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    Summary
    EudraCT Number:2014-003590-41
    Sponsor's Protocol Code Number:EA-14-01-077
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-10-21
    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 ConcernedGermany - BfArM
    A.2EudraCT number2014-003590-41
    A.3Full title of the trial
    Randomized, controlled, double-blind, multi-center trial to evaluate the efficacy and safety of a liquid containing ivy leaves dry extract vs. placebo in the treatment of acute cough
    Randomisierte, kontrollierte, doppelblinde, multizentrische Studie zur Bewertung der Wirksamkeit und Sicherheit der Anwendung eines Liquids mit Efeublätter-Trockenextrakt gegenüber Placebo in der Behandlung von akutem Husten
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial to evaluate the efficacy and safety of a liquid containing ivy leaves dry extract vs. placebo in the treatment of acute cough
    Studie zur Bewertung der Wirksamkeit und Sicherheit der Anwendung eines Liquids mit Efeublätter-Trockenextrakt gegenüber Placebo in der Behandlung von akutem Husten
    A.4.1Sponsor's protocol code numberEA-14-01-077
    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 SponsorEngelhard Arzneimittel GmbH & Co.KG
    B.1.3.4CountryGermany
    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 supportEngelhard Arzneimittel GmbH & Co.KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinsearch GmbH
    B.5.2Functional name of contact pointProf. Dr. Dr. Bruno Giannetti
    B.5.3 Address:
    B.5.3.1Street AddressPoststrasse 30
    B.5.3.2Town/ cityZug
    B.5.3.3Post code6301
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number00491722763628
    B.5.6E-mailb.giannetti@web.de
    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 Prospan Hustenliquid
    D.2.1.1.2Name of the Marketing Authorisation holderProspan Hustenliquid
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameProspan Hustenliquid
    D.3.4Pharmaceutical form Oral liquid
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIvy leaves Cough Liquid
    D.3.9.3Other descriptive nameIVY LEAVES, DRY EXTRACT
    D.3.9.4EV Substance CodeSUB26939
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral liquid
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute cough
    Akuter Husten
    E.1.1.1Medical condition in easily understood language
    Acute cough
    Akuter Husten
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10066522
    E.1.2Term Acute cough
    E.1.2System Organ Class 100000004855
    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 efficacy of Ivy leaves Cough Liquid compared with placebo applied three times a day in subjects with acute cough, in particular with regard to cough severity (CS).
    Primäres Ziel: Die Bewertung der Wirksamkeit eines dreimal täglich angewendeten Hustenliquids mit Efeublätter-Trockenextrakt im Vergleich zu Placebo bei Patienten mit akutem Husten, insbesondere in Bezug auf den Schweregrad des Hustens (cough severity (CS)).
    E.2.2Secondary objectives of the trial
    - Difference of the Bronchitis Severity Score (BSS) assessed between V1 and each of the visits V2, V3, V4 and V5
    - CS on VAS over the whole observation period (AUC over 14 days, V1, V2, V3, V4, V5 and V6)
    - CS on Verbal Category Descriptive Score (VCD) over the whole treatment period (AUC over 7 days, V1, V2, V3, V4 and V5)
    - Global efficacy assessment at V5 and V6
    - Safety of Ivy leaves Cough Liquid compared with placebo applied three times a day over the whole treatment period (7 days, V1, V2, V3, V4 and V5).
    - Unterschiede im Schweregrad der Bronchitis (Bronchitis Severity Score (BSS)) bewertet zwischen Randomisierungsvisite (V1) und den einzelnen Visiten V2, V3, V4 und V5
    - Unterschiede im Schweregrad des Hustens (CS) gemessen anhand der VAS über den gesamten Beobachtungszeitraum (AUC über 14 Tage, V1, V2, V3, V4, V5 und V6)
    - CS gemessen mit einer Bewertungsskala unterteilt nach Verbalkategorien (Verbal Category Descriptive Score (VCD)) über den gesamten Behandlungszeitraum (AUC über 7 Tage, V1, V2, V3, V4 und V5)
    - Gesamtbeurteilung der globalen Wirksamkeit bei Visiten V5 und V6
    - Unbedenklichkeit von dreimal täglich angewendetem Hustenliquid mit Efeublätter-Trockenextrakt im Vergleich zu Placebo, beurteilt über den gesamten Behandlungszeitraum (7 Tage, Visiten V1, V2, V3, V4 und V5)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects eligible for inclusion in this trial must fulfill all of the following criteria:
    1. Acute cough with symptoms lasting 2-3 days prior to treatment
    2. Men or women of any ethnic origin
    3. Age 18 to 75 years
    4. Subjects who are able to understand and are willing to comply to trial instructions
    5. Having given written informed consent
    6. Satisfactory health except for the cough as determined by the investigator based on medical history and physical examination
    7. CS score of at least 50 mm on a 100 mm VAS at V1
    8. Acute BSS of at least 10 points at V1
    9. VCD score of at least 2 points at V1

    Einzuschließende Patienten müssen alle folgenden Einschlusskriterien erfüllen:
