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    Summary
    EudraCT Number:2013-001707-36
    Sponsor's Protocol Code Number:20120295
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-12-02
    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 ConcernedFinland - Fimea
    A.2EudraCT number2013-001707-36
    A.3Full title of the trial
    A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Chronic Migraine Prevention
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of the Effects of AMG 334 to Prevent Migraine Headaches
    A.4.1Sponsor's protocol code number20120295
    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 (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.5.4Telephone numberN/A
    B.5.5Fax numberN/A
    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.3.9.2Current sponsor codeAMG 334
    D.3.9.3Other descriptive nameAMG 334
    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
    Prevention of chronic migraine
    E.1.1.1Medical condition in easily understood language
    Migraine Headaches
    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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10027608
    E.1.2Term Migraine, unspecified
    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 effect of AMG 334 compared to placebo on the change from baseline in monthly migraine days, in subjects with chronic migraine
    E.2.2Secondary objectives of the trial
    Efficacy:
    • To evaluate the effect of AMG 334, compared to placebo, on the proportion of subjects
    with at least 50% reduction from baseline in monthly migraine days, in subjects with
    chronic migraine
    • To evaluate the effect of AMG 334, compared to placebo, as measured by the change from
    baseline on monthly migraine-specific medication treatment usage
    • To evaluate the effect of AMG 334, compared to placebo, as measured by change from
    baseline on monthly cumulative hours of headache

    Safety: To evaluate the safety and tolerability of AMG 334
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    There is an optional Pharmacokinetic (PK) Substudy.
    Subjects may also elect to participate in a Novel Patient-reported Outcome Substudy.
    E.3Principal inclusion criteria
    - Adults ≥ 18 to ≤ 65 years of age upon entry into screening
    - History of at least 5 attacks of migraine without aura and/or migraine with visual,
    sensory, speech and/or language, retinal or brainstem aura according to the IHS Classification ICHD-III (Headache Classification Committee of the International
    Headache Society, 2013) based on medical records and/or patient self-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
    E.4Principal exclusion criteria
    - Older than 50 years of age at migraine onset
    - History of cluster headache or hemiplegic migraine headache
    - Chronic migraine with continuous pain, in which the subject does not experience any pain free periods (of any duration) during the 1 month prior to screening
    - Taken an opioid and/or opioid-containing analgesic for any indication on greater than 12 days during the 3 months prior to screening
    - Taken a butalbital-containing analgesic for any indication on greater than 6 days during the 3 months prior to screening
    - No therapeutic response in prophylaxis of migraine after an adequate therapeutic trial to > 3 of the medication categories (detailled in the protocol)
    - Used a prohibited migraine prophylactic medication, device or procedure within 2 months prior to the start of the baseline phase (Refer to Section 6.5 for the list
    of excluded medications, devices and procedures)
    - Changing the dose of a concomitant medication that is not prescribed for migraine prophylaxis but that may have migraine prophylaxis effects within 1 month prior to screening. (Refer to Section 6.4 and Section 6.5 for the list of these medications)
    - Received botulinum toxin in the head and/or neck region within 4 months prior to Screening
    - History or evidence of unstable or clinically significant medical condition that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures of completion.
    - Excluded medical conditions include but not limited to:
    ∙ Currently diagnosed with fibromyalgia, and/or chronic pelvic pain
    ∙ History of major psychiatric disorder (such as schizophrenia or other psychotic disorders, bipolar disorder, obsessive-compulsive disorder, post-traumatic stress disorder), or current evidence of depression based on a Beck Depression Inventory (BDI)-II total score > 24 at screening.
    ∙ History of seizure disorder or other significant neurological conditions other than migraine
    ∙ Poorly controlled hypertension in the judgment of the investigator, or systolic blood pressure (BP) ≥ 160 mm Hg or diastolic BP ≥ 100 mm Hg as measured at the screening or week -4 study visits
    ∙ Myocardial infarction (MI), stroke, transient ischemic attack (TIA), unstable angina, coronary artery bypass surgery or other revascularization procedure within 12 months prior to screening
    - Female subject of childbearing potential who is unwilling to use an acceptable method of effective contraception during treatment with investigational product through 16 weeks after the last dose of investigational product.
    - 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), or previous discontinuation from another drug study due to a serious adverse event
    E.5 End points
    E.5.1Primary end point(s)
    Change in monthly migraine days from baseline to the last 4 weeks of the
    12-week double-blind treatment phase
    E.5.1.1Timepoint(s) of evaluation of this end point
    Change in monthly migraine days from baseline to the last 4 weeks of the
    12-week double-blind treatment phase, calculated based on the following: (number of migraine days during the last 4 weeks of the double-blind treatment phase, ie, between weeks 9 and 12) - (number of migraine days during the 4-week baseline phase)
    E.5.2Secondary end point(s)
    Efficacy:
    • At least a 50% reduction from baseline in monthly migraine days in the last 4 weeks of
    the 12-week double-blind treatment phase
    • Change from baseline on monthly migraine-specific medication treatment days in the last 4 weeks of the 12-week double-blind treatment phase
    • Change from baseline in cumulative monthly headache hours in the last 4 weeks of the 12-week double-blind treatment phase

    Safety:
    • Adverse events
    • Clinical laboratory values and vital signs
    • Anti-AMG 334 antibodies
    E.5.2.1Timepoint(s) of evaluation of this end point
    For full details, please refer to the schedule of assessments table in the protocol.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 concerned5
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Czech Republic
    Denmark
    Finland
    Germany
    Norway
    Poland
    Sweden
    United Kingdom
    United States
    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"
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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: 622
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 26
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 334
    F.4.2.2In the whole clinical trial 651
    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)
    N/A
    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 Decision2014-01-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-04-28
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