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 were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43233   clinical trials with a EudraCT protocol, of which   7153   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 on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    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:2014-002627-10
    Sponsor's Protocol Code Number:RILUMEX
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-11-05
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-002627-10
    A.3Full title of the trial
    A randomized, double-blind, controlled, monocenter, pivotal phase IIb study to evaluate the efficacy and safety of riluzole versus mexiletine in patients with non dystrophic myotonia mutated in SCN4A or CLCN1 genes.
    Studio pilota fase IIb, randomizzato, in doppio cieco, controllato, monocentrico, per valutare l'efficacia e la sicurezza di riluzolo vs mexiletina in soggetti con miotonia non distrofica mutati nei geni SCN4A o
    CLCN1.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pivotal study to evaluate the efficacy and safety of riluzole versus mexiletine in patients with non dystrophic myotonia mutated in SCN4A or
    CLCN1 genes.
    Studio clinico pilota per valutare l'efficacia e la sicurezza di riluzolo rispetto mexiletina in pazienti affetti da miotonia non distrofica mutati nei geni
    SCN4A o CLCN1.
    A.3.2Name or abbreviated title of the trial where available
    RILUMEX
    RILUMEX
    A.4.1Sponsor's protocol code numberRILUMEX
    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 SponsorFONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA
    B.1.3.4CountryItaly
    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 supportMINISTERO DELLA SALUTE - FONDI 5 X 1000
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione IRCCS Istituto Neurologico Carlo Besta
    B.5.2Functional name of contact pointServizio Ricerca e Sviluppo Clinico
    B.5.3 Address:
    B.5.3.1Street Addressvia Celoria 11
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20133
    B.5.3.4CountryItaly
    B.5.4Telephone number0223942321
    B.5.5Fax number0223943569
    B.5.6E-mailcrc@istituto-besta.it
    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 RILUZOLO TEVA - 50 MG COMPRESSE RIVESTITE CON FILM 90 COMPRESSE IN BLISTER AL/PVC
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA ITALIA S.R.L.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameRILUZOLO
    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 INNRILUZOLO
    D.3.9.2Current sponsor codeN07XX02
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/13/1189
    D.3 Description of the IMP
    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 INNMEXILETINA CLORIDRATO
    D.3.9.2Current sponsor code700002138
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    NDM patients with mutations in SCN4A or CLCN1 gene
    Miotonie non distrofiche con mutazione nei geni SCN4A o CLCN1
    E.1.1.1Medical condition in easily understood language
    Patients with myotonic phenomenon
    Pazienti con fenomeno miotonico
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029205
    E.1.2Term Nervous system disorders
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To assess the efficacy of riluzole compared to mexiletine in reducing severity of myotonia in patients affected by NDM with mutations in CLCN1 or SCN4A genes through stiffness evaluation by the Interactive Web Response diary
    Valutare l'efficacia di riluzolo comparato a mexiletina nei pazienti affetti da MND mutati nei geni SCN4A o CLCN1attraverso stima della rigidit¿ mediante Interactive Web Response Diary
    E.2.2Secondary objectives of the trial
    - To assess the safety and tolerability of riluzole in patients affected by NDM with mutations in CLCN1 or SCN4A gene
    - To assess the efficacy of riluzole compared to mexiletine in reducing severity of myotonia in patients affected by NDM with mutations in
    CLCN1 or SCN4A genes, assessed by other measures of functionality and also its impact on quality of life.
    - valutare la sicurezza e la tollerabilit¿ di riluzolo nei pazienti affetti da MND mutati nei geni SCN4A o CLCN1
    - testare l'efficacia di riluzolo comparato a mexiletina nel ridurre il grado di severit¿ della miotonia nei pazienti affetti da MND mutati nei geni SCN4A o CLCN1attraverso misure di funzionalit¿ ed il relativo
    impatto sulla qualit¿ di vita
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Aged at least 18 years.
    - Clinical signs or symptoms of myotonia.
    - Myotonic potentials on electromyography.
    - Genetically confirmed NDM (patients mutated in SCN4A or CLCN1
    gene).
    - Written informed consent.
