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    Summary
    EudraCT Number:2019-001820-36
    Sponsor's Protocol Code Number:CAMG334AES01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    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 number2019-001820-36
    A.3Full title of the trial
    A 12-month prospective, phase IIIb, multicenter, open-label clinical trial to assess health-related quality of life (HRQoL) in patients with chronic or high-frequency episodic migraine treated with erenumab who present associated comorbidities
    Estudio multicéntrico, prospectivo, fase IIIb, abierto, de 12 meses de tratamiento para evaluar la calidad de vida relacionada con la salud (CVRS) en pacientes con migraña crónica o episódica de alta frecuencia tratados con erenumab que presentan comorbilidades asociadas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Quality of life in subjects with chronic or high-frequency episodic migraine and associated comorbidities treated with erenumab
    Estudio de la calidad de vida en sujetos con migraña crónica o episódica de alta frecuencia y comorbilidades asociadas tratados con erenumab.
    A.3.2Name or abbreviated title of the trial where available
    COMIG
    COMIG
    A.4.1Sponsor's protocol code numberCAMG334AES01
    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 SponsorNovartis Farmacéutica, 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 supportNovartis Farmacéutica, S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica, S.A.
    B.5.2Functional name of contact pointTrial Monitoring Organization (TMO)
    B.5.3 Address:
    B.5.3.1Street AddressGran Via de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number34900353036
    B.5.5Fax number34932479903
    B.5.6E-maileecc.novartis@novartis.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 Yes
    D.2.1.1.1Trade name AIMOVIG
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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.3.2Product code AMG334
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    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.3.9.2Current sponsor codeAMG334
    D.3.9.3Other descriptive nameAMG334
    D.3.9.4EV Substance CodeSUB183612
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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
    Study of Quality of life in subjects with chronic or high-frequency episodic migraine and associated comorbidities treated with erenumab
    Estudio de la calidad de vida en sujetos con migraña crónica o episódica de alta frecuencia y comorbilidades asociadas tratados con erenumab.
    E.1.1.1Medical condition in easily understood language
    Migraine headache
    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 assess HRQoL, measured by the Migraine-Specific Quality of Life Questionnaire (MSQ 2.1), after treatment with erenumab in patients with CM or HFEM who present at least one associated comorbidity (fibromyalgia, chronic fatigue, and/or IBS).
    Evaluar la CVRS, medida por el Migraine-Specific Quality-of-Life Questionnaire (MSQ 2.1), después del tratamiento con erenumab en pacientes con MC o MEAF que presentan al menos una comorbilidad asociada (fibromialgia, fatiga crónica o SII).
    E.2.2Secondary objectives of the trial
    Objective 1: To assess the association between MSQ 2.1 and other HRQoL scores in each comorbidity (fibromyalgia, chronic fatigue, and/or IBS).
    Objective 2: To assess change in HRQoL in each comorbidity (fibromyalgia, chronic fatigue, and IBS).
    Objective 3: To assess the efficacy of erenumab.
    Objective 4: To describe the profile of patients treated with erenumab
    Objective 5: To collect and evaluate safety data in patients with CM or HFEM treated with erenumab.
    Objective 6: To describe the management of erenumab (70-140 mg) in patients with CM or HFEM.
    Objetivo 1: evaluar la asociación entre MSQ 2.1 y otras puntuaciones de la CVRS en cada comorbilidad (fibromialgia, fatiga crónica o SII).
    Objetivo 2: evaluar el cambio en la CVRS en cada comorbilidad (fibromialgia, fatiga crónica y SII).
    Objetivo 3: evaluar la eficacia de erenumab.
    Objetivo 4: describir el perfil de los pacientes tratados con erenumab.
    Objetivo 5: recoger y evaluar los datos de seguridad en pacientes con MC o MEAF tratados con erenumab.
    Objetivo 6: describir el control de erenumab (70-140 mg) en pacientes con MC o MEAF.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    During the Screening Epoch:
    1. Signed informed consent must be obtained prior to participation in the study.
    2. Adults ≥18 years of age upon entry into screening.
    3. Patient diagnosed with chronic and high -frequency episodic migraine (with or without aura) for at least 1 year prior to screening according to the International Classification of Headache Disorders-3rd Edition (ICHD-3).
    4. Patient with a documented diagnosis in clinical history of one or more of the following comorbidities: chronic fatigue, fibromyalgia and/or IBS.
    5. Patients previously treated with other monoclonal antibodies for migraine can be included if the appropriate washout period according to product half-life has been done for each monoclonal antibody.
    During the Baseline Epoch:
    1. Migraine frequency of ≥ 10 migraine days during the Baseline Epoch, confirmed by the eDiary.
    2. ≥ 80% eDiary compliance during the Baseline Epoch.
    Durante la fase de selección:
    1. Se deberá obtener el consentimiento informado firmado antes de la participación en el estudio.
    2. Adultos ≥18 años de edad en el momento de la selección.
    3. Paciente diagnosticado con migraña crónica y episódica de alta frecuencia (con o sin aura) durante al menos un año antes de la selección según la International Classification of Headache Disorders-3rd Edition (ICHD-3).
    4. Paciente con un diagnóstico documentado en su historia clínica de al menos una de las comorbilidades siguientes: fatiga crónica, fibromialgia o SII.
    5. Se pueden incluir pacientes anteriormente tratados con otros anticuerpos monoclonales para la migraña si se ha realizado el periodo de lavado apropiado según la semivida del producto en cada anticuerpo monoclonal.
    Durante la fase basal:
    1. Frecuencia de la migraña ≥10 días con migraña durante la fase basal, confirmada por el diario electrónico.
    2. Cumplimiento ≥80 % del diario electrónico durante la fase basal
    E.4Principal exclusion criteria
    1. Older than 50 years of age at migraine onset.
    2. Unable to differentiate migraine from other headaches.
    3. History of cluster headache or hemiplegic migraine headache.
    4. Used a device, or procedure within 2 months prior to the start of or during baseline or during the treatment period.
    5. Use of other investigational drugs within 5 half-lives of enrollment or inappropriate washout period in case of monoclonal antibodies, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
    6. Unlikely to be able to complete all protocol required study visits or procedures, and/or to comply with all required study procedures.
    7. History or evidence of any other unstable or clinically significant medical condition that in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
    1. Sujetos mayores de 50 años de edad al inicio de la migraña.
    2. Sujetos que no puedan diferenciar la migraña de otras cefaleas.
    3. Antecedentes de cefalea en racimos o cefalea migrañosa hemipléjica.
    4. Uso de un dispositivo o procedimiento durante los 2 meses anteriores al inicio de la basal, durante la basal o durante el periodo de tratamiento.
    5. Uso de otros fármacos en investigación durante 5 semividas del reclutamiento o periodo de lavado inadecuado en caso de anticuerpos monoclonales o hasta que el efecto farmacodinámico previsto vuelva al nivel basal, aquel periodo que sea más largo.
    6. Improbabilidad de poder completar todos los procedimientos o visitas del estudio requeridos en el protocolo o cumplir todos los procedimientos del estudio requeridos.
    7. Antecedentes o pruebas de cualquier otra enfermedad inestable o clínicamente significativa que, en opinión del investigador, pudiera suponer un riesgo en la seguridad del sujeto o interferir en la evaluación, procedimientos o finalización del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    • Percentage of patients (in the overall population and by each comorbidity) who achieve a ≥5-point increase in the MSQ-RFR, MSQ-RFP domains and a ≥8-point increase in the MSQ-EF domain of the MSQ 2.1 from baseline to 6 and 12 months
    • Porcentaje de pacientes (en la población general y por cada comorbilidad) que logran un aumento de ≥5 puntos en los dominios MSQ-RFR, MSQ-RFP y un aumento de ≥8 puntos en el dominio MSQ-EF del MSQ 2.1 desde la basal a los 6 y 12 meses
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to 6 and 12 months
    Desde la basal a los 6 y 12 meses.
    E.5.2Secondary end point(s)
    •Correlation between HRQoL scores in migraine questionnaire (MSQ 2.1) and HRQoL scores in each comorbidity questionnaire: fibromyalgia (Fibromyalgia Impact Questionnaire, FIQ), chronic fatigue (Short Form health survey, SF-12) and IBS (Irritable Bowel Syndrome Quality of Life, IBS-QOL) in all study visits.
    • Mean change in HRQoL in each associated comorbidity from baseline to 6 and 12 months assessed with the FIQ, SF-12 and IBS-QOL in patients with fibromyalgia, chronic fatigue and IBS, respectively.
    • Efficacy of erenumab will be assessed by migraine days.-Percentage of patients who achieve at least 50% or greater reduction in the mean number of migraine days per month from baseline to month 12. - Change in the mean number of migraine days per month from baseline to month 12. -Change in the mean number of days of use of acute migraine–specific medication per month from baseline to month 12.
    • Exploratory: -Correlation between the monthly mean number of days with migraine and scores obtained in the Modified Migraine Disability Assessment scale (mMIDAS). - Correlation between mean number of days with migraine and the scores obtained in the 6-item WPAI-G (Work Productivity and Activity Impairment General) questionnaire. -Comparison of mean change in MSQ 2.1 (MSQ-RFR, MSQ-RFP and MSQ-EF) scores from baseline to 6 and 12 months between patients with one comorbidity and patients with two or more comorbidities (in the overall population and by each comorbidity)
    • Correlación entre las puntuaciones de la CVRS en el cuestionario de migraña (MSQ 2.1) y las puntuaciones de la CVRS en cada cuestionario de comorbilidad: fibromialgia (Cuestionario de Impacto de Fibromialgia, FIQ), fatiga crónica (encuesta de salud de forma corta, SF-12) y SII (Síndrome del Intestino Irritable Calidad de Vida, IBS-QOL) en todas las visitas de estudio.
    • Cambio promedio en la CVRS en cada comorbilidad asociada desde el inicio hasta los 6 y 12 meses evaluados con el FIQ, SF-12 y IBS-QOL en pacientes con fibromialgia, fatiga crónica y IBS, respectivamente.
    • La eficacia de erenumab se evaluará en los días de migraña.-Porcentaje de pacientes que logran al menos un 50% o más de reducción en el número promedio de días de migraña por mes desde el inicio hasta el mes 12. - Cambio en el número promedio de días de migraña por mes desde el inicio hasta el mes 12. -Cambio en la cantidad promedio de días de uso de medicamentos específicos para la migraña aguda por mes desde el inicio hasta el mes 12.
    • Exploratorio: -Correlación entre el número promedio mensual de días con migraña y las puntuaciones obtenidas en la escala de Evaluación de Discapacidad Migraña Modificada (mMIDAS). - Correlación entre el número medio de días con migraña y los puntajes obtenidos en el cuestionario WPAI-G (Productividad en el trabajo y Discapacidad general de la actividad) de 6 ítems. -Comparación del cambio medio en las puntuaciones del MSQ 2.1 (MSQ-RFR, MSQ-RFP y MSQ-EF) desde el inicio hasta los 6 y 12 meses entre pacientes con una comorbilidad y pacientes con dos o más comorbilidades (en la población general y por cada comorbilidad).
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline to 6 and 12 months
    Desde el inicio hasta los 6 y 12 meses
    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) 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 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.8.3 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 concerned28
    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
    End of study will be the last visit of last patient who is is follow up visit.
    Fin de ensayo despues de la ultima visita del último paciente que está en seguimiento
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months13
    E.8.9.1In the Member State concerned days
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state300
    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)
    Not applicable, no protocol extension is expected.
    The investigator must provide follow-up medical care for all patients and it will be up to the investigator to decide which treatment the patient should follow once the trial is finished or discontinued
    No aplicable, no se espera realizar ninguna extensión de protocolo.
    El investigador debe proporcionar atención médica de seguimiento para todos los pacientes y será a juicio del investigador la decisión de qué tratamiento deberá seguir el paciente una vez finalice o discontinúe del ensayo
    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 Decision2019-08-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-10-21
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