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   43871   clinical trials with a EudraCT protocol, of which   7290   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:2018-002485-39
    Sponsor's Protocol Code Number:TAK-935-18-001(OV935)Amendment1
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-04-12
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2018-002485-39
    A.3Full title of the trial
    A PHASE 2, PROSPECTIVE, INTERVENTIONAL, OPEN-LABEL, MULTI-SITE, EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY AND TOLERABILITY OF TAK-935 (OV935) AS ADJUNCTIVE THERAPY IN PATIENTS WITH RARE EPILEPSY (ENDYMION)
    Estudio de extensión de fase 2, prospectivo, intervencionista, abierto y multicéntrico para evaluar la seguridad y tolerabilidad a largo plazo de TAK-935 (OV935) como tratamiento complementario en pacientes con epilepsia rara (ENDYMION)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A PHASE 2, PROSPECTIVE, INTERVENTIONAL, OPEN-LABEL, MULTI-SITE, EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY AND TOLERABILITY OF TAK-935 AS ADJUNCTIVE THERAPY IN PATIENTS WITH RARE EPILEPSY
    Estudio de extensión de fase 2, prospectivo, intervencionista, abierto y multicéntrico para evaluar la seguridad y tolerabilidad a largo plazo de TAK-935 como tratamiento complementario en pacientes con epilepsia rara
    A.4.1Sponsor's protocol code numberTAK-935-18-001(OV935)Amendment1
    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 SponsorOvid Therapeutics, Inc.
    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 supportOvid Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOvid Therapeutics, Inc.
    B.5.2Functional name of contact pointAsif Parker
    B.5.3 Address:
    B.5.3.1Street Address1460 Broadway
    B.5.3.2Town/ cityNew York, NY
    B.5.3.3Post code10036
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34900834223
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.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 nameTAK-935
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPGastroenteral use
    Oral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNon at this time
    D.3.9.1CAS number 1429505-03-2
    D.3.9.2Current sponsor codeTAK-935
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 nameTAK-935
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPGastroenteral use
    Oral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNon at this time
    D.3.9.1CAS number 14295005-03-
    D.3.9.2Current sponsor codeTAK-935
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    developmental and epileptic encephalopathies
    encefalopatías epilépticas y del desarrollo
    E.1.1.1Medical condition in easily understood language
    developmental and epileptic encephalopathies
    encefalopatías epilépticas y del desarrollo
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the long-term safety and tolerability of TAK-935 when administered for 2 years as adjunctive therapy in patients with rare epilepsies
    Evaluar la seguridad y la tolerabilidad a largo plazo de TAK-935 cuando se administra durante 2 años como tratamiento complementario en pacientes con epilepsias raras.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of TAK-935 on seizure frequency over 2 years
    Evaluar el efecto de TAK-935 en la frecuencia de las crisis epilépticas durante 2 años.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Patients must have participated in a previous TAK-935 study and meet one of the following conditions:
     Successfully completed a TAK-935 clinical study.
     Received at least 10 weeks of treatment (combined dose optimization and maintenance period) with the study
    drug in a TAK-935 clinical study and the patient did not have a serious or severe AE that, in the
    investigator’s or Sponsor's opinion, was related to the study drug and would make it unsafe for the patient to
    continue receiving the study drug.
    2) In the opinion of the investigator, the patient has the potential to benefit from the administration of TAK-
    935.
    3) The patient provides written informed consent, or the patient’s legal representative (parent or legal guardian) provides written
    informed consent and the patient provides assent, before any study procedures are performed.
    4) The patient and legal representative (parent or guardian) are willing to comply with all study requirements.
    5) Sexually active female patients of childbearing potential (defined as first menarche) must agree to use a
    highly effective method of birth control during the study and for 30 days following the last dose of study. Highly effective contraceptive methods are as follows:
    a) Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of
    ovulation:
     Oral
     Intravaginal
     Transdermal
    b) Progestogen-only hormonal contraception associated with inhibition of ovulation:
     Oral
     Injectable
     Implantable
    c) Intrauterine device
    d) Intrauterine hormone-releasing system
    e) Bilateral tubal occlusion
    f) Vasectomized partner
    g) Sexual abstinence
    Sexually active male patients (post-pubertal unless permanently sterilized by bilateral orchidectomy) must
    agree to use male contraception (condom) during the study and for a minimum of 90 days following the
    last dose of study drug. Male patients must also not donate sperm during the Screening and Treatment
    Periods and for at least 90 days after the last dose of study drug.