    - Daily access to a personal computer and internet connection, for IWR
    diary report.
    a) età superiore a 18 aa.
    b) Fenomeno miotonico clinicamente evidente.
    c) Evidenza di miotonia all'esame elettromiografico ad ago.
    d) Mutazione nei geni SCN4A o CLCN1.
    e) Consenso informato scritto.
    f) Disponibilità quotidiana per compilazione interactive web response (IWR) diary.
    E.4Principal exclusion criteria
    - Other neurological conditions that might affect the study assessments.
    - Genetic confirmation of DM1 (more than 50 repeats of CTG) or DM2.
    - Existing atrial flutter or fibrillation or other cardiac conduction defects, as evidenced on ECG at screening visit, including but not limited to the following conditions: malignant arrhythmia or cardiac conduction disturbances (e.g., second degree AV block, third degree AV block, or prolonged QT interval). Any cardiological controindications to mexiletine use will be excluded by a cardiologist. If required by the cardiologist, the patient will undergo heart echo scan and/or Holter ECG.
    - Existing permanent pacemaker.
    - Current use of any of the following antiarrhythmic medications for a cardiac disorder: flecainide acetate, encainide, disopyramide, procainamide, quinidine, propafenone, or mexiletine.
    - Currently use of mexiletine for myotonia in 7 days before randomization.
    - Use of medications for myotonia, such as phenytoin and flecainide acetate, within 5 days of study entry, carbamazepine within 3 days of study entry; or propafenone, procainamide, disopyramide, quinidine, and encainide within 2 days of study entry.
    - Use of medications that produce myotonia, which may include fibrate acid derivatives, hydroxymethylglutaryl CoA reductase inhibitors, chloroquine, and colchicines.
    - Kidney or liver disease or abnormally high levels of liver enzymes such as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT), alkaline phosphatase (AP), GGT, serum bilirubin, except for Gilbert’s Disease:
    The investigator should be guided by the following criteria:
    ¿ Any single transaminase may not exceed 3x times upper limits of normal (ULN). A single parameter elevated up to and including 3 x ULN should be re-checked as soon as possible, and in all cases, at least prior to randomization, to rule out any lab error. Normal lab values are shown in table 3.
    ¿ AP and/or GGT may not exceed 2x times ULN. A single parameter elevated up to and including 2 x ULN should be re-checked as soon as possible, and in all cases, at least prior to randomization, to rule out any lab error.
    ¿ If the total bilirubin (TBL) concentration is increased above 1.5x ULN, total bilirubin should be differentiated into the direct and indirect reacting bilirubin. In any case, serum bilirubin should not exceed the value of 1.6 mg/dL.
    - Known heart failure or symptomatic cardiomyopathy or recent cardiac infarction (<3 months before randomization).
    - Significant coagulopathy, platelet count less than 75,000/mm3, hemoglobin less than 11.0 g/dL.
    - Seizure disorder.
    - Currently pregnant or breastfeeding.
    a) Altre patologie neurologiche che possano influenzare la valutazione dei diversi endpoint.
    b) conferma genetica di DM1 (maggiore 50 ripetizioni di CTG) o DM2
    c) Flatter o fibrillazione atriale o altri difetti di conduzione cardiaca, come documentato all'ECG alla visita di screening, incluse ma non limitate alle seguenti condizioni: aritmia magligna o disturbi di conduzione cardiaca (per es. blocco atrioventricolare di secondo o terzo grado o aumentato intervallo QT). Ogni controindicazione cardiologica all'uso di mexiletina sarà escluso da un cardiologo. Se richiesto dal cardiologo il paziente sarà sottoposto a ecografia cardiaca e/o Holter ECG.
    d) Pacemaker permanente.
    e) Terapia concomitante con uno dei seguenti antiartimici per patologia cardiaca: flecainide acetate, encainide, disopiramide, procainamide, chinidina, propafenone o mexiletina.
    f) Assunzione di mexiletina nei sette giorni precedenti la randomizzazione.
    g) Assunzione di farmaci per il trattamento della miotonia, come fenitoina e flecainide acetate, entro 5 giorni dall'ingresso nello studio, carbamazepina entro 3 giorni dall'ingresso nello studio o propafenone, procainamide, disopiramide, chinidina ed encainide entro 2 giorni dall'ingresso nello studio.
    h) Assunzione terapie che determinano miotonia che può includere fibrati, inibitori della idrossimetilglutaril coenzima Areduttasi, clorochina e colcichine.
    i) Patologia epatica o renale, aumento enzimi epatici come aspartato aminotransferasi (AST) e/o alanina aminotransferasi (ALT), fosfatasi alcalina (AP), GGT, bilirubina sierica, eccetto per malattie di Gilbert.
