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    Summary
    EudraCT Number:2015-000922-12
    Sponsor's Protocol Code Number:TV44400-CNS-40083
    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:2016-01-13
    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 number2015-000922-12
    A.3Full title of the trial
    A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE)
    Estudio abierto, internacional, multicéntrico, aleatorizado y de grupos paralelos para evaluar la satisfacción con la medicación en pacientes con esclerosis múltiple (EM) remitente recidivante tratados con inyecciones subcutáneas de Copaxone® (acetato de glatirámero) 40 mg/ml tres veces a la semana en comparación con 20 mg/ml diarios (CONFIDENCE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily
    Estudio clínico para evaluar la satisfacción con la medicación en pacientes con esclerosis múltiple (EM) remitente recidivante tratados con Copaxone 40 mg/ml tres veces a la semana en comparación con Copaxone 20 mg/ml diarios
    A.3.2Name or abbreviated title of the trial where available
    CONFIDENCE
    A.4.1Sponsor's protocol code numberTV44400-CNS-40083
    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 SponsorTeva Pharmaceutical Industries, Ltd
    B.1.3.4CountryIsrael
    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 supportTeva Pharmaceutical Industries, Ltd
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTeva Pharma GmbH
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressWaldecker Str. 7
    B.5.3.2Town/ cityMoerfelden-Walldorf
    B.5.3.3Post code64546
    B.5.3.4CountryGermany
    B.5.4Telephone number0034913542598
    B.5.6E-mailInformacion.medical@tevaes.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 Copaxone 20 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Neuroscience, 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.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGLATIRAMER ACETATE
    D.3.9.1CAS number 147245-92-9
    D.3.9.2Current sponsor codeGLATIRAMER ACETATE
    D.3.9.3Other descriptive nameGLATIRAMER ACETATE
    D.3.9.4EV Substance CodeSUB13971MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 Copaxone 40 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Neuroscience, 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.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGLATIRAMER ACETATE
    D.3.9.1CAS number 147245-92-9
    D.3.9.2Current sponsor codeGLATIRAMER ACETATE
    D.3.9.3Other descriptive nameGLATIRAMER ACETATE
    D.3.9.4EV Substance CodeSUB13971MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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
    Relapsing-Remitting Multiple Sclerosis (RRMS)
    Esclerosis múltiple remitente recidivante (EMRR)
    E.1.1.1Medical condition in easily understood language
    Relapsing-Remitting Multiple Sclerosis (RRMS)
    Esclerosis múltiple remitente recidivante (EMRR)
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to compare patient medication satisfaction as measured by the Medication Satisfaction Questionnaire (MSQ) scores between the Copaxone 40 mg/mL three times a week (TIW) group and the Copaxone 20 mg/mL once daily (QD) group over 6 months of treatment.
    El objetivo principal de este estudio consiste en comparar la satisfacción de los pacientes con la medicación, determinada mediante las puntuaciones en el cuestionario MSQ (Cuestionario de satisfacción con la medicación), entre los grupos de Copaxone 40 mg/ml tres veces a la semana y Copaxone 20 mg/ml una vez al día durante 6 meses de tratamiento.
    E.2.2Secondary objectives of the trial
    - To compare the convenience perception as measured by the convenience scale within the Treatment Satisfaction Questionnaire for Medication (TSQM-9) in patients treated with subcutaneous (SC) injection of Copaxone 40 mg/mL TIW vs. Copaxone 20 mg/mL QD over 6 months of treatment
    - To compare symptomatic changes as determined by the Multiple Sclerosis Quality of Life Inventory (MSQLI) subscales Modified Fatigue Impact Scale (MFIS) and Mental Health Inventory (MHI) in patients treated with SC injection of Copaxone 40 mg/mL TIW vs. Copaxone 20 mg/mL QD over 6 months of treatment
    - To compare patients depressive symptoms as measured by Beck Depression Inventory II (BDI-II) scale in patients treated with SC injection of Copaxone 40 mg/mL TIW vs. Copaxone 20 mg/mL QD over 6 months of treatment

    The exploratory and other objectives of the study are detailed in the study protocol.
    -Comparar la percepción sobre la comodidad, determinada mediante la escala de comodidad del cuestionario TSQM 9, en pacientes tratados con inyecciones por vía subcutánea (SC) de Copaxone 40 mg/ml tres veces a la semana y Copaxone 20 mg/ml una vez al día en los 6 meses de tratamiento.
    - Comparar los cambios sintomáticos, determinados mediante las subescalas MFIS (Escala modificada del impacto de la fatiga) y MHI (Inventario de salud mental) del cuestionario de calidad de vida en la esclerosis múltiple (MSQLI), en pacientes tratados con inyecciones SC de Copaxone 40 mg/ml tres veces a la semana y Copaxone 20 mg/ml una vez al día en los 6 meses de tratamiento.
    -Comparar los síntomas depresivos del paciente, determinados mediante la escala de depresión BDI-II, en pacientes tratados con inyecciones SC de Copaxone 40 mg/ml tres veces a la semana y Copaxone 20 mg/ml una vez al día en los 6 meses de tratamiento
    Objetivos exploratorios y otros objetivos están detallados en el protocolo.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Neuroimmunological Ancillary Study: The neuroimmunological ancillary study has the following objectives:
    - To compare throughout the study, the cytokine profile induced in the Copaxone 40 mg/mL TIW group as compared to baseline.
    - To compare throughout the study, the distribution of T and B cells subpopulations as measured by flow cytometry in the Copaxone 40 mg/mL TIW group as compared to baseline.
    - To compare throughout the study, the levels of neurotrophic and gliotrophic factors (platelet-derived growth factor [PDGF], nerve growth factor [NGF], brain-derived neurotrophic factor [BDNF], and epidermal growth factor core domain peptide of neuregulin-1 [eNRG1]) in the Copaxone 40 mg/mL TIW group as compared to baseline.
    Estudio complementario neuroinmunológico: El estudio complementario neuroinmunológico tiene los objetivos siguientes:
    -Comparar, durante todo el estudio, el perfil de citocinas inducido en el grupo de Copaxone 40 mg/ml tres veces a la semana con respecto al momento basal.
    -Comparar, durante todo el estudio, la distribución de subpoblaciones de linfocitos T y B, determinada mediante citometría de flujo, en el grupo de Copaxone 40 mg/ml tres veces a la semana con respecto al momento basal.
    -Comparar, durante todo el estudio, las concentraciones de factores neurotróficos y gliotróficos (factor de crecimiento derivado de las plaquetas [PDGF], factor de crecimiento nervioso [NGF], factor neurotrófico derivado del cerebro [BDNF] y péptido del dominio principal del factor de crecimiento epidérmico de la neurregulina 1 [eNRG1]) en el grupo de Copaxone 40 mg/ml tres veces a la semana con respecto al momento basal.
    E.3Principal inclusion criteria
    Patients may be included in the study only if they meet all of the following criteria:
    a. Men or women at least 18 years of age or older
    b. Patients must have a confirmed and documented RRMS diagnosis, as defined by the Revised
    McDonald criteria (Polman et al 2011).
    c. Patients must be ambulatory with a Kurtzke Expanded Disability Status Scale (EDSS) score of 0 to 5.5 at Screening visit.
    d. Patients must be in a stable neurological condition, relapse-free and free of any corticosteroid treatment (intravenous [IV], intramuscular [IM] and/or per os [PO]) or adrenocorticotrophic hormone (ACTH), 30 days prior to randomization.
    e. Women of child-bearing potential must have a negative serum pregnancy test at screening visit and must practice a highly effective method of birth control. Highly effective methods of birth control are defined as those, alone or in combination, that result in a low failure rate (ie, less than 1% per year) when used consistently and correctly. Highly effective methods of birth control in this study include: combined (estrogen and progestogen containing) or progestogen-only
    hormonal contraception associated with inhibition of ovulation, intrauterine device,intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomizedpartner, and sexual abstinence.
    f. Patients must be able to sign and date a written informed consent prior to entering the study.
    g. Patients must be willing and able to comply with the protocol requirements for the duration of the study.
    Solo podrán ser incluidos en el estudio los pacientes que cumplan todos los criterios siguientes:
    a.Varón o mujer con una edad mínima de 18 años.
    b.Diagnóstico confirmado y documentado de EMRR, conforme a lo definido por los criterios revisados de McDonald (Polman y cols. 2011).
    c.Capacidad de caminar, con una puntuación en la Escala ampliada del estado de discapacidad de Kurtzke (EDSS) de 0 a 5,5 en la visita de selección.
    d.Situación neurológica estable, sin recaídas ni tratamientos con corticoides (por vía intravenosa [IV], intramuscular [IM] u oral [VO]) o corticotropina (ACTH), en los 30 días previos a la aleatorización.
    e.En las mujeres en edad fértil, resultado negativo en una prueba de embarazo en suero realizada en la visita de selección y uso de un método anticonceptivo muy eficaz. Los métodos anticonceptivos muy eficaces son aquellos que, solos en combinación, tienen un bajo índice de fallos (es decir, inferior al 1% anual) cuando se utilizan de forma correcta y sistemática. Los métodos anticonceptivos muy eficaces permitidos en este estudio son: anticonceptivos hormonales combinados (con estrógeno y progestágeno) o solo con progestágeno asociados a la inhibición de la ovulación, dispositivo intrauterino, sistema intrauterino de liberación de hormonas, ligadura de trompas bilateral, vasectomía de la pareja y abstinencia sexual.
    f.Capacidad del paciente para firmar y fechar un consentimiento informado por escrito antes de incorporarse el estudio.
    g.Disposición y capacidad del paciente para cumplir los requisitos del protocolo durante el estudio.
    E.4Principal exclusion criteria
    Patients will be excluded from participating in this study if they meet any of the following
    criteria:
    a. Patient had any contraindication to Copaxone therapy.
    b. Previous use of Copaxone 40 mg/mL TIW.
    c. Patients with progressive forms of MS.
    d. Patients with neuromyelitis optica.
    e. Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening.
    f. Patients who have been treated with:
    - immunosuppressive medications such as azathioprine or methotrexate within 6 months prior
    to the first visit
    - immunoglobulins and/or monoclonal antibodies (including natalizumab) within at least
    3 months prior to inclusion
    - alemtuzumab, cladribine, cyclophosphamide or mitoxantrone at any time
    g. Chronic (more than 30 consecutive days) systemic (IV, PO or IM) corticosteroid treatment within 6 months prior to screening visit.
    h. Pregnancy or breastfeeding.
    i. Clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation
    j. Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals
    Quedarán excluidos de este estudio los pacientes que cumplan cualquiera de los criterios siguientes:
    a.Presencia de cualquier contraindicación al tratamiento con Copaxone.
    b.Uso previo de Copaxone 40 mg/ml tres veces a la semana.
    c.Formas progresivas de EM.
    d. Pacientes con neuromielitis óptica.
    e.Uso de fármacos experimentales o en investigación o participación en estudios clínicos sobre fármacos en los 6 meses previos a la selección.
    f.Tratamiento previo con:
    -Inmunosupresores tales como azatioprina o metotrexato en los 6 meses previos a la primera visita.
    -Inmunoglobulinas o anticuerpos monoclonales (incluido natalizumab) en los 3 meses previos a la inclusión.
    -Alemtuzumab, cladribina, ciclofosfamida o mitoxantrona en cualquier momento.
    g.Tratamiento crónico (más de 30 días consecutivos) con corticoides sistémicos (IV, VO o IM) en los 6 meses previos a la visita de selección.
    h.Embarazo o lactancia.
    i.Trastorno médico o quirúrgico clínicamente importante o inestable que pueda impedir una participación segura y completa en el estudio.
    j.Empleados del centro del estudio clínico o cualquier otra persona implicada en la realización del estudio, así como los familiares cercanos de dichas personas.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint(s):
    - MSQ scores over 6 months of treatment.
    Criterio de valoración principal de la eficacia:
    -Puntuaciones MSQ durante 6 meses de tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary Efficacy Measure and Time Point: Medication satisfaction will be assessed with the MSQ at months 0 (baseline, except for treatment naïve patients), 1, 3, 6 (end of core phase), 9, and 12 (end of extension phase), and the ETD visit (if applicable). In addition MSQ will be SRFH on days 1 to 7.
    Momento de evaluacion y determinacion de eficacia de principal:La satisfacción con la medicación se evaluará mediante la puntuación MSQ en los meses 0 (momento basal, excepto en los pacientes no tratados previamente), 1, 3, 6 (final de la fase principal), 9 y 12 (final de la fase de extensión) y la visita de SPT (si procede). Además, la puntuación MSQ será una ECPD entre los días 1 y 7.
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints:
    - Convenience perception as measured by the convenience scale within TSQM-9 over 6 months of treatment
    - Symptomatic changes as determined by the MSQLI subscales MFIS and MHI over 6 months of
    treatment
    - Depressive symptoms as measured by BDI-II scale over 6 months of treatment

    Exploratory Endpoints:
    - Gene expression profiles of patients over 6 and 12 months of treatment (patients previously naïve to Copaxone only)
    - Associations between genetics and selected clinical and exploratory endpoints over 6 and 12 months of treatment
    - Retention rate at 6, 9, and 12 months.
    - Adherence to treatment as measured by the MS-TAQ scale over 6 months of treatment
    - For patients who use the CSYNC device, device satisfaction after 1, 6, and 12 months of treatment
    - Evaluation of key variables at 9 and 12 months

    Endpoints - Neuroimmunological Ancillary Study
    - Cytokine profiles throughout the study.
    - Distribution of T and B cells subpopulations as measured by flow cytometry, throughout the study.
    - Levels of neurotrophic and gliotrophic factors (PDGF, NGF, BDNF, and eNRG1).

    Safety Endpoints: Safety variables and endpoints will include the following:
    - occurrence of adverse events throughout the study
    - vital signs measurements at each visit
    - clinical laboratory test results at screening, and months 1, 3, and 6

    Assessment of Tolerability: Tolerability variables and endpoints are as follows:
    -Proportion of patients (%) who prematurely discontinued from the study due to adverse events and the time to withdrawal.
    Criterios de valoración secundarios de la eficacia:
    -Percepción sobre la comodidad, determinada mediante la escala de comodidad del cuestionario TSQM 9, durante 6 meses de tratamiento.
    -Cambios sintomáticos, determinados mediante las subescalas MFIS y MHI del cuestionario MSQLI, durante 6 meses de tratamiento.
    -Síntomas depresivos, determinados mediante la escala BDI II, durante 6 meses de tratamiento.

    Criterios de valoración exploratorios:
    -Perfiles de expresión génica de los pacientes durante 6 y 12 meses de tratamiento (únicamente en los pacientes no tratados previamente con Copaxone).
    -Asociaciones entre genética y determinados criterios de valoración clínicos y exploratorios durante 6 y 12 meses de tratamiento.
    -Tasa de retención de pacientes a los 6, 9 y 12 meses.
    -Cumplimiento terapéutico, determinado mediante la escala MS TAQ, durante 6 meses de tratamiento.
    -En los pacientes que emplean el dispositivo CSYNC, satisfacción con el dispositivo después de 1, 6 y 12 meses de tratamiento.
    -Evaluación de variables fundamentales a los 9 y 12 meses.

    Criterios de valoración del estudio complementario neuroinmunológico
    -Perfiles de citocinas durante todo el estudio.
    -Distribución de subpoblaciones de linfocitos T y B, determinada mediante citometría de flujo, durante todo el estudio.
    -Concentraciones de factores neurotróficos y gliotróficos (PDGF, NGF, BDNF y eNRG1).

    Criterios de valoración de la seguridad: Las variables y criterios de valoración de la seguridad serán los siguientes:
    -Aparición de acontecimientos adversos durante todo el estudio.
    -Determinaciones de constantes vitales en todas las visitas.
    -Resultados de las pruebas analíticas en la visita de selección y los meses 1, 3 y 6.
    Evaluación de la tolerabilidad: Las variables y criterios de valoración de la tolerabilidad serán los siguientes:
    -Proporción de pacientes (%) que se retiren prematuramente del estudio por acontecimientos adversos y tiempo hasta la retirada.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary Efficacy Measures:
    - Convenience : months 0, 1, 3, 6, 9, and 12, ETD visit
    - Symptomatic changes: months 0, 1, 3, 6, 9, and 12, ETD visit
    - Depression: months 0, 1, 3, 6, 9, and 12, ETD visit

    Safety Measures:
    - inquiries about adverse events at every visit
    - CBC at screening, and months 1, 3, and 6
    - serum chemistry at screening, months 1, 3, and 6
    - ß hCG in women of child-bearing potential at screening.
    - urine pregnancy test at months 0, 1, 3, 6, 9, and 12, ETD visit
    - vital signs at every visit
    - physical examinations at screening, month 6, 12 and ETD visit
    - inquiries about concomitant medication usage at every visit

    Exploratory and Ancillary Study Measures and Time Points are detailed in the study protocol.
    Variables secundarias de eficacia
    -Comodidad:meses 0,1,3,6,9,12 y visita de SPT
    -Cambios sintomáticos:meses 0,1,3,6 ,9,12 y visita de SPT
    -Depresión:meses 0,1,3,6,9,12 y visita de SPT
    Variables de seguridad
    -Indagación de acontecimientos adversos en todas las visitas
    -Fórmula leucocitaria en visita selección y meses 1,3 y 6
    -Bioquímica sérica en visita selección y meses 1,3 y 6
    -ß hCG en suero en mujeres en edad fértil en visita selección
    -Prueba de embarazo en orina en los meses 0,1,3, 6,9,12 y visita de SPT
    -Constantes vitales en todas las visitas
    -Exploración física en visita selección, meses 6,12 y visita de SPT
    -Indagación del uso de medicamentos concomitantes en todas las visitas
    Medidas exploratorias, complementarias y puntos de evaluación se detallan en el protocolo.
    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 No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Patient medication satisfaction
    Satisfacion del paciente con la medicación.
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA68
    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
    Argentina
    Austria
    Belgium
    Croatia
    Finland
    France
    Germany
    Ireland
    Italy
    Mexico
    Poland
    Russian Federation
    Spain
    Turkey
    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
    LVLS
    LPLV
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 756
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 84
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 620
    F.4.2.2In the whole clinical trial 820
    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)
    Not applicable.
    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 Decision2016-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-06-02
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