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    Summary
    EudraCT Number:2015-005234-21
    Sponsor's Protocol Code Number:I5Q-MC-CGAR
    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:2016-07-15
    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 number2015-005234-21
    A.3Full title of the trial
    A Phase 3b Multicenter, Single-Arm, Open-Label Safety Study of LY2951742 (galcanezumab) in Patients with Episodic or Chronic Cluster Headache
    Estudio de fase 3b multicéntrico, de seguridad, con tratamiento abierto, con un único grupo en el que se evalúa LY2951742 (galcanezumab) en pacientes ambulatorios con cefalea en racimos crónica o episódica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study in Patients With Cluster Headache  
    Estudio en pacientes con cefalea en racimos
    A.4.1Sponsor's protocol code numberI5Q-MC-CGAR
    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 Jose Hernandez
    B.5.3 Address:
    B.5.3.1Street AddressAvenida de la Industria 30
    B.5.3.2Town/ cityAlcobendas/Madrid
    B.5.3.3Post code28108
    B.5.3.4CountrySpain
    B.5.4Telephone number+34916231577
    B.5.5Fax number+34916633481
    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 nameGalcanezumab
    D.3.2Product code LY2951742
    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 INNgalcanezumab
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Episodic Cluster Headache, Chronic Cluster Headache
    Cefalea en racimos crónica, cefalea en racimos episódica
    E.1.1.1Medical condition in easily understood language
    Episodic Cluster Headache, Chronic Cluster Headache
    Cefalea en racimos crónica, cefalea en racimos episódica
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10059133
    E.1.2Term Cluster headache
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety of open-label galcanezumab within the context of dosing during expected medical practice in eligible patients with episodic or chronic cluster headache.
    Evaluar la seguridad de galcanezumab, administrado sin enmascaramiento en el contexto de la práctica médica habitual, en pacientes con cefalea en racimos crónica o episódica considerados idóneos
    E.2.2Secondary objectives of the trial
    1. To characterize the reasons for discontinuation and AEs of interest for galcanezumab.
    2. To characterize the immunogenicity of galcanezumab.
    1. Determinar las razones que motiven la interrupción definitiva y los AA de interés relacionados con galcanezumab.
    2. Conocer la inmunogenicidad de galcanezumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Participants who participated in and completed either Study CGAL or Study CGAM.
    •Investigator judges the participant as reliable to follow all study procedures, keep all study visits, and be compliant with study requirements.
    • Participantes que hayan participado y completado el estudio CGAL o CGAM.
    • El investigador considera que se puede confiar en que el participante seguirá todos los procedimientos, realizará todas las visitas y cumplirá los requisitos del estudio.
    E.4Principal exclusion criteria
    •Current enrollment in or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device (with the exception of Study CGAL or Study CGAM).
    •Current use or any prior exposure to any calcitonin-gene-related peptide (CGRP) antibody, any antibody to the CGRP receptor, or antibody to nerve growth factor (NGF) (with the exception of Study CGAL or Study CGAM).
    •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.
    • Participar en la actualidad o haber abandonado en el transcurso de los 30 días anteriores un ensayo clínico en el que se administre un fármaco o se utilice un producto sanitario en fase de investigación (salvo los estudios CGAL o CGAM).
    • Recibir en la actualidad o haber recibido algún anticuerpo contra el péptido asociado al gen de la calcitonina (CGRP), algún anticuerpo contra el receptor del CGRP o un anticuerpo contra el factor de crecimiento nervioso (NGF), salvo en el contexto de los estudios CGAL o CGAM.
    • Presentar antecedentes de tipos de migraña que puedan implicar la presencia de isquemia o confundirse con esta.
    • Padecer hipersensibilidad a diversos fármacos, anticuerpos monoclonales u otras proteínas terapéuticas.
    • Presentar antecedentes de, o padecer, otras enfermedades que sean indicativas de un problema médico que impida la participación en el estudio.
    • Presentar signos de enfermedad psiquiátrica activa o inestable importante, de acuerdo con el criterio del investigador.
    • Estar embarazada o en período de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    1.Number of Participants With Treatment Emergent Adverse Events (AEs) or Serious AEs (SAEs)
    [Time Frame: Baseline through End of Study
    2.Number of Participants With Suicidal Ideation and Behaviors Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)
    [Time Frame: Baseline through End of Study
    1. Número de participantes que experimenten acontecimientos adversos (AA) surgidos durante el tratamiento o AA graves (AAG).
    (Período de tiempo: desde el período basal hasta el final del estudio).
    2. Número de participantes con ideaciones y comportamientos suicidas, de acuerdo con la escala Columbia de evaluación del riesgo de suicidio (C-SSRS).
    (Período de tiempo: desde el período basal hasta el final del estudio).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline through End of Study (Approximately 5 Years)
    Desde el período basal hasta el final del estudio (aproximadamente 5 años).
    E.5.2Secondary end point(s)
    Number of Participants with Treatment Emergent Anti-Galcanezumab Antibodies
    Número de participantes que desarrollan anticuerpos contra galcanezumab durante el tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline through End of Study (Approximately 5 Years)
    Desde el período basal hasta el final del estudio (aproximadamente 5 años).
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    Denmark
    Finland
    France
    Germany
    Italy
    Spain
    United Kingdom
    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
    Ultima Visita Ultimo Paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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: 304
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 156
    F.4.2.2In the whole clinical trial 324
    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 Decision2016-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-01-21
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