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    The EU Clinical Trials Register currently displays   41225   clinical trials with a EudraCT protocol, of which   6755   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    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
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-000657-36
    A.3Full 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.3.1Title 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.3.2Name 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.4.1Sponsor's protocol code number46934
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity Medical Center Groningen
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUniversity Medical Center Groningen
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Groningen
    B.5.2Functional name of contact pointCoordinating Investigator
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9713GZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31503611519
    B.5.6E-mailr.w.k.borgemeester@umcg.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Hydrocortisone cream 10mg/g FNA Fagron
    D.2.1.1.2Name of the Marketing Authorisation holderFagron b.v.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameHydrocortisone cream
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Solu-Cortef, powder for solution for injection, 100mg, and 'Act-O-Vial'
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer bv
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSolu-Cortef
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name APO-go
    D.2.1.1.2Name of the Marketing Authorisation holderBritannia Pharmaceuticals Limited
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameApomorphine
    D.3.4Pharmaceutical form Solution for infusion in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another 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.1.1Medical condition(s) being investigated
    Parkinson's disease
    Ziekte van Parkinson
    E.1.1.1Medical condition in easily understood language
    Parkinson's disease
    Ziekte van Parkinson
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.2.2Secondary 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.2.3Trial contains a sub-study No
    E.3Principal 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.4Principal 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.5.1Primary end point(s)
    Changes on global perceived effect (GPE) scale
    Verandering op de global perceived effect (GPE) schaal
    E.5.1.1Timepoint(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.5.2Secondary 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.5.2.1Timepoint(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.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Massage met een massageballetje
    Massage with a spikey ball
    E.8.2.4Number of treatment arms in the trial4
    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 No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    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
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-12-31
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