Parkinson's DiseasePhase 2NCT02230930
Treatment of Apomorphine-induced Skin Reactions: a Pilot Study
A Phase 2 study testing Apomorphine 0.25% (2.5mg/ml), Massage with a spiky ball and Hydrocortisone cream 1% in people with Parkinson's Disease and Apomorphine-induced Skin Reactions, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson's Disease, Apomorphine-induced Skin Reactions
- What is being tested?
- Apomorphine 0.25% (2.5mg/ml), Massage with a spiky ball and Hydrocortisone cream 1%
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2015to 31 Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label Crossover Trial to Investigate the Efficacy of Treatments in Apomorphine-induced Skin Reactions
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.
- Being tested
- Apomorphine 0.25% (2.5mg/ml), Massage with a spiky ball, Hydrocortisone cream 1%, Subcutaneous hydrocortisone 10mg
- Keywords
- Parkinson's disease, Apomorphine, Infusion, Skin reactions, Subcutaneous nodules, Hydrocortisone, Massage, Dilution
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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%).
Massage with a spiky ballDevice
Each patient will massage skin reactions with a spiky ball 3 times a day for 2 minutes.
Hydrocortisone cream 1%Drug
Hydrocortisone cream 1% (1mg/g) will be administered on each nodule one time a day
Subcutaneous hydrocortisone 10mgDrug
Also called Solu-Cortef
Subcutaneous hydrocortisone 10mg will be administered previous to apomorphine infusion making use of the apomorphine infusion system
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Massage with a spiky ball |
| Hydrocortisone cream 1% | Active comparator | Subjects are instructed to apply hydrocortisone cream 1% once daily for 14 days. Receives: 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. Receives: 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. Receives: Drug: Apomorphine 0.25% (2.5mg/ml) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes on global perceived effect scale
Measured: 14 days
Secondary outcomes (6)
Changes in histological skin tissue characteristics
Histological skin tissue characteristics are presence of eosinophils, melanin-like pigment, fibrosis, lymphocytes and histiocytes.
Measured: 14 days
Changes in nodule size (diameter)
Measured: 14 days
Changes in erythema size (diameter)
Measured: 14 days
Eosinophilia
Defined as increased absolute eosinophil count
Measured: 14 days
Personal or family history of atopic constellation
Assessed with a questionnaire
Measured: 14 days
Personal or family history of allergies
Assessed with a questionnaire
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study startJun 2015
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Why it stopped: Delayed inclusion - stopped when 10 patients completed the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teus Van Laar, MD PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02230930
- Sponsor's protocol ID
- 46934
- Status last verified
- Mar 2024
- First submitted
- 29 Aug 2014
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34218046
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Crossover Trial to Investigate the Efficacy of Treatments in Apomorphine-induced Skin Reactions
- ClinicalTrials.gov ID
- NCT02230930
- Acronym / sponsor ID
- 46934
- Keywords
- Parkinson's disease, Apomorphine, Infusion, Skin reactions, Subcutaneous nodules, Hydrocortisone, Massage, Dilution
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Delayed inclusion - stopped when 10 patients completed the study
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 3 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Massage with a spiky ball | Active comparator | Device: Massage with a spiky ballSubjects are instructed to massage the apomorphine-induced skin reactions with a spiky ball 3 times a day for 2 minutes for 14 days. |
| Hydrocortisone cream 1% | Active comparator | Drug: Hydrocortisone cream 1%Subjects are instructed to apply hydrocortisone cream 1% once daily for 14 days. |
| Subcutaneous hydrocortisone 10mg | Active comparator | Drug: Subcutaneous hydrocortisone 10mgSubjects 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. |
| Apomorphine 0.25% (2.5mg/ml) | Active comparator | Drug: 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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%). | Drug | Apomorphine 0.25% (2.5mg/ml) |
| Massage with a spiky ballEach patient will massage skin reactions with a spiky ball 3 times a day for 2 minutes. | Device | Massage with a spiky ball |
| Hydrocortisone cream 1%Hydrocortisone cream 1% (1mg/g) will be administered on each nodule one time a day | Drug | Hydrocortisone cream 1% |
| Subcutaneous hydrocortisone 10mgAlso: Solu-CortefSubcutaneous hydrocortisone 10mg will be administered previous to apomorphine infusion making use of the apomorphine infusion system | Drug | Subcutaneous hydrocortisone 10mg |
Primary outcome
Changes on global perceived effect scale
Time frame: 14 days
6 secondary outcomes
Changes in histological skin tissue characteristics
Time frame: 14 days
Changes in nodule size (diameter)
Time frame: 14 days
Changes in erythema size (diameter)
Time frame: 14 days
Eosinophilia
Time frame: 14 days
Personal or family history of atopic constellation
Time frame: 14 days
Personal or family history of allergies
Time frame: 14 days
Results and safety
The study was stopped early (reason given: Delayed inclusion - stopped when 10 patients completed the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Derived from this study: PubMed 34218046Borgemeester 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teus Van Laar, MD PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apomorphine 0.25% (2.5mg/ml), Massage with a spiky ball and Hydrocortisone cream 1% in people with Parkinson's Disease and Apomorphine-induced Skin Reactions, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Delayed inclusion - stopped when 10 patients completed the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes on global perceived effect scale (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02230930, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.