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   43857   clinical trials with a EudraCT protocol, of which   7284   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:2018-001661-17
    Sponsor's Protocol Code Number:H8H-MC-LAIJ
    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:2018-10-09
    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 number2018-001661-17
    A.3Full title of the trial
    Randomized Controlled Trial of Lasmiditan Over Four Migraine Attacks
    Estudio controlado y aleatorizado de lasmiditán durante cuatro episodios de migraña
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test whether lasmiditan is safe and effective in the treatment of migraine with or without aura over four attacks
    Estudio para evaluar si lasmiditán es seguro y eficaz en el tratamiento de la migraña con o sin aura durante cuatro episodios.
    A.4.1Sponsor's protocol code numberH8H-MC-LAIJ
    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 SponsorLilly 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 supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLilly S.A.
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressAvda de la Industria nº 30
    B.5.3.2Town/ cityAlcobendas (Madrid)
    B.5.3.3Post code28108
    B.5.3.4CountryUnited States
    B.5.4Telephone number34916635103
    B.5.5Fax number34916633481
    B.5.6E-mailensayosclinicos@lilly.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 nameLasmiditan
    D.3.2Product code LY573144
    D.3.4Pharmaceutical form 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 INNLASMIDITAN
    D.3.9.2Current sponsor codeLY573144
    D.3.9.4EV Substance CodeSUB187183
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 nameLasmiditan
    D.3.2Product code LY573144
    D.3.4Pharmaceutical form 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 INNLASMIDITAN
    D.3.9.2Current sponsor codeLY573144
    D.3.9.4EV Substance CodeSUB187183
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Migraine
    Migraña
    E.1.1.1Medical condition in easily understood language
    Migraine
    Migraña
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10027599
    E.1.2Term Migraine
    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
    - To evaluate the efficacy of lasmiditan 200 mg and 100 mg on migraine headache pain freedom compared to placebo.
    - To evaluate the consistency of response to lasmiditan 200 mg and 100 mg compared to placebo.
    -Comparar la eficacia de lasmiditán 200 mg y 100 mg con la del placebo, desde el punto de vista de la ausencia de dolor relacionado con la jaqueca.
    -Evaluar la estabilidad de la respuesta a lasmiditán 200 mg y 100 mg, en comparación con la del placebo.
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of lasmiditan 200 mg and 100 mg on PGI-C compared to placebo.
    - To evaluate the efficacy of lasmiditan 200 mg and 100 mg on HRQoL during an acute migraine attack compared to placebo
    -Comparar la eficacia de lasmiditán 200 mg y 100 mg con la del placebo, desde el punto de vista de la impresión global del paciente sobre el cambio (PGI-C).
    -Comparar la eficacia de lasmiditán 200 mg y 100 mg con la del placebo, desde el punto de vista de la calidad de vida relacionada con la salud (CdVRS) durante un episodio de migraña agudo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Are of an acceptable age to provide informed consent according to the local regulations and are at least 18 years of age at time of screening (Visit 1) with migraine with or without aura fulfilling the IHS (International Headache Society) diagnostic criteria 1.1 or 1.2.
    - History of disabling migraine for at least 1 year.
    - Migraine onset before the age of 50 years.
    - History of 3 to 8 migraine attacks per month (< 15 headache days per month).
    - MIDAS score ≥11.
    - Able and willing to complete an eDiary to record the details of each migraine attack treated with study drug.
    - Women of child-bearing potential must be using or willing to use a highly effective form of contraception or a combination of 2 less effective methods of contraception until 30 days after the last dose.
    - Agree not to post any personal medical data or information related to the study on any website or social media site until the entire trial has completed.
    - Are able and willing to give signed informed consent
    - Edad suficiente para proporcionar el consentimiento informado de conformidad con las normativas locales y al menos 18 años en el momento de la selección (visita 1), y presentar migraña (con o sin aura) que cumpla los criterios diagnósticos 1.1 o 1.2 de la IHS (International Headache Society).
    - Antecedentes de migraña incapacitante al menos durante 1 año.
    - Aparición de la migraña antes de los 50 años.
    - Antecedentes de 3-8 episodios de migraña al mes (< 15 días/mes con cefaleas).
    - Puntuación ≥ 11 en la prueba MIDAS.
    - Ser capaz de cumplimentar un diario electrónico para recoger los detalles de cada episodio de migraña tratado con el medicamento del estudio y estar dispuesto a ello.
    - Las mujeres fértiles deben utilizar o estar dispuestas a utilizar un método anticonceptivo muy eficaz o una combinación de 2 métodos anticonceptivos menos eficaces hasta 30 días después de la última dosis.
    - Estar de acuerdo en no publicar ningún dato médico personal ni información relacionada con el estudio en páginas web ni redes sociales hasta que se haya completado el estudio.
    - Ser capaz de firmar el consentimiento informado y estar dispuesto a ello.
