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    Summary
    EudraCT Number:2018-003342-16
    Sponsor's Protocol Code Number:20170703
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-07-04
    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 number2018-003342-16
    A.3Full title of the trial
    A Phase 4, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Chronic Migraine and Medication Overuse Headache
    Estudio de fase 4 aleatorizado, doble ciego, controlado con
    placebo y de grupos paralelos para evaluar la eficacia y seguridad de erenumab en adultos con migraña crónica y cefalea por abuso de medicación
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 4 Randomized Controlled Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache
    Estudio de fase 4 aleatorizado y controlado para evaluar la eficacia y seguridad de erenumab en adultos con cefalea por abuso de medicación
    A.4.1Sponsor's protocol code number20170703
    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 SponsorAmgen Inc
    B.1.3.4CountryUnited States
    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 supportAmgen Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen S.A.
    B.5.2Functional name of contact pointIHQ-Medical Info - Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressWTC Barcelona, Moll de Barcelona s/n, Edifici Sud,7ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08039
    B.5.3.4CountrySpain
    B.5.4Telephone number+34936001860
    B.5.6E-mailiCOM_Spain@amgen.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 nameAMG 334
    D.3.2Product code AMG 334
    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 INNNot applicable
    D.3.9.1CAS number 1582205-90-0
    D.3.9.2Current sponsor codeAMG 334
    D.3.9.3Other descriptive nameAMG 334
    D.3.9.4EV Substance CodeSUB74690
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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 migraine
    Migraña crónica
    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 effect of erenumab compared with placebo on achieving medication overuse headache (MOH) remission during the double-blind treatment period (DBTP)
    Evaluar el efecto de erenumab en comparación con placebo sobre el logro de la remisión de la cefalea por abuso de medicación (CAM) durante el período de tratamiento a doble ciego (PTDC).
    E.2.2Secondary objectives of the trial
    - To evaluate the effect of erenumab compared with placebo in reducing AHMD during the DBTP
    - To evaluate the effect of erenumab compared with placebo on sustaining MOH remission during the DBTP
    - To evaluate the effect of erenumab compared with placebo on reducing the impact of migraines on physical impairment and
    everyday activities as measured by the Migraine Physical Function Impact Diary (MPFID) during the DBTPa
    - • To evaluate the effect of erenumab compared to placebo on change from baseline in headache impact scores as measured by the
    Headache Impact Test (HIT-6)a
    - Evaluar el efecto de erenumab en comparación con placebo en la reducción de los DMCA durante el PTDC.
    - Evaluar el efecto de erenumab en comparación con placebo sobre el mantenimiento de la remisión de la CAM durante el PTDC.
    - Evaluar el efecto de erenumab en comparación con placebo sobre la reducción del impacto de las migrañas sobre la disfunción física y las actividades cotidianas según las determinaciones del diario del impacto de la migraña en la función física (DIMFF) durante el PTDCa
    - Evaluar el efecto de erenumab en comparación placebo sobre el cambio respecto al valor basal de las puntuaciones del impacto de la cefalea, determinado mediante la escala de impacto de la cefalea de 6 puntos (HIT-6).a
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    101 Subject has provided informed consent prior to initiation of any study-specific activities/procedures
    102 Age ≥ 18 years on entry into the study
    103 Documented history of migraine without aura and/or migraine with aura according to the ICHD-3 Classification for ≥ 12 months at screening
    104 Documented history of CM for a minimal duration of 6 months before screening
    105 Current diagnosis of MOH
    106 History of treatment failure with at least 1 preventive treatment as defined as treatment discontinuation due to lack of efficacy, adverse event or general poor tolerability
    107. ≥ 14 headache days during the 28-day baseline period out of which ≥ 8 headache days meet criteria as migraine days
    108 Observation of acute migraine medication overuse during baseline. Medication overuse at baseline is defined as:
    - ≥ 10 days of combination treatment OR
    - ≥ 10 days of short-acting opioids/opioid-containing medication OR
    - ≥ 10 days of triptans, ergots, OR
    - ≥ 15 days of NSAIDs or simple analgesics intake
    110 At least 2 acute headache medication days per week for each week with at least 5 diary days
    111 Demonstrated at least 80% compliance with the eDiary (eg, must complete eDiary items on at least 23 out of 28 days during the baseline phase)
    101. El sujeto ha proporcionado su consentimiento informado antes de iniciar
    cualquier procedimiento/actividad específicos del estudio.
