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    Summary
    EudraCT Number:2013-002228-18
    Sponsor's Protocol Code Number:AB-GEN-2013
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-09-16
    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 number2013-002228-18
    A.3Full title of the trial
    A randomized controlled clinical trial for assessing the effectiveness of pharmacogenetic information obtained with NEUROFARMAGEN in the treatment of patients with mental disorders
    Ensayo clínico aleatorizado, con grupo control, de seguimiento en paralelo acerca de la eficacia de la información farmacogenética obtenida con NEUROFARMAGEN en el tratamiento de pacientes con trastornos mentales
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial for assessing if gentic information obtained with NEUROFARMAGEN test is effective for selecting the treatment in patients with mental disorders
    Ensayo clínico para evaluar si la información genetica obtenida con el análisis NEUROFARMAGEN es eficaz para la selección del tratamiento en los pacientes con trastornos mentales
    A.4.1Sponsor's protocol code numberAB-GEN-2013
    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 SponsorAB-BIOTICS S.A.
    B.1.3.4CountrySpain
    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 supportAB-BIOTICS
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAB-BIOTICS
    B.5.2Functional name of contact pointAriana Salavert
    B.5.3 Address:
    B.5.3.1Street AddressCampus UAB - Edifici EUREKA
    B.5.3.2Town/ cityBellaterra (Barcelona)
    B.5.3.3Post code08193
    B.5.3.4CountrySpain
    B.5.4Telephone number0034935946024
    B.5.5Fax number0034972183213
    B.5.6E-mailsalavert@ab-biotics.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 Yes
    D.2.1.1.1Trade name NEUROFARMAGEN, genetic test
    D.2.1.1.2Name of the Marketing Authorisation holderAB-BIOTICs
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameNEUROFARMAGEN
    D.3.4Pharmaceutical form Mouthwash
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPBuccal use
    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 Yes
    D.3.11.13.1Other medicinal product typeNEUROFARMAGEN is a genetic test that assesses drug response. It is no an IMP. This trial has been considered a clinical trial since the test results can modify doctor's intention to treat.
    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
    Major depressive disorder
    schizophrenia
    Bipolar disorder
    obsessive-compulsive disorder
    trastorno depresivo mayor
    esquizofrenia
    trastorno bipolar
    trastorno obsesivo-compulsivo
    E.1.1.1Medical condition in easily understood language
    Depression
    schizophrenia
    Bipolar disorder
    obsessive-compulsive disorder
    Depresión
    esquizofrenia
    trastorno bipolar
    trastorno obsesivo-compulsivo
    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 NEUROFARMAGEN test effectiveness in selecting drug treatments for mental disorders (major depressive disorder, bipolar disorder, schizophrenia and obsessive-compulsive disorder) by the proportion of patients achieving sustained response over a period of six months. Sustained response is considered when the patient gets a PGI-I of 2 points or less in two consecutive assessments after the last change in treatment.
    Eficacia del test NEUROFARMAGEN en la selección de los tratamientos farmacológicos para trastornos mentales (trastorno de depresión mayor, trastorno bipolar, esquizofrenia y trastorno obsesivo-compulsivo) mediante la proporción de pacientes que obtienen respuesta sostenida durante un periodo de 6 meses. Se considerará respuesta sostenida cuando el paciente disponga de un PGI-I de 2 o menos puntos en dos valoraciones consecutivas posterior al último cambio de tratamiento.
    E.2.2Secondary objectives of the trial
    Differences in the proportion of patients who discontinued treatment between groups
    Differences in tolerability between treatment groups.
    Changes in patient-perceived disability between groups.
    Differences in changes in the severity of the patient's disease by patient and investigator between groups.
    Differences in time to file a PGI-I of 2 or less points between groups.
    Differences in the clinical course of the patient according to specific scales of each of the diseases among groups
    Differences in satisfaction with treatment by patients
    Population Subgroup analysis of the primary and secondary listed above.
    Find new genetic markers predictive of good response or adverse effects to treatment
    Absolute cost savings involved in making Neurofarmagen
    Cost - effectiveness of Neurofarmagen
    Diferencias en la proporción de pacientes que discontinúan el tratamiento entre grupos
    Diferencias en la tolerabilidad al tratamiento entre grupos.
    Cambios en la discapacidad percibida por el paciente entre grupos.
    Diferencias en los cambios en la severidad de la enfermedad del paciente según paciente e investigador entre grupos.
    Diferencias en el tiempo a presentar de una PGI-I de 2 o menos puntos entre grupos.
    Diferencias en la evolución clínica del paciente según escalas específicas de cada una de las patologías entre grupos
    Diferencias en la satisfacción con el tratamiento por parte de los pacientes
    Análisis de subgrupos de población del objetivo principal y secundarios citados anteriormente.
    Buscar nuevos marcadores genéticos predictivos de buena respuesta o de efectos adversos al tratamiento
    Ahorro en coste absoluto que implica realizar Neurofarmagen
    Relación coste ? efectividad de Neurofarmagen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients of either sex over 18 years.
    - Patients with any of the following psychiatric diagnoses according to DSM-IV-TR: bipolar disorder, schizophrenia, major depressive disorder or obsessive-compulsive disorder
    - Patients who have given their written informed consent to participate in the study. In the case of disabled patients, informed consent of the legal representative or family member.
    - Patients with a value on the clinical global impression scale of severity (CGI-S) according to the doctor less than 4.
    - Patients who are newly diagnosed and that require medication or that are undergoing treatment and require a substitution or addition of medication with an antidepressant, antipsychotic or mood stabilizer.
    antidepresivo, antipsicótico o estabilizador del ánimo.
    - Pacientes de cualquier sexo mayores de 18 años.
    - Pacientes con alguno de los diagnósticos psiquiátricos siguientes, de acuerdo a criterios DSM-IV-TR: trastorno bipolar , esquizofrenia, trastorno depresivo mayor i trastorno obsesivo-compulsivo
    - Pacientes que den su consentimiento informado por escrito para participar en el estudio. En el caso de pacientes incapacitados, consentimiento informado del representante legal o familiar responsable.
    - Pacientes con un valor en la escala de impresión clínica global de gravedad (CGI-S) según el médico igual o superior a 4.
    - Pacientes que sean diagnosticados de novo que a criterio clínico requieran de medicación o que estén en tratamiento y requieran de una sustitución o adición de la medicación con un fármaco antidepresivo, antipsicótico o estabilizador del ánimo.
    E.4Principal exclusion criteria
    -Patients who are expected no to be able to complete the study.
    -Patients who are actively participating or have participated in the last three months in another clinical trial
    -Patients who are pregnant or breastfeeding, or patients who intend to become pregnant in the next 12 months.
    -Patients who are or require treatment with quinidine, cinacalcet and / or terbinafine (potent CYP2D6 inhibitors).
    - Pacientes que se prevea que no podrán realizar el seguimiento completo del estudio.
    - Pacientes que estén participando activamente o que hayan participado en los últimos tres meses en algún otro estudio clínico.
    - Pacientes embarazadas o en período de lactancia, o pacientes que tengan la intención de quedarse embarazadas en los próximos 12 meses.
    - Pacientes que estén o requieran tratamiento con Quinidina, cinacalcet y/o terbinafina (potentes inhibidores del CYP2D6).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is to test the effectiveness of Neurofarmagen in the selection of pharmacological treatments for mental disorders (major depression, bipolar disorder, schizophrenia and obsessive-compulsive disorder) by the proportion of patients who obtained sustained response over a period of six months . The study will be performed by comparing the group of patients with access to test information at baseline and patients without access to this information until the end of follow up period.
    Sustained response in relation to diagnosed mental disorder will be evaluated over the 6-month follow-up study by the score on the PGI-I scale. It is considered that a patient has a sustained response when submitting a PGI-I score of 2 or less for two consecutive points. Assessments are conducted monthly telephone. The interviewer will not know the group assigned to the patient, so that the evaluation of the primary endpoint will be a single-blind evaluation by blinded.
    La variable principal del estudio es la eficacia del test NEUROFARMAGEN en la selección de los tratamientos farmacológicos para trastornos mentales (depresión mayor, trastorno bipolar, esquizofrenia y trastorno obsesivo-compulsivo) mediante la proporción de pacientes que obtiene respuesta sostenida durante un periodo de 6 meses. El estudio se realizará por comparación entre el grupo de pacientes con acceso a la información del test en la visita basal y el grupo de pacientes sin acceso a dicha información hasta el final del periodo de seguimiento.
    La respuesta sostenida en relación al trastorno mental diagnosticado se evaluará a lo largo de los 6 meses de seguimiento del estudio mediante la puntuación en la escala PGI-I. Se considerará que un paciente presenta una respuesta sostenida cuando presente una puntuación PGI-I de 2 o menos puntos durante dos evaluaciones consecutivas. Las evaluaciones serán realizadas mensualmente vía telefónica. El encuestador no conocerá el grupo asignado al paciente, por lo que la evaluación de la variable principal será a simple ciego con evaluación ciega por terceros.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6-month follow-up
    Período de seguimiento de 6 meses
    E.5.2Secondary end point(s)
    Frequency of polymorphisms, through genetic test results Neurofarmagen.
    Tolerability through FIBSER scale modified in order to be valid for the 4 conditions under study. Likewise for tolerability study also be employed corresponding items SATMED Scale-Q.
    Satisfaction with treatment as SATMED-Q scale, by the change in the total score of the same. It will also examine the changes in the scores of the different dimensions of the scale.
    Study of disability under the SDI scale, describing the same total score and analyze developments along the track of the patient group and the comparison of the evolution of the two groups.
    Disease severity by the CGI-S, comparing initial and final values ??inter and intra groups. The Clinical Global Impression scale (CGI-S, Clinical Global Impression-Severity) is a descriptive scale that provides qualitative information on the severity of the clinical picture of the patient. In this study, both self-reported version administered as hetero version, in which the clinical severity will be evaluated by the doctor.
    Clinical course of the patient as specific scale for each condition under study. It will analyze the evolution from baseline visit to follow-up within the same group as well as a comparative between the groups.
    GWAS, polymorphisms analyzed results regarding the efficacy and safety of treatments for the whole study population (randomized patients baseline visit and follow-up patients without active)
    About pharmacoeconomic study. It will consider whether the decision to use Neurofarmagen implies economic benefits to the healthcare system. There will be a study of direct and indirect costs of all randomized patients. In the direct costs will consider the following items: direct cost of drug treatment, cost of any revenue in emergency shelters or centers, visits or checkups. In the indirect costs are only considered: lost work time (if applicable). The average economic cost per patient of each group of patients (control and study) will show if the pharmacogenetic test is cost - effective.

    The following variables are purely descriptive, yet inference can be analyzed between patient groups in order to assess possible differences between groups. In the case of pre-randomization variables, however, still have inferential results purely descriptive and not this information being used in the analysis of post-randomization results:
    Socio-demographic data: age, sex, educational level, employment status, marital status.
    Clinical data: diagnosis, age of diagnosis, comorbidities, concomitant medications, addictions.
    Pharmacological treatments for mental disorders at the time of the pre-randomization visit and changes throughout the follow-up period for the whole of the population included in the study.
    Description of the population at baseline visit for meeting selection criteria and excluded group of patients in follow-up phase.
    Neurofarmagen researcher satisfaction by Likert scale of 5 points.
    Evolution along the study scores CGI-S questionnaires administered by the physician and the patient.
    Clinical course of patients not randomized (excluded from active follow-up phase) by comparing disease-specific scale between baseline and final visit (at 6 months).

    Considerations for the evaluation of disease specific scales:

    Changes in scale scores were HAM-D, BPRS, CGI-BP-M and YALE-BROWN among the final hearing and sight one comparing patients in the study group and control groups.
    - Hamilton Scale for Depression (HAM-D) assesses the clinical severity of depression.
    -The Brief Psychiatric Rating Scale (BPRS) is a standardized scale to the clinical course of schizophrenia.
    - The clinical global impression scale for bipolar disorder modified (CGI-BP-M) is a scale used on several occasions even the evaluation of the effectiveness of drug treatments for this disease.
    -The Yale-Brown scale for obsessive-compulsive disorder is a scale used to assess the severity of obsessions and compulsions of OCD patients previously diagnosed.
    Frecuencia de los polimorfismos, por medio de los resultados del test genético NEUROFARMAGEN.
    Tolerabilidad, por medio de la escala FIBSER modificada para que pueda ser válida para las 4 patologías en estudio. Asimismo para el estudio de la tolerabilidad se emplearán también los ítems correspondientes de la escala SATMED-Q.
    Satisfacción con el tratamiento, según escala SATMED-Q, por el cambio en la puntuación total de la misma. Se analizarán también los cambios en las puntuaciones de las distintas dimensiones de la escala.
    Estudio de la discapacidad según la escala SDI, describiendo la puntuación total de la misma y analizando la evolución a lo largo del seguimiento del grupo de pacientes así como la comparación de la evolución de ambos grupos.
    Severidad de la enfermedad, mediante la escala CGI-S, comparando valores iniciales y finales inter y intra grupos. La escala de impresión clínica global (CGI-S, Clinical Global Impression-Severity) es una escala descriptiva que proporciona información cualitativa sobre la gravedad del cuadro clínico del paciente. En este estudio se administrará tanto la versión autoaplicada como la versión heteroaplicada, en la que la gravedad clínica será evaluada por el médico.
    Evolución clínica del paciente, según escala específica para cada patología en estudio. Se analizará la evolución desde visita basal a fin de seguimiento dentro de un mismo grupo así como de forma comparativa entre los grupos.
    GWAS, resultados de los polimorfismos analizados con relación a la eficacia y seguridad de los tratamientos para el conjunto de población del estudio (pacientes aleatorizados en visita basal y pacientes sin seguimiento activo)
    Acerca del estudio farmacoeconómico. Se analizará si la decisión de emplear NEUROFARMAGEN implica ventajas económicas para el sistema sanitario. Se realizará un estudio de costes directos e indirectos del conjunto de pacientes aleatorizados. En los costes directos se considerarán los siguientes ítems: coste directo del tratamiento farmacológico; coste de los posibles ingresos en centros tutelados o urgencias; visitas o controles médicos. En los costes indirectos tan solo se considerará: tiempo laboral perdido (si corresponde). El coste económico promedio por paciente de cada grupo de pacientes (control y de estudio) deberá mostrar si es el test farmacogenético es coste ? efectivo.

    Las siguientes variables serán meramente descriptivas, no obstante se podrá analizar la inferencia entre los grupos de pacientes con el fin valorar posibles diferencias entre grupos. En el caso de variables pre-aleatorización, no obstante, los resultados inferenciales seguirán teniendo un carácter puramente descriptivo, no empleándose esta información en el análisis de los resultados post-aleatorización:
    Datos socio-demográficos: edad, sexo, nivel de estudios, situación laboral, estado civil.
    Datos clínicos: diagnóstico, antigüedad del diagnóstico, enfermedades concomitantes, medicación concomitante, adicciones.
    Tratamientos farmacológicos para trastornos mentales en el momento de la visita pre-aleatorización y cambios a lo largo del periodo de seguimiento para el conjunto de la población incluida en el estudio.
    Descripción de la población en visita basal por cumplimiento de criterios de selección y pacientes en grupo excluido de la fase de seguimiento.
    Satisfacción del investigador con NEUROFARMAGEN, por escala de Likert de 5 puntos.
    Evolución a lo largo del estudio de las puntuaciones de los cuestionarios CGI-S administrados por el médico y el paciente.
    Evolución clínica de los pacientes no aleatorizados (excluidos de la fase de seguimiento activo) por comparación de escala específica de enfermedad entre la visita basal y final (a los 6 meses).

    Consideraciones acerca de la evaluación de las escalas específicas de la enfermedad:

    Cambios en les puntuaciones de las escalas HAM-D, BPRS, CGI-BP-M y YALE-BROWN entre la vista final y la vista 1 comparando los pacientes del grupo de estudio y del grupo control.
    1. La escala Hamilton para la depresión (HAM-D) valora la gravedad clínica de la depresión.
    2. La escala breve de evaluación psiquiátrica (BPRS) es una escala estandarizada para el curso clínico de la esquizofrenia.
    3. La escala de impresión clínica global para el trastorno bipolar modificada (CGI-BP-M) es una escala empleada en diversas ocasiones par la valoración de la eficacia de tratamientos farmacológicos de dicha patología.
    4. La escala Yale Brown para el trastorno obsesivo-compulsivo es una escala empleada para valorar la severidad de las obsesiones y compulsiones de los pacientes previamente diagnosticados por TOC.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6-month follow-up
    Período de seguimiento de 6 meses
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    La muestra de saliva para la realización del test se tomarà a todos los pacientes
    The saliva sample for test performance will be taken to all patients
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned17
    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
    LVLS
    El final del estudio clínico se define como la última visita del último paciente reclutado
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1800
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state1800
    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)
    NONE
    NINGUNO
    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 Decision2013-10-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-15
    P. End of Trial
    P.End of Trial StatusCompleted
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