Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   38164   clinical trials with a EudraCT protocol, of which   6269   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).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2012-002863-88
    Sponsor's Protocol Code Number:LP0041-64
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-12-11
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-002863-88
    A.3Full title of the trial
    A Simultaneous Treatment Regimen Compared to a Sequential Treatment
    Regimen with Ingenol Mebutate Gel 0.015% and 0.05% of Two Areas with
    Actinic Keratosis on Face/Scalp and Trunk/Extremities
    Un regime di trattamento simultaneo comparato ad un regime di trattamento sequenziale con Ingenolo mebutato Gel allo 0.015% e 0.05% di due aree con cheratosi attinica su Viso/Cuoio cappelluto e Tronco/Estremita'
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Simultaneous Treatment Regimen Compared to a Sequential Treatment
    Regimen with Ingenol Mebutate Gel 0.015% and 0.05% of Two Areas with
    Actinic Keratosis on Face/Scalp and Trunk/Extremities
    Un regime di trattamento simultaneo comparato ad un regime di trattamento sequenziale con Ingenolo mebutato Gel allo 0.015% e 0.05% di due aree con cheratosi attinica su Viso/Cuoio cappelluto e Tronco/Estremità
    A.4.1Sponsor's protocol code numberLP0041-64
    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 SponsorLEO PHARMA A/S
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLEO PHARMA A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeo Pharma France
    B.5.2Functional name of contact pointFlorence Preaud
    B.5.3 Address:
    B.5.3.1Street Address2, Rue René Caudron
    B.5.3.2Town/ cityVoisins-Le-Bretonneux
    B.5.3.3Post code78960
    B.5.3.4CountryFrance
    B.5.4Telephone number+33130144000
    B.5.5Fax number+33130144059
    B.5.6E-mailflorence.preaud@leo-pharma.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    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 Picato
    D.2.1.1.2Name of the Marketing Authorisation holderLEO PHARMA A/S
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameINGENOL MEBUTATE
    D.3.9.4EV Substance CodeSUB32495
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number.015
    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 RoleTest
    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 Picato
    D.2.1.1.2Name of the Marketing Authorisation holderLEO PHARMA A/S
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameINGENOL MEBUTATE
    D.3.9.4EV Substance CodeSUB32495
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number.05
    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
    Actinic Keratosis
    Cheratosi Attinica
    E.1.1.1Medical condition in easily understood language
    Actinic Keratosis
    Cheratosi Attinica
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10000614
    E.1.2Term Actinic keratosis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety of a simultaneous treatment regimen compared to
    a sequential treatment regimen when two separate areas with AKs (one
    located on face or scalp and the other located on trunk or extremities)
    are treated with ingenol mebutate gel.
    The primary response criterion is the composite Local Skin Reaction
    (LSR) score 3 days after treatment start of each selected treatment area.
    Valutare la sicurezza di un regime di trattamento simultaneo rispetto ad un regime di trattamento sequenziale nel trattamento di due aree distinte affette da cheratosi attinica (AK) (una situata sul viso o sul cuoio capelluto e l’altra sul tronco o sulle estremità) con gel a base di ingenolo mebutato.

    Il criterio della risposta primaria è il punteggio di risposta cutanea locale (LSR composito) raggiunto 3 giorni dopo l’inizio del trattamento di ciascuna area di trattamento selezionata.
    E.2.2Secondary objectives of the trial
    To determine the efficacy and treatment satisfaction of a simultaneous
    treatment regimen compared to a sequential treatment regimen when
    two separate areas with AKs (one located on face or scalp and the other
    located on trunk or extremities) are treated with ingenol mebutate gel.
    Determinare l’efficacia e la soddisfazione relative ad un regime di trattamento simultaneo rispetto ad un regime di trattamento sequenziale nel trattamento di due aree distinte affette da cheratosi attinica (AK) (una situata sul viso o sul cuoio capelluto e l’altra situata sul tronco o sulle estremità) con gel a base di ingenolo mebutato.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Following verbal and written information about the trial, subject
    must provide informed consent documented by signing the Informed
    Consent Form (ICF) prior to any trial-related procedures.
    2. Subjects with 4 to 8 clinically typical, visible and discrete AKs within
    a contiguous 25 cm2 treatment area on face or scalp.
    3. Subjects with 4 to 8 clinically typical, visible and discrete AKs within
    a contiguous 25 cm2 treatment area on trunk or extremities.