    102. Edad ≥ 18 años en el momento de entrada en el estudio.
    103. Antecedentes documentados de migraña sin aura y/o migraña con aura según la clasificación ICHD-3 durante ≥ 12 meses en el momento de la selección.
    104. Antecedentes documentados de MC durante un mínimo de 6 meses antes de la selección.
    105. Diagnóstico actual de CAM
    106. Antecedentes de fracaso del tratamiento con al menos 1 tratamiento preventivo, según la definición de interrupción del tratamiento por falta de eficacia, acontecimientos adversos o una mala tolerabilidad general.
    107 ≥ 14 días con cefalea durante el período basal de 28 días, de los que ≥ 8 días con cefalea cumplieron los criterios de días con migraña
    108. Observación de abuso de medicación para la migraña aguda durante el período basal. El abuso de medicación en la situación basal se define como:
    - ≥ 10 días de tratamiento combinado O
    - ≥ 10 días de medicación con opioides/medicamentos que contengan opioides de acción corta O
    - ≥ 10 días de triptanes, ergóticos O
    - ≥ 15 días de consumo de AINE o analgésicos simples.
    110. Al menos 2 días de medicación para la cefalea aguda a la semana durante cada semana con al menos 5 días en el diario.
    111. Haber demostrado como mínimo un cumplimiento del 80% con el diario-E (p. ej., se deben cumplimentar ítems del diario-E en al menos 23 de los 28 días durante el período basal).
    E.4Principal exclusion criteria
    201 Age > 50 years at migraine onset or > 65 years at CM onset
    202 History of hemiplegic migraine, cluster headache or other trigeminal autonomic cephalalgia
    203 Current concomitant diagnosis of a secondary type of headache other than MOH
    204 History of clinically significant orofacial pain (eg, painful cranial neuropathies,
    temporomandibular disorder) that in the opinion of the investigator or Amgen's
    physician, if consulted, could interfere with the study evaluation, procedures or
    completion
    205 Chronic headache with continuous pain, in which the subject does not
    experience headache-free periods of any duration
    206 No therapeutic response in prevention of migraine after an adequate therapeutic trial of > 3 of the following medication categories. These medication categories include:
    - Category 1: Topiramate
    - Category 2: Other antiepileptics (eg, divalproex sodium, sodium
    valproate, carbamazepine)
    - Category 3: Beta blockers
    - Category 4: Tricyclic antidepressants
    - Category 5: Serotonin-norepinephrine reuptake inhibitors, selective
    serotonin-reuptake inhibitors and other antidepressants
    - Category 6: Calcium channel blockers (eg, verapamil, amlodipine) or
    calcium antagonists (eg, flunarizine)
    - Category 7: Angiotensin receptor blockers (eg, candesartan) or
    angiotensin-converting enzyme (ACE) inhibitors (eg, lisinopril)
    - Category 8: Botulinum toxin
    - Category 9: Other centrally acting drugs used for migraine prophylaxis
    (eg, pizotifen)
    207 Changes in drug regimen (ie, changes in dose or frequency of use) of an allowed migraine preventive medication within 2 months from baseline OR change in drug regimen of a medication with potential for migraine prevention within 2 months from baseline
    208 Received botulinum toxin in the head and/or neck region within 4 months prior to screening
    209 Documented history of treatment with an anti-CGRP product
    210 Anticipated to require any excluded medication/device or procedure during the study
    211 Subject likely to not be available to complete all protocol required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments [COAs]) to the best of the subject’s and investigator's knowledge
    212 History or evidence of unstable or clinically significant medical condition that, in the opinion of the investigator or Amgen's physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or
    completion.
    201. Edad > 50 años durante la aparición de la migraña o > 65 años durante la aparición de la MC.
    202. Antecedentes de migraña hemipléjica, cefalea en racimos u otra cefalalgia trigeminal autonómica.
    203. Diagnóstico concomitante actual de un tipo secundario de cefalea que no sea CAM.
    204. Antecedentes de dolor orofacial clínicamente significativo (p. ej., neuropatías
    craneales dolorosas, trastorno temporomandibular) que, en opinión del
    investigador o el médico de Amgen, si se les consulta, pudieran interferir en la evaluación, los procedimientos o la finalización del estudio.
    205. Cefalea crónica con dolor continuo en la que el sujeto no experimenta períodos sin cefalea de cualquier duración.
    206. Falta de respuesta terapéutica en la prevención de la migraña después de un
    estudio terapéutico adecuado de > 3 de las siguientes categorías de medicación. Las categorías de medicación son:
    - Categoría 1: topiramato.
    - Categoría 2: otros antiepilépticos (p. ej., divalproex sódico, valproato sódico, carbamazepina).
    - Categoría 3: betabloqueantes.
    - Categoría 4: antidepresivos tricíclicos.
    - Categoría 5: otros antidrepresivos (p. ej., inhibidores de la recaptación de serotonina y noradrenalina, inhibidores selectivos de la recaptación de serotonina).
    - Categoría 6: bloqueantes de los canales del calcio (p. ej., verapamilo, amlodipino, cinarizina, lomerizina) o antagonistas del calcio (p. ej.,
    flunarizina).
    - Categoría 7: bloqueantes del receptor de angiotensina (p. ej., candesartán) o inhibidores de la enzima convertidora de la angiotensina
    (ECA) (p. ej., lisinopril).
    - Categoría 8: toxina botulínica.
    - Categoría 9: otros fármacos utilizados para la prevención de la migraña (p. ej., pizotifen).
    207. Cambios en el régimen farmacológico (es decir, cambios en la dosis o la frecuencia de uso) de un medicamento permitido para la prevención de la migraña en los 2 meses posteriores a la selección o cambio en el régimen farmacológico de un medicamento con potencial para la prevención de la migraña en los 2 meses posteriores a la selección.
    208. Haber recibido toxina botulínica en la región de la cabeza y/o cuello en los 4 meses anteriores a la selección.
    209. Antecedentes documentados de tratamiento con un fármaco anti-CGRP.
    210. Previsión de necesidad de un medicamento, producto sanitario o procedimiento excluido durante el estudio.
    211. Según informan el sujeto y el investigador, es probable que el sujeto no esté disponible para completar todas las visitas o procedimientos del estudio requeridos por el protocolo y/o cumplir todos los procedimientos del estudio (p. ej., evaluaciones de resultados clínicos [ERC]).
    212. Antecedentes o evidencia de enfermedad inestable o clínicamente significativa que, en opinión del investigador o del médico de Amgen, si se les consulta, pudieran suponer un riesgo para la seguridad del sujeto o interferir
    en la evaluación, los procedimientos o la finalización del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Absence of MOH at month 6 as defined by mean monthly treatment acute headache medication days (AHMD) < 10 days over months 4, 5, and 6 OR mean monthly headache days (MHD) < 14 days over months 4, 5, and 6 of the DBTP where AHMD include any eDiary day in which an acute headache medication intake is reported
    Ausencia de CAM en el mes 6 según la definición de una media mensual de días de
    medicación para la cefalea aguda (DMCA) < 10 días durante los meses 4, 5 y 6 o una media de días con cefalea al mes (DCM) < 14 días durante
    los meses 4, 5 y 6 del PTDC, donde los DMCA incluyen cualquier día del diario-E en el que se haya registrado el consumo de un medicamento
    para la cefalea aguda.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Months 4,5 and 6
    Meses 4, 5 y 6
    E.5.2Secondary end point(s)
    - Change from baseline in mean monthly AHMD over months 4, 5, and
    6 of the DBTP
    - Change from baseline in mean monthly average physical impairment
    domain scores as measured by the MPFID over months 4, 5, and 6 of the DBTP
    - Change from baseline in mean monthly average impact on everyday
    activities domain scores as measured by the MPFID over months 4, 5, and 6 of the DBTP
    - Change from baseline in mean HIT-6 score over months 4, 5, and 6 of the DBTP
    - Cambio respecto al valor basal en la media mensual de DMCA durante los meses 4, 5 y 6 del
    PTDC.
    - Cambio respecto al valor basal de la media mensual del promedio de las puntuaciones
    del dominio de disfunción física, determinado mediante el DIMFF durante los meses 4, 5 y 6 del PTDC.
    - Cambio respecto al valor basal de la media mensual del promedio de las puntuaciones del dominio de impacto sobre las actividades cotidianas, determinado mediante el DIMFF
    durante los meses 4, 5 y 6 del PTDC.
    - Cambio respecto al valor basal de la media de la puntuación en la HIT-6 durante los meses 4, 5 y 6 del PTDC.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Months 4,5 and 6
    Meses 4, 5 y 6
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    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
    Australia
    Austria
    Canada
    Czech Republic
    Finland
    France
    Hungary
    Italy
    Japan
    Poland
    Portugal
    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
    Última visita del último paciente
    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 days0
    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 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: 458
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 229
    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 state67
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 410
    F.4.2.2In the whole clinical trial 687
    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 Decision2019-08-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-08-05
    P. End of Trial
    P.End of Trial StatusOngoing
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