    E.4Principal exclusion criteria
    -Known hypersensitivity to lasmiditan, or to any excipient of lasmiditan oral tablets
    -History or evidence of hemorrhagic stroke, epilepsy, or any other condition placing the patient at increased risk of seizures
    -History of recurrent dizziness and/or vertigo including benign paroxysmal positional vertigo, Meniere’s disease, vestibular migraine, and other vestibular disorders
    -History of diabetes mellitus with complications (diabetic retinopathy, nephropathy, or neuropathy)
    -History of orthostatic hypotension with syncope
    -Significant renal or hepatic impairment in the opinion of the investigator or if they meet hepatic monitoring criteria
    -Patients who, in the investigator’s judgment, are actively suicidal and therefore deemed to be at significant risk for suicide
    -Known Hepatitis B or C or HIV infection
    -History, within past 12 months, of chronic migraine or other forms of primary or secondary chronic headache disorder (eg, hemicranias continua, medication overuse headache where headache frequency is ≥15 headache days per month
    - Use of more than 3 doses per month of either opioids or barbiturates
    - Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes within 3 months prior to Screening/Visit 1
    -Pregnant or breast-feeding women
    - History of drug or alcohol abuse/dependence within 1 year prior to Visit 1
    -Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the participant unsuitable for the study.
    Currently enrolled in any other clinical study involving an investigational product
    -Relatives of, or staff directly reporting to, the Investigator.
    -Participants who are employees of the sponsor.
    - Hipersensibilidad a lasmiditán o a cualquier excipiente de los comprimidos de lasmiditán de administración oral.
    - Antecedentes o signos de accidente cerebrovascular hemorrágico, epilepsia o cualquier otra enfermedad que suponga mayor riesgo de convulsiones.
    - Antecedentes de mareos o vértigo recurrentes, incluidos el vértigo postural paroxístico benigno, la enfermedad de Menière, la migraña vestibular y otros trastornos vestibulares.
    - Antecedentes de diabetes mellitus con complicaciones (retinopatía diabética, nefropatía o neuropatía).
    - Antecedentes de hipotensión ortostática con síncope.
    - Insuficiencia renal o hepática importante según el criterio del investigador o que cumplan los criterios de seguimiento hepático.
    - Presentar, según el criterio del investigador, tendencias suicidas y, por lo tanto, riesgo importante de suicidio.
    - Presentar infección por hepatitis B, hepatitis C o VIH.
    - Antecedentes en los últimos 12 meses de migraña crónica u otros tipos de trastornos de cefalea crónica primaria o secundaria (por ejemplo, hemicránea continua, cefalea por abuso de medicamentos, y al menos 15 días/mes con cefalea).
    - Uso de más de 3 dosis/mes de opiáceos o barbitúricos.
    - Que en el transcurso de los 3 meses anteriores a la selección/visita 1 se inicie la administración de medicamentos concomitantes para reducir la frecuencia de los episodios de migraña o se modifique su pauta posológica.
    - Mujeres embarazadas o en período de lactancia.
    - Antecedentes de consumo excesivo ocasional o habitual de alcohol, drogadicción o drogodependencia en el transcurso del año anterior a la visita 1.
    - Cualquier enfermedad o resultado en los análisis clínicos que, según el criterio del investigador, haga que el paciente no sea idóneo para participar en el estudio.
    - Participar en la actualidad en cualquier otro estudio clínico en el que se administre un producto en investigación.
    - Familiares del investigador o personal que trabaje directamente para este.
    - Empleados del promotor.
    E.5 End points
    E.5.1Primary end point(s)
    1. Percentage of patients in each group that are pain free (defined as mild, moderate, or severe headache pain becoming none).
    2. Percentage of patients in each group that are pain free (defined as mild, moderate, or severe headache pain becoming none).
    1. Porcentaje de pacientes de cada grupo que no presenten dolor (es decir, que pasen de tener dolor por cefalea leve, moderado o intenso a no tener dolor)
    2. Porcentaje de pacientes de cada grupo que no presenten dolor (es decir, que pasen de tener dolor por cefalea leve, moderado o intenso a no tener dolor)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1: at 2 hours postdose during the first attack.
    2: at 2 hours postdose in at least 2 out of 3 attacks.
    1: dos horas después de la administración de la dosis, durante el primer episodio.
    2: dos horas después de la administración de la dosis, al menos en 2 de 3 episodios.
    E.5.2Secondary end point(s)
    3. Percentage of Participants Very Much or Much Better as Measured by Patient Global Impression of Change (PGI-C).
    4. Mean HRQoL score for domains of social functioning, migraine symptoms, and feelings/concerns, as measured by the 24-hour MQoLQ.
    5. Percentage of Participants Free of Most Bothersome Symptom (MBS) Associated with Migraine.
    6. Percentage of Participants with Pain Relief.
    7. Percentage of Participants with 24-Hour Sustained Pain Freedom during the First Attack.
    8. Percentage of Participants Requiring Rescue Medication for Migraine.
    9. Percentage of Participants that are Free of Symptoms Associated with Migraine.
    10. Percentage of Participants with Migraine Recurrence.
    11. Percentage of Participants with Pain Freedom, Pain Relief, Freedom from MBS, and No Disability after Taking the First Dose of Study Drug During First Attack.
    12. Change from Baseline in Total Score as Measured by the MIDAS Scale.
    13. Percentage of Participants with no Disability as Measured by the Disability Item.
    14. Change from Baseline in Utility as Measured by the EuroQol 5-Dimension 5-Level Scale (EQ-5D-5L).
    15. Percentage of Participants with Pain Relief.
    16. Percentage of Participants that are Pain Free.
    17. Percentage of Participants with Pain Relief.
    3. Porcentaje de pacientes que, de acuerdo con la impresión global del paciente sobre el cambio (PGI-C), estén muchísimo o mucho mejor.
    4. Media de la puntuación de los dominios de la función social, los síntomas de la migraña y los sentimientos/las preocupaciones, de acuerdo con el cuestionario de calidad de vida relacionada con las migrañas durante 24 horas (MQoLQ [CdVRS]).
    5. Porcentaje de pacientes que no presenten los síntomas más molestos asociados con la migraña.
    6. Porcentaje de pacientes que presenten alivio del dolor
    7. Porcentaje de pacientes que no presenten dolor de forma ininterrumpida al cabo de 24 horas durante el primer episodio
    8. Porcentaje de pacientes que precisen medicamentos de rescate para la migraña
    9. Porcentaje de pacientes que no presenten síntomas asociados con la migraña
    10. Porcentaje de pacientes que sufran recaídas de las migrañas
    11. Porcentaje de pacientes que presenten alivio del dolor, ausencia de dolor, no presenten los síntomas más molestos ni ninguna incapacidad tras tomar la primera dosis del fármaco del estudio durante el primer episodio
    12. Variación respecto al período inicial en la puntuación total de la prueba para la evaluación de la incapacidad provocada por la migraña (MIDAS)
    13. Porcentaje de pacientes sin incapacidad de acuerdo con el ítem relativo a la incapacidad
    14. Variación respecto al período inicial en la utilidad de conformidad con el cuestionario EQ-5D-5L
    15. Porcentaje de pacientes que presenten alivio del dolor
    16. Porcentaje de pacientes que no presenten dolor
    17. Porcentaje de pacientes que presenten alivio del dolor
    E.5.2.1Timepoint(s) of evaluation of this end point
    3.at 2 hours postdose during the first attack.
    4.at 24 hours post first dose of study during first attack.
    5.at 2 Hours Postdose During the First Attack.
    6.at 2 Hours Post First Dose during the First Attack.
    7.with 24-Hour Sustained Pain Freedom during the First Attack.
    8.within 24 Hours of Treatment during the First Attack.
    9. at 2 Hours Postdose During the First Attack.
    10. at 24 Hours During the First Attack.
    11. 2 Hours Postdose.
    12. Baseline, Week 16.
    13. at 2 Hours Postdose during the First Attack.
    14. Baseline, 24 Hours Postdose.
    15. at 2 Hours Postdose in at Least 2 out of 3 Attacks
    16, 17. at 2 Hours Postdose in at Least 3 out of 4 Attacks.
    3. 2h después de la dosis durante el 1er episodio
    4. 24h después de la 1era dosis del estudio durante el 1er episodio
    5. 2h después de la dosis durante el 1er episodio
    6. 2h después de la 1era dosis durante el 1er episodio
    7. Al cabo de las 24h sin presentar dolor de forma ininterrumpida durante el 1er episodio
    8. En el transcurso de las 24h posteriores al tratamiento durante el 1er episodio
    9. 2h después de la dosis durante el 1er episodio
    10. A las 24h durante el 1er episodio
    11. 2h después de la dosis
    12. Periodo inicial,semana 16
    13. 2h después de la dosis durante el 1er episodio
    14. Periodo inicial,24 h después de la dosis
    15. 2h después de la dosis al menos en 2 de 3 episodios
    16,17. 2h después de la dosis al menos en 3 de 4 episodios
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA76
    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
    Austria
    Belgium
    China
    Czech Republic
    Denmark
    France
    Germany
    Hungary
    India
    Italy
    Mexico
    Netherlands
    Russian Federation
    Spain
    Switzerland
    United Kingdom
    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
    End of the study is the date of the last visit or last scheduled procedure shown in the Schedule of Activities for the last patient.
    El final del ensayo es la fecha de la última visita o del último procedimiento programado para el último paciente del estudio según se detalla en el calendario de actividades.
    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 months5
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days16
    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: 1440
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 160
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1221
    F.4.2.2In the whole clinical trial 1600
    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)
    Subject will return to their normal standard of care therapy as determined by their physician
    Los pacientes volverán a recibir el tratamiento de referencia habitual que les prescriba su médico.
    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 Decision2018-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-05-18
    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-Tue Apr 23 15:18:26 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA