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Treatment of Apomorphine-induced Skin Reactions: a Pilot Study

Primary Purpose

Parkinson's Disease, Apomorphine-induced Skin Reactions

Status

Unknown status

Phase

Phase 2

Locations

Netherlands

Study Type

Interventional

Intervention

Apomorphine 0.25% (2.5mg/ml)

Massage with a spiky ball

Hydrocortisone cream 1%

Subcutaneous hydrocortisone 10mg

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Apomorphine, Infusion, Skin reactions, Subcutaneous nodules, Hydrocortisone, Massage, Dilution

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of NeurologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

Massage with a spiky ball

Hydrocortisone cream 1%

Subcutaneous hydrocortisone 10mg

Apomorphine 0.25% (2.5mg/ml)

Arm Description

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

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

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.

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.

Outcomes

Primary Outcome Measures

Changes on global perceived effect scale

Secondary Outcome Measures

Changes in histological skin tissue characteristics

Histological skin tissue characteristics are presence of eosinophils, melanin-like pigment, fibrosis, lymphocytes and histiocytes.

Changes in nodule size (diameter)

Changes in erythema size (diameter)

Eosinophilia

Defined as increased absolute eosinophil count

Personal or family history of atopic constellation

Assessed with a questionnaire

Personal or family history of allergies

Assessed with a questionnaire

Full Information

NCT ID

NCT02230930

First Posted

August 29, 2014

Last Updated

May 1, 2017

Sponsor

University Medical Center Groningen

1. Study Identification

Unique Protocol Identification Number

NCT02230930

Brief Title

Treatment of Apomorphine-induced Skin Reactions: a Pilot Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Unknown status

Study Start Date

June 2015 (undefined)

Primary Completion Date

October 2017 (Anticipated)

Study Completion Date

November 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Medical Center Groningen

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease, Apomorphine-induced Skin Reactions

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Massage with a spiky ball

Arm Type

Active Comparator

Arm Description

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

Arm Title

Hydrocortisone cream 1%

Arm Type

Active Comparator

Arm Description

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

Arm Title

Subcutaneous hydrocortisone 10mg

Arm Type

Active Comparator

Arm Description

Arm Title

Apomorphine 0.25% (2.5mg/ml)

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Apomorphine 0.25% (2.5mg/ml)

Intervention Description

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%).

Intervention Type

Device

Intervention Name(s)

Massage with a spiky ball

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Hydrocortisone cream 1%

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Subcutaneous hydrocortisone 10mg

Other Intervention Name(s)

Solu-Cortef

Intervention Description

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

Primary Outcome Measure Information:

Title

Changes on global perceived effect scale

Time Frame

14 days

Secondary Outcome Measure Information:

Title

Changes in histological skin tissue characteristics

Description

Histological skin tissue characteristics are presence of eosinophils, melanin-like pigment, fibrosis, lymphocytes and histiocytes.

Time Frame

14 days

Title

Changes in nodule size (diameter)

Time Frame

14 days

Title

Changes in erythema size (diameter)

Time Frame

14 days

Title

Eosinophilia

Description

Defined as increased absolute eosinophil count

Time Frame

14 days

Title

Personal or family history of atopic constellation

Description

Assessed with a questionnaire

Time Frame

14 days

Title

Personal or family history of allergies

Description

Assessed with a questionnaire

Time Frame

14 days

Other Pre-specified Outcome Measures:

Title

Liver enzymes

Description

aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), alkaline phosphatase (AF), lactate dehydrogenase (LDH), gamma-glutamyl transpeptidase (gGT)

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Robbert WK Borgemeester, MD

Phone

+31 (0) 50-3611519

r.w.k.borgemeester@umcg.nl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Teus Van Laar, MD PhD

Organizational Affiliation

University Medical Center Groningen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Neurology

City

Groningen

ZIP/Postal Code

9713GZ

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Robbert Borgemeester, MD

Phone

+31 (0) 50-3611519

r.w.k.borgemeester@umcg.nl

First Name & Middle Initial & Last Name & Degree

Robbert Borgemeester, MD

First Name & Middle Initial & Last Name & Degree

Teus van Laar, MD PhD

12. IPD Sharing Statement

Citations:

PubMed Identifier

34218046

Citation

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.

Results Reference

derived

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Treatment of Apomorphine-induced Skin Reactions: a Pilot Study

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