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    Summary
    EudraCT Number:2019-002056-16
    Sponsor's Protocol Code Number:TV48125-CNS-30084
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-14
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-002056-16
    A.3Full title of the trial
    A Multicenter, Open-Label Study Evaluating the Long-Term Safety, Tolerability, and Efficacy of Monthly Subcutaneous Administration of Fremanezumab for the Preventive Treatment of Episodic and Chronic Migraine in Pediatric Patients 6 to 17 Years of Age
    Studio multicentrico, in aperto che valuta sicurezza, tollerabilità ed efficacia a lungo termine della somministrazione sottocutanea mensile di Fremanezumab per il trattamento preventivo di emicrania episodica e cronica in pazienti pediatrici da 6 a 17 anni di età
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Test if Fremanezumab is Effective in Preventing Migraine in
    Children and Adolescents
    Uno studio per verificare se fremanezumab sia efficace nella prevenzione dell'emicrania in bambini e adolescenti
    A.3.2Name or abbreviated title of the trial where available
    SPACE
    SPACE
    A.4.1Sponsor's protocol code numberTV48125-CNS-30084
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/411/2019
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, 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 supportTeva Branded Pharmaceutical Products R&D, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerckle GmbH
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressGraf-Arco-Str.3
    B.5.3.2Town/ cityUlm
    B.5.3.3Post code89079
    B.5.3.4CountryGermany
    B.5.6E-mailInfo.Era-clinical@teva.de
    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 AJOVY
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namefremanezumab
    D.3.2Product code [TEV-48125]
    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 INNfremanezumab
    D.3.9.1CAS number 1655501-53-3
    D.3.9.2Current sponsor codeTEV-48125
    D.3.9.4EV Substance CodeSUB181665
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.IMP: 2
    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 AJOVY
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namefremanezumab
    D.3.2Product code [TEV-48125]
    D.3.4Pharmaceutical form Solution for injection/infusion
    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 INNfremanezumab
    D.3.9.1CAS number 1655501-53-3
    D.3.9.2Current sponsor codeTEV-48125
    D.3.9.4EV Substance CodeSUB181665
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Episodic and Chronic Migraine
    Emicrania episodica e cronica
    E.1.1.1Medical condition in easily understood language
    Episodic and Chronic Migraine
    Emicrania episodica e cronica
    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
    To evaluate the longterm safety and tolerability of subcutaneous
    fremanezumab in the preventive treatment of migraine in pediatric
    patients 6 to 17 years of age (inclusive at enrollment in the pivotal
    study)
    Valutare la sicurezza e la tollerabilità a lungo termine di fremanezumab per via sottocutanea nel trattamento preventivo dell’emicrania in pazienti pediatrici di età compresa tra 6 e 17 anni (inclusi, in occasione dell’arruolamento nello studio pivotale).
    E.2.2Secondary objectives of the trial
    -To evaluate the efficacy of subcutaneous fremanezumab in pediatric
    patients with migraine
    -To evaluate the immunogenicity of fremanezumab and the impact of
    ADAs on clinical outcomes in pediatric patients exposed to
    fremanezumab
    - valutare l’efficacia di fremanezumab per via sottocutanea in pazienti pediatrici con emicrania
    - valutare l’immunogenicità di fremanezumab e l’impatto degli ADA sugli esiti clinici in pazienti pediatrici esposti a fremanezumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Criteri di inclusione per i pazienti trasferiti dagli studi pivotali di efficacia: I pazienti potranno essere inclusi nello studio soltanto se soddisferanno tutti i seguenti criteri:

    a. I pazienti hanno completato lo studio pivotale di efficacia e, secondo il parere dello Sperimentatore o dello Sponsor, sono in grado di completare lo studio in modo sicuro e conforme.

    b. Il/i genitore/i o il/i tutore/i del/la paziente deve/devono fornire il consenso scritto e il/la paziente deve fornire l’assenso (ai sensi delle normative locali).
    Nota: in alcuni paesi, i pazienti con età compresa fra 15 e17 anni (inclusi) possono fornire il consenso informato scritto; tuttavia, il/i genitore/i o il/i tutore/i del/la paziente deve/devono essere informato/i, ai sensi delle normative locali.

    c. I pazienti possono continuare con una dose/regime stabile del medicinale preventivo che assumevano durante gli studi pivotali di efficacia.

    d. Il/la paziente deve acconsentire ed essere in grado di conformarsi alle restrizioni dello studio e rimanere presso la clinica per il tempo necessario durante il periodo dello studio ed acconsentire a tornare alla clinica per la valutazione di follow-up come specificato in questo protocollo.
    e. Il/la paziente continua a soddisfare i criteri appropriati in continuità con lo studio pivotale di efficacia, come segue:

    f. Le pazienti di sesso femminile post menarca o con età =12 anni, possono essere incluse solo se hanno un test negativo alla gonadotropina corionica beta umana (ß-HCG) al basale o se sono sterili. Le definizioni di soggetti di sesso femminile potenzialmente fertili e di soggetti di sesso femminile che non sono potenzialmente fertili sono fornite nella Appendice G.

    g. Le pazienti di sesso femminile post menarca o con età =12 anni e sessualmente attive devono usare metodi contraccettivi altamente efficaci con i loro partner di sesso maschile per la durata dello studio (cioè almeno 2 mesi prima dello screening) e per 6 mesi dopo l’ultima dose di IMP. I pazienti di sesso maschile che sono sessualmente attivi devono usare il preservativo per la durata dello studio e per 6 mesi dopo l’ultima somministrazione di IMP. Ulteriori dettagli sono inclusi nell’Appendice G.

    h. Il/la paziente ha ricevuto tutti i vaccini raccomandati in base all’età in conformità allo standard di cura e al programma locale.

    i. Il/la paziente è in buona salute come determinato mediante anamnesi clinica e psichiatrica, esame obiettivo, elettrocardiogramma a 12 derivazioni (ECG), chimica sierica, ematologia, coagulazione, analisi delle urine e sierologia.

    j. Il/la paziente pesa almeno 17,0 kg il giorno dell’arruolamento nello studio.

    k. Il/la paziente ha un indice di massa corporea che varia dal 5o al 95o percentile, compreso, il giorno dell'arruolamento nello studio.


    Spazio insufficiente, per uteriori criteri fare riferimento allla sinossi.
    Patients Rolling Over from the Pivotal Efficacy Studies may be included
    only if they meet all of the following criteria:
    a. Completion of the pivotal efficacy study and in the opinion of the
    Investigator/Sponsor able to complete the study in a safe and compliant
    way
    b. Patient's parent(s) or legal guardian(s) must give written informed
    consent, and the patient must give assent (in accordance with local
    regulations) Note: In some countries, patients aged 15 to 17 years
    (inclusive) may give written informed consent; however, the patient's
    parent(s) or legal guardian(s) must be informed, per local regulations.
    c. Patients may continue with a stable dose/regimen of the preventive
    medication they were taking during the pivotal efficacy studies
    d. Willing and able to comply with study restrictions and to remain
    at the clinic for the required duration during the study period and willing
    to return to the clinic for the follow-up evaluation as specified in this
    protocol
    e. Patient continues to meet appropriate criteria carried forward from
    the pivotal efficacy study, as follows:
    f. Females who are postmenarchal or =12 years of age may be included
    only if they have a negative beta-human chorionic gonadotropin (ß-HCG)
    test at baseline or are sterile
    g. Females who are postmenarchal or =12 years of age and sexually
    active must use highly effective birth control methods with their male
    partners for the duration of the study (ie, at least 2 months before
    screening) and for 6 months after the last dose of IMP. Males who are
    sexually active with female partners must use a condom for the duration
    of the study and for 6 months after the last administration of IMP
    h. Receipt of all recommended age-appropriate vaccines according to
    local standard of care and schedule
    i. Good health, determined by a medical and psychiatric history,
    medical examination, 12-lead ECG, serum chemistry, hematology,
    coagulation, urinalysis, and serology
    j. Weight of at least 17.0 kg on the day of study enrollment
    k. BMI ranging from the 5th to the 95th percentile, incl. on the day of
    study enrollment

    Patients Rolling Over from Study TV48125-CNS-10141: may be included
    only if they meet all of the following criteria
    a. Patient is male/female, 6 - 17 years old (inclusive)
    b. Written informed consent is obtained from each patient's parent or
    legal guardian and written assent (according to local regulations) is
    obtained from each patient. Note: In some countries, patients aged 15 to
    17 years (inclusive) may give written informed consent; however, the
    patient's parent(s) or legal guardian(s) must be informed, per local
    regulations.
    c. The patient/caregiver has demonstrated compliance with the
    electronic headache diary during the 28-day baseline period by entry of
    headache data on a minimum of 21 out of 28 days (approximately 75%
    diary compliance)
    d. Females who are postmenarchal or =12 years of age may be included
    only if they have a negative ß-HCG test at the screening/pre-treatment
    period or are sterile
    e. Females who are postmenarchal or =12 years of age and sexually
    active must use highly effective birth control methods with their male
    partners for the duration of the study (ie, at least 2 months before
    screening) and for 6 months after the last dose of the IMP. Males who
    are sexually active with female partners must use a condom for the
    duration of the study and for 6 months after the last administration of
    the IMP
    f. The patient has received all recommended age-appropriate vaccines
    according to local standard of care and schedule
    g. The patient is in good health as determined by a medical and
    psychiatric history, medical examination, 12-lead ECG, serum chemistry,
    hematology, coagulation, urinalysis, and serology

    Spazio insufficiente, per uteriori criteri fare riferimento al Protocollo.
    E.4Principal exclusion criteria
    Patients from the Pivotal Efficacy Studies (any criteria met):
    a. Significant abnormal finding on study entry (e.g. hematology), repeat
    abnormal tests for confirmation
    b. Pregnant, nursing, or taking a combined estrogen and progestogen
    hormonal contraceptive
    c. Abnormal clinically significant finding on baseline 12-lead ECG
    d. One of the following criteria is met:
    e. Use of medications containing opioids (incl. codeine), barbiturates
    (incl. Fiorinal®, any other combination containing butalbital) for
    migraine treatment during the 3 months prior to screening visit day
    f. Use of an intervention/device (eg, scheduled nerve block) for migraine
    treatment during the 2 months prior to screening visit day
    g. Any clinically significant disease (e.g. cardiovascular), or
    complications of an infection
    h. History of clinically significant psychiatric condition/history of a
    suicide attempt/history of suicidal ideation with a specific plan within
    the past 2 years, at the discretion of the investigator.
    i. Ongoing infection/known history of e.g. HIV infection/tuberculosis,
    Lyme disease, chronic hepatitis B or C, or a known infection of
    coronavirus disease 2019 (COVID-19)
    j. Past or current history of cancer
    k. History of hypersensitivity reactions to injected proteins, incl. mAbs,
    history of Stevens-Johnson Syndrome, toxic epidermal necrolysis
    syndrome, or the patient in concomitantly using lamotrigine.
    l. Current participation in another IMP/medical device study
    m. Hepatic enzymes (ALT, AST, ALP) > 1.5× ULN after a repeat test
    confirmation, or suspected hepatocellular damage (fulfilling Hy's law)
    n. Serum creatinine > 1.5× the ULN, clinically significant proteinuria
    (urine dipstick +4), an estimated glomerular filtration rate of
    <90 mL/min/1.73m2, as calculated by the Schwartz formula
    (CrCl=[k×Ht]/Serum Creatinine), or evidence of renal disease
    o. Patient cannot fully participate in/successfully complete the study for its full duration for any of the following reasons:
    -In custody due to an administrative or a legal decision or in residential
    treatment
    -Patient/caregiver unable to be contacted in case of emergency
    -Presence of any other condition, which makes the patient inappropriate
    for study inclusion
    -Patient is a relative of a study center or sponsor employee who is
    directly involved in the study
    p. Vulnerable patients (eg, people in detention) that are vulnerable due
    to other conditions than age
    q. Receipt of a live attenuated vaccine (eg, intranasal flu vaccine) within
    the 12-week period prior to screening. Note: If a medical need arises during the study, the patient may receive a live attenuated vaccine
    r. The patient has a known hypersensitivity to the active substance or to
    any of the excipients of the study drug.

    Spazio insufficiente, per ulteriori criteri fare riferimento al Protocollo.
    Criteri di esclusione per i pazienti trasferiti dagli studi pivotali di efficacia: I pazienti saranno esclusi dalla partecipazione a questo studio se soddisferanno uno qualunque dei seguenti criteri:

    a. Secondo il parere dello sperimentatore, il/la paziente ha un risultato anomalo clinicamente significativo all’ingresso nello studio, compresi valori/risultati di esami di ematologia, chimica clinica, coagulazione o analisi delle urine (i test anomali possono essere ripetuti per conferma).

    b. La paziente è in stato di gravidanza,sta allattando con latte materno o sta assumendo un contraccettivo ormonale a base di estrogeni e progestinici combinati.

    c. Secondo il parere dello sperimentatore, il/la paziente ha un risultato anomalo all’ECG a 12 derivazioni al basale, considerato clinicamente significativo.

    d. Il/la paziente continua a soddisfare i seguenti criteri:

    e. Il/la paziente sta usando medicinali contenenti oppioidi (compresa codeina) o barbiturici (compreso Fiorinal®, Fioricet®, o qualsiasi altra combinazione contenente butalbital) per il trattamento dell’emicrania nei 3 mesi precedenti il giorno della visita di screening.

    f. Il/la paziente ha usato un intervento/dispositivo (ad es. blocco nervoso o stimolazione transcranica magnetica programmati) per il trattamento dell’emicrania nei 2 mesi precedenti il giorno della visita di screening.

    g. Il/la paziente ha una qualsiasi malattia cardiovascolare (comprese anomalie cardiache congenite o eventi tromboembolici), endocrina, gastrointestinale, genitourinaria, ematologia, epatica, immunologica, neurologica, oftalmica, polmonare, renale clinicamente significativa, ovvero complicanze di un’infezione, a discrezione dello sperimentatore.







    h. Il/la paziente ha un’anamnesi corrente di una condizione psichiatrica clinicamente significativa, qualsiasi precedente anamnesi di tentato suicidio, o anamnesi di ideazione suicidaria con un piano specifico negli ultimi 2 anni, a discrezione dello sperimentatore.

    i. Il/la paziente ha un’infezione in corso o un’anamnesi nota di virus dell’immunodeficienza umana (HIV), tubercolosi, malattia di Lyme, epatite cronica B o C, oppure un’infezione attiva nota da malattia da coronavirus 2019 (COVID-19).

    j. Il/la paziente ha un’anamnesi pregressa o attuale di cancro.

    k. Il/la paziente ha un’anamnesi di reazioni di ipersensibilità alle proteine iniettate, compresi gli anticorpi monoclonali (mAB), o un’anamnesi della sindrome di Stevens-Johnson o una sindrome di necrolisi epidermica tossica, o il/la paziente sta facendo uso concomitante di lamotrigina.

    l. Il/la paziente sta attualmente partecipando ad un altro studio di un IMP (o dispositivo medico).

    m. Il/la paziente ha valori degli enzimi epatici (alanina aminotransferasi [ALT], aspartato aminotransferasi [AST], fosfatasi alcalina [ALP]) maggiore di 1,5 volte il limite superiore della norma (ULN) dopo conferma con un esame ripetuto, o presenta sospetto di danno epatocellulare che soddisfa i criteri per la legge di Hy.

    n. Il/la paziente ha un valore di creatinina sierica maggiore di 1,5 volte l’ULN, proteinuria (stick urinario +4) clinicamente significativa, un tasso di filtrazione glomerulare stimato di <90 ml/min/1,73 m2 calcolato in base alla formula di Schwartz (CrCl = [k × Ht]/creatinina sierica), o evidenza di malattia renale.


    Spazio insufficiente, per ulteriori criteri fare riferimento alla sinossi
    E.5 End points
    E.5.1Primary end point(s)
    Safety:
    -Occurrence of adverse events throughout the study, including local injection site reactions/pain
    -Changes from baseline in clinical laboratory (serum chemistry, hematology, coagulation, and urinalysis) test results and height and weight measurements taken at V5, V8, and at the end of treatment (V11)
    -Abnormal standard 12-lead electrocardiogram findings at each study visit up to the end of treatment (V11)
    -Changes from baseline in vital signs (pulse, systolic and diastolic blood pressure, temperature, and respiratory rate) at each study visit up to the
    end of treatment (V11)
    -Abnormal physical examination findings at study visits V6, V7, V11, and V12
    -Suicidal ideation and behavior as suggested by the Columbia-Suicide Severity Rating Scale throughout the study
    Sicurezza:
    • verificarsi di eventi avversi nel corso dello studio, compresi reazioni/dolore locale nella sede dell’iniezione
    • cambiamenti dal basale nei risultati degli esami clinici di laboratorio (chimica sierica, ematologia, coagulazione e analisi delle urine) e misurazioni dell’altezza e del peso rilevate alla V5, V8 e alla fine del trattamento (V11)
    • risultati anomali all’elettrocardiogramma standard a 12 derivazioni a ciascuna visita dello studio fino alla fine del trattamento (V11)
    • cambiamenti dal basale nei parametri vitali (battito, pressione sanguigna sistolica e diastolica, temperatura e frequenza respiratoria) a ciascuna visita dello studio fino alla fine del trattamento (V11)
    • risultati anormali dell'esame obiettivo alle visite dello studio V6, V7, V11 e V12
    • ideazione e comportamenti suicidari rilevati in base alla Scala Columbia per la valutazione della gravità del rischio di suicidio nel corso dello studio
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety will be assessed throughout the study
    La sicurezza sarà valutata durante tutto lo studio
    E.5.2Secondary end point(s)
    Efficacy:
    -Mean change from baseline (defined as the original baseline from the EM and CM studies) in the number of headache days of at least moderate
    severity during the 4-week periods after V2, V6, and V10
    -Mean change from baseline (defined as the original baseline from the EM and CM studies) in the number of migraine days during the 4-week
    periods after V2, V6, and V10
    -Proportion of patients reaching at least 50% reduction in the number of migraine days during the 4-week periods after V2, V6, and V10
    -Proportion of patients reaching at least 50% reduction in the number of headache days of at least moderate severity during the 4-week periods
    after V2, V6, and V10
    -Mean change from baseline (defined as the original baseline from the EM and CM studies) in the number of days of use of any acute headache
    medications during the 4-week periods after V2, V6, and V10
    -Mean change from baseline (day 1) in migraine-related disability score, as measured by the PedMIDAS questionnaire at V5, V8, V11, and V12
    -Proportion of patients developing ADAs throughout the study. The impact of ADAs on safety and efficacy will be analyzed if the number of
    ADA-positive patients allows
    Efficacia:
    • cambiamento medio dal basale (definito come basale originale dagli studi EM e CM) nel numero di giorni con cefalea di gravità almeno moderata nei periodi di 4 settimane dopo la V2, V6 e V10
    • cambiamento medio dal basale (definito come basale originale dagli studi EM e CM) nel numero di giorni con emicrania nei periodi di 4 settimane dopo la V2, V6 e V10
    • proporzione di pazienti che raggiungono una riduzione pari ad almeno il 50% nel numero di giorni con emicrania nel periodo di 4 settimane dopo la V2, V6 e V10
    • proporzione di pazienti che raggiungono una riduzione pari ad almeno il 50% nel numero di giorni con cefalea di gravità almeno moderata nel periodo di 4 settimane dopo la V2, V6 e V10
    • cambiamento medio dal basale (definito come basale originale dagli studi EM e CM) nel numero di giorni di utilizzo di qualsiasi medicinale per la cefalea acuta nei periodi di 4 settimane dopo la V2, V6 e V10
    • cambiamento medio dal basale (giorno 1) nel punteggio di disabilità correlata all’emicrania, misurato mediante il questionario PedMIDAS alla V5, V8, V11 e V12
    • proporzione di pazienti che sviluppano ADA nel corso dello studio. L’impatto degli ADA sulla sicurezza e l’efficacia sarà analizzato
    se il numero di pazienti positivi per ADA lo permetterà
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy will be assessed through
    V11 (end of treatment)
    L'efficacia sarà valutata attraverso la V11 (fine del trattamento)
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tollerabilità
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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.8.2.4Number 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 EEA30
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Finland
    Germany
    Israel
    Italy
    Netherlands
    Poland
    Spain
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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 Yes
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 151
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 399
    F.1.2Adults (18-64 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Study patients are minors
    I pazienti sono minorenni,
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 193
    F.4.2.2In the whole clinical trial 550
    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)
    There will be no access to IMP after the end of the study. The
    investigator should advise the patients to return to their primary
    physician.
    Dopo la fine dello studio non ci sarà accesso al medicinale in fase di sperimentazione. Lo sperimentatore dovrebbe consigliare ai pazienti di far ritorno al medico curante.
    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 Decision2020-08-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-08
    P. End of Trial
    P.End of Trial StatusOngoing
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