    Lo sperimentatore dovrebbe essere guidato dai seguenti criteri:
    -ogni singola transaminasi non dovrebbe superare 3 volte il limite superiore di normalità (LSN). Un singolo parametro elevato fino a o uguale a 3 volte il LSN, dovrebbe essere ricontrollato il prima possibile, e in tutti i casi almeno prima della randomizzazione, per escludere qualunque errore di laboratorio. I normali valori di laboratorio sono mostrati nella tabella 3 allegata al protocollo.
    - AP e/o GGT non dovrebbero superare di 2 volte il LSN. Un singolo parametro elevato fino a o uguale a 2 volte il LSN, dovrebbe essere ricontrollato il prima possibile, e in tutti i casi almeno prima della randomizzazione, per escludere qualunque errore di laboratorio.
    - se la concentrazione della bilirubina totale (TBL) è aumentata sopra 1,5 LSN la TBL dovrebbe essere differenziata nella bilirubina diretta e indiretta. In ogni caso la bilirubina sierica non dovrebbe superare il valore di 1,6 mg/dL.
    m) Insufficienza cardiaca nota o cardiomiopatia. sintomatica o recente infarto miocardico (inferiore di 3 mesi prima della randomizzazione).
    n) Significativa coagulo patia, conta piastrinica inferiore <75.000/mm3, emoglobina inferiore a 11,0 g/dL
    o) Crisi comiziali.
    p) Gravidanza od allattamento in atto.
    E.5 End points
    E.5.1Primary end point(s)
    Patient-reported stiffness on the Interactive Web Response (IWR) diary, a variant of interactive voice response (IVR) diary. IVR system assessed symptom severity and frequency in four categories: muscle stiffness,weakness, pain, and tiredness (Statland et al., 2011).
    Valutazione rigidità secondo IWR diary (versione in italiano), a scadenza giornaliera, da eseguire nelle settimane 1, 5, 9 e 13.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1, 5, 9, 13 weeks
    1, 5, 9, 13 settimane
    E.5.2Secondary end point(s)
    a) Patient-reported Pain, Weakness and Tiredness on the IWR diary. b) Quantitative measure of handgrip myotonia (seconds). c) Clinical hand-grip myotonia evaluation (seconds). d) Individualized Neuromuscular Quality of Life Scale (INQoL). e) Short Form 12 (SF-12)
    a) valutazione dolore, debolezza e stanchezza secondo IWR diary (versione in italiano), a scadenza giornaliera, da eseguire nelle settimane 1, 5, 9 e 13. b) valutazione clinica della miotonia (handgrip, orbicolare oculare); da effettuare alla visita iniziale e alla settimana 6, 10 e 14. c) valutazione della miotonia mediante dinamometro (handgrip), mediante calcolo tempo di rilassamento dal 90% al 5% della forza massima mediante un software specifico; da effettuare alla visita iniziale e alla settimana 6, 10 e 14. d) Individualized Neuromuscular Quality of Life (Sansone at al., 2012); da effettuare alla visita iniziale e alla settimana 6, 10 e 14. e) SF-12; da effettuare alla visita iniziale e alla settimana 6, 10 e 14
    E.5.2.1Timepoint(s) of evaluation of this end point
    a) 1, 5, 9 and 13 weeks. b, c, d, e) 6, 10 and 14 weeeks.
    a) 1, 5, 9 e 13 settimane. b, c, d, e) 6, 10 e 14 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) 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) Yes
    E.8.2.2Placebo No
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 Information not present in EudraCT
    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 years0
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months12
    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.1.1.1In 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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 13
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-11-05. Yes
    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 state58
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 58
    F.4.2.2In the whole clinical trial 58
    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 and care based on normal clinical practice
    Trattamento e assistenza secondo normale pratica clinica
    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 Decision2015-11-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-10
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2023 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA