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    Clinical Trial Results:
    An Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 334

    Summary
    EudraCT number
    2013-005311-27
    Trial protocol
    SE   DE   DK   NO   PL   CZ   FI   GB  
    Global end of trial date
    26 May 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    09 Jun 2018
    First version publication date
    09 Jun 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    20130255
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02174861
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Amgen Inc.
    Sponsor organisation address
    One Amgen Center Drive, Thousand Oaks, CA, United States, 91320
    Public contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.com
    Scientific contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    09 Aug 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 May 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to characterize the safety and tolerability of long-term administration of erenumab.
    Protection of trial subjects
    This study was conducted in accordance with International Council for Harmonisation (ICH) Good Clinical Practice (GCP) regulations/guidelines, the GCPs applicable to all regions where the study was conducted and in accordance with the ethical principles set forth in the Declaration of Helsinki. The study protocol and all amendments, the informed consent form, and any accompanying materials provided to subjects were reviewed and approved by an independent Ethics Committee (IEC) or Institutional Review Board (IRB), as appropriate, at each center/country. The investigator or his/her designee informed the subject of all aspects pertaining to the subject’s participation in the study before any screening procedures were performed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    30 Jun 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 10
    Country: Number of subjects enrolled
    United States: 276
    Country: Number of subjects enrolled
    Czech Republic: 52
    Country: Number of subjects enrolled
    Denmark: 24
    Country: Number of subjects enrolled
    Finland: 35
    Country: Number of subjects enrolled
    Germany: 69
    Country: Number of subjects enrolled
    Norway: 31
    Country: Number of subjects enrolled
    Poland: 31
    Country: Number of subjects enrolled
    Sweden: 63
    Country: Number of subjects enrolled
    United Kingdom: 18
    Worldwide total number of subjects
    609
    EEA total number of subjects
    323
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    608
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Participants were enrolled at 64 centers across North America and Europe from 30 June 2014 to 4 March 2016. Participants who completed the 12-week double-blind treatment of the parent Study 20120295 (2013-001707-36) and met all Study 20130255 eligibility criteria were eligible for enrollment into this study.

    Pre-assignment
    Screening details
    Participants at sites in the United States, Sweden, and Germany had the option of enrolling in the Clinical Home Use (CHU) Substudy to assess their ability to self-administer 140 mg erenumab for in-home use. Participants in the substudy were randomized 1:1 to self-administer erenumab using either a prefilled syringe or autoinjector/pen.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Erenumab
    Arm description
    Participants received erenumab 70 mg once a month (QM) and/or 140 mg QM by subcutaneous injection for up to 52 weeks. Participants who enrolled prior to amendment 2 received erenumab 70 mg once a month (QM). Participants who had not completed the week 28 visit at the time of amendment 2 had their dose increased to 140 mg QM at their next visit whereas participants who had already completed the week 28 visit remained on erenumab 70 mg QM. Participants who enrolled after amendment 2 received erenumab 140 mg QM for the duration of the study.
    Arm type
    Experimental

    Investigational medicinal product name
    Erenumab
    Investigational medicinal product code
    AMG 334
    Other name
    Aimovig™
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered by subcutaneous injection once a month

    Number of subjects in period 1
    Erenumab
    Started
    609
    Received Erenumab 70 mg QM at Any Time
    549
    Received Erenumab 70 mg QM Only
    350 [1]
    Received Erenumab 70 mg and 140 mg QM
    199 [2]
    Received Erenumab 140 mg QM Only
    60 [3]
    Enrolled in CHU Substudy
    53 [4]
    Completed
    451
    Not completed
    158
         Decision by sponsor
    8
         Consent withdrawn by subject
    124
         Lost to follow-up
    26
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Data represent the number of subjects who enrolled prior to implementation of protocol amendment 2 and received erenumab 70 mg QM for the entire study.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Data represent the number of subjects who enrolled prior to implementation of protocol amendment 2 and initially received erenumab 70 mg QM and whose dose was increased to 140 mg QM after protocol amendment 2.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Data represent the number of subjects who enrolled after implementation of protocol amendment 2 and received erenumab 140 mg QM for the duration of the study.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Data represent the number of subjects who enrolled in the CHU substudy

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    Participants received erenumab 70 mg once a month (QM) and/or 140 mg QM by subcutaneous injection for up to 52 weeks. Participants who enrolled prior to amendment 2 received erenumab 70 mg once a month (QM). Participants who had not completed the week 28 visit at the time of amendment 2 had their dose increased to 140 mg QM at their next visit whereas participants who had already completed the week 28 visit remained on erenumab 70 mg QM. Participants who enrolled after amendment 2 received erenumab 140 mg QM for the duration of the study.

