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    Summary
    EudraCT Number:2017-002399-23
    Sponsor's Protocol Code Number:20160354
    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:2020-10-07
    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 number2017-002399-23
    A.3Full title of the trial
    A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Erenumab in Children (6 to < 12 Years) and Adolescents (12 to < 18 Years) With Chronic Migraine (OASIS PEDIATRIC [CM])
    Studio di fase 3 randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli, volto a valutare l’efficacia e la sicurezza di Erenumab nei bambini (da 6 a <12 anni) e negli adolescenti (da 12 a <18 anni) con emicrania cronica (OASIS PEDIATRIC [CM])
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine
    Efficacia e sicurezza di Erenumab in soggetti pediatrici con emicrania cronica
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code number20160354
    A.5.4Other Identifiers
    Name:NANumber:NA
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/370/2016
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAMGEN INC.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAmgen Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen (Europe) GmbH
    B.5.2Functional name of contact pointIHQ-Medical Info - Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressDammstrasse 23, P.O Box 1557
    B.5.3.2Town/ cityZug
    B.5.3.3Post codeCH-6300
    B.5.3.4CountrySwitzerland
    B.5.6E-mailMedinfoInternational@amgen.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAMG 334
    D.3.2Product code [AMG 334]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNERENUMAB
    D.3.9.1CAS number 1582205-90-0
    D.3.9.2Current sponsor codeAMG 334
    D.3.9.4EV Substance CodeSUB74690
    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 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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAMG 334 PFS
    D.3.2Product code [AMG 334]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNERENUMAB
    D.3.9.1CAS number 1582205-90-0
    D.3.9.2Current sponsor codeAMG 334
    D.3.9.4EV Substance CodeSUB74690
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic migraine
    Emicrania cronica
    E.1.1.1Medical condition in easily understood language
    Migraine
    Emicrania
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10027599
    E.1.2Term Migraine
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of erenumab compared with placebo on the change in monthly migraine days (MMDs) from baseline to week 9 through week 12 (month 3) of the double-blind treatment phase (DBTP)
    Valutare l'effetto di erenumab rispetto al placebo sulla variazione in termini di giorni di emicrania mensile (MMD) dal basale alle settimane 9-12 (mese 3) della fase di trattamento in doppio cieco (DBTP)
    E.2.2Secondary objectives of the trial
    - To evaluate the effect of erenumab compared with placebo on the change in monthly headache days from baseline to week 9 through week 12 of the DBTP.
    - To evaluate the effect of erenumab compared with placebo on the proportion of subjects with at least 50% reduction in MMDs from baseline to week 9 through week 12 of the DBTP.
    - To evaluate the effect of erenumab compared with placebo on change in MMDs from baseline to the average of the first 3 months of the DBTP.
    - To evaluate the effect of erenumab compared with placebo on change in MMDs from baseline to the average of the 6-month DBTP.
    - To evaluate the effect of erenumab compared with placebo on change in monthly average severity of migraine attacks from baseline to week 9 through week 12 of the DBTP.
    - To evaluate the effect of erenumab compared with placebo on change in migraine-related disability and productivity as measured by the modified Pediatric Migraine Disability Assessment from baseline to month 3 of the DBTP
    - Valutare l’effetto di erenumab rispetto al placebo sulla variazione dei giorni di cefalea mensili dal basale alle settimane 9-12 della DBTP.
    - Valutare l’effetto di erenumab rispetto al placebo sulla proporzione di soggetti con una riduzione di almeno il 50% degli MMD dal basale alle settimane 9-12 della DBTP.
    - Valutare l’effetto di erenumab rispetto al placebo sulla variazione degli MMD dal basale alla media dei primi 3 mesi della DBTP.
    - Valutare l’effetto di erenumab rispetto al placebo sulla variazione degli MMD dal basale alla media della DBTP di 6 mesi.
    - Valutare l’effetto di erenumab rispetto al placebo sulla variazione della gravità media mensile degli attacchi di emicrania dal basale alle settimane 9-12 della DBTP.
    - Valutare l’effetto di erenumab rispetto al placebo sulla variazione della disabilità correlata all’emicrania e sulla produttività misurata tramite il questionario PedMIDAS modificato dal basale al mese 3 della DBTP.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: 40-week optional dose-level-blinded extension phase (DLBEP), during which all subjects will receive erenumab at the blinded dose level.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Fase di estensione facoltativa in cieco rispetto alla dose (DLBEP) della durata di 40 settimane, durante la quale tutti i soggetti riceveranno erenumab in cieco rispetto alla dose.
    E.3Principal inclusion criteria
    -Children (6 to < 12 years of age) or adolescent (12 to < 18 years of age) at the time of signing, if developmentally appropriate, the formal assent to participate to the study.
    -Subject's parent or legal representative has provided written informed consent before initiation of any study-specific activities/procedures.
    -History of migraine (with or without aura) for > =12 months before screening according to the IHS Classification ICHD-3 based on medical records and/or subject self-report or parents' or legal representative's report
    -History of < 15 headache days per month of which > = 8 headache days were assessed by the subject as migraine days per month in each of the 3 months prior to screening
    -Migraine frequency: > = 8 migraine days during the baseline phase based on the eDiary calculations.
    -Headache frequency of > = 15 headache days during the baseline phase based on the eDiary calculations.
    -Demonstrated at least 80% compliance with the eDiary (eg, completing eDiary items for at least 23 out of 28 days during the baseline phase).
