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    Summary
    EudraCT Number:2019-002224-32
    Sponsor's Protocol Code Number:SYNCHRO
    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:2019-07-26
    Trial 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 number2019-002224-32
    A.3Full title of the trial
    Sense, rhYhm & Networks: the study of how erenumab modulates CHROnic migraine
    Sentidos, ritmo y conexiones: un estudio de cómo Erenumab® modula la migraña crónica. Estudio SYNCHRO.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Sense, rhYhm & Networks: the study of how erenumab modulates CHROnic migraine
    Sentidos, ritmo y conexiones: un estudio de cómo Erenumab® modula la migraña crónica.
    A.3.2Name or abbreviated title of the trial where available
    SYNCHRO
    SYNCHRO
    A.4.1Sponsor's protocol code numberSYNCHRO
    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 SponsorFundació Hospital Universitari Vall d' Hebrón - Institut de Recerca (VHIR)
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNOVARTIS
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundació Hospital Universitari Vall d' Hebrón - Institut de Recerca (VHIR)
    B.5.2Functional name of contact pointPatricia Pozo Rosich
    B.5.3 Address:
    B.5.3.1Street AddressPasseig Vall d' Hebrón, 119-129
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08035
    B.5.3.4CountrySpain
    B.5.4Telephone number34932746606
    B.5.6E-mailpatricia.pozo@vhir.org
    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 Aimovig
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameErenumab
    D.3.4Pharmaceutical form 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 INNERENUMAB
    D.3.9.1CAS number 1582205-90-0
    D.3.9.4EV Substance CodeSUB183612
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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 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
    Chronic migraine
    Migraña crónica
    E.1.1.1Medical condition in easily understood language
    Chronic migraine
    Migraña 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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10066636
    E.1.2Term Chronic migraine
    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
    SYNCHRO’s main objective is to elucidate and describe how blocking CGRP in the periphery can modulate the brain in migraine measuring anatomic and neurophysiological changes
    Elucidar y describir cómo el bloqueo de la acción de CGRP en la periferia puede modular el cerebro en la migraña, midiendo los cambios anatómicos y neurofisiológicos
    E.2.2Secondary objectives of the trial
    1. To characterize changes in brain morphometric measures and sensory/cognitive processes in migraine within the interictal period at neuroanatomic and neurophysiological level.
    2. To characterize changes in brain morphometric measures and sensory/cognitive responses in non-migraine subjects at neuroanatomic and neurophysiological level.
    3. To describe the impact of erenumab in adaptive sensory/cognitive processes.
    4. To link the modulation of sensory/cognitive processes with the clinical efficacy of erenumab, finding predictors or response and impact on daily life.
    1. Caracterizar los cambios en las medidas morfométricas del cerebro y los procesos sensoriales / cognitivos en la migraña dentro del período interictal a nivel neuroanatómico y neurofisiológico.
    2. Caracterizar los cambios en las medidas morfométricas del cerebro y las respuestas sensoriales / cognitivas en sujetos no migrañosos a nivel neuroanatómico y neurofisiológico.
    3. Describir el impacto de erenumab en los procesos sensoriales / cognitivos adaptativos.
    4. Vincular la modulación de los procesos sensoriales / cognitivos con la eficacia clínica de erenumab, encontrando predictores o respuesta e impacto en la vida diaria.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adults between 30 and 50 years of age
    - Mediterranean ethnicity
    - Patients diagnosed with high-frequent episodic and chronic migraine with or without aura, confirmed by a neurologist according to the International Classification of Headache Disorders, 3rd edition, beta version (ICHD-3 beta) that require prevention
    - Healthy controls will be recruited among hospital staff and non-related acquaintances of the patients that denied past or first-degree familial history of any recurrent primary or secondary headache disorder.
    - Adultos entre 30 y 50 años
    - Etnia mediterránea
    - Pacientes diagnosticados con episodios de alta frecuencia y migraña crónica, con o sin aura, confirmada por un neurólogo de acuerdo a la Clasificación Internacional de las Cefaleas, III Edición, versión beta (ICHD-3 beta) que requiere prevención
    - Controles sanos reclutados entre miembros del personal hospitalario y conocidos de los pacientes sin antecedentes primarios o secundarios de cefaléas.
    E.4Principal exclusion criteria
    Presence of any other significant medical condition (neurological disorders, severe psychiatric illness or cardiovascular disease)
    - Evidence of drug, smoking or alcohol abuse or dependence within 12 months prior to V1, based on medical records or patient self-report. An alcohol consumption >100mg/week will be considered an abuse.
    - Pregnant or nursing (lactating) women
    - Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of contraception during dosing with study treatment.
    - Presencia de cualquier otra condición médica significativa (desórdenes neurológicos, enfermedades psiquiátricas severas o enfermedades cardiovasculares)
    - Evidencia de abuso o dependencia de drogas, tabaco o alcohol en los 12 meses anteriores a la visita 1, según historia clínica o información facilitada del paciente. Se considera abuso de alcohol un consumo >100mg/semana
    - Mujeres embarazadas o en periodo de lactancia
    - Mujeres con capacidad de quedarse embarazadas, a menos que durante la fase de tratamiento utilicen un método básico de contracepción
    E.5 End points
    E.5.1Primary end point(s)
    Measure changes in cortical thickness, grey matter volumes and network connectivity (measured structurally) in migraine within the interictal period evaluated by MRI in migraine after administration of erenumab
    Medir los cambios en el grosor cortical, los volúmenes de materia gris y la conectividad de red (medida estructuralmente) en migraña dentro del período interictal evaluado por MRI en migraña después de la administración de Erenumab
    E.5.1.1Timepoint(s) of evaluation of this end point
    On the seventh month
    Al séptimo mes
    E.5.2Secondary end point(s)
    - Determine a quantitative threshold between migraine and non-migraine subjects in their sensory/cognitive outputs using cognitive and attention measurement tasks evaluated by ERP studies.- Evaluate changes in the threshold after the effect of erenumab between treated patients and non-migraine subjects at sensory/cognitive levels
    - Identify clinical features, neuroanatomic measures and neurophysiological factors to predict response to treatment.
    - Determine un umbral cuantitativo entre los sujetos migrañosos y no migrañosos en sus resultados sensoriales / cognitivos utilizando tareas cognitivas y de medición de la atención evaluadas por estudios de ERP. / niveles cognitivos
    - Identificar características clínicas, medidas neuroanatómicas y factores neurofisiológicos para predecir la respuesta al tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    In the sixth month
    En el sexto mes
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Anatomical and neurological changes
    Cambios anatómicos y neurológicos
    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 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 Yes
    E.8.1.7.1Other trial design description
    Grupo pacientes/ Grupo voluntarios
    Patient group / Group of volunteers
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    UVUP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned 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: 94
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state94
    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 Decision2019-11-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-12-03
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