    Reporting group values
    Overall Study Total
    Number of subjects
    609 609
    Age Categorical
    Units: Subjects
        18 - 64 years
    608 608
        65 - 74 years
    1 1
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    42.5 ± 11.3 -
    Gender Categorical
    Units: Subjects
        Female
    509 509
        Male
    100 100
    Race
    Units: Subjects
        American Indian or Alaska Native
    0 0
        Asian
    7 7
        Black or African American
    25 25
        Native Hawaiian or Other Pacific Islander
    0 0
        White
    574 574
        Other
    3 3
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    25 25
        Not Hispanic or Latino
    584 584

    End points

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    End points reporting groups
    Reporting group title
    Erenumab
    Reporting group description
    Participants received erenumab 70 mg once a month (QM) and/or 140 mg QM by subcutaneous injection for up to 52 weeks. Participants who enrolled prior to amendment 2 received erenumab 70 mg once a month (QM). Participants who had not completed the week 28 visit at the time of amendment 2 had their dose increased to 140 mg QM at their next visit whereas participants who had already completed the week 28 visit remained on erenumab 70 mg QM. Participants who enrolled after amendment 2 received erenumab 140 mg QM for the duration of the study.

    Subject analysis set title
    Erenumab 140 mg PFS
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants in the CHU substudy self-administered erenumab 140 mg on days 29 and 57 by subcutaneous injection using a prefilled syringe (PFS).

    Subject analysis set title
    Erenumab 140 mg AI/Pen
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants in the CHU substudy self-administered erenumab 140 mg on days 29 and 57 by subcutaneous injection using a autoinjector/pen (AI/Pen).

    Primary: Number of Participants with Adverse Events

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    End point title
    Number of Participants with Adverse Events [1]
    End point description
    Adverse events (AEs) were graded for severity using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, where Grade 1 = mild AE, asymptomatic or mild symptoms; Grade 2 = Moderate AE; Grade 3 = Severe or medically significant but not immediately life-threatening; Grade 4 = Life-threatening consequences; urgent intervention indicated; Grade 5 = Death related to AE.
    End point type
    Primary
    End point timeframe
    From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks).
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The clinical hypothesis was that long-term exposure of erenumab would be safe and well tolerated in subjects with chronic migraine. No formal hypothesis was tested. This was a single-arm estimation study.
    End point values
    Erenumab
    Number of subjects analysed
    609
    Units: participants
        Any adverse event
    398
        Adverse event grade ≥ 2
    302
        Adverse event grade ≥ 3
    34
        Adverse event grade ≥ 4
    0
        Treatment-related adverse events
    114
        Serious adverse events
    24
        AE leading to discontinuation of erenumab
    16
        Fatal adverse events
    0
    No statistical analyses for this end point

    Primary: CHU Substudy: Number of Participants Able to Administer a Full Dose of Erenumab in Home-use

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    End point title
    CHU Substudy: Number of Participants Able to Administer a Full Dose of Erenumab in Home-use [2]
    End point description
    At the CHU substudy day 28 and day 56 visits, the site provided erenumab 140 mg to participants to self-administer at home on the following day. Study site staff then called the participants and asked if they administered a full, partial, or no dose of erenumab. A full dose was defined when the entire volume of both prefilled syringes or autoinjector/pens were injected.
    End point type
    Primary
    End point timeframe
    Day 29 (week 4) and day 57 (week 8) of the substudy
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: In the CHU substudy it was hypothesized that users were able to administer a full dose of erenumab comparably using either the prefilled syringe or autoinjector/pen. No formal hypotheses were tested.
    End point values
    Erenumab 140 mg PFS Erenumab 140 mg AI/Pen
    Number of subjects analysed
    27
    26
    Units: participants
        Week 4
    25
    26
        Week 8
    25
    25
    No statistical analyses for this end point

