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    Summary
    EudraCT Number:2018-003342-16
    Sponsor's Protocol Code Number:20170703
    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 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-003342-16
    A.3Full title of the trial
    A Phase 4, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of
    Erenumab in Adults With Chronic Migraine and Medication Overuse Headache
    Studio di fase 4 randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli per valutare l’efficacia e la sicurezza di erenumab in adulti con emicrania cronica e cefalea da uso eccessivo di farmaci
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 4 Randomized Controlled Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache
    Studio di fase 4 randomizzato e controllato per valutare l’efficacia e la sicurezza di erenumab in adulti con cefalea da uso eccessivo di farmaci
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code number20170703
    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 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 S.r.l.
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressVia Tazzoli 6
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20154
    B.5.3.4CountryItaly
    B.5.4Telephone number0039026241121
    B.5.5Fax number0039026241121
    B.5.6E-mailmedicalinformationitaly@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 - pre-filled syringe 70 mg/mL
    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.3.9.1CAS 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 milligram(s)
    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 - pre-filled pen 70mg/mL
    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.3.9.1CAS 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 milligram(s)
    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: 3
    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 - pre-filled pen 140mg/mL
    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.3.9.1CAS 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 milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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 achieving medication overuse headache (MOH) remission during the double-blind treatment period (DBTP)
    Valutare l’effetto di erenumab rispetto al placebo in termini di conseguimento di una remissione della cefalea da uso eccessivo di farmaci (MOH) durante il periodo di trattamento in doppio cieco (Double-Blind Treatment Period, DBTP)
    E.2.2Secondary objectives of the trial
    - To evaluate the effect of erenumab compared with placebo in reducing AHMD during the DBTP
    - To evaluate the effect of erenumab compared with placebo on sustaining MOH remission during the DBTP
    - To evaluate the effect of erenumab compared with placebo on reducing the impact of migraines on physical impairment and
    everyday activities as measured by the Migraine Physical Function Impact Diary (MPFID) during the DBTPa
    - To evaluate the effect of erenumab compared to placebo on change from baseline in headache impact scores as measured by the Headache Impact Test (HIT-6)
    - Valutare l'effetto di erenumab rispetto al placebo nel ridurre AHMD (Acute Headache Medication Days) durante il DBTP
    - Valutare l'effetto di erenumab rispetto al placebo in termini di mantenimento della remissione della cefalea da uso eccessivo
    di farmaci durante il periodo di trattamento in doppio cieco
    - Valutare l'effetto di erenumab rispetto al placebo in termini di riduzione dell’impatto dell’emicrania sulla disabilità fisica e sulle attività quotidiane in base all’MPFID (Migraine Physical Function Impact Diary) durante il periodo di trattamento in doppio cieco
    -Valutare l'effetto di erenumab rispetto al placebo in termini di variazione rispetto al basale dei punteggi riferiti all’impatto della cefalea, misurati con lo strumento HIT-6 (Headache Impact Test)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subject has provided informed consent prior to initiation of any study-specific activities/procedures
    - Age > = 18 years on entry into the study
    - Documented history of migraine without aura and/or migraine with aura according to the ICHD-3 Classification for > = 12 months at screening
    - Documented history of CM for a minimal duration of 6 months before screening
    - Current diagnosis of MOH
    - History of treatment failure with at least 1 preventive treatment as defined as treatment discontinuation due to lack of efficacy, adverse event or general poor tolerability

    *Please, refers to protocol for the full list.
    - ll soggetto ha fornito il consenso informato prima di iniziare qualsiasi attività/procedura studio specifica
    - Età > = 18 anni all'entrata nello studio
    - Anamnesi documentata di emicrania senza aura e/o emicrania con aura secondo la classificazione ICHD-3 (International Classification of Headache Disorders) a > = 12 mesi al momento dello screening
    - Anamnesi documentata di emicrania cronica per una durata minima di 6 mesi prima dello screening
    - Diagnosi attuale di MOH (Medication-overuse headache)
    - Storia di fallimento terapeutico con almeno un trattamento preventivo definito come interruzione del trattamento per mancanza di efficacia, evento avverso o generale scarsa tollerabilità

    *Fare riferimento al protocollo per la lista completa
    E.4Principal exclusion criteria
    - Age > 50 years at migraine onset or > 65 years at CM onset
    - History of hemiplegic migraine, cluster headache or other trigeminal autonomic cephalalgia
    - Current concomitant diagnosis of a secondary type of headache other than MOH
    - History of clinically significant orofacial pain (eg, painful cranial neuropathies, temporomandibular disorder) that in the opinion of the investigator or Amgen's physician, if consulted, could interfere with the study evaluation, procedures or completion
    - Chronic headache with continuous pain, in which the subject does not experience headache-free periods of any duration

    *Please, refers to protocol for the full list.
    - Età > 50 anni alla comparsa di emicrania o > 65 alla comparsa di emicrania cronica
    - Anamnesi di emicrania emiplegica, cefalea a grappolo o altre cefalee autonomiche trigeminali
    - Diagnosi concomitante di un tipo secondario di cefalea oltre alla MOH
    - Anamnesi di dolore orofacciale clinicamente significativo (es. Neuropatie craniche dolorose, disordine temporo-mandibolare) che secondo il parere dello sperimentatore o del medico di Amgen, se consultato, potrebbe interferire con la valutazione, le procedure o il completamento dello studio
    - Mal di testa cronico con dolore continuo, in cui il soggetto non sperimenta periodi senza mal di testa di qualsiasi durata

    *Fare riferimento al protocollo per la lista completa
    E.5 End points
    E.5.1Primary end point(s)
    Absence of MOH at month 6 as defined by mean monthly acute headache medication days (AHMD) < 10 days over months 4, 5, and 6 (week 12 through 24) OR mean monthly headache days (MHD) < 14 days over months 4, 5, and 6 (week 12 through 24) of the DBTP where AHMD include any eDiary day in which an acute headache medication intake is reported
    Assenza di cefalea da uso eccessivo di farmaci al mese 6 intesa come un numero medio mensile di giorni di utilizzo di farmaci per cefalea acuta (Acute Headache Medication
    Days, AHMD) <10 nel corso dei mesi 4, 5 e 6 (settimana dalla 12 alla 24) OPPURE come un numero medio di giorni mensili di cefalea (MHD) <14 nel corso dei mesi 4, 5 e 6
    (settimana dalla 12 alla 24) del periodo di trattamento in doppio cieco, includendo tra gli AHMD qualsiasi giorno del diario elettronico in cui sia annotata l’assunzione di un farmaco per il trattamento acuto della cefalea
    E.5.1.1Timepoint(s) of evaluation of this end point
    Months 4,5 and 6 (week 12 through 24)
    Mesi 4, 5 e 6 (settimana dalla 12 alla 24)
    E.5.2Secondary end point(s)
    - Change from baseline in mean monthly AHMD over months 4, 5, and 6 (week 13 through 24) of the DBTP
    - Sustained MOH remission during DBTP, as defined by absence of MOH at months 3 (week 12) and 6 (week 24) of the DBTP, and "absence of MOH" is achieved when mean monthly AHMD < 10 days OR mean MHD < 14 days over the respective 3-month period
    - Change from baseline in mean monthly average physical impairment domain scores as
    measured by the MPFID over months 4, 5, and 6 (week 13 through 24) of the DBTP
    - Change from baseline in mean monthly average impact on everyday activities domain
    scores as measured by the MPFID over months 4, 5, and 6 (week 13 through 24) of the
    DBTP
    - Change from baseline in mean HIT-6 score over months 4, 5, and 6 (week 13 through
    24) of the DBTP
    - Variazione rispetto al basale del numero medio di giorni mensili di utilizzo di farmaci per il trattamento acuto della cefalea nel corso dei mesi 4, 5 e 6 (settimana dalla 13 alla 24) del periodo di trattamento in doppio cieco
    - Remissione protratta della cefalea da uso eccessivo di farmaci durante il periodo di
    trattamento in doppio cieco, intesa come assenza di cefalea da uso eccessivo di
    farmaci ai mesi 3 (12 settimane) e 6 (24 settimane) del periodo di trattamento in doppio
    cieco, con “assenza di cefalea da uso eccessivo di farmaci” raggiunta in presenza di
    un numero medio di giorni mensili di utilizzo di farmaci per il trattamento acuto
    della cefalea <10 OPPURE in presenza di un numero medio di giorni mensili di cefalea
    <14 nel corso del rispettivo intervallo di 3 mesi
    - Variazione rispetto al basale dei punteggi medi mensili riferiti al dominio di disabilità fisica media misurati mediante MPFID nel corso dei mesi 4, 5 e 6 (dalla settimana 13 alla 24) del periodo di trattamento in doppio cieco
    - Variazione rispetto al basale dei punteggi medi mensili riferiti al dominio dell’impatto medio sulle attività quotidiane misurati mediante MPFID nel corso dei mesi 4, 5 e 6 (dalla settimana 13 alla 24) del periodo di trattamento in doppio cieco
    - Variazione rispetto al basale del punteggio HIT-6 medio nel corso dei mesi 4, 5 e 6
    (dalla settimana 13 alla 24) del periodo di trattamento in doppio cieco
    E.5.2.1Timepoint(s) of evaluation of this end point
    Months 4,5 and 6 (week 12 through 24)
    Mesi 4, 5 e 6 (settimana dalla 12 alla 24)
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 EEA55
    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
    Australia
    Canada
    Japan
    United States
    Austria
    Finland
    France
    Hungary
    Italy
    Poland
    Portugal
    Spain
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    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 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: 687
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state58
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 410
    F.4.2.2In the whole clinical trial 687
    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
    Nessuno
    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 Decision2019-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-11
    P. End of Trial
    P.End of Trial StatusOngoing
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