiocytes.

  2. Changes in nodule size (diameter) [ Time Frame: 14 days ]
  3. Changes in erythema size (diameter) [ Time Frame: 14 days ]
  4. Eosinophilia [ Time Frame: 14 days ]
    Defined as increased absolute eosinophil count

  5. Personal or family history of atopic constellation [ Time Frame: 14 days ]
    Assessed with a questionnaire

  6. Personal or family history of allergies [ Time Frame: 14 days ]
    Assessed with a questionnaire


Other Outcome Measures:
  1. Liver enzymes [ Time Frame: 14 days ]
    aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), alkaline phosphatase (AF), lactate dehydrogenase (LDH), gamma-glutamyl transpeptidase (gGT)



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02230930


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

Locations
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Netherlands
Department of Neurology Recruiting
Groningen, Netherlands, 9713GZ
Contact: Robbert Borgemeester, MD    +31 (0) 50-3611519    r.w.k.borgemeester@umcg.nl   
Sub-Investigator: Robbert Borgemeester, MD         
Principal Investigator: Teus van Laar, MD PhD         
Sponsors and Collaborators
University Medical Center Groningen
Investigators
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Principal Investigator: Teus Van Laar, MD PhD University Medical Center Groningen

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Responsible Party: Teus van Laar, MD PhD, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02230930     History of Changes
Other Study ID Numbers: 46934
First Posted: September 3, 2014    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: May 2017

Keywords provided by Teus van Laar, University Medical Center Groningen:
Parkinson's disease
Apomorphine
Infusion
Skin reactions
Subcutaneous nodules
Hydrocortisone
Massage
Dilution

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Cortisone
Apomorphine
Anti-Inflammatory Agents
Emetics
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action