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   43851   clinical trials with a EudraCT protocol, of which   7283   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:2012-001630-33
    Sponsor's Protocol Code Number:MEM-MD-69
    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:2012-10-24
    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 number2012-001630-33
    A.3Full title of the trial
    An Open-Label Extension Study of the Safety and Tolerability of Memantine in Pediatric Patients with Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
    Studio di estensione in aperto sulla sicurezza e tollerabilita' di memantina in pazienti pediatrici affetti da autismo, sindrome di Asperger o disturbo pervasivo dello sviluppo non altrimenti specificato (Pervasive Developmental Disorder Not Otherwise Specified, PDD-NOS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Open-Label Extension Study of the Safety and Tolerability of Memantine in Pediatric Patients with Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
    Studio di estensione in aperto sulla sicurezza e tollerabilita' di memantina in pazienti pediatrici affetti da autismo, sindrome di Asperger o disturbo pervasivo dello sviluppo non altrimenti specificato (Pervasive Developmental Disorder Not Otherwise Specified, PDD-NOS)
    A.4.1Sponsor's protocol code numberMEM-MD-69
    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 SponsorFOREST RESEARCH INSTITUTE
    B.1.3.4CountryUnited States
    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 supportFOREST RESEARCH INSTITUTE
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQuintiles Contact Center
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressThe Alba Campus
    B.5.3.2Town/ cityRosebank, Livingston
    B.5.3.3Post codeEH54 7EG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number862 261 3634
    B.5.5Fax number862 261 3634
    B.5.6E-mailQEudraCThelpdesk@quintilescontact.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 No
    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 nameMemantine Hydrochloride
    D.3.2Product code MRZ 2/145
    D.3.4Pharmaceutical form Prolonged-release capsule
    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 INNMEMANTINE HYDROCHLORIDE
    D.3.9.1CAS number 41100-52-1
    D.3.9.4EV Substance CodeSUB03137MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 No
    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 nameMemantine Hydrochloride
    D.3.2Product code MRZ 2/145
    D.3.4Pharmaceutical form Prolonged-release capsule
    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 INNMEMANTINE HYDROCHLORIDE
    D.3.9.1CAS number 41100-52-1
    D.3.9.4EV Substance CodeSUB03137MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboProlonged-release capsule
    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
    Autism or Asperger's Disorder or Pervasive Developmental Disorder Not
    Otherwise Specified (PDD-NOS) Previously Treated with Memantine
    Autismo, Sindrome di Asperger o Disturbo Pervasivo dello Sviluppo non altrimenti specificato (Pervasive Developmental Disorder Not Otherwise Specified, PDD-NOS)
    E.1.1.1Medical condition in easily understood language
    Autism Previously Treated with Memantine
    Autismo precedentemente trattato con memantina
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10008520
    E.1.2Term Childhood autism
    E.1.2System Organ Class 100000004852
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10003484
    E.1.2Term Asperger's disorder
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10034739
    E.1.2Term Pervasive developmental disorder NOS
    E.1.2System Organ Class 10037175 - Psychiatric 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 long-term safety and tolerability of memantine in the
    treatment of pediatric patients with autism, Asperger's Disorder or
    Pervasive Developmental Disorder Not Otherwise Specified
    (PDD-NOS).
    L’obiettivo di questo studio è la valutazione della sicurezza e tollerabilità a lungo termine nel trattamento di pazienti pediatrici affetti da autismo, sindrome di Asperger o disturbo pervasivo dello sviluppo non altrimenti specificato (PDD-NOS).