    4. Subject at least 18 years of age.
    5. Female subjects must be of either:
    a. Non-childbearing potential, i.e. post-menopausal or have a confirmed
    clinical history of sterility (e.g. the subject is without a uterus) or,
    b. Childbearing potential, provided there is a confirmed negative urine
    pregnancy test prior to trial treatment, to rule out pregnancy.
    6. Female subjects of childbearing potential must be willing to use effective contraception at trial entry and until completion.
    Effective contraception is defined as follows:
    - Oral/implant/injectable/transdermal/oestrogenic vaginal ring
    contraceptives, intrauterine device, condom with spermicide, diaphragm
    with spermicide.
    - Abstinence or partner's vasectomy are acceptable if the female agrees
    to implement one of the other acceptable methods of birth control if her
    partner changes.
    1. Dopo essere stati informati verbalmente e per iscritto sullo studio, i soggetti dovranno fornire il proprio consenso informato, documentato dalla firma del modulo per il consenso informato (ICF) prima dell’inizio delle procedure dello studio.
    2. Soggetti con 4-8 lesioni di cheratosi attinica (AK) clinicamente tipiche e ben visibili situate entro un’area di trattamento contigua di 25 cm2 sul viso o sul cuoio capelluto.
    3. Soggetti con 4-8 lesioni di cheratosi attinica (AK) clinicamente tipiche e ben visibili situate entro un’area di trattamento contigua di 25 cm2 sul tronco o sulle estremità.
    4. Soggetti di almeno 18 anni di età.
    5. I soggetti femminili devono essere:
    a. non in età fertile, ossia in età post-menopausale o con una storia clinica confermata di sterilità (es. donne precedentemente sottoposte ad isterectomia); oppure
    b. in età fertile, ma con test di gravidanza effettuato sull’urina con risultato negativo confermato eseguito prima del trattamento sperimentale per escludere una gravidanza.
    6. I soggetti femminili in età fertile devono essere disposte ad utilizzare un contraccettivo efficace a partire dall’inizio dello studio e fino al termine dello stesso.
    Per contraccettivo efficace si intende:
    – contraccettivi orali, ad impianto, iniettabili, transdermici, anello vaginale a estrogeni, dispositivo intrauterino, preservativo con agente spermicida, diaframma con agente spermicida.
    - L’astinenza o la vasectomia del partner sono accettabili se il soggetto femminile accetta di utilizzare uno degli altri metodi ammessi per il controllo delle nascite in caso di cambio di partner.
    E.4Principal exclusion criteria
    1. Location of the selected treatment areas:
    • on the periorbital skin,
    • within 5 cm of an incompletely healed wound,
    • within 10 cm of a suspected basal cell carcinoma (BCC) or squamous
    cell carcinoma (SCC).
    2. Prior treatment with ingenol mebutate gel on face/scalp and on
    trunk/extremities.
    3. Lesions in the selected treatment areas that have:
    • atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or
    cutaneous horns) and/or,
    • recalcitrant disease (e.g., did not respond to cryotherapy on two
    previous occasions).
    4. History or evidence of skin conditions other than the trial indication
    that would interfere with the evaluation of the trial medication (e.g.,
    eczema, unstable psoriasis, xeroderma pigmentosum).
    5. Use of cosmetic or therapeutic products and procedures which could
    interfere with the assessments of the selected treatment areas.
    6. Clinical diagnosis/history or evidence of any medical condition that
    would expose a subject to an undue risk of a significant AE or interfere
    with assessments of safety and efficacy during the course of the trial, as
    determined by the investigator's clinical judgment.
    7. Anticipated need for hospitalisation or out-patient surgery during the
    first 15 days after the first trial medication application. Note that
    cosmetic/therapeutic procedures are not excluded if they fall outside of
    the criteria detailed in Prohibited Therapies or Medications (see
    Exclusion Criteria Nos. 14-21).
    8. Known sensitivity or allergy to any of the ingredients in ingenol
    mebutate gel.
    9. Presence of sunburn within the selected treatment areas.
    10. Current enrolment or participation in an investigational clinical trial
    within 30 days of entry into this trial.
    11. Subjects previously randomised in the trial.
    12. Female subjects who are breastfeeding.
    13. In the opinion of the investigator, the subject is unlikely to comply
    with the Clinical Study Protocol (e.g. alcoholism, drug dependency or
    psychotic state).
    1. Ubicazione delle aree di trattamento selezionate:
    • sulla cute periorbitale;
    • a meno di 5 cm da una ferita non completamente guarita;
    • a meno di 10 cm da un sospetto carcinoma delle cellule basali (BCC) o carcinoma a cellule squamose (SCC).
    2. Precedente trattamento con gel a base di ingenolo mebutato sul viso/cuoio capelluto e sul tronco/estremità.
    3. Lesioni nelle aree di trattamento selezionate che presentano:
    • un aspetto clinico atipico (es. ipertrofia, ipercheratosi o corni cutanei) e/o,
    • malattia recalcitrante (ad es. mancata risposta alla crioterapia in due occasioni precedenti).
    4. Anamnesi o evidenza di patologie cutanee diverse da quelle trattate nello studio che potrebbero interferire sulla valutazione del farmaco sperimentale (come eczema, psoriasi instabile, xeroderma pigmentoso).
    5. Uso di prodotti e procedure cosmetiche o terapeutiche che potrebbe interferire sulle valutazioni delle aree di trattamento selezionate.
    6. Diagnosi clinica/anamnesi o evidenza di una qualsiasi condizione medica che potrebbe esporre il soggetto a un rischio troppo alto di eventi avversi significativi o interferire sulle valutazioni relative alla sicurezza e all’efficacia durante lo svolgimento dello studio, secondo il giudizio clinico dello sperimentatore.
    7. Previsto bisogno di ricovero ospedaliero o di intervento chirurgico ambulatoriale durante i primi 15 giorni dopo l’applicazione del primo farmaco sperimentale. Si noti che non sono escluse le procedure cosmetiche o terapeutiche che non rientrano nei criteri illustrati nell'elenco delle Terapie o Farmaci Vietati (vedi Criteri di esclusione n° 14-21).
    8. Sensibilità o allergia nota ad uno degli ingredienti del gel a base di ingenolo mebutato.
    9. Presenza di scottature solari nelle aree di trattamento selezionate.
    10. Arruolamento o partecipazione ad uno studio clinico sperimentale ad una distanza di meno di 30 giorni dall’ingresso nel presente studio.
    11. Soggetti precedentemente randomizzati nello studio.
    12. Soggetti femminili nel periodo dell’allattamento.
    13. Quando, secondo lo sperimentatore, il soggetto sia ritenuto non idoneo a garantire l’osservanza del Protocollo dello studio clinico (ad es. per alcolismo, tossicodipendenza o stato psicotico).
    E.5 End points
    E.5.1Primary end point(s)
    Composite LSR score 3 days after treatment start of each selected
    treatment area
    Punteggio ottenuto all’LSR composito 3 giorni dopo l’inizio del trattamento di ciascuna area di trattamento selezionata.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 days
    3 giorni
    E.5.2Secondary end point(s)
    • TSQM after a treatment cycle of 8 weeks,
    • Complete clearance of AKs in each separate treatment area 8 weeks
    after treatment,
    • Partial clearance of AKs in each separate treatment area 8 weeks
    after treatment, defined as 75% or greater reduction in AKs from start of
    treatment to 8 weeks after treatment,
    • Percent reduction in number of AKs in each separate treatment area 8
    weeks after treatment.
    • TSQM dopo un ciclo di trattamento di 8 settimane;
    • scomparsa totale delle lesioni di AK in ogni area di trattamento 8 settimane dopo il trattamento;
    • scomparsa parziale delle lesioni di AK in ogni area di trattamento 8 settimane dopo il trattamento, intesa come riduzione pari ad almeno il 75% delle lesioni a partire dall’inizio del trattamento fino all’ottava settimana di trattamento;
    • riduzione della percentuale di lesioni di AK in ogni area di trattamento 8 settimane dopo il trattamento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    8 weeks
    8 settimane
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Trattamento simultaneo comparato a trattamento sequenziale con Ingenolo Mebutato gel 0,015% e 0,05%
    Simultaneous Treatment Compared to a Sequential Treatment with Ingenol Mebutate Gel 0.015%
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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
    LVLS
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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)
    Treatment after the subject has ended the participation in the trial will
    be let up to Investigator judgement.
    Il trattamento dopo che il soggetto ha concluso la partecipazione allo studio sarà lasciato al giudizio dello sperimentatore.
    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 Decision2013-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-01-22
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA