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    Summary
    EudraCT Number:2016-005022-10
    Sponsor's Protocol Code Number:SYN-1748-MAL-0030-I
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-11-09
    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 number2016-005022-10
    A.3Full title of the trial
    Improvement of synaptic plasticity and cognitive function in RAS pathway disorders
    Verbesserung der synaptischen Plastizität und kognitiven Funktionen bei Patienten mit Erkrankungen des RAS Signalweges
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Improvement of synaptic plasticity and cognitive function in RAS pathway disorders
    Verbesserung der synaptischen Plastizität und kognitiven Funktionen bei Patienten mit Erkrankungen des RAS Signalweges
    A.4.1Sponsor's protocol code numberSYN-1748-MAL-0030-I
    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 SponsorTechnische Universität München, Fakultät für Medizin
    B.1.3.4CountryGermany
    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 supportBMBF DLR Projektträger Grant Number: 01 GM1519C
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTechnische Universität München
    B.5.2Functional name of contact pointLehrstuhl für Sozialpädiatrie
    B.5.3 Address:
    B.5.3.1Street AddressHeiglhofstraße 65
    B.5.3.2Town/ city München
    B.5.3.3Post code81377
    B.5.3.4CountryGermany
    B.5.4Telephone number00498971009236
    B.5.5Fax number00498971009253
    B.5.6E-mailnikolai.jung@tum.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 No
    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 nameLovastatin
    D.3.4Pharmaceutical form Capsule, hard
    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 INNLovastatin
    D.3.9.1CAS number 75330-75-5
    D.3.9.3Other descriptive nameLOVASTATIN
    D.3.9.4EV Substance CodeSUB08604MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    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 No
    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 nameLamotrigin beta
    D.3.4Pharmaceutical form Capsule, hard
    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 INNLamotrigin
    D.3.9.1CAS number 84057-84-1
    D.3.9.4EV Substance CodeSUB08393MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    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
    Noonan Syndrom and Neurofibromatosis Type 1
    Noonan Syndrom und Neurofibromatosis Type 1
    E.1.1.1Medical condition in easily understood language
    Noonan Syndrom and Neurofibromatosis Type 1
    Noonan Syndrom und Neurofibromatosis Type 1 (Erbkrankheiten)
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10029748
    E.1.2Term Noonan syndrome
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10029268
    E.1.2Term Neurofibromatosis
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objective:
    Does the pharmacological intervention with (a) Lovastatin and (b) Lamotrigine improve synaptic plasticity in patients with Noonan syndrome and neurofibromatosis type 1.

    Primäres Ziel:
    Führen (a) Lovastatin und (b) Lamotrigin zu einer Verbesserung bzw. Normalisierung der synaptischen Plastizität bei Patienten mit Noonan Syndrom und Neurofibromatose Typ I

    E.2.2Secondary objectives of the trial
    Secondary Objective:
    Does the pharmacological intervention with (a) Lovastatin and (b) Lamotrigine improve attentional performance measured by the Test for Attentional Performance (TAP) in patients with Noonan syndrome and neurofibromatosis type 1.
    Nebenziel:
    Führt die Einnahme von (a) Lovastatin und (b) Lamotrigin zu einer Verbesserung der Kognition/Aufmerksamkeit bei Patienten mit Noonan Syndrom und Neurofibromatose Typ I
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 1. Group 1: NS, Group 2: NF1 (both genetically assured)
    2. Age ≥16 years
    3. The adolescent (≥16) and legal guardian who are capable to give their consent and understand the aim and rationale of the study. In case of doubts, an independent medical practitioner will evaluate the capacity to consent.
    4. Signed informed consent if ≥ 16 years and legal guardian.
    5. Persons who are ≥ 18 years old and capable to give their consent and understand the aim and rationale of the study. In case of doubts, an independent medical practitioner will evaluate the capacity to consent.
    6. Signed informed consent if ≥ 18 years.
    7. Male participants and female participants who are not capable of bearing children or who use a method of contraception that is medically approved by the health authority of the respective country.
    This includes:
    - A woman who is not capable of bearing a child is defined as follows: post-menopausal (12 months natural (spontaneous) amenorrhea or 6 months spontaneous amenorrhea with serum-FSH-values (follicle-stimulating hormone) of >40 mIU/mL); 6 weeks after a bilateral ovariectomy with or without hysterectomy or sterilization by means of tubal ligation
    - A woman capable of bearing child is defined as follows: a woman who is physiologically capable of becoming pregnant, including women whose occupation, lifestyle or sexual orientation exclude sexual intercourse with a male partner and women whose partners have been sterilized by vasectomy or other measures.
    - Medically-approved methods of contraception can include the following: hormonal contraceptives, intrauterine device and double barrier method. Acceptable preventive measures can include total abstinence at the discretion of the investigator, in cases where compliance is ensured because of the study participant’s age, occupation, lifestyle or sexual orientation. Periodical abstinence (e.g. calendar, ovulation, symptothermal methods or abstinence until the 4th day after the ovulation) as well as coitus interruptus are not acceptable methods of contraception.
    - A reliable method of contraception must be used for the entire duration of the study.
    The dosage of oral contraceptives has to be doubled during the study period or two different methods of contraception should be combined.
    1. 2. 1. Gruppe 1: NS; Gruppe 2 NF1 (beide Syndrome genetisch bestätigt):
    2. Alter ≥ 16 Jahre
    3. Jugendliche (≥ 16) und Erziehungsberechtigte, die in der Lage sind, ihre Zustimmung zu geben und das Ziel und den Zweck der Studie zu verstehen. Im Zweifelsfall beurteilt ein unabhängiger Arzt die Einwilligungsfähigkeit.
    4. Unterzeichnete Einverständniserklärung, ≥ 18 Jahre.
    5. Unterzeichnete Einverständniserklärung, ≥ 16 Jahre und dem Erziehungsberechtigten.
    6. Patienten (≥ 18) die in der Lage sind, ihre Zustimmung zu geben und das Ziel und den Zweck der Studie zu verstehen. Im Zweifelsfall beurteilt ein unabhängiger Arzt die Einwilligungsfähigkeit.
    7. Männliche Teilnehmer und weibliche Teilnehmer, die keine Kinder gebären können oder die eine Verhütungsmethode nutzen, die medizinisch / ärztlich durch die Gesundheitsbehörde des jeweiligen Landes anerkannt ist.
    Dies schliesst ein:
     Eine Frau, die keine Kinder gebären kann ist folgendermaßen definiert: postmenopausal (12 Monate natürliche (spontane) Amenorrhö oder 6 Monate spontane Amenorrhö mit Serum-FSH Werten (Follikel-stimulierendes Hormon) >40 mlU/ml); 6 Wochen nach beidseitiger Ovarektomie mit oder ohne Hysterektomie oder Sterilisation durch Tubenligatur.
     Eine Frau, die Kinder gebären kann, ist folgendermaßen definiert: Frauen, die physiologischerweise schwanger werden können. Dies schließt Frauen mit ein, deren Arbeit, Lebensstil oder sexuelle Orientierung Geschlechtsverkehr mit einem männlichen Partner ausschließen und Frauen, deren Partner sterilisiert wurden durch eine Vasektomie oder andere Methode.
     Medizinisch anerkannte Verhütungsmethoden können folgende mit einschließen: hormonelle Kontrazeptiva, Intrauterinpessar und doppelte Verhütung. Akzeptierte präventive Methoden schließen die totale Abstinenz nach dem Ermessen des Untersuchungsleiters mit ein, in Fällen, in denen die Compliance durch das Alter des Teilnehmers, die Arbeit, den Lebensstil oder die sexuelle Orientierung sichergestellt werden kann. Eine periodische Abstinenz (z.B. Kalender, Ovulation, symptothermale Verhütung oder eine Abstinenz bis 4 Tage nach der Ovulation) oder Koitus interruptus sind keine akzeptierten Methoden der Verhütung.
     Eine sichere Methode der Verhütung muss für die gesamte Dauer der Studie angewendet werden.
    E.4Principal exclusion criteria
    1. Epilepsy
    2. Medication with known CNS effects
    3. Severe mental retardation
    4. Side effects during previous medication with and contraindications to LTG and/or LOV and/or TMS
    5. Psychiatric diseases
    6. Previous history of allergic reactions with LTG and LOV medications
    7. Potentially unreliable patients
    8. Patients who are not suitable for the study in the opinion of the investigator
    9. Pregnancy (incl. positive urine pregnancy test)
    10. Persons who are incapable of giving consent or do not understand the aim or rationale of the study.
     Epilepsie
     Medikation mit nachgewiesener ZNS Wirksamkeit
     Schwere mentale Retardierung
     Nebeneffekte unter einer vorangegangenen Medikation mit Lamotrigin und / oder Lovastatin und / oder bei der TMS.