    E.2.2Secondary objectives of the trial
    Not Applicable - no secondary objectives
    non applicabile- non ci sono obiettivi secondari
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The parents/guardian/LAR must provide written informed consent before the patient's participation in the study.2. Parents who are capable of providing reliable information about the patient's condition, attending all clinic visits with the patient, and overseeing the administration of study drug. 3. Patients who completed Study MEM-MD-68 or MEM-MD-91. Patients who discontinued Study MEM-MD-68 due to meeting the criterion for loss of therapeutic response. Sponsor approval is required before enrolling any other patient who discontinued a preceding memantine study. 4. Females who are 9 years and older or who have had onset of menses must have a negative urine pregnancy test at Visit 1. 6. Have a family that is sufficiently organized and stable to guarantee adequate safety monitoring and continuous attendance to clinic visits for the duration of the study 7. Be able to speak and understand Italian sufficiently, as well as have parents who are able to speak and understand Italian sufficiently to comprehend the nature of the study and to allow for the completion of all study assessments
    1.I genitori devono fornire un consenso informato scritto prima della partecipazione del paziente nello studio.2. Genitori in grado di fornire informazioni affidabili sulle condizioni del paziente, in grado di partecipare a tutte le visite in ospedale con il paziente, e in grado di controllare la somministrazione del prodotto in sperimentazione. 3. I pazienti che hanno completato lo studio MEM-MD-68 o MEM-MD-91. I pazienti che hanno interrotto lo studio MEM-MD-68 avendo soddisfatto il criterio per la perdita della risposta terapeutica. L'approvazione dello Sponsor è richiesta prima dell’arruolamento di qualsiasi altro paziente che ha interrotto un precedente studio con memantina. 4. Le femmine che hanno 9 anni di età o che hanno avuto inizio delle mestruazioni devono avere un test di gravidanza negativo sulle urine alla Visita 1. 5. Avere risultati normali all'esame obiettivo, normali esami di laboratorio, ECG, segni vitali alla Visita 1 del presente studio (ultima visita dello studio MEM-MD-91). Eventuali risultati anomali devono essere considerati non clinicamente significativi dallo sperimentatore e documentati. 6. Avere una famiglia che è sufficientemente organizzata e stabile per garantire un adeguato controllo di sicurezza e assistenza continua per le visite ambulatoriali per tutta la durata dello studio 7. Essere in grado di parlare e capire l'italiano a sufficienza,così come avere dei genitori in grado di parlare e capire l'italiano a sufficienza, per comprendere la natura dello studio e per consentire il completamento di tutte le valutazioni di studio
    E.4Principal exclusion criteria
    1. Patients who discontinued a preceding memantine study due to an
    adverse event possibly related to study drug 2. Patients with a concurrent medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger the patient's well being 3. Significant risk of suicidality based on the Investigator's judgment, ABC-I, or if appropriate, as indicated by a response of ''yes'' to questions 4 or 5 in the suicidal ideation section of the Children's C-SSRS (Columbia-Suicide Severity Rating Scale) or any suicidal behavior 4. Patients with evidence or history of malignancy (other than excised basal cell carcinoma) or any significant hematologic, endocrine, cardiovascular (including any rhythm disorder), neurologic, respiratory, renal, hepatic, or gastrointestinal disease 5. Female patients of child-bearing potential who are not using or not willing to use a conventional method of contraception approved by the PI. Abstinence is an acceptable method of contraception 6. Patients requiring treatment with prohibited concomitant medications 7. Patients who, in the opinion of the Investigator, might not be suitable for the study 8. Employee or immediate relative of an employee of Forest Laboratories, Inc., any of its affiliates or partners, or the study center
    1.I pazienti che hanno interrotto un precedente studio con memantina a causa di un evento avverso possibilmente correlati al farmaco in studio1. 2.I pazienti con una condizione medica concomitante che potrebbe interferire con la conduzione dello studio, confondendo l'interpretazione dei risultati dello studio, o mettendo in pericolo il benessere del paziente 3. Significativo rischio di suicidio in base al giudizio dello sperimentatore, ABC-I, o, se del caso, come indicato dalla risposta ''sì'' alle domande 4 o 5 nella sezione di ideazione suicidaria di C-SSRS dei bambini (Columbia-Suicide Severity Rating Scale), o qualsiasi comportamento suicidario. 4.I pazienti con evidenza o anamnesi di tumore maligno (diverso dal carcinoma a patologia significativa ematologica, endocrina, cardiovascolare (incluso qualsiasi disturbo del ritmo), neurologica, respiratoria, renale, epatica o gastrointestinale 5. Pazienti di sesso femminile in età fertile che non utilizzano o non vogliono utilizzare un metodo convenzionale di contraccezione approvato dal PI. L'astinenza è un metodo accettabile di contraccezione 6. I pazienti che richiedono un trattamento con farmaci concomitanti vietati 7. Pazienti che, a giudizio del ricercatore, potrebbero non essere adatti per lo studio 8. Dipendente o parente stretto di un dipendente di Forest Laboratories, Inc., o di una delle sue affiliate o partner, o del centro
    E.5 End points
    E.5.1Primary end point(s)
    Standard safety assessments are being conducted to align withthe main
    objectives of the study stated above. exploratory efficacy assessment
    evaluation.
    Le valutazioni standard di sicurezza sono condotte per allinearsi con l'obiettivo principale dello studio sopra descritto.Valutazione esploratoria dell'efficacia.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety assessments are evaluated at:
    Visit 1 (End of Week 0)
    Visit 4 (End of Week 6)
    Visit 5 (End of Week 12)
    Visit 6 (End of Week 24)
    Visit 7 (End of Week 36)
    Visit 8/Early Termination (End of Week 48)
    Le valutazioni di sicurezza saranno valutate alla:
    Visita 1 (Fine della settimana 0)
    Visita 4 (Fine della settimana 6)
    Visita 5 (Fine della settimana 12)
    Visita 6 (Fine della settimana 24)
    Visita 7 (Fine della settimana 36)
    Visita 8/Terminazione anticipata (Fine della settimana 48)
    E.5.2Secondary end point(s)
    Exploratory efficacy assessment evaluation
    Valutazione esploratoria dell'efficacia
    E.5.2.1Timepoint(s) of evaluation of this end point
    Exploratory Efficacy assessments are evaluated at:
    Visit 1 (End of Week 0)
    Visit 4 (End of Week 6)
    Visit 5 (End of Week 12)
    Visit 6 (End of Week 24)
    Visit 7 (End of Week 36)
    Visit 8/Early Termination (End of Week 48)
    Valutazione esploratoria dell'efficacia:
    Visita 1 (Fine della settimana 0)
    Visita 4 (Fine della settimana 6)
    Visita 5 (Fine della settimana 12)
    Visita 6 (Fine della settimana 24)
    Visita 7 (Fine della settimana 36)
    Visita 8/Terminazione anticipata (Fine della settimana 48)
    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 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 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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 trial1
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Colombia
    Korea, Republic of
    Mexico
    New Zealand
    Philippines
    Russian Federation
    Singapore
    South Africa
    Taiwan
    Thailand
    Ukraine
    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 months23
    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 months23
    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 Yes
    F.1.1Number of subjects for this age range: 110
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 93
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 17
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    The patient's parents will provide informed consent.
    I genitori del bambino firmeranno il consenso informato.
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 220
    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)
    Memantine is investigational for this indication and is not available for
    purchase for this indication. After the patients complete or early terminate from the study, they will no longer have access to the study drug.Patients who complete MEM-MD-69 will return to standard of care,which may include treatments that have been approved for some of the commonly co-existing symptoms of ASD,such as anxiety,depression,obsessive-compulsive disorder and sevire maladaptive behavioural problems
    La memantina è in fase di sperimentazione e non è disponibile sul mercato per questa indicazione.Dopo che i pazienti completano o terminano in anticipo lo studio,essi non avranno più accesso ai farmaco.I pazienti che completano MEM-MD-69 torneranno alla terapia standard, che può includere i trattamenti che sono stati approvati per alcuni dei più comuni co-esistenti sintomi di ASD,come ansia,depressione,disturbo ossessivo-compulsivo e seri problemi di comportamento disadattivo
    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 Decision2012-10-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-01-31
    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-Sat Apr 20 01:14:11 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA