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    Summary
    EudraCT Number:2017-002399-23
    Sponsor's Protocol Code Number:20160354
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2019-03-27
    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 ConcernedGermany - PEI
    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])
    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
    A.4.1Sponsor's protocol code number20160354
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03836040
    A.5.4Other Identifiers
    Name:EU CT NUmberNumber:2023-504928-26
    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 GmbH
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressRiesstr. 24
    B.5.3.2Town/ cityMünchen
    B.5.3.3Post code80992
    B.5.3.4CountryGermany
    B.5.4Telephone number+498002643644
    B.5.6E-maileudemedinf@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 Yes
    D.2.1.1.1Trade name Aimovig
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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 nameAMG 334 vials
    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.3.9.3Other descriptive nameAMG 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 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 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 Aimovig
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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 nameAMG 334 PFS
    D.3.2Product code AMG 334
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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.3.9.3Other descriptive nameAMG 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 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 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
    E.1.1.1Medical condition in easily understood language
    Migraine
    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).
    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 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 week
    9 through week 12 (month 3) of the 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
    40-week optional dose-level-blinded extension phase (DLBEP),
    during which all subjects will receive erenumab at the blinded dose level.
    E.3Principal inclusion criteria
    101 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.
    102 Subject's parent or legal representative has provided written
    informed consent before initiation of any study-specific
    activities/procedures.
    103 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
    104 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
    105 Migraine frequency: ≥ 8 migraine days based on the eDiary data
    during the last 28 days of the baseline phase if > 28 days in duration.
    106 Headache frequency of ≥ 15 headache days based on the eDiary
    data during the last 28 days of the baseline phase if > 28 days in
    duration.
    107 Demonstrated at least 80% compliance with the eDiary based on the
    last 28 days of the baseline period, if > 28 days in duration (eg,
    completing eDiary items for at least 23 out of the last 28 days of the
    baseline phase).
    E.4Principal exclusion criteria
    201 History of cluster headache or hemiplegic migraine headache.
    202 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
    203 No therapeutic response with > 3 of the following 10 medication
    categories for prophylactic treatment of migraine after an adequate
    therapeutic trial.
    204 Malignancy within 5 years before screening.
    205 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.
    206 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).
    207 Human immunodeficiency virus (HIV) infection by history.
    208 History of seizure disorder or other significant neurological disorder
    other than migraine. Note: a single childhood febrile seizure is not
    exclusionary.
    209 History of major psychiatric disorder
    210 Use of a prohibited medication within 15 days before the start of
    the baseline phase and/or during the baseline phase
    211 Use of prohibited devices (such as stimulation devices) or
    procedures (such as acupuncture, biofeedback, relaxation techniques, or
    psychotherapy) with the goal of preventing migraines, within 3 months
    before the start of the baseline phase and/or during the baseline phase.
    Note: Subjects who have discontinued CBT within 3 months prior to the
    start of the baseline phase are eligible for the study provided that there
    is evidence of CBT failure/lack of efficacy prior to initial screening (per
    medical records or investigator's assessment).
    212 Received botulinum toxin in the head and/or neck region within 4
    months before the start of the baseline phase or during the baseline phase
    213 Received medication targeting the CGRP pathway within 4 months
    before the start of the baseline phase or during the baseline phase
    214 Taken the following for any indication in any month during the 2
    months before the start of the baseline phase or during the baseline
    phase:
     Opioid or butalbital-containing analgesics on ≥ 4 days per month.
    215 Currently receiving treatment in another investigational device or
    drug study, or less than 90 days since ending treatment on another
    investigational device or drug study(ies). Other investigational
    procedures while participating in this study are excluded
    216 Subject has clinically significant vital signs, laboratory results, or
    ECG
    abnormality during screening that, in the opinion of the investigator,
    could pose a risk to subject safety or interfere with the study evaluation.
    217 Hepatic disease by history or total bilirubin (TBL) ≥ 2.0 x upper limit
    of normal (ULN) or alanine aminotransferase (ALT) or aspartate
    aminotransferase (AST) ≥ 3.0 x ULN, as assessed by the central
    laboratory at initial screening.
    218 Female subject is pregnant or breastfeeding or planning to become
    pregnant or breastfeed during the study and for an additional 16 weeks
    after the last dose of investigational product. (Females of childbearing
    potential should only be included in the study after a confirmed
    menstrual period and a negative highly sensitive urine or serum
    pregnancy test.)
    219 Female subjects of childbearing potential unwilling to use an
    acceptable method of effective contraception during treatment and for
    an additional 16 weeks after the last dose of investigational product.
    Refer to Appendix 5 for additional contraceptive information.
    220 Subject has known sensitivity to any of the products or components
    to be
    administered during dosing
    221 Subject likely to not be available to complete all protocol-required
    study visits or procedures, and/or to comply with all required study
    procedures (eg, Clinical Outcome Assessments [COAs]) to the best of the
    subject's legal representative and investigator's knowledge.
    222 History or evidence of any other clinically significant disorder,
    condition or
    disease (with the exception of those outlined above) that, in the opinion
    of the
    investigator or Amgen physician, if consulted, would pose a risk to
    subject safety
    or interfere with the study evaluation, procedures or completion
    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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months
    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 monthly average 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 week 9 through week 12 (month
    3) of the DBTP.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3,6 months
    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 concerned6
    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 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
    Colombia
    Canada
    Japan
    Russian Federation
    United Kingdom
    United States
    Belgium
    Germany
    Hungary
    Italy
    Poland
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days8
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 286
    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 No
    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
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    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)
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-08-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-16
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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