    Secondary: Change from Study 20120295 Baseline in Monthly Migraine Days

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    End point title
    Change from Study 20120295 Baseline in Monthly Migraine Days
    End point description
    A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine with or without aura. The change from baseline in monthly migraine days was calculated as the number of migraine days during the 4 weeks prior to each study visit – the number of migraine days during the 4-week baseline phase. The number of participants analyzed includes enrolled participants who received at least one dose of erenumab and had at least one change from baseline measurement in monthly migraine day in study 20130255 and with available data at each time point.
    End point type
    Secondary
    End point timeframe
    4-week baseline phase of Study 20120295 and the 4 weeks prior to the week 4, 8, 12, 24, 40, and 52 visits of Study 20130255
    End point values
    Erenumab
    Number of subjects analysed
    605
    Units: migraine days / month
    arithmetic mean (standard deviation)
        Baseline
    18.11 ± 4.53
        Change from baseline at week 4 (n = 561)
    -6.72 ± 6.22
        Change from baseline at week 8 (n = 574)
    -7.38 ± 6.50
        Change from baseline at week 12 (n = 560)
    -7.63 ± 6.49
        Change from baseline at week 24 (n = 481)
    -8.36 ± 6.29
        Change from baseline at week 40 (n = 430)
    -8.72 ± 6.53
        Change from baseline at week 52 (n = 383)
    -9.29 ± 6.64
    No statistical analyses for this end point

    Secondary: Percentage of Participants with at Least a 50% Reduction in Monthly Migraine Days From Study 20120295 Baseline

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    End point title
    Percentage of Participants with at Least a 50% Reduction in Monthly Migraine Days From Study 20120295 Baseline
    End point description
    A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine without aura or a migraine with aura. Monthly migraine days were calculated as the number of migraine days in the 4-week baseline phase and during the 4 weeks prior to each study visit. At least a 50% reduction from baseline (of study 20120295) in monthly migraine days was determined if the change in monthly migraine days from the 4-week baseline phase to the 4 weeks prior to each study visit * 100 / baseline monthly migraine days was less than or equal to -50%. The number of participants analyzed includes enrolled participants who received at least one dose of erenumab and had at least one change from baseline measurement in monthly migraine day in study 20130255 and with available data at each time point.
    End point type
    Secondary
    End point timeframe
    4-week baseline phase of Study 20120295 and the 4 weeks prior to the week 4, 8, 12, 24, 40, and 52 visits of Study 20130255
    End point values
    Erenumab
    Number of subjects analysed
    605
    Units: percentage of participants
    number (confidence interval 95%)
        Week 4 (n = 561)
    39.2 (35.3 to 43.3)
        Week 8 (n = 574)
    45.6 (41.6 to 49.7)
        Week 12 (n = 560)
    45.7 (41.6 to 49.9)
        Week 24 (n = 481)
    53.6 (49.2 to 58.0)
        Week 40 (n = 430)
    55.6 (50.9 to 60.2)
        Week 52 (n = 383)
    59.0 (54.0 to 63.8)
    No statistical analyses for this end point

    Secondary: Change From Study 20120295 Baseline in Monthly Acute Migraine-Specific Medication Treatment Days

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    End point title
    Change From Study 20120295 Baseline in Monthly Acute Migraine-Specific Medication Treatment Days
    End point description
    Monthly acute migraine-specific medication treatment days is the number of days on which migraine specific medications were used between monthly doses of study drug. Migraine-specific medications includes two categories of medications: triptan-based migraine medications and ergotamine-based migraine medications. The number of participants analyzed includes enrolled participants who received at least one dose of erenumab and had at least one change from baseline measurement in monthly migraine day in study 20130255 and with available data at each time point.
    End point type
    Secondary
    End point timeframe
    4-week baseline phase of Study 20120295 and the 4 weeks prior to the week 4, 8, 12, 24, 40, and 52 visits of Study 20130255
    End point values
    Erenumab
    Number of subjects analysed
    605
    Units: acute migraine treatment days / month
    arithmetic mean (standard deviation)
        Baseline
    9.53 ± 7.26
        Change from baseline at Week 4 (n = 561)
    -3.59 ± 4.62
        Change from baseline at Week 8 (n = 574)
    -4.01 ± 4.96
        Change from baseline at Week 12 (n = 560)
    -3.96 ± 5.03
        Change from baseline at Week 24 (n = 481)
    -4.39 ± 4.99
        Change from baseline at Week 40 (n = 430)
    -4.58 ± 5.00
        Change from baseline at Week 52 (n = 383)
    -4.97 ± 5.33
    No statistical analyses for this end point

    Secondary: Change From Study 20120295 Baseline in Cumulative Monthly Headache Hours

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    End point title
    Change From Study 20120295 Baseline in Cumulative Monthly Headache Hours
    End point description
    The cumulative duration of any qualified headache between monthly doses of study drug regardless of acute treatment use. A qualified headache was defined as follows: • a qualified migraine headache (including an aura-only event that is treated with acute migraine-specific medication), or • a qualified non-migraine headache, which is a headache that lasted continuously for ≥ 4 hours and was not a qualified migraine headache, or • a headache of any duration for which acute headache treatment was administered. The number of participants analyzed includes enrolled participants who received at least one dose of erenumab and had at least one change from baseline measurement in monthly migraine day in study 20130255 and with available data at each time point.
    End point type
    Secondary
    End point timeframe
    4-week baseline phase of Study 20120295 and the 4 weeks prior to the week 4, 8, 12, 24, 40, and 52 visits of Study 20130255
    End point values
    Erenumab
    Number of subjects analysed
    605
    Units: hours / month
    arithmetic mean (standard deviation)
        Baseline
    226.84 ± 125.54
        Change from baseline at week 4 (n = 561)
    -79.38 ± 107.56
        Change from baseline at week 8 (n = 574)
    -85.24 ± 110.24
        Change from baseline at week 12 (n = 560)
    -89.30 ± 111.47
        Change from baseline at week 24 (n = 481)
    -100.41 ± 112.30
        Change from baseline at week 40 (n = 430)
    -101.07 ± 111.77
        Change from baseline at week 52 (n = 383)
    -107.44 ± 113.60
    No statistical analyses for this end point

    Secondary: CHU Substudy: Number of Participants with Adverse Events

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    End point title
    CHU Substudy: Number of Participants with Adverse Events
    End point description
    Adverse events were graded for severity using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Injection site reactions were derived from a Medical Dictionary for Regulatory Activities (MedDRA) query using a list of pre-specified preferred terms. An adverse device effect (ADE) is any adverse event related to the use of a medical device.
    End point type
    Secondary
    End point timeframe
    From first dose of erenumab in the CHU substudy to 28 days after last dose of erenumab in the CHU substudy; up to 12 weeks.
    End point values
    Erenumab 140 mg PFS Erenumab 140 mg AI/Pen
    Number of subjects analysed
    27
    26
    Units: participants
        Any adverse event
    2
    6
        Adverse event grade ≥ 2
    1
    4
        Adverse event grade ≥ 3
    0
    0
        Adverse event grade ≥ 4
    0
    0
        Serious adverse events
    0
    0
        AE leading to discontinuation of erenumab
    0
    0
        Fatal adverse events
    0
    0
        Injection site reactions
    0
    1
        Adverse device effects
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Erenumab
    Reporting group description
    Participants received erenumab 70 mg once a month (QM) and/or 140 mg QM by subcutaneous injection for up to 52 weeks.

    Serious adverse events
    Erenumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    24 / 609 (3.94%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Post procedural oedema
         subjects affected / exposed
    1 / 609 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Congenital, familial and genetic disorders
    Myocardial bridging
         subjects affected / exposed
    1 / 609 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Medication overuse headache
         subjects affected / exposed
    1 / 609 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Migraine
         subjects affected / exposed
    4 / 609 (0.66%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Presyncope
         subjects affected / exposed
    1 / 609 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 609 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Radicular syndrome
         subjects affected / exposed
    1 / 609 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vestibular migraine
         subjects affected / exposed
    1 / 609 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    2 / 609 (0.33%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Alcoholism
         subjects affected / exposed
    1 / 609 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 609 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Volvulus
         subjects affected / exposed
    1 / 609 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Oesophagitis
         subjects affected / exposed
    1 / 609 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Alcoholic liver disease
         subjects affected / exposed
    1 / 609 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Costochondritis
         subjects affected / exposed
    1 / 609 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    3 / 609 (0.49%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 609 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Gastroenteritis viral
         subjects affected / exposed
    1 / 609 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 609 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 609 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Erenumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    162 / 609 (26.60%)
    Infections and infestations
    Sinusitis
         subjects affected / exposed
    44 / 609 (7.22%)
         occurrences all number
    57
    Upper respiratory tract infection
         subjects affected / exposed
    45 / 609 (7.39%)
         occurrences all number
    52
    Viral upper respiratory tract infection
         subjects affected / exposed
    96 / 609 (15.76%)
         occurrences all number
    127

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Jan 2015
    - updated to extend treatment phase by 3 months to align with 20120295 parent study - added novel PRO substudy for English-speaking subjects in US only - added Event Adjudication Committee to cover data from this study - refined some eligibility criteria and clarified some protocol text
    14 Oct 2015
    - primary objective and secondary objective of CHU substudy were added; 2 secondary and 1 exploratory objectives were added to the main study; 1 secondary objective was deleted; and 1 exploratory objective was modified - Study Rationale section was updated to include results from AMG 334 2012078 global phase 2 study - AMG 334 was increased to 140 mg to provide additional 6-month and one-year safety data at this dose - sample size was increased from 490 subjects to 651 subjects to align with increase in parent study - expansion of novel PRO substudy to all subjects, not just English-speaking subjects - added clarification to text of CHU substudy - expanded description of C-SSRS - clarified protