Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   33754   clinical trials with a EudraCT protocol, of which   5467   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2014-004463-20
    Sponsor's Protocol Code Number:20120297
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-06-29
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2014-004463-20
    A.3Full title of the trial
    A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in 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.3.2Name or abbreviated title of the trial where available
    ARISE study
    A.4.1Sponsor's protocol code number20120297
    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, PO 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 INNNot applicable
    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
    Migraine Prevention
    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 18.1
    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 AMG 334 compared to placebo on the change from baseline in monthly migraine days, in subjects with episodic 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
    • To evaluate the effect of AMG 334 compared to placebo on the change from baseline in monthly acute migraine-specific medication treatment days
    • To evaluate the effect of AMG 334 compared to placebo on the change from baseline in physical impairment as measured by the Migraine Physical Function Impact Diary (MPFID)
    • To evaluate the effect of AMG 334 compared to placebo on the change from baseline in impact on everyday activities as measured by the MPFID
    Safety: To evaluate the safety and tolerability of AMG 334
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Criteria to be Assessed Prior to Entering the Subject into the Initial Screening Phase and/or Baseline Phase:
    • Adults ≥ 18 to ≤ 65 years of age upon entry into screening
    • Provided informed consent prior to initiation of any study-specific activities/procedures
    • History of migraine (with or without aura) for ≥ 12 months prior to screening according to the IHS Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2013) based on medical records and/or patient self-report
    • Migraine frequency: ≥ 4 and < 15 migraine days per month on average across the 3 months prior to screening
    • Headache (ie, migraine and non-migraine headache) frequency: < 15 headache days per month on average across the 3 months prior to screening
    Criteria to be Assessed During the Baseline Phase and Confirmed Prior to Randomizing the Subject into the Double-blind Treatment Phase:
    • Migraine frequency: ≥ 4 and < 15 migraine days during the baseline phase based on the eDiary calculations
    • Headache frequency: < 15 headache days during the baseline phase based on the eDiary calculations
    • Demonstrated at least 80% compliance with the eDiary (for example, completing eDiary items for at least 23 out of 28 days during the baseline phase)
    E.4Principal exclusion criteria
    • Older than 50 years of age at migraine onset
    • History of cluster headache or hemiplegic migraine headache
    • Unable to differentiate migraine from other headaches
    • No therapeutic response with > 2 of the following 7 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial. These medication categories are:
    - Category 1: Divalproex sodium, sodium valproate
    - Category 2: Topiramate
    - Category 3: Beta blockers
    - Category 4: Tricyclic antidepressants
    - Category 5: Serotonin-norepinephrine reuptake inhibitors
    - Category 6: Flunarizine, verapamil
    - Category 7: Lisinopril, candesartan
    • Used a prohibited medication, device, or procedure within 2 months prior to the start of the baseline phase or during the baseline phase
    • Received botulinum toxin in the head and/or neck region within 4 months prior to the start of the baseline phase or during the baseline phase
    • Taken the following for any indication in any month during the 2 months prior to the start of the baseline phase:
    - Ergotamines or triptans on ≥ 10 days per month, or
    - Simple analgesics on ≥ 15 days per month, or
    - Opioid- or butalbital-containing analgesics on ≥ 4 days per month
    • Anticipated to require any excluded medication, device, or procedure during the study
    • Active chronic pain syndromes (such as fibromyalgia and chronic pelvic pain)
    • Concomitant use of 2 or more medications with possible migraine
    prophylactic effects within 2 months prior to the start of the baseline phase or during the baseline phase
    • History of major psychiatric disorder (such as schizophrenia and bipolar disorder), or current evidence of depression based on a Beck Depression Inventory (BDI)-II total score > 19 at screening. Subjects with anxiety disorder and/or major depressive disorder are permitted in the study if they are considered by the investigator to be stable (with BDI-II ≤ 19) and are taking no more than 1 medication for each disorder. Subjects must have been on a stable dose within the 3 months prior to the start of the baseline phase.
    • History of seizure disorder or other significant neurological conditions other than migraine. Note: A single childhood febrile seizure is not exclusionary.
    • Malignancy within the 5 years prior to screening, except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ
    • Human immunodeficiency virus (HIV) infection by history
    • Hepatic disease by history or total bilirubin ≥ 2.0 x upper limit of normal (ULN) or alanine transaminase (ALT) or aspartate aminotransferase (AST) ≥ 3.0 x ULN, as assessed by the central laboratory at initial screening
    • Myocardial infarction (MI), stroke, transient ischemic attack (TIA), unstable angina, or coronary artery bypass surgery or other revascularization procedure within 12 months prior to screening
    • History or evidence of any other 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 or completion
    • Subject has any clinically significant vital sign, laboratory, 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
    • The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior or endorsing items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) assessed at screening
    • Evidence of drug or alcohol abuse or dependence within 12 months prior to screening, based on medical records, patient self-report, or positive urine drug test performed during screening (with the exception of prescribed medications such as opioids or barbiturates)
    • Pregnant or breastfeeding, or is a female expecting to conceive or breastfeed during the study, including through 12 weeks after the last dose of investigational product
    • Female subject of childbearing potential who is unwilling to use an acceptable method of effective contraception during treatment with investigational product through 12 weeks after the last dose of investigational product.
    • Currently receiving treatment in another investigational device or drug study, or less than 90 days prior to screening since ending treatment on another investigational device or drug study(-ies)
    • Known sensitivity to any component of the investigational product (Refer to the Investigational Product Instruction Manual [IPIM] for details)
    • Previously randomized into an AMG 334 study
    • Member of investigational site staff or relative of the investigator
    • Unlikely to be able to complete all protocol required study visits or procedures, and/or to comply with all required study procedures (eg, independent completion of electronic diary [eDiary] items) to the best of the subject’s and investigator’s knowledge
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in monthly migraine days in the last month (month 3) of the double-blind treatment phase
    E.5.1.1Timepoint(s) of evaluation of this end point
    For full details, please refer to the schedule of assessments table in the protocol.
    E.5.2Secondary end point(s)
    Efficacy:
    • Achievement of at least a 50% reduction from baseline in monthly migraine days in the last month of the double-blind treatment phase
    • Change from baseline in monthly acute migraine-specific medication treatment days in the last month of the double-blind treatment phase
    • Change from baseline in physical impairment in the last month of the double-blind treatment phase as measured by the Migraine Physical Function Impact Diary (MPFID)
    • Change from baseline in impact on everyday activities in the last month of the double-blind treatment phase as measured by the MPFID
    If the second tier of the secondary endpoints are statistically significant at significant level 0.01, then the first tier of the secondary endpoints can be tested at significance level 0.05 if it is not statistically significant under the original significance level 0.04.
    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 Yes
    E.6.3Therapy No
    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 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    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
    Denmark
    France
    Greece
    Mexico
    Portugal
    Russian Federation
    Spain
    Switzerland
    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 years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days27
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days27
    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: 540
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 161
    F.4.2.2In the whole clinical trial 540
    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 Decision2015-09-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-03-20
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-Sat Dec 15 14:13:04 GMT 2018 | 30 Churchill Place, Canary Wharf, London E14 5EU
    Legal notice
    EMA HMA