    -Bambini (di età compresa tra 6 e 12 anni) o adolescenti (di età compresa tra i 12 e i 18 anni) che al momento della firma, se appropriato dal punto di vista dello sviluppo, l'assenso formale a partecipare allo studio.
    -Genitore o legale rappresentante del soggetto ha fornito il consenso informato scritto prima dell'avvio di qualsiasi attività / procedura specifica dello studio.
    -Anamnesi di emicrania (con o senza aura) per un periodo > = 12 mesi prima dello screening in base alla classificazione IHS ICHD-3 basata su cartelle cliniche e/o soggetto ad autovalutazione o relazione di genitori o rappresentanti legali.
    -Amamnesi di emicrania < 15 giorni al mese di cui > = 8 giorni di emicrania sono stati valutati dal soggetto come giorni di emicrania al mese in ciascuno dei 3 mesi precedenti allo screening.
    -Frequenza dell'emicrania: > = 8 giorni di emicrania durante la fase di riferimento basata sui calcoli di eDiary.
    -Frequenza del mal di testa pari a > = 15 giorni di mal di testa durante la fase di riferimento basata sui calcoli di eDiary.
    -Dimostrata almeno l'80% di conformità con l'eDiary (ad esempio, completando gli articoli eDiary per almeno 23 giorni su 28 durante la fase di riferimento).
    E.4Principal exclusion criteria
    -History of cluster headache or hemiplegic migraine headache.
    -Chronic migraine with continuous pain, in which the subject does not have any pain free periods (of any duration) during the 1 month prior to screening
    -No therapeutic response with > 3 of the following 10 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial.
    -Malignancy within 5 years before screening.
    -History of suicidal behavior or the subject is at risk of self-harm or harm to others as evidenced by endorsement of items 4 or 5 on the CSSRS assessed at screening.
    -Evidence of drug or alcohol abuse or dependence within 12 months before screening, based on medical records, subject self-report, or positive urine drug test performed during screening (with the exception of prescribed medications such as opioids or barbiturates).

    *Please, refers to protocol for the full list
    -Storia di cefalea a grappolo o emicrania emiplegica.
    -Emicrania cronica con dolore continuo, durante la quale i soggetti non manifestano periodi senza dolore (di qualsiasi durata) durante il mese precedente lo screening.
    -Nessuna risposta terapeutica con > 3 delle seguenti 10 categorie di farmaci per il trattamento profilattico dell'emicrania dopo un adeguato studio terapeutico.
    -Malignità entro 5 anni prima dello screening.
    -Storia di comportamento suicida o il soggetto è a rischio di autolesionismo o danno verso gli altri come dimostrato dall'approvazione dei punti 4 o 5 sulla CSSRS valutata allo screening.
    -Prova di abuso o dipendenza da alcol o da droghe nei 12 mesi precedenti lo screening, sulla base di cartelle cliniche, autoreferti, o test delle urine positivo eseguito durante lo screening (ad eccezione di farmaci prescritti come oppioidi o barbiturici).

    *Fare riferimento al protocollo per la lista completa
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in MMDs to week 9 through week 12 (month 3) of the DBTP.
    Variazione degli MMD dal basale alle settimane 9-12 (mese 3) della DBTP.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months
    3 mesi
    E.5.2Secondary end point(s)
    - Change from baseline in monthly headache days to week 9 through week 12 (month 3) of the DBTP
    - Achievement of at least 50% reduction in MMDs from baseline to week 9 through week 12 (month 3) of the DBTP.
    - Change from baseline in MMDs to the average of the first 3 months (week 1 through week 12) of the DBTP.
    - Change from baseline in MMDs to the average of the 6-month DBTP (week 1 through week 24).
    - Change from baseline in average monthly severity of migraine attacks to week 9 through week 12 (month 3) of the DBTP.
    - Change from baseline in migraine-related disability and productivity as measured by the modified PedMIDAS to month 3 of the DBTP.
    -Variazione dei giorni di cefalea mensili dal basale alle settimane 9-12 (mese 3) della DBTP.
    -Raggiungimento di una riduzione di almeno il 50% degli MMD dal basale alle settimane 9-12 (mese 3) della DBTP.
    -Variazione degli MMD dal basale alla media dei primi 3 mesi (settimane 1-12) della DBTP.
    -Variazione degli MMD dal basale alla media della DBTP di 6 mesi (settimane 1-24).
    -Variazione della gravità media mensile degli attacchi di emicrania dal basale alle settimane 9-12 (mese 3) della DBTP.
    -Variazione della disabilità correlata all’emicrania e alla produttività misurata tramite il PedMIDAS modificato dal basale al mese 3 della DBTP.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3,6 months
    3,6 mesi
    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 trial4
    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 EEA37
    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
    Belgium
    Canada
    Colombia
    Finland
    Germany
    Hungary
    Poland
    Russian Federation
    Switzerland
    United States
    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
    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 months6
    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 months6
    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: 30
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 256
    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
    Subject's parent or legal representative may provide written informed consent
    Il genitore o il legale rappresentante del soggetto può fornire il consenso informato scritto
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 98
    F.4.2.2In the whole clinical trial 286
    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)
    12-week safety follow-up (16 weeks after the last dose of investigational product)
    Follow-up di sicurezza a 12 settimane (16 settimane dopo l'ultima dose di prodotto sperimentale)
    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 Decision2019-10-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-14
    P. End of Trial
    P.End of Trial StatusOngoing
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