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    Summary
    EudraCT Number:2021-001979-16
    Sponsor's Protocol Code Number:M21-307
    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:2021-11-12
    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 number2021-001979-16
    A.3Full title of the trial
    Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study of BOTOX (Botulinum Toxin Type A) for the Prevention of Migraine in Subjects with Episodic Migraine
    Estudio de fase 3 multicentro, aleatorizado, doble ciego y controlado con placebo de BOTOX (Toxina botulínica tipo A) para prevención de migraña en pacientes con migraña episódica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 3 study of BOTOX for the Prevention of Migraine in Subjects with Episodic Migraine
    Estudio fase 3 de BOTOX para la prevención de migraña en pacientes con migraña episódica
    A.4.1Sponsor's protocol code numberM21-307
    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 SponsorAbbVie Deutschland GmbH & Co. KG
    B.1.3.4CountryGermany
    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 supportAbbVie Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd.
    B.5.2Functional name of contact pointGlobal Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+91901200103
    B.5.6E-mailabbvie_reec@abbvie.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 BOTOX
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan Pharmaceuticals Ireland
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 nameBOTOX (botulinum toxin type A)
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBOTOX
    D.3.9.1CAS number 93384-43-1
    D.3.9.3Other descriptive nameBOTULINUM TOXIN TYPE A
    D.3.9.4EV Substance CodeSUB13117MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder and solution for suspension for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Episodic Migraine
    Migraña episodica
    E.1.1.1Medical condition in easily understood language
    Recurrent headaches
    Dolores de cabeza recurrentes
    E.1.1.2Therapeutic area Body processes [G] - Chemical Phenomena [G02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level LLT
    E.1.2Classification code 10082019
    E.1.2Term Episodic 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
    The objective of this study is to evaluate the efficacy and safety of 2
    dose levels of BOTOX compared with placebo as migraine prevention in
    subjects with EM.
    El objetivo de este estudio es evaluar la eficacia y la seguridad de 2 niveles de dosis de BOTOX en comparación con un placebo como prevención de la migraña en sujetos con ME.
    E.2.2Secondary objectives of the trial
    Not Applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Adult male or female, 18 to 65 years old.
    -Completed at least 20 out of 28 days in the e-Diary during the screening/baseline phase.
    -Negative result on the urine drug and alcohol screen at Visit 1 unless explained by permitted concomitant medication use (e.g., opioids prescribed for migraine pain).
    -History of migraine headache disorder meeting ICHD-3 diagnostic criteria for migraine with aura or migraine without aura (1.1 and 1.2) for ≥ 12 months.
    -Onset of migraine before 50 years of age.
    -History of 6 to 14 migraine days/month in each of the 3 months prior to Visit 1.
    -Six to 14 migraine days during the 4-week screening/baseline phase.
    -< 15 headache days/month in each of the 3 months prior to Visit 1 and during the 4-week screening/baseline phase.
    - Adulto hombre o mujer, de 18 a 65 años de edad
    - Se haya completado al menos 20 de 28 días en el diario electrónico durante la fase de selección inicial
    - Resultado negativo en la prueba de alcohol y drogas en orina inicial en la visita 1 a menos que este permitido como medicación concomitante (Ej.: opiáceos prescritos para el dolor de migraña
    - Antecedentes de migraña que cumpla con los criterios de diagnóstico de la ICHD-3 para migraña con aura o migraña sin aura (1.1 y 1.2) durante ≥ 12 meses.
    - Inicio de la migraña antes de los 50 años
    - Antecedentes de 6 a 14 días / mes de migraña en cada uno de los 3 meses anteriores a la Visita 1
    - De seis a 14 días de migraña durante las 4 semanas del periodo de selección
    - <15 días / mes con dolor de cabeza en cada uno de los 3 meses previos a la Visita 1 y durante la fase de selección de 4 semanas.
    E.4Principal exclusion criteria
    -No history of or current diagnosis of the following headache disorders according to ICHD-3:
    a. Migraine with brainstem aura (1.2.2) or retinal migraine (1.2.4)
    b. Complications of migraine (1.4), chronic tension-type headache (2), trigeminal autonomic cephalalgias (3), hypnic headache (4.9), hemicrania continua (3.4) or new daily persistent headache (4.10)
    -No history of headache attributed to another disorder (e.g., cervical dystonia, craniotomy, head/neck trauma).
    -No history of inadequate response to > 4 prophylactic treatment for migraine, 2 of which have different mechanisms of action (see Section 8.1 of the Operations Manual for the list of medications and criteria for determining inadequate response).
    -No unremitting headache lasting continuously throughout the 4-week baseline period.
    -No known active Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection. If a subject has signs/symptoms suggestive of SARS-CoV-2 infection, the subject must have a negative molecular (e.g., polymerase chain reaction [PCR]) test result.
    - In addition, if based on the answers to the SARS-CoV-2 Infection Risk Assessment Tool the site considers the subject currently at risk for developing SARS-CoV-2 infection, then the subject should either be tested or advised to come back for study screening after 14 days.
    -Subjects who do not meet SARS-CoV-2 infection eligibility criteria must be screen failed and may only rescreen after they meet the following SARS-CoV-2 infection viral clearance criteria:
    •At least 14 days since first negative PCR test result have passed in asymptomatic patients or 14 days since recovery, defined as resolution of fever without use of antipyretics and improvement in symptoms.
    -For all females of childbearing potential; a negative serum pregnancy test at Visit 1 and a negative urine pregnancy test at Visit 2 prior to the first dose of study drug.
    - Sin antecedentes o diagnóstico actual de los siguientes trastornos de cefalea según ICHD-3
    A. Migraña con aura del tronco encefálico (1.2.2) o migraña retiniana (1.2.4)
    B. Complicaciones de migraña (1.4), cefalea tensional crónica (2), cefalea autonómica del trigémino (3), cefalea hipnótica (4.9), hemicránea continua (3.4) o nueva cefalea persistente diaria (4.10)
    -Sin antecedentes de cefalea atribuida a otro trastorno (p. Ej., Distonía cervical, craneotomía, traumatismo de cabeza / cuello).
    -No hay antecedentes de respuesta inadecuada a> 4 tratamientos profilácticos para la migraña, 2 de los cuales tienen diferentes mecanismos de acción (consulte la Sección 8.1 del Manual de operaciones para obtener la lista de medicamentos y criterios para determinar la respuesta inadecuada).
    -No hay dolor de cabeza incesante que dure de forma continua durante el período de selección de 4 semanas.
    -Ninguna infección activa conocida por coronavirus 2 (SARS-CoV-2) por síndrome respiratorio agudo severo. Si un sujeto tiene signos / síntomas que sugieren infección por SARS-CoV-2, el sujeto debe tener un resultado de prueba molecular negativo (p. Ej., Reacción en cadena de la polimerasa [PCR]).
    - Además, si con base en las respuestas a la Herramienta de evaluación de riesgo de infección por SARS-CoV-2, el centro considera que el sujeto está actualmente en riesgo de desarrollar la infección por el SARS-CoV-2, entonces el sujeto debe realizar un test o se le aconsejará que regrese para la selección del estudio después de 14 días.
    -Los sujetos que no cumplan con los criterios de elegibilidad para la infección por el SARS-CoV-2 deben ser considerados como fallo de selección y solo pueden volver a la selección del estudio después de que cumplan con los siguientes criterios de eliminación del virus de la infección por el SARS-CoV-2:
    • Han pasado al menos 14 días desde la primera prueba de PCR negativa en pacientes asintomáticos o 14 días desde la recuperación, definida como resolución de la fiebre sin uso de antipiréticos y mejoría de los síntomas.
    -Para todas las mujeres en edad fértil; una prueba de embarazo en suero negativa en la Visita 1 y una prueba de embarazo en orina negativa en la Visita 2 antes de la primera dosis del fármaco del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change from baseline in the frequency of monthly migraine days across Months 5 and 6.
    El criterio de valoración principal es el cambio con respecto al valor inicial en la frecuencia de los días mensuales de migraña en los meses 5 y 6.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Across Months 5 and 6.
    A lo largo de los meses 5 y 6.
    E.5.2Secondary end point(s)
    The secondary endpoints will be as follows (and will be evaluated in the stated order):
    1. Change from baseline in the frequency of monthly headache days across Months 5 and 6
    2. Responder status of 50% reduction from baseline in the frequency of monthly migraine days across Months 5 and 6
    3. Change from baseline in the frequency of monthly acute headache medication days across Months 5 and 6
    4. Change from baseline in Migraine-Specific Quality-of-Life Questionnaire version 2.1 Role Function – Restrictive domain score at Month 6
    5. Change from baseline in the Activity Impairment in Migraine – Diary Physical Impairment domain score across Months 5 and 6 (6-item Headache Impact Test [HIT-6] in Europe)
    6. Change from baseline in the frequency of monthly neck pain days associated with headache across Months 5 and 6 among subjects who report at least 1 day of neck pain associated with headache during baseline
    Los criterios de valoración secundarios serán los siguientes (y se evaluarán en el orden indicado):
    1. Cambio con respecto al valor inicial en la frecuencia de los días mensuales con dolor de cabeza en los meses 5 y 6
    2. Estado del respondedor de reducción del 50% desde el inicio en la frecuencia de los días mensuales de migraña en los meses 5 y 6
    3. Cambio con respecto al valor inicial en la frecuencia de los días mensuales de medicación para el dolor de cabeza agudo en los meses 5 y 6
    4. Cambio con respecto al valor inicial en el Cuestionario de calidad de vida específico de la migraña versión 2.1 Función de rol - Puntaje de dominio restrictivo en el mes 6
    5. Cambio con respecto al valor inicial en la puntuación del dominio de deterioro de la actividad en la migraña: deterioro físico del diario en los meses 5 y 6 (prueba de impacto del dolor de cabeza de 6 ítems [HIT-6] en Europa)
    6. Cambio con respecto al valor inicial en la frecuencia de los días mensuales de dolor de cuello asociados con dolor de cabeza durante los meses 5 y 6 entre los sujetos que informaron al menos 1 día de dolor de cuello asociado con dolor de cabeza durante el período inicial.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Across Months 5 and 6.
    A lo largo de los meses 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) 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 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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
    Canada
    United States
    Denmark
    Germany
    Netherlands
    Poland
    Spain
    Sweden
    Switzerland
    United Kingdom
    Czechia
    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
    The end-of-study is defined as the date of the last visit of the last subject in the study.

    A subject is considered to have completed the study if he/she has completed all phases of the study including the Study Exit visit.
    El final del estudio se define como la fecha de la última visita del último sujeto del estudio.
    Se considera que un sujeto ha completado el estudio si ha completado todas las fases del estudio, incluida la visita de salida del estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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: 738
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 39
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 228
    F.4.2.2In the whole clinical trial 777
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Signant Health
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-11-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-11
    P. End of Trial
    P.End of Trial StatusOngoing
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