    1) Los pacientes deberán haber participado en un estudio previo con TAK-935 y cumplir una de las condiciones siguientes:
    Haber completado con éxito un estudio clínico con TAK-935.
    Haber recibido al menos 10 semanas de tratamiento (período de optimización de la dosis y mantenimiento combinados) con el fármaco del estudio en un estudio clínico de TAK-935 y no haber presentado ningún AA grave o intenso que, en opinión del investigador o del promotor, esté relacionado con el fármaco del estudio y haga que no sea seguro para el paciente seguir recibiendo el fármaco del estudio.
    2) En opinión del investigador, el paciente puede beneficiarse de la administración de TAK-935.
    3) El paciente otorga su consentimiento informado por escrito, o el representante legal del paciente (es decir, los padres o el tutor legal) da su consentimiento informado por escrito y el paciente da su asentimiento antes de que se realice ningún procedimiento del estudio.
    4) El paciente y su representante legal (es decir, padre o tutor [según proceda) están dispuestos a cumplir todos los requisitos del estudio.
    5) Las mujeres en edad fértil sexualmente activas (definidas por la primera menarquia) deberán comprometerse a utilizar un método anticonceptivo muy eficaz durante el estudio y hasta 30 dúas después de la última dosis del fármaco del estudio. Los métodos anticonceptivos muy eficaces son los siguientes:
    a) Anticonceptivos hormonales combinados (con estrógenos y progestágenos) asociados a inhibición de la ovulación:
    Orales
    Intravaginales
    Transdérmicos
    b) Anticonceptivos hormonales solo con progestágeno asociados a inhibición de la ovulación:
    Orales
    Inyectables
    Implantables
    c) Dispositivo intrauterino.
    d) Sistema intrauterino de liberación hormonal
    e) Ligadura de trompas bilateral
    f) Vasectomía de la pareja
    g) Abstinencia sexual
    Los varones sexualmente activos (pospuberales a menos que estén esterilizados permanentemente mediante orquidectomía bilateral) deberán comprometerse a utilizar anticonceptivos masculinos (preservativo) durante el estudio y hasta por lo menos 90 días después de recibir la última dosis del fármaco del estudio. Los varones tampoco podrán donar semen durante los períodos de selección y tratamiento y hasta por lo menos 90 días después de recibir la última dosis del fármaco del estudio.
    E.4Principal exclusion criteria
    1. Clinically significant disease, that, in the investigator’s opinion, precludes study participation
    2. Enrollment in any other clinical trial involving an investigational drug, device, or treatment in the past 90 days (with the exception of an antecedent study involving TAK-935)
    3. Patient is currently pregnant or breastfeeding or is planning to become pregnant during the study or
    within 90 days of the last study drug administration
    4. Suicide attempt within the last year, at significant risk of suicide (either in the opinion of the investigator or defined as ‘yes’ to suicidal ideation question 4 or 5 on the Columbia- Suicide Severity Rating Scale [C-SSRS] at Screening) or appearing suicidal per investigator judgment
    1. Enfermedad clínicamente significativa que, en opinión del investigador, impida la participación en el estudio.
    2. Participación en cualquier otro ensayo clínico con un fármaco, dispositivo o tratamiento en investigación en los últimos 90 días (a excepción de un estudio previo con TAK-935).
    3. La paciente está embarazada o en período de lactancia o tiene previsto quedarse embarazada durante el estudio o en los 90 días siguientes a la última administración del fármaco del estudio.
    4. Intento de suicidio en el último año, con riesgo importante de suicidio (en opinión del investigador o definido como una respuesta afirmativa a la pregunta 4 o 5 sobre ideación suicida de la Escala de valoración de la intensidad del comportamiento suicida de Columbia [C-SSRS] en la selección) o aspecto de suicida según el criterio del investigador.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoints - Safety
    •Incidence of AEs
    •Change from Baseline in behavioral and adaptive functional measures using the Vineland Adaptive
    Behavior Scale
    •Change from Baseline in behavior measures using total scores and subscale scores of the Aberrant
    Behavior Checklist-Community Edition for patients ≥6 years of age
    •Change from Baseline in the Columbia-Suicide Severity Rating Scale categorization based onColumbia Classification Algorithm of Suicide Assessment categories 1,2,3,4, and 7 for patients
    ≥6 years of age.
    •Absolute values and change from Baseline in clinical laboratory assessments, vital sign measurements,
    body weight, and ECG parameters
    •Incidence of potentially clinically significant clinical safety laboratory test values, vital signs, weight,
    height/length, and ECG evaluations

    Exploratory Endpoints - Quality of Life
    •Change from Baseline in overall Quality of Life Childhood Epilepsy score (pediatric patients)
    •Change from Baseline in the Sleep Disruption Numerical Rating Scale
    - Criterios de valoración principales - seguridad
    Incidencia de AA
    Variación con respecto al momento basal de las mediciones conductuales y funcionales adaptativas con las Escalas de conducta adaptativa de Vineland Behavior Scale.
    Variación con respecto al momento basal de las mediciones conductuales utilizando las puntuaciones totales y las puntuaciones de las subescalas de la Lista de comprobación de conductas anómalas [Comunidad] para pacientes ≥ 6 años.
    Variación con respecto al momento basal de la clasificación según la Escala de valoración del riesgo de suicidio de Columbia basada en las categorías 1, 2, 3, 4 y 7 del Algoritmo de clasificación de Columbia para la evaluación del riesgo de suicidio en pacientes ≥ 6 años de edad.
    Valores absolutos y variación con respecto al momento basal de las evaluaciones analíticas, las mediciones de las constantes vitales, el peso corporal y los parámetros de ECG.
    Incidencia de valores que podrían ser clínicamente importantes en las evaluaciones analíticas de seguridad, las constantes vitales, el peso, la talla/longitud y las evaluaciones ECG.
    - Criterios de valoración exploratorios - Calidad de vida
    Variación con respecto al valor basal de la puntuación global de calidad de vida en la epilepsia infantil (pacientes pediátricos).
    Variación con respecto al momento basal de la puntuación en la Escala de valoración numérica de la alteración del sueño
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary end points will be assessed throughout the study.
    Los criterios de valoracion primarios y finales seran evaluados a lo largo del estudio
    E.5.2Secondary end point(s)
    Secondary Endpoints - Efficacy
    •Change from Baseline in all seizure frequency over 28-days at Weeks 12, 24, 36, 48, 64, 80, 104, and 108
    •Change from Baseline in mean drop seizure frequency over 28-days at Weeks 12, 24, 36, 48, 64, 80, 104, and 108
    •Change from Baseline in mean convulsive seizure frequency over 28-days at Weeks 12, 24, 36, 48, 64, 80, 104, and 108
    •Change from Baseline in mean motor seizure frequency over 28-days at Weeks 12, 24, 36, 48, 64, 80, 104, and 108
    - Criterios de valoración secundarios - Eficacia
    Variación con respecto al momento basal de la frecuencia total de crisis epilépticas durante 28 días en las semanas 12, 24, 36, 48, 64, 80, 104 y 108.
    Variación con respecto al momento basal de la frecuencia media de crisis atónicas durante 28 días en las semanas 12, 24, 36, 48, 64, 80, 104 y 108.
    Variación con respecto al momento basal de la frecuencia media de crisis convulsivas durante 28 días en las semanas 12, 24, 36, 48, 64, 80, 104 y 108.
    Variación con respecto al momento basal de la frecuencia media de crisis motoras durante 28 días en las semanas 12, 24, 36, 48, 64, 80, 104 y 108.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At Weeks 12, 24, 36, 48, 64, 80, 104, and 108
    En las semanas 12, 24, 36, 48, 64, 80, 104 y 108
    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
    Tolerability
    Tolerabilidad
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Canada
    China
    Israel
    Poland
    Portugal
    Spain
    United States
    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
    It has been defined as the last subject last visit
    Se ha definido como la última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days1
    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: 165
    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: 83
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 82
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 11
    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 No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    pediatric population (≥2 years ≤17 years)
    población pediátrica (≥2 años ≤17 años)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 176
    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)
    Will be provided to subjects for the duration of the study and not afterwards.
    TAK-935 será proporcioanod a los sujetos durante la duración del estudio y no después.
    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 Decision2019-06-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-05
    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-Thu May 02 18:26:02 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA