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    Summary
    EudraCT Number:2013-001694-24
    Sponsor's Protocol Code Number:D1050302
    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:2013-11-27
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2013-001694-24
    A.3Full title of the trial
    A 104-WEEK, FLEXIBLE-DOSE, OPEN-LABEL, MULTICENTER, EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFECTIVENESS OF LURASIDONE IN PEDIATRIC SUBJECTS WITH SCHIZOPHRENIA AND SUBJECTS WITH IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER
    ESTUDIO MULTICÉNTRICO DE EXTENSIÓN, CON DOSIS FLEXIBLE, ABIERTO, DE 104 SEMANAS DE DURACIÓN, PARA EVALUAR LA SEGURIDAD Y LA EFICACIA A LARGO PLAZO DE LURASIDONA EN SUJETOS PEDIÁTRICOS CON ESQUIZOFRENIA Y SUJETOS CON IRRITABILIDAD ASOCIADA AL TRASTORNO AUTISTA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 104-WEEK, FLEXIBLE-DOSE, OPEN-LABEL, MULTICENTER, EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFECTIVENESS OF LURASIDONE IN PEDIATRIC SUBJECTS WITH SCHIZOPHRENIA AND SUBJECTS WITH IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER
    ESTUDIO MULTICÉNTRICO DE EXTENSIÓN, CON DOSIS FLEXIBLE, ABIERTO, DE 104 SEMANAS DE DURACIÓN, PARA EVALUAR LA SEGURIDAD Y LA EFICACIA A LARGO PLAZO DE LURASIDONA EN SUJETOS PEDIÁTRICOS CON ESQUIZOFRENIA Y SUJETOS CON IRRITABILIDAD ASOCIADA AL TRASTORNO AUTISTA
    A.4.1Sponsor's protocol code numberD1050302
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/145/2012
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSUNOVION PHARMACEUTICALS 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 supportSunovion Pharmaceuticals Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSunovion Pharmaceuticals Inc.
    B.5.2Functional name of contact pointRobert Goldman
    B.5.3 Address:
    B.5.3.1Street AddressOne Bridge Plaza Suite 510
    B.5.3.2Town/ cityFort Lee,
    B.5.3.3Post codeNJ 07024
    B.5.3.4CountryUnited States
    B.5.4Telephone number1201-592-2050
    B.5.6E-mailRobert.Goldman@sunovion.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 LATUDA
    D.2.1.1.2Name of the Marketing Authorisation holderSunovion Pharmaceuticals Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameLURASIDONE
    D.3.2Product code SM-13496
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNLurasidone Hydrochloride
    D.3.9.1CAS number 367514-88-3
    D.3.9.3Other descriptive nameSM-13496
    D.3.9.4EV Substance CodeSUB34204
    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.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 Yes
    D.2.1.1.1Trade name LATUDA
    D.2.1.1.2Name of the Marketing Authorisation holderSunovion Pharmaceuticals Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameLURASIDONE
    D.3.2Product code SM-13496
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Yes
    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 INNLurasidone Hydrochloride
    D.3.9.1CAS number 367514-87-2
    D.3.9.3Other descriptive nameLURASIDONE
    D.3.9.4EV Substance CodeSUB32185
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    SCHIZOPHRENIA AND IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER
    Esquizofrenia e irritabilidad asociada al trastorno autista
    E.1.1.1Medical condition in easily understood language
    SCHIZOPHRENIA AND IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER
    Esquizofrenia e irritabilidad asociada al trastorno autista
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLGT
    E.1.2Classification code 10039628
    E.1.2Term Schizophrenia and other psychotic disorders
    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, tolerability, and effectiveness of lurasidone (20, 40, 60 or 80 mg/day, flexibly dosed) in pediatric subjects with schizophrenia and subjects with irritability associated with autism.
    Evaluar la seguridad, tolerabilidad y eficacia a largo plazo de lurasidona (20, 40, 60 u 80 mg/día, en dosis flexibles) en sujetos pediátricos con esquizofrenia y sujetos con irritabilidad asociada al autismo.
    E.2.2Secondary objectives of the trial
    For all subjects:
    - Proportions of subjects with adverse events (AEs), discontinuations due to AEs, and serious AEs (SAEs);
    - Change in the Clinical Global Impression ? Severity (CGI-S).

    For subjects continued from Study D1050301:
    - Change in Positive and Negative Syndrome Scale (PANSS) total, positive, negative, general psychopathology, and excitability subscale scores;
    - Change in the Clinician-rated Children?s Global Assessment Scale (CGAS);
    - Change in the Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q).

    For subjects continued from Study D1050325:
    - Change in Aberrant Behavior Checklist (ABC) irritability subscale, and the following subscale scores (hyperactivity, stereotypy, inappropriate speech, and lethargy/social withdrawal);
    - Change in Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) modified for pervasive developmental disorders (PDDs);
    - Change in the Caregiver Strain Questionnaire (CGSQ).
    Se evaluarán los sig. parámetros en todos los sujetos:
    ? Proporción de sujetos con AA, interrupciones debidas a AA y AA graves (AAG)? Cambio en la impresión clínica global de la intensidad (CGI-S)/En los sujetos procedentes del estudio D1050301, se evaluará lo siguiente:? Cambio en Escala de los síndromes pos y neg (PANSS) y en las subescalas de síndromes pos, neg, psicopatología general y excitabilidad.? Cambio en la Escala CGAS? Cambio en el Cuestionario pediátrico PQ-LES-Q/ En los sujetos procedentes del estudio D1050325 se evaluará lo siguiente:? Cambio en la subescala de irritabilidad de la Lista de comprobación de comportamientos aberrantes (Aberrant Behavior Checklist, ABC) y las siguientes puntuaciones de subescala (hiperactividad, estereotipia, habla inapropiada y letargo/aislamiento social)? Cambio en la Escala CY-BOCS modificada para los trastornos del desarrollo generalizados (TDG)? Cambio en el Cuestionario de carga del cuidador (Caregiver Strain Questionnaire, CGSQ)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent from parent(s) or legal guardian(s) with sufficient intellectual capacity to understand the study and support subjects? participation in the study procedures must be obtained for subjects who are not emancipated. In accordance with Institutional Review Board (IRB) or Independent Ethics Committee (IEC) requirements, the subject will complete an informed assent when developmentally appropriate, to participate in the study before conduct of any study-specific procedures.
    2. Subject has completed Study D1050301 (Visit 9); OR Subject has completed Study D1050325 (Visit 9).
    3. Subject is judged by the investigator to be appropriate for participation in a 104-week clinical trial in an outpatient setting involving open-label lurasidone treatment, and is able to comply with the protocol.
    4. A reliable informant (eg, parent, legal guardian, or caregiver) must be available to accompany the subject at each visit.
    5. Females who participate in this study:
    - are unable to become pregnant (eg, premenarchal, surgically sterile, etc.)
    OR
    - practices true abstinence (consistent with lifestyle) and must agree to remain abstinent from signing informed consent to at least 30 days after the last dose of study drug has been taken;
    OR
    - are sexually active and willing to use a medically effective method of birth control (eg, male using condom and female using condom, diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) from signing informed consent to at least 30 days after the last dose of study drug has been taken.
    6. Males must be willing to remain sexually abstinent (consistent with lifestyle) or use an effective method of birth control (eg, male using condom and female using condom, diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) from signing informed consent to at least 30 days after the last dose of study drug has been taken.
    1. En el caso de los sujetos que no estén emancipados se debe obtener el consentimiento informado escrito del padre, de la madre, o de ambos, o del tutor o tutores legales con capacidad intelectual suficiente para entender el estudio y respaldar la participación de los sujetos en los procedimientos del estudio. De acuerdo con los requisitos de la Junta de Revisión Institucional (JRS) o el Comité Ético de Investigación Clínica (CEIC), el sujeto cumplimentará un asentimiento informado cuando sea apropiado desde el punto de vista del desarrollo, para participar en el estudio antes de realizar cualquier procedimiento específico del estudio.
    2. El sujeto ha completado el estudio D1050301 (visita 9); O el sujeto ha completado el estudio D1050325 (
    visita 9).
    3. El sujeto es, a juicio del investigador, elegible para participar en el ensayo clínico de 104 semanas en un entorno ambulatorio con tratamiento de lurasidona, y es capaz de cumplir con el protocolo.
    4. Un informador fiable (p. ej.: padre, madre, tutor legal o cuidador) debe estar disponible para acompañar al sujeto en cada visita.
    5. Las mujeres que participen en este estudio:
    ? no pueden quedarse embarazadas (p. ej.: premenárquicas, esterilizadas quirúrgicamente, etc.)
    O
    ? practican abstinencia real (coherente con su estilo de vida) y deben acceder a seguir manteniendo la abstinencia desde el momento de la firma del consentimiento informado hasta al menos 30 días después de haber tomado la última dosis del fármaco del estudio;
    O
    ? son sexualmente activas y están dispuestas a usar un método anticonceptivo médicamente eficaz (p. ej.: los varones usarán un preservativo y las mujeres usarán preservativo, diafragma, esponja anticonceptiva, espermicida, la píldora anticonceptiva o el dispositivo intrauterino) desde el momento de la firma del consentimiento informado hasta al menos 30 días después de haber tomado la última dosis del fármaco del estudio.
    6. Los varones deben estar dispuestos a seguir practicando la abstinencia sexual (coherente con su estilo de vida) o usar un método anticonceptivo eficaz (p. ej.: los varones usarán un preservativo y las mujeres usarán preservativo, diafragma, esponja anticonceptiva, espermicida, la píldora anticonceptiva o el dispositivo intrauterino) desde el momento dela firma del consentimiento informado hasta al menos 30 días después de haber tomado la última dosis del fármaco del estudio.
    E.4Principal exclusion criteria
    1. Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.

    2. Exhibits evidence of moderate or severe extrapyramidal symptoms, dystonia, tardive dyskinesia, or any other moderate or severe movement disorder. Severity to be determined by the investigator.
    1. El investigador considera que el sujeto corre un riesgo inminente de suicidarse o autolesionarse, o dañar a otras personas o propiedades.
    2. Muestra evidencias de discinesia tardía, distonía, síntomas extrapiramidales moderados o intensos, o cualquier otro trastorno del movimiento moderado o intenso. La intensidad la debe determinar el investigador.
    E.5 End points
    E.5.1Primary end point(s)
    6.1. Safety Assessments
    All Subjects:
    ? Treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation and serious AEs (SAEs);
    ? Laboratory tests, vital signs, body weight and body mass index (BMI), physical examination, height (as measured by stadiometer), electrocardiogram (ECG);
    ? Movement disorders as assessed by Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and the Simpson-Angus Scale (SAS);
    ? Tanner staging, and menstrual cyclicity (female subjects).
    For subjects continued from Study D1050301:
    ? Columbia Suicide Severity Rating Scale (C-SSRS);
    ? Composite Score of the CogState Computerized Cognitive Test Battery;
    ? Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU).
    6.2. Effectiveness Assessments
    All Subjects:
    ? Clinical Global Impression severity (CGI-S) scale.
    For subjects continued from Study D1050301:
    ? Positive and Negative Syndrome Scale (PANSS);
    ? Clinician-rated Children?s Global Assessment Scale (CGAS);
    ? Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q).
    For subjects continued from Study D1050325:
    ? Aberrant Behavior Checklist (ABC);
    ? Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) modified for pervasive developmental disorders (PDDs);
    ? Caregiver Strain Questionnaire (CGSQ).
    6.1. Evaluaciones de la seguridad
    Todos los sujetos:
    ? Acontecimientos adversos emergentes del tratamiento (AAET), los AAET que provoquen la interrupción y AA graves (AAG).
    ? Pruebas de laboratorio, constantes vitales, peso e índice de masa corporal (IMC), exploración física, estatura (medida según un estadiómetro), electrocardiograma (ECG).
    ? Trastornos del movimiento según la evaluación de la Escala de movimientos involuntarios anormales (AIMS), la Escala de acatisia de Barnes (BARS), y la Escala de Simpson-Angus (SAS).
    ? Estadios de Tanner y ciclicidad menstrual (mujeres).
    Para los sujetos que continúen procedentes del estudio D1050301:
    ? Escala Columbia para evaluar el riesgo de suicidio (C-SSRS).
    ? Puntuación compuesta de la batería de pruebas cognitivas computerizadas CogState.
    ? Escala de efectos secundarios UKU (Udvalg für Kliniske Undersogelser).
    6.2. Evaluaciones de la eficacia
    Todos los sujetos:
    ? Escala de impresión clínica global de la intensidad (CGI-S).
    Para los sujetos que continúen procedentes del estudio D1050301:
    ? Escala de los síndromes positivo y negativo (PANSS).
    ? Escala de evaluación global del niño puntuada por el médico (CGAS).
    ? Cuestionario pediátrico sobre el disfrute y la satisfacción de la calidad de vida (PQ-LES-Q).
    Para los sujetos que continúen procedentes del estudio D1050325:
    ? Lista de comprobación de comportamientos aberrantes (ABC).
    ? Escala de obsesiones y compulsiones de Yale-Brown para niños (CY-BOCS) modificada para los trastornos del desarrollo generalizados (TDG).
    ? Cuestionario de carga del cuidador (CGSQ).
    E.5.1.1Timepoint(s) of evaluation of this end point
    throughout the study
    Durante todo el estudio
    E.5.2Secondary end point(s)
    Safety Assessments:
    All Subjects:
    - Laboratory tests, vital signs, body weight and body mass index (BMI), physical examination, height (as measured by stadiometer), electrocardiogram (ECG);
    - Movement disorders as assessed by Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and the Simpson-Angus Scale (SAS);
    - Tanner staging, and menstrual cyclicity (female subjects).
    For subjects continued from Study D1050301:
    - Composite Score of the CogState Computerized Cognitive Test Battery;
    - Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU).

    Effectiveness Assessments:
    For subjects continued from Study D1050301:
    - Clinician-rated Children?s Global Assessment Scale (CGAS);
    - Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q).
    For subjects continued from Study D1050325:
    - Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) modified for pervasive developmental disorders (PDDs);
    - Caregiver Strain Questionnaire (CGSQ).
    Evaluaciones de la seguridad:
    Todos los sujetos:
    ? Acontecimientos adversos emergentes del tratamiento (AAET), los AAET que provoquen la interrupción y AA graves (AAG).
    ? Pruebas de laboratorio, constantes vitales, peso e índice de masa corporal (IMC), exploración física, estatura (medida según un estadiómetro), electrocardiograma (ECG).
    ? Trastornos del movimiento según la evaluación de la Escala de movimientos involuntarios anormales (AIMS), la Escala de acatisia de Barnes (BARS), y la Escala de Simpson-Angus (SAS).
    ? Estadios de Tanner y ciclicidad menstrual (mujeres).

    Para los sujetos que continúen procedentes del estudio D1050301:
    ? Escala Columbia para evaluar el riesgo de suicidio (C-SSRS).
    ? Batería de pruebas cognitivas computerizadas CogState.
    ? Escala de efectos secundarios UKU (Udvalg für Kliniske Undersogelser).
    Evaluaciones de la eficacia:
    Todos los sujetos:
    ? Escala de impresión clínica global de la intensidad (CGI-S).
    Para los sujetos que continúen procedentes del estudio D1050301:
    ? Escala de los síndromes positivo y negativo (PANSS).
    ? Escala de evaluación global del niño puntuada por el médico (CGAS).
    ? Cuestionario pediátrico sobre el disfrute y la satisfacción de la calidad de vida (PQ-LES-Q).
    Para los sujetos que continúen procedentes del estudio D1050325:
    ? Lista de comprobación de comportamientos aberrantes (ABC).
    ? Escala de obsesiones y compulsiones de Yale-Brown para niños (CY-BOCS) modificada para los trastornos del desarrollo generalizados (TDG).
    ? Cuestionario de carga del cuidador (CGSQ).
    E.5.2.1Timepoint(s) of evaluation of this end point
    throughout the study
    Durante todo el estudio
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    Bulgaria
    China
    Colombia
    Italy
    Philippines
    Malaysia
    Mexico
    Puerto Rico
    Romania
    Ukraine
    Korea, Republic of
    Serbia
    Spain
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    Visit 29E EOS/ET (Week 104)
    Visita de 29E EOS/ET (semana 104)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months2
    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: 295
    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: 148
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 147
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    peadiatric population starting at 2 years
    Población pediatrica empezando a los 2 años
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 72
    F.4.2.2In the whole clinical trial 295
    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)
    Please ref to:
    Section 11.4.30 of the protocol: 'Follow-Up: Visit 30 Week 105' (pages 60-61)
    2nd paragraph of the section 12.2 (of the protocol): 'Follow-up Procedures Upon Discontinuation or Withdrawal' (page 62)
    Por favor dirigirse a:

    Sección 11.4.30 del protocolo: "Visita de seguimiento: Visita 30E (semana 105)" (páginas 63 y 64)

    2º párrafo de la sección 12.2 (del protocolo): "Procedimientos de seguimiento después de la interrupción/retirada"
    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 Decision2014-03-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-10-17
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