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    Summary
    EudraCT Number:2014-005429-11
    Sponsor's Protocol Code Number:I5Q-MC-CGAM
    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:2015-05-29
    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 number2014-005429-11
    A.3Full title of the trial
    A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 with a Long-Term Open-Label Extension in Patients with Chronic Cluster Headache
    Estudio de fase III aleatorizado, doble ciego, controlado con placebo de LY2951742 con un periodo de extensión abierto a largo plazo en pacientes con cefalea en racimos crónica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study in Patients with Chronic Cluster Headache
    Estudio en pacientes con cefalea en racimos crónica
    A.3.2Name or abbreviated title of the trial where available
    I5Q-MC-CGAM
    A.4.1Sponsor's protocol code numberI5Q-MC-CGAM
    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 pointMaria José Hernandez
    B.5.3 Address:
    B.5.3.1Street AddressAvenida de la Industria 30
    B.5.3.2Town/ cityAlcobendas
    B.5.3.3Post code28108
    B.5.3.4CountrySpain
    B.5.4Telephone number34916231577
    B.5.5Fax number34916633481
    B.5.6E-mailhernandez_maria_jose@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 nameLY2951742
    D.3.2Product code LY2951742
    D.3.4Pharmaceutical form Lyophilisate for 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 INN--
    D.3.9.3Other descriptive nameLY2951742
    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 number100
    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
    Chronic Cluster Headache
    Cefalea en racimos crónica
    E.1.1.1Medical condition in easily understood language
    Chronic Cluster Headache
    cefalea en racimos crónica
    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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10009698
    E.1.2Term Cluster headaches
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of LY2951742 compared with placebo in reducing the frequency of weekly cluster headache attacks
    Comparar la eficacia de LY2951742 300 mg administrado cada 30 días con la del placebo, en términos de reducción de la frecuencia semanal de las crisis de cefalea en racimos, en pacientes con cefalea en racimos crónica
    E.2.2Secondary objectives of the trial
    To assess the efficacy of LY2951742 compared with placebo on the Patient Global Impression of Improvement (PGI-I).

    To evaluate the safety and tolerability of LY2951742.
    Comparar la eficacia de LY2951742 con la del placebo de acuerdo a escala de
    Impresión global de mejoría percibida por el paciente?(PGI-I)
    Evaluar la seguridad y tolerabilidad de LY2951742
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Participants (or patients) with a history of chronc cluster headache occuring without a remission period, or with remissions lasting less than 1 month for at least 1 year.

    ? Participants (or patients) are able to distinguish cluster headache
    attacks from other headaches.
    Participantes (o pacientes) con antecedentes de cefalea en racimos crónica con
    crisis que se produzcan sin un período de remisión, o con remisiones que duren < 1 mes, al menos durante 1 año
    Participantes (o pacientes) capaces de distinguir los ataques de cefalea en racimos de otros tipos de cefaleas
    E.4Principal exclusion criteria
    ? Current enrollment in or discontinuation within the last 30 days from, a
    clinical trial involving any investigational drug or device.
    ? Current use or any prior exposure to any CGRP antibody, any antibody
    to the CGRP receptor, or antibody to nerve growth factor (NGF).
    ? Are taking indomethacin and/or are suspected of having another
    distinct trigeminal autonomic cephalalgia
    ? A history of migraine variants that could implicate or could be
    confused with ischemia
    ? Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins.
    ? A history or presence of other medical illness that indicates a medical problem that would preclude study participation.
    ? Evidence of significant active or unstable psychiatric disease, in the opinion of the investigator.
    ? Women who are pregnant or nursing.
    ? Estar participando en la actualidad o haber abandonado en el transcurso de los 30 días previos un ensayo clínico en el que se administre un fármaco o se utilice un producto sanitario en fase de investigación
    ? Estar recibiendo en la actualidad o haber recibido algún anticuerpo frente al péptido CGRP , algún anticuerpo frente al receptor del CGRP o un anticuerpo frente al factor de crecimiento nervioso (NGF)
    ? Estar recibiendo indometacina o posible presencia de otra cefalalgia neurovegetativa del trigémino bien diferenciada
    ?Antecedentes de migraña que puedan implicar la aparición de isquemia o confundirse
    con esta
    ?Hipersensibilidad a múltiples sustancias farmacéuticas, anticuerpos monoclonales u otras proteínas terapéuticas
    ?Historia o presencia de otra enfermedad médica que indica un problema médico que impida la participación en el estudio
    ?Datos sugestivos de enfermedad psiquiátrica inestable o activa significativa, en opinión del investigador
    ?Mujeres embarazadas o en período de lactancia
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be mean change in weekly cluster headache
    attack frequency with LY2951742 compared with placebo.
    El criterio de valoración es la reducción de la frecuencia de los ataques de cefalea cada semana con LY2951742 comparado con placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to week 3/4
    Desde el inicio hasta la semana 3/4
    E.5.2Secondary end point(s)
    Patients with a 50% or greater reduction in the weekly number of cluster headache attacks

    Patients with a 30% or greater reduction in the weekly number of
    cluster headache attacks

    Mean change in the weekly cluster headache attack frequency

    Treatment emergent adverse events

    Clinical Laboratory and vital signs

    Anti-LY2951742 antibodies

    Proportion of patients reporting a score of 1 ("very much better") or 2
    ("much better") on the Patient Global Impression of Improvement (PGI-I)
    Pacientes con un 50% o más de reducción en el número semanal de los ataques
    Pacientes con un 30% o más de reducción en el número
    semanal de los ataques de cefalea
    Cambio en la frecuencia de los ataques de cefalea cada semana
    Tratamiento de los acontecimientos adversos surgidos
    Análisis clínicos y constantes vitales
    Anticuerpos LY2951742
    Porcentaje de pacientes que notifiquen una puntuación de 1 (?muchísimo mejor?) o de 2 (?mucho mejor?) en la escala de Impresión global de mejoría percibida por el paciente (PGI-I)
    E.5.2.1Timepoint(s) of evaluation of this end point
    For first six secondary endpoints from baseline through week 12

    For PGI-I secondary endpoint: at month 1, 2, and 3.
    Para los seis primeros criterios de valoración desde el período basal hasta la
    semana 12. Para el segundo criterio de valoración Impresión global de mejoría
    percibida por el paciente (PGI-I): en los meses 1, 2 y 3
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    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
    Denmark
    Finland
    France
    Germany
    Italy
    Spain
    United Kingdom
    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
    LVLS this is the end of the trial.
    Ultima Visita Ultimo Paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    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: 157
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 76
    F.4.2.2In the whole clinical trial 162
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Ninguno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-07-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-08-14
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