    1. Akuter Husten mit Symptomen, die bereits seit 2-3 Tagen vor der Behandlung bestehen
    2. Männliche oder weibliche Patienten jeglichen ethnischen Ursprungs
    3. Alter 18 bis 75 Jahre
    4. Patienten, die in der Lage sind, die Studienvorschriften zu verstehen und Willens sind, diese zu befolgen
    5. Patienten, die eine schriftliche Einwilligung zur Studie abgegeben haben
    6. Mit Ausnahme des vorhandenen Hustens ansonsten zufriedenstellender Gesundheitszustand basierend auf der Anamnese und der körperlichen Untersuchung
    7. CS Wert von mindestens 50 mm auf der 100 mm VAS bei V1
    8. ein BSS von mindestens 10 Punkten bei V1
    9. ein VCD Wert von mindestens 2 Punkten bei V1
    E.4Principal exclusion criteria
    Subjects eligible for inclusion in this trial must not fulfill any of the following criteria:
    1. Allergic bronchial asthma, bronchial hyperreactivity, chronic bronchitis, other chronic or inherited lung disease
    2. History of hypersensitivity to any excipient of the applied drugs
    3. History of drug hypersensitivity, asthma, urticaria, or other severe allergic diathesis as well as current hay fever
    4. History of chronic gastritis or peptic ulcers
    5. Any gastrointestinal complaints within 7 days before V1
    6. Participation in a clinical trial within 30 days prior to the treatment phase of this study or concomitantly
    7. Treatment with corticoids, beta-2 agonists (e.g. salbutamol, fenoterol), expectorants, theophylline, antitussives, anaesthetics, acetylsalicylic acid (e.g. aspirin) or other non-steroidal anti-inflammatory drugs, leukotriene inhibitors, angiotensin-converting enzyme (ACE) inhibitors, antiviral drugs or antibiotics, antihistamines, immunosuppressants, isoprenaline, atropine, sodium cromoglycate or homeopathic drugs against common cold within 7 days before V1
    8. Drug or alcohol abuse in the opinion of the investigator
    9. Pregnant or nursing (lactating) women
    10. Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) who are not using an acceptable method of contraception defined as:
    • Surgical sterilization
    • Hormonal contraception
    • Intra-Uterine Device (IUD)
    • Double barrier method
    • Total abstinence throughout the trial at the discretion of the investigator
    Periodic abstinence is NOT an acceptable method of contraception. An acceptable method of contraception must be maintained throughout the trial.
    A woman who is post-menopausal must have a negative urine pregnancy test at screening but will not need to comply with an acceptable method of contraception. Women are considered post-menopausal and not of child-bearing potential if they had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
    11. Subjects with significant diseases, defined as a disease which, in the opinion of the investigator, may either put the subject at risk because of participation in the trial or a disease which may influence the results of the trial or the subject’s ability to participate in the trial; includes subjects with a history of gastrointestinal bleeding, significant cardiovascular, liver or renal disease.
    12. Subjects directly or indirectly involved in the execution of this protocol, including employees of the CRO and persons related to them.
    Patienten, die sich für eine Teilnahme an dieser Studie eignen, dürfen keines der folgenden Kriterien erfüllen:
    1. Allergisches bronchiales Asthma, Bronchienhyperreagibilität, chronische Bronchitis, andere chronische oder erbliche Lungenerkrankungen
    2. Anamnese von Überempfindlichkeit gegenüber einem der Bestandteile der angewendeten Medikamente
    3. Anamnese von Arzneimittelüberempfindlichkeit, Asthma, Urtikaria oder andere schwerwiegende allergische Diathesen sowie aktuell Heuschnupfen
    4. Anamnese von chronischer Gastritis oder peptischem Ulcus
    5. Jegliche gastrointestinale Beschwerden innerhalb der letzten 7 Tage vor Visite1
    6. Teilnahme an einer klinischen Prüfung innerhalb der letzten 30 Tage vor der Behandlungsphase in dieser Studie
    7. Behandlung mit Korticoiden, Beta-2 Agonisten (z.B. Salbutamol, Fenoterol), Expektorantien, Theophyllin, Antitussiva, Anästhetika, Acetylsalicylsäure (z.B. Aspirin) oder anderen nicht-steroidalen anti-inflammatorischen Arzneimitteln, Leukotrien-Inhibitoren, ACE-Hemmern, antiviralen Arzneimitteln oder Antibiotika, Antihistaminika, Immunsuppressiva, Isoprenaline, Atropin, Natrium Cromoglycat oder homöopathischen Arzneimitteln gegen Erkältung innerhalb der letzten 7 Tagen vor Visite 1.
    8. Medikamenten- oder Alkoholabusus laut Meinung des Prüfers
    9. Schwangere oder stillende Frauen
    10. Gebärfähige Frauen (das heißt alle Frauen, die physiologisch in der Lage sind, schwanger zu werden), die keine akzeptable Verhütungsmethode anwenden, definiert wie folgt:
    a. Chirurgische Sterilisation
    b. Hormonelle Kontrazeption
    c. Intrauterinpessar (IUD)
    d. Doppelte Barrieremethode
    e. Völlige Abstinenz während der gesamten Studiendauer nach Ermessen des Prüfers
    Periodische Abstinenz ist als kontrazeptive Methode nicht akzeptabel. Eine akzeptable Verhütungsmethode muss über die gesamte Studiendauer beibehalten werden.
