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    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).

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    Summary
    EudraCT Number:2018-000600-42
    Sponsor's Protocol Code Number:I5Q-MC-CGAW
    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:2018-05-21
    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 number2018-000600-42
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adults with Treatment-Resistant Migraine - The CONQUER Study
    Estudio aleatorizado, doble ciego de galcanezumab frente a placebo, en pacientes adultos con migraña resistente al tratamiento - Estudio CONQUER
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to see if galcanezumab is effective for migraine prevention in people who have not responded to or have not tolerated previous migraine prevention treatments
    Estudio para determinar si galcanezumab es eficaz en la prevención de la migraña en personas que no han respondido o tolerado tratamientos anteriores para la prevención de la migraña
    A.3.2Name or abbreviated title of the trial where available
    I5Q-MC-CGAW
    A.4.1Sponsor's protocol code numberI5Q-MC-CGAW
    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 organisationEli Lilly and Company
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center, DC 1526
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    B.5.6E-mailEU_Lilly_Clinical_Trials@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 nameGalcanezumab
    D.3.2Product code LY2951742
    D.3.4Pharmaceutical form Solution for injection
    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 INNGalcanezumab
    D.3.9.2Current sponsor codeLY2951742
    D.3.9.4EV Substance CodeSUB166280
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment-resistant Migraine
    Migraña resistente al tratamiento
    E.1.1.1Medical condition in easily understood language
    Migraine headaches that do not respond to currently available medicatio
    Migrañas que no responden a los medicamentos actualmente disponibles
    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 LLT
    E.1.2Classification code 10027602
    E.1.2Term Migraine headache
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To test the hypothesis that galcanezumab is superior to placebo in the prevention of migraine in patients with treatment-resistant migraine
    Evaluar la hipótesis de que galcanezumab es superior al placebo en la prevención de la migraña en pacientes con migraña resistente al tratamiento
    E.2.2Secondary objectives of the trial
    To compare galcanezumab with placebo with respect to:
    • prevention of migraine in the episodic migraine subpopulation
    • 50% response rate
    • change in functioning
    • 75% response rate
    • 100% response rate
    • safety and tolerability
    Comparar galcanezumab con el placebo respecto a los parámetros siguientes:
    • prevención de la migraña en la subpoblación de pacientes con migraña episódica
    • tasa de respuesta del 50 %
    • variación en la capacidad funcional
    • tasa de respuesta del 75 %
    • tasa de respuesta del 100 %
    • seguridad y tolerabilidad
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients are 18 to 75 years of age (inclusive) at the time of screening.

    Have a diagnosis of migraine as defined by IHS ICHD-3 guidelines (1.1, 1.2, or 1.3) (ICHD-3 2018), with a history of migraine headaches of at least 1 year prior to Visit 1, and migraine onset prior to age 50.

    Prior to Visit 1, have a history of at least 4 migraine headache days and at least 1 headache-free day per month on average within the past 3 months.

    Prior to Visit 1, have documentation (medical or pharmacy record or by physician’s confirmation) of previous failure to 2 to 4 migraine preventive medication categories in the past 10 years from the following list due to inadequate efficacy (that is, maximum tolerated dose for at least 2 months) and/or safety/tolerability reasons.
    a) propranolol or metoprolol
    b) topiramate
    c) valproate or divalproex
    d) amitriptyline
    e) flunarizine
    f) candesartan
    g) botulinum toxin A or B (if documented that botulinum toxin was taken for chronic migraine)
    h) medication locally approved for prevention of migraine
    Pacientes de 18 a 75 años (ambos inclusive) en el momento de la selección.

    Diagnóstico de migraña según los criterios de la ICHD-3 de la IHS (1.1, 1.2 o 1.3) (ICHD-3 2018), con antecedentes de migrañas al menos durante el año anterior a la visita 1 y aparición de la migraña antes de los 50 años.

    En el transcurso de los 3 meses anteriores a la visita 1, haber sufrido migrañas al menos durante 4 días al mes y presentar al menos 1 día al mes sin cefaleas (en promedio).

    Documentación (en la historia clínica o los registros farmacéuticos, o confirmación por parte del médico) previa a la visita 1 de que en los últimos 10 años el paciente no ha respondido a 2-4 tipos de medicamentos preventivos para la migraña, bien porque la eficacia fue insuficiente (es decir, el paciente recibió la dosis máxima tolerada al menos durante 2 meses), bien por cuestiones de seguridad o tolerabilidad.
    a) propranolol o metoprolol
    b) topiramato
    c) valproato o divalproex
    d) amitriptilina
    e) flunarizina
    f) candesartán
    g) toxina botulínica de tipo A o B (si se ha documentado que se tomó para la migraña crónica)
    h) medicamentos aprobados localmente para la prevención de la migraña
    E.4Principal exclusion criteria
    • Are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product.

    • Current use or prior exposure to galcanezumab or another CGRP antibody.

