Clinical Trials Register

Summary
EudraCT Number:	2014-000657-36
Sponsor's Protocol Code Number:	46934
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2015-06-03
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Netherlands - Competent Authority

A.2

EudraCT number

2014-000657-36

A.3

Full title of the trial

Open-label crossover trial to investigate the efficacy of treatments in apomorphine-induced skin reactions

Open-label crossover onderzoek naar de effectiviteit van behandelingen bij apomorfine-geïnduceerde huidreacties

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Trial to investigate the efficacy of treatments in apomorphine-induced skin reactions

Onderzoek naar de effectiviteit van behandelingen van apomorfine-geïnduceerde huidreacties

A.3.2

Name or abbreviated title of the trial where available

Treatment of apomorphine-induced skin reactions: a pilot study

Behandeling van apomorfine-geïnduceerde huidreacties: een verkennend onderzoek

A.4.1

Sponsor's protocol code number

46934

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	University Medical Center Groningen
B.1.3.4	Country	Netherlands
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	University Medical Center Groningen
B.4.2	Country	Netherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	University Medical Center Groningen
B.5.2	Functional name of contact point	Coordinating Investigator
B.5.3	Address:
B.5.3.1	Street Address	Hanzeplein 1
B.5.3.2	Town/ city	Groningen
B.5.3.3	Post code	9713GZ
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	+31503611519
B.5.6	E-mail	r.w.k.borgemeester@umcg.nl

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Hydrocortisone cream 10mg/g FNA Fagron
D.2.1.1.2	Name of the Marketing Authorisation holder	Fagron b.v.
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Hydrocortisone cream
D.3.4	Pharmaceutical form	Cream
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Solu-Cortef, powder for solution for injection, 100mg, and 'Act-O-Vial'
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer bv
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Solu-Cortef
D.3.4	Pharmaceutical form	Powder and solvent for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	APO-go
D.2.1.1.2	Name of the Marketing Authorisation holder	Britannia Pharmaceuticals Limited
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Apomorphine
D.3.4	Pharmaceutical form	Solution for infusion in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Parkinson's disease

Ziekte van Parkinson

E.1.1.1

Medical condition in easily understood language

Parkinson's disease

Ziekte van Parkinson

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of this pilot study is to investigate the effectiveness of treatment used in the treatment of skin reactions induced by continuous subcutaneous apomorphine infusion.

Het primaire doel van dit verkennende onderzoek is om de effectiviteit van behandelmogelijkheden te onderzoeken die gebruikt worden bij huidreacties veroorzaakt door continue subcutane apomorfine infusie.

E.2.2

Secondary objectives of the trial

The secondary objective is to investigate the role of allergy in apomorphine-induced skin reactions.

Het secundaire doel is de rol van allergie te onderzoeken bij apomorfine-geïnduceerde huidreacties.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Female and male subjects aged ≥30;
• Diagnosis of idiopathic Parkinson’s disease of >3 years’ duration, defined by the 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.

• Vrouwelijke en mannelijke proefpersonen met eenleeftijd van ≥30;
• Gediagnosticeerd met idiopathisch ziekte van Parkinson met een ziekteduur van >3 jaren, volgens de definitie van de UK Brain Bank criteria, met de uitzondering dat >1 aangedaan familielid is toegestaan, zonder dat er een andere bekende of veronderstelde oorzaak ten grondslag ligt aan Parkinsonisme (Gibb & Lees, 1988);
• Behandeling met continue subcutane apomorfine infusie;
• Hebben van apomorfine-geïnduceerde huidreacties (dat wil zeggen erytheem, zwelling en/of vorming van noduli);
• Mannelijke en vrouwelijke proefpersonen moeten een zeer betrouwbare anti-conceptiemethode toepassen (orale hormonale anti-conceptie alleen wordt niet beschouwd als een zeer betrouwbare methode en moet gecombineerd worden met een barrièremethode) tijdens het onderzoek, als zij sexueel actief zijn;
• Proefpersonen die beschouwd worden als betrouwbaar en in staat zich te houden aan het protocol, afspraken en medicatie-inname volgens het oordeel van de onderzoeker.

E.4

Principal 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 or (gluco)corticosteroids;
• 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.

• Sterke verdenking op een ander Parkinson syndroom ;
• Een verleden met ademhalingsdepressie;
• Overgevoeligheid voor hydrocortison of een ander bestandsdeel van het geneesmiddel;
• Gelijktijdige behandeling met anti-histaminica of (gluco)corticosteroïden;
• Cushing of hypercortisolisme;
• Elke medische conditie die een adequate participatie aan het onderzoek onmogelijk maakt, waaronder onstabiele epilepsie, klinisch relevant cardiale dysfunctie en/of een myocardinfarct of een herseninfarct in de afgelopen 12 maanden;
• Zwangere vrouwen of vrouwen die borstvoeding geven;
• Op het moment van onderzoek een infectieuze ziekte met koorts.

E.5 End points

E.5.1

Primary end point(s)

Changes on global perceived effect (GPE) scale

Verandering op de global perceived effect (GPE) schaal

E.5.1.1

Timepoint(s) of evaluation of this end point

After each treatment administered. Each treatment has a duration of 14 days.

Na elke behandeling. Elke behandeling heeft een duur van 14 dagen.

E.5.2

Secondary end point(s)

• Changes in histological skin tissue characteristics
• Changes in nodule size (diameter)
• Changes in erythema size (diameter)
• Eosinophilia (total eosinophils, complete full blood count with differential blood count)
• Personal or family history of atopic constellation
• Personal or family history of allergies

Verandering in grootte van noduli;
Verandering in grootte van erytheem;
Verandering in histologische weefsel karakteristieken;
Eosinofilie om een systemische allergische reactie te bepalen.
Om allergische predispositie voor het optreden van huidreacties te bepalen wordt de proefpersoon gevraagd naar bekende allergieën en atopie bij de proefpersoon zelf en bij zijn/haar familie.

E.5.2.1

Timepoint(s) of evaluation of this end point

After each treatment administered. Each treatment has a duration of 14 days.

Na elke behandeling. Elke behandeling heeft een duur van 14 dagen.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

Yes

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Massage met een massageballetje

Massage with a spikey ball

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

End of the trial is defined as the last visit of the last subject undergoing the trial

Het einde van het onderzoek is gedefinieerd als het laatste bezoek van de laatste proefpersoon in het onderzoek

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Subjects can continue a treatment option or a combination of options in case of a good clinical reaction without the occurrence of adverse events

Proefpersonen kunnen een behandelmogelijkheid of een combinatie van behandelmogelijkheden levenslang voortzetten in het geval van een goede klinische reactie zonder het optreden van bijwerkingen

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2015-06-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-05-11

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2018-12-31

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