    Frauen in der post-Menopause müssen einen negativen Urinschwangerschaftstest beim Einschluss aufweisen, müssen aber nicht eine der o.g. akzeptablen kontrazeptiven Methoden anwenden. Frauen werden als in der post-Menopause eingestuft und als nicht mehr gebärfähig, wenn sie in den letzten 12 Monaten eine natürliche (spontane) Amenorrhoe mit entsprechendem klinischen Profil (z.B. passendes Alter, Anamnese von vasomotorischen Symptomen) oder sechs Monate spontane Amenorrhoe mit Serum FSH Werten > 40mIU/mL aufweisen, oder wenn sie sich einer chirurgischen bilateralen Oophorektomie (mit oder ohne Hysterektomie) mindestens sechs Wochen vor der Studie unterzogen haben. Falls nur eine Oophorektomie durchgeführt wurde, muss die fehlende Gebärfähigkeit der Frau durch Bestimmung der Hormonspiegel bestätigt werden.
    11. Patienten, die an einer signifikanten Erkrankung leiden;definiert als eine Erkrankung, die im Ermessen des Prüfers entweder den Patienten durch die Teilnahme an der Studie einem Risiko aussetzt, oder die die Ergebnisse der Studie oder die Fähigkeit des Patienten, an der Studie teilzunehmen, beeinträchtigt; schließt Patienten mit einer Anamnese von gastrointestinalen Blutungen, signifikanten kardiovaskulären, hepatischen oder renalen Erkrankungen ein.
    12. Patienten, die direkt oder indirekt an der Durchführung dieser Studie beteiligt sind, einschließlich Mitarbeiter der CRO und deren Verwandte.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy outcome is CS assessed by Visual Analogue Scale (VAS) over the whole treatment period (area under the curve (AUC))
    Die primäre Zielvariable für die Wirksamkeit ist CS, gemessen anhand einer Visuellen Analogskala (VAS) über den gesamten Behandlungszeitraum
    E.5.1.1Timepoint(s) of evaluation of this end point
    7 days, V1, V2, V3, V4 and V5
    7 Tage, Visiten V1, V2, V3, V4 und V5
    E.5.2Secondary end point(s)
    a) Difference of the Bronchitis Severity Score (BSS)
    b) CS on VAS over the whole observation period
    c) CS on Verbal Category Descriptive Score (VCD) over the whole treatment period (AUC)
    d) Global efficacy assessment
    e) Safety of Ivy leaves Cough Liquid compared with placebo applied three times a day over the whole treatment period
    a) Unterschiede im Schweregrad der Bronchitis (Bronchitis Severity Score (BSS))
    b) Unterschiede im Schweregrad des Hustens (CS) gemessen anhand der VAS über den gesamten Beobachtungszeitraum
    c) CS gemessen mit einer Bewertungsskala unterteilt nach Verbalkategorien (Verbal Category Descriptive Score (VCD))
    d) Gesamtbeurteilung der globalen Wirksamkeit
    e) Unbedenklichkeit von dreimal täglich angewendetem Hustenliquid mit Efeublätter-Trockenextrakt im Vergleich zu Placebo, beurteilt über den gesamten Behandlungszeitraum
    E.5.2.1Timepoint(s) of evaluation of this end point
    a) between V1 and each of the visits V2, V3, V4 and V5
    b) over 14 days, V1, V2, V3, V4, V5 and V6
    c) over 7 days, V1, V2, V3, V4 and V5)
    d) V5 and V6
    e) 7 days, V1, V2, V3, V4 and V5
    a) zwischen Randomisierungsvisite (V1) und den einzelnen Visiten V2, V3, V4 und V5
    b) AUC über 14 Tage, V1, V2, V3, V4, V5 und V6
    c) AUC über 7 Tage, V1, V2, V3, V4 und V5
    d) V5 und V6
    e) 7 Tage, Visiten V1, V2, V3, V4 und V5
    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) 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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned5
    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
    The termination of the trial is defined as the time of clean data base
    Die klinische Prüfung ist beendet bei "clean data base"
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months5
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state180
    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)
    No continuation supplies will be made available for the subjects as no further treatment is expected to be necessary at the end of the trial. However, if necessary, the investigator will continue to treat the subject with other medications until the cough is resolved. Alternatively, the investigator will inform the subject’s general practitioner (GP) at the end of the trial period and the subject will then be advised to visit his GP directly
    Es ist nicht zu erwarten, dass eine weitere Behandlung nach dem Ende der klinischen Prüfung notwendig sein sollte.
    Falls dies dennoch notwendig sein sollte, wird der Prüfer den Patienten mit anderen Medikamenten behandeln bis der Husten geheilt ist.
    Alternativ wird der Prüfer den Hausarzt über das Ende der Studie informieren und den Patienten bitten, seinen Hausarzt aufzusuchen.
    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 Decision2014-11-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-08-25
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