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    Summary
    EudraCT Number:2017-000630-57
    Sponsor's Protocol Code Number:20150308
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-06-30
    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 ConcernedSweden - MPA
    A.2EudraCT number2017-000630-57
    A.3Full title of the trial
    A Phase 2a Randomized Double-blind Placebo Controlled Study to Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2a Study of AMG 301 in Migraine Prevention
    A.4.1Sponsor's protocol code number20150308
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03238781
    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 301
    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 INNN/A
    D.3.9.2Current sponsor codeAMG 301
    D.3.9.3Other descriptive nameAMG 301
    D.3.9.4EV Substance CodeSUB172960
    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
    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 10058734
    E.1.2Term Migraine prophylaxis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    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 301 compared to placebo on the change from the baseline period in mean monthly migraine days in subjects with migraine
    E.2.2Secondary objectives of the trial
    •To evaluate the effect of AMG 301 compared to placebo on the proportion of subjects with at least 50% reduction from the baseline period in monthly migraine days

    •To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period in mean monthly acute migraine specific medication treatment days

    •To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period in mean monthly physical impairment domain score as measured by the Migraine Physical Function Impact Diary (MPFID)

    •To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period in mean monthly impact on everyday activities domain score as measured by the MPFID

    •To evaluate the safety and tolerability of AMG 301


    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    PART 1
    Subjects are eligible to be included in the baseline period of the study only if all of the following criteria apply:
    - Subject has provided informed consent prior to any study-specific activities/procedures being initiated
    - Adults ≥ 18 to ≤ 60 years of age at the time of signing the informed consent form.
    - History of migraine (with or without aura) for ≥ 12 months before screening according to the International Headache Society (IHS) Classification ICHD-III based on medical records and/or patient self-report.
    - Migraine frequency: ≥ 4 migraine days per month on average across the 3 months before screening
    - Failed at least 1 medication for prophylactic treatment of migraine due to tolerability or lack of efficacy as determined by the investigator, after an adequate therapeutic trial at a dose that is used in the prevention of migraine
    - Must meet 1 of the following acute migraine-specific treatment criteria:
    1. currently taking triptans or ergotamines as acute migraine treatment (within the last month)
    2. had previously responded to triptans or ergotamines but had to discontinue due to intolerance
    3. unable to take triptans or ergotamines as acute migraine treatments due to contraindications

    PART 2
    - Must meet the one of the following migraine criteria:
    CM is defined as:
    • ≥ 15 headache days of which ≥ 8 headache days meet criteria as migraine days during the baseline period based on the electronic diary (eDiary) calculations
    EM is defined as:
    • < 15 headache days of which at least 4 or more headache days meet criteria as migraine days during the baseline period 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 period)
    E.4Principal exclusion criteria
    PART 1
    Subjects are excluded from the study and the baseline period if any of the following criteria apply:
    Disease Related
    - Older than 50 years of age at migraine onset.
    - History of cluster headache, hemiplegic migraine headache
    - Unable to differentiate migraine from other headaches
    - Migraine with continuous pain, in which the subject does not experience any pain-free periods (of any duration) during the 1 month before the screening period

    Other Medical Conditions
    - Currently diagnosed with chronic pain syndromes (eg, fibromyalgia, chronic back pain, chronic pelvic pain)
    - History of major psychiatric disorder, (such as schizophrenia and bipolar disorder), or current evidence of depression based on a Beck Depression Inventory II (BDI-II) total score > 19 at screening. Subjects with anxiety disorder and/or major depressive disorder are permitted in the study if the investigator considers the subject 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 2 months before the start of the baseline period.
    - 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 before screening, except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ.
    - Known human immunodeficiency virus infection by history
    - Hepatic disease by history or total bilirubin ≥ 1.5 x upper limit of normal (ULN) or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.0 x ULN, as assessed by the central laboratory at screening.
    - Glycosylated hemoglobin (HbA1c) ≥ 6.0% at screening
    - Serum plasma glucose level ≥ 100 mg/dL at screening; ideally performed while fasting
    - History of diabetes mellitus or history of impaired fasting glucose
    - Body mass index (BMI) ≤ 18.0 or ≥ 40 at screening
    - Poorly controlled hypertension (systolic blood pressure 150 mmHg and/or diastolic blood pressure 90 mmHg or greater)
    - Myocardial infarction, stroke, transient ischemic attack, unstable angina, or coronary artery bypass surgery or other revascularization procedure within 12 months before 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 electrocardiogram (ECG) abnormality during screening that, in the opinion of the investigator, could pose a risk to subject safety or interfere with the study evaluation
    - Subject has a history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the Columbia-Suicide Severity Rating Scale (C-SSRS) 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 refer to study protocol for additional exclusions

    Part 2
    Subjects are excluded from the study if any of the following criteria apply:
    - Used a prohibited medication, device or procedure during the baseline period
    - Received botulinum toxin in the head and/or neck region during the baseline period
    - Taken opioid- or butalbital-containing analgesics or other narcotics (including tramadol, Fiorinal, Fioricet) on ≥ 4 days per month for any indication in any month during the baseline period
    - Subject has a history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the C-SSRS at baseline.
    E.5 End points
    E.5.1Primary end point(s)
    •Change from the baseline period in mean monthly migraine days. The mean monthly migraine days will be calculated using the migraine days over the last 4 weeks of the 12 week double blind treatment period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    •At least a 50% reduction from the baseline period in mean monthly migraine days in the last 4 weeks of the 12-week double-blind treatment period

    •Change from the baseline period in monthly acute migraine specific medication days in the last 4 weeks of the 12-week double-blind treatment period.

    •Change from the baseline period in mean physical impairment domain scores as measured by the MPFID over the last 4 weeks of the 12-week double-blind treatment period

    •Change from the baseline period in mean impact on everyday activities domain scores as measured by the MPFID over the last 4 weeks of the 12-week double blind treatment period

    Safety
    •Adverse events
    •Clinical laboratory values and vital signs
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    Austria
    Canada
    Czech Republic
    Denmark
    Finland
    Germany
    Sweden
    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
    The end of study date is defined as the date when the last subject across all sites is assessed or receives an intervention for evaluation in the study (ie, last subject last visit), following any additional parts in the study (eg, long-term follow-up), as applicable.
    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 months0
    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 months0
    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: 335
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 186
    F.4.2.2In the whole clinical trial 335
    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
    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 Decision2017-07-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-21
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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