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    Summary
    EudraCT Number:2020-001669-35
    Sponsor's Protocol Code Number:19139A
    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:2022-12-21
    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 number2020-001669-35
    A.3Full title of the trial
    Interventional, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of eptinezumab for the preventive treatment of migraine in patients with a dual diagnosis of migraine and Medication Overuse Headache.
    Estudio intervencionista, aleatorizado, doble ciego, con grupos paralelos y controlado con placebo para evaluar la eficacia y la seguridad de eptinezumab para el tratamiento preventivo de las migrañas en pacientes con un doble diagnóstico de migraña y cefalea por abuso de medicamentos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Eptinezumab in Adults With Migraine and Medication Overuse Headache
    Eptinezumab para el tratamiento preventivo de las migrañas en pacientes con un doble diagnóstico de migraña y cefalea por abuso de medicamentos
    A.4.1Sponsor's protocol code number19139A
    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 SponsorH. Lundbeck A/S (Lundbeck)
    B.1.3.4CountryDenmark
    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 supportH. Lundbeck A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationH. Lundbeck A/S.
    B.5.2Functional name of contact pointLundbeckClinicalTrials@lundbeck.com
    B.5.3 Address:
    B.5.3.1Street AddressOttiliavej 9
    B.5.3.2Town/ cityValby
    B.5.3.3Post code2500
    B.5.3.4CountryDenmark
    B.5.4Telephone number0034900834223
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.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 nameEptinezumab
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEPTINEZUMAB
    D.3.9.2Current sponsor codeLu AG09221
    D.3.9.4EV Substance CodeSUB188646
    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 infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Preventive treatment of migraine in patients with a dual diagnosis of migraine and Medication Overuse Headache
    Tratamiento preventivo de la migraña en pacientes con un doble diagnóstico de migraña y cefalea por abuso de medicamentos
    E.1.1.1Medical condition in easily understood language
    Migraine and headache because of medication overuse.
    Migraña y dolor de cabeza por abuso de medicamentos
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This study evaluates the efficacy of eptinezumab to prevent migraine and headache in patients with the combined diagnosis of migraine and medication
    overuse headache
    Este estudio evalúa la eficacia de eptinezumab en la prevención de la migraña y la cefalea en pacientes con doble diagnóstico de migraña y cefalea por abuso de medicamentos
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The patient has a diagnosis of migraine as defined by IHS ICHD-3 guidelines confirmed at the Screening Visit with a history of migraine onset of at least 12 months prior to the Screening Visit.
    2. The patient has ≥8 migraine days per month for each month on average within the past 3 months prior to the Screening Visit.
    3. The patient has a diagnosis of MOH as defined by IHS ICHD-3 guidelines.
    4. The patient has headache on ≥15 days/month for each month within the past 3 months prior to the Screening Visit.
    5. The patient has regular overuse of one or more drugs that can be taken for acute and/or symptomatic treatment of headache, for >3 months.
    6. The patient has ≥15 to ≤26 headache days, of which ≥8 days were assessed as migraine days during the Screening Period, based on prospectively collected information in the eDiary.
    7. The patient overuses drugs that can be taken for acute and/or symptomatic treatment of headache during the Screening Period, based on prospectively collected information in the eDiary.
    8. The patient has demonstrated compliance with the Headache eDiary by entry of data for at least 24 of the 28 days of the Screening Period.
    9. The patient has had an onset of migraine at <50 years of age.
    10. The patient is aged ≥18 and ≤75 years at the Screening Visit.
    Other inclusion criteria may apply.
    1. El paciente tiene un diagnóstico de migraña definido por las directrices de la IHS ICHD-31 confirmado en la visita de selección con antecedentes de inicio de la migraña al menos 12 meses antes de la visita de selección.
    2. El paciente tiene un promedio de ≥ 8 días de migraña al mes en los 3 meses previos a la visita de selección.
    3. El paciente tiene un diagnóstico de CAM según lo definido por las directrices de la IHS ICHD-3.1
    4. El paciente ha tenido cefalea durante ≥ 15 días/mes en los 3 meses previos a la visita de selección.
    5. El paciente hace un uso excesivo de forma habitual de uno o más fármacos que pueden tomarse para el tratamiento agudo o sintomático de la cefalea durante > 3 meses.
    6. El paciente tiene ≥ 15 a ≤ 26 días con cefalea, de los que ≥ 8 días se consideraron días con migraña durante el período de selección, de acuerdo con la información recogida prospectivamente en el diario electrónico.
    7. El paciente usa en exceso fármacos que pueden tomarse para el tratamiento agudo o sintomático de la cefalea1 durante el período de selección, de acuerdo con la información recogida prospectivamente en el diario electrónico.
    8. Se ha demostrado el cumplimiento del diario electrónico de cefaleas introduciendo los datos durante al menos 24 de los 28 días del período de selección.
    9. El paciente ha tenido un inicio de la migraña con <50 años de edad.
    10. El paciente tiene ≥ 18 y ≤ 75 años en la visita de selección.
    Existen criterios de inclusión adicionales
    E.4Principal exclusion criteria
    1. The patient has experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway.
    2. The patient has confounding and clinically significant pain syndromes, (for example, fibromyalgia, chronic low back pain, complex regional pain syndrome).
    3. The patient has a diagnosis of acute or active temporomandibular disorder.
    4. The patient has a history or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), ophthalmoplegic migraine, migraine with brainstem aura and migraine with
    neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long
    duration).
    5. Patients with a lifetime history of psychosis, bipolar mania, or dementia are excluded. Patients with other psychiatric conditions whose symptoms are not controlled or who have not been adequately treated for a minimum of 6 months prior to screening are also excluded.
    6. The patient has a history of clinically significant cardiovascular disease, including uncontrolled hypertension, vascular ischaemia or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism).
    Other exclusion criteria may apply
    1. El paciente ha presentado fracaso con un tratamiento previo dirigido contra la vía del péptido relacionado con el gen de la calcitonina (CGRP).
    2. El paciente tiene síndromes dolorosos que causan confusión y son clínicamente significativos (por ejemplo, fibromialgia, lumbalgia crónica, síndrome de dolor regional complejo).
    3. El paciente tiene un diagnóstico de trastorno temporomandibular agudo o activo.
    4. El paciente tiene antecedentes o diagnóstico de cefalea tensional crónica, cefalea hípnica, cefalea en brotes, hemicránea continua, cefalea nueva diaria persistente o subtipos inusuales de migraña, como migraña hemipléjica (esporádica y familiar), migraña oftalmopléjica, migraña con aura del tronco encefálico y migraña con acompañamientos neurológicos que no son típicos del aura de la migraña (diplopía, alteración de la conciencia o duración prolongada).
    5. Quedarán excluidos los pacientes con antecedentes de psicosis, manía bipolar o demencia en algún momento de la vida. También se excluirá a los pacientes con otros trastornos psiquiátricos cuyos síntomas no estén controlados o que no hayan sido tratados adecuadamente durante un mínimo de 6 meses antes de la selección.
    6. El paciente tiene antecedentes de enfermedad cardiovascular clínicamente significativa, como hipertensión no controlada, isquemia vascular o episodios tromboembólicos (por ejemplo, accidente cerebrovascular, trombosis venosa profunda o embolia pulmonar).
    Existen criterios de exclusión adicionales
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in the number of monthly migraine days (MMDs)
    Variación con respecto a la situación basal del número de días mensuales con migraña (DMM)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weeks 1-12
    Semanas 1-12
    E.5.2Secondary end point(s)
    1. Change from baseline in MMDs with use of acute medication
    2. Response: ≥50% reduction from baseline in MMDs
    3. Migraine rate on the day after dosing (Day 1)
    4. Response: ≥75% reduction from baseline in MMDs
    5. Change from baseline in the number of monthly headache days (MHDs)
    6. Response: ≥75% reduction from baseline in MMDs
    7. Response: ≥75% reduction from baseline in MHDs
    8. Response: ≥75% reduction from baseline in MHDs
    9. Change from baseline in the number of MHDs with use of acute medication
    10. Change from baseline in rate of migraines with severe pain intensity
    11. Change from baseline in rate of headaches with severe pain intensity
    12. Patient Global Impression of Change (PGIC) score
    13. Most Bothersome Symptom (MBS) (score measured relative to Screening)
    1. Variación con respecto a la situación basal de los DMM con uso de medicación aguda
    2. Respuesta: Reducción ≥ 50% con respecto a la situación basal de los DMM
    3. Tasa de migraña el día después de la administración
    4. Respuesta: Reducción ≥ 75% con respecto a la situación basal de los DMM
    5. Variación con respecto a la situación basal del número de días mensuales con cefalea (DMC)
    6. Respuesta: Reducción ≥ 75% con respecto a la situación basal de los DMM
    7. Respuesta: Reducción ≥ 75 % de los DMC con respecto a la situación basal
    8. Respuesta: Reducción ≥ 75 % de los DMC con respecto a la situación basal
    9. Variación con respecto a la situación basal del número de DMC con uso de medicación aguda
    10. Variación con respecto a la situación basal de la tasa de migrañas con dolor intenso
    11. Variación con respecto a la situación basal de la tasa de cefaleas intensas
    12. Puntuación en la Impresión Global del Cambio por el paciente (PGIC)
    13. Variación de la puntuación del síntoma más molesto (SMM) (según lo indicado en la selección)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Weeks 1-12
    2. Weeks 1-12
    3. Day 1
    4. Weeks 1-4
    5. Weeks 1-12
    6. Weeks 1-12
    7. Weeks 1-12
    8. Weeks 1-4
    9. Weeks 1-12
    10. Weeks 1-12
    11. Weeks 1-12
    12. Weeks 12
    13. Weeks 12
    1. Semanas 1-12
    2. Semanas 1-12
    3. Día 1
    4. Semanas 1-4
    5. Semanas 1-12
    6. Semanas 1-12
    7. Semanas 1-12
    8. Semanas 1-4
    9. Semanas 1-12
    10. Semanas 1-12
    11. Semanas 1-12
    12. Semana 12
    13. Semana 12
    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 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) 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 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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    China
    Korea, Republic of
    Taiwan
    Spain
    Georgia
    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
    The end of the trial for an individual patient is defined as the last protocol-specified contact with that patient in the study.
    El fin del estudio para un paciente se define como el último contacto definido en el protocolo del estudio para ese 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 days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    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: 145
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 37
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 182
    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)
    Patients in the study will have access to appropriate medical care after they complete or withdraw from the study.
    Los pacientes participantes en el estudio tendrán acceso a un tratamiento médico adecuado cuando finalicen o se retiren anticipadamente del estudio
    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 Decision2021-02-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-09-30
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