     Psychiatrische Erkrankungen
     Vorangegangene allergische Reaktion auf die Studienmedikation
     Potentiell unzuverlässige Patienten
     Patienten, die nach Ansicht des Studienleiters nicht für die Studie geeignet sind.

    Es können keine Patienten eingeschlossen die nicht selbständig ihr Einverständnis geben können und die nicht in der Lage den Sinn dieser Studie zu verstehen.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint:
    The primary efficacy endpoint analyses will be performed in three separate testing procedures:
    I: Lovastatin vs. placebo on group 1
    II: Lamotrigine vs. placebo on group 1
    III: Lamotrigine vs. placebo on group 2
    The global significance level will be 5%. Since experiments I and II are done on the same set of patients, the significance level for those two experiments will each be 2.5%. The significance level of experiment III will be 5%. The primary endpoint analysis will consist of three series of three paired samples two-sided t-tests, comparing MEP under Verum vs. placebo at the three measurement time points. The local significance level will be adjusted using the Bonferroni-Holm procedure.
    All analyses will be performed on the full analysis set (FAS-I, FAS-II, FAS-III), consisting of all patients who delivered a full set of MEP measurements after interventional TMS within the corresponding experiment.
    Primärer Endpunkt
    Die Analyse besteht aus drei separaten Testprozeduren. Das globale Signifikanzniveau (α) liegt bei 5%. Da Experiment I und II auf dem gleichen Kollektiv durchgeführt werden, das α von Exp. I und II beträgt jeweils 2,5%. Das α von Exp. III bleibt bei 5%. Da MEP jeweils an drei Zeitpunkte gemessen wird, besteht die Analyse aus drei zweiseitigen T-Tests für verbundene Stichproben pro Experiment mit Bonferroni-Holm Justierung vom α.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Lovastatin and Lamotrigin have 2 timepoints
    es gibt bei Lovastatin und Lamotrigin je 2 Zeitpunkte
    E.5.2Secondary end point(s)
    Analyses of baseline data, secondary endpoints, and safety data will be done using appropriate descriptive statistics and paired samples tests for difference between the two study groups. All tests will be two-sided with an exploratory significance level of 5%. No adjustment for multiple comparisons will be done.
    Another endpoint is the comparison of LTG and LOV effects on synaptic plasticity and attentional performance in the NS group.
    Sekundäre Endpunkte
    Die Analyse besteht aus geeignete beschreibende Statistiken und Tests für verbundene Stichproben um die Gruppendifferenzen zu verdeutlichen. Alle Tests werden zweiseitig mit α von 5% explorativ gerechnet. Keine Justierung für multiples Testen wird angewendet.
    Safety
    Inzidenzraten von AEs werden pro Therapiegruppe und Experiment angegeben. Die Analyse basiert auf dem Safety Set, der aus allen Patienten, welche Studienmedikation genommen haben, besteht.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Lovastatin and Lamotrigin have 2 timepoints
    es gibt bei Lovastatin und Lamotrigin je 2 Zeitpunkte
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Basic science
    Naturwissenschaftliche Basisinformationen
    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 Yes
    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) 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 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
    Last Patient Last Visit is the end of the trial
    Die letzte Visite des letzten Patienten ist das Ende der Studie.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    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 Yes
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 6
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 22
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state30
    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)
    After the end of the study patients regardless of whether the study end
    according to the protocol or early / non-terminated according to
    protocol, the patient get continued Treatment by Physician or clinic
    standard therapie.
    Nach Ende der Studie können Patienten unabhängig davon, ob die
    Studie protokollgemäß oder vorzeitig/nicht-protokollgemäß beendet
    wurde, bekommen die Patienten eine Weiterbehandlung beim Hausarzt
    oder die Standard Therapie der jeweiligen Klinik in der der Patient
    liegt.
    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 Decision2018-02-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-13
    P. End of Trial
    P.End of Trial StatusOngoing
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