    • History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine) defined by IHS ICHD-3.

    • Are currently receiving medication or other treatments for the prevention of migraine headaches. Patients must have discontinued such treatment at least 5 days prior to starting the baseline period. Botulinum toxin A and B that has been administered in the head or neck area for migraine prevention must be discontinued at least 3 months prior to starting the baseline period. Nerve block or device use (such as transcranial magnetic stimulation) in the head or neck area or for migraine prevention must be discontinued at least 30 days prior to starting the baseline period.
    • Participar en la actualidad o haber participado en el transcurso de los 30 últimos días (o de un período de 5 semividas, lo que sea mayor) en un ensayo clínico en el que se administre un producto en fase de investigación.

    • Recibir en la actualidad o haber recibido galcanezumab u otro anticuerpo dirigido al CGRP.
    • Antecedentes de cefalea constante y a diario, cefalea en racimos o subtipos de migraña, incluidas la migraña hemipléjica (esporádica o familiar), la migraña oftalmopléjica y la migraña con aura del troncoencéfalo (migraña basilar), de acuerdo con los criterios de la ICHD-3 de la IHS.

    • Recibir en la actualidad medicamentos u otros tratamientos para la prevención de migrañas. Los pacientes deben haber dejado de recibir dicho tratamiento al menos 5 días antes del inicio del período basal. La administración de toxina botulínica de tipo A o B en la zona craneal o cervical para la prevención de migrañas debe interrumpirse al menos 3 meses antes del inicio del período basal. El bloqueo nervioso o el uso de dispositivos (por ejemplo, la estimulación magnética transcraneal) en la zona craneal o cervical para la prevención de migrañas debe interrumpirse al menos 30 días antes del inicio del período basal.
    E.5 End points
    E.5.1Primary end point(s)
    The overall mean change from baseline in the number of monthly migraine headache days during the 3-month double-blind treatment phase in the total population (episodic and chronic migraine).
    Promedio global de la variación respecto al período basal en el número de días al mes con migraña durante la fase de tratamiento con enmascaramiento doble de 3 meses de duración (población total de pacientes con migraña episódica y crónica)
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 month double blind treatment phase.
    Fase de tratamiento con enmascaramiento doble de 3 meses de duración.
    E.5.2Secondary end point(s)
    • The overall mean change from baseline in the number of monthly migraine headache days during the 3-month double-blind treatment phase in patients with episodic migraine

    • The percentage of patients with ≥50% reduction from baseline in monthly migraine headache days during the 3 month double-blind treatment phase

    • The mean change from baseline in the Role Function-Restrictive domain score of the Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1) at Month 3

    • The percentage of patients with ≥75% reduction from baseline in monthly migraine headache days during the 3 month double-blind treatment phase

    • The percentage of patients with 100% reduction from baseline in monthly migraine headache days during the 3 month double-blind treatment phase

    • Analysis of:
    o treatment-emergent adverse events (TEAEs)
    o serious adverse events (SAEs)
    o discontinuation due to adverse events (AEs)
    o discontinuation rates
    o vital signs and weight
    o electrocardiograms (ECGs)
    o laboratory measures
    • Promedio global de la variación respecto al período basal en el número de días al mes con migraña durante la fase de tratamiento con enmascaramiento doble de 3 meses de duración en pacientes con migraña episódica

    • Porcentaje de pacientes que hayan experimentado una reducción ≥50 % respecto al período basal en el número de días/mes con migraña durante la fase de tratamiento con enmascaramiento doble de 3 meses de duración

    • Media de la variación en la puntuación del dominio de limitaciones del rol físico del cuestionario de calidad de vida específico para la migraña, versión 2.1 (MSQ v2.1) en el mes 3

    • Porcentaje de pacientes que hayan experimentado una reducción ≥75 % respecto al período basal en el número de días/mes con migraña durante la fase de tratamiento con enmascaramiento doble de 3 meses de duración

    • Porcentaje de pacientes que hayan experimentado una reducción del 100 % respecto al período basal en el número de días/mes con migraña durante la fase de tratamiento con enmascaramiento doble de 3 meses de duración

    • Análisis de:
    • acontecimientos adversos surgidos durante el tratamiento (AAST).
    • acontecimientos adversos graves (AAG)
    • interrupciones definitivas por acontecimientos adversos (AA)
    • tasas de abandono
    • constantes vitales y peso
    • electrocardiogramas (ECG)
    • parámetros analíticos
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 month double blind treatment phase.
    Fase de tratamiento con enmascaramiento doble de 3 meses de duración.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 No
    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 No
    E.8.1.4Double blind Yes
    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 Yes
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    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
    Belgium
    Canada
    Czech Republic
    Denmark
    France
    Germany
    Hungary
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Spain
    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
    LVLS
    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
    E.8.9.2In all countries concerned by the trial years1
    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 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: 410
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state38
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 420
    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
    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 Decision2018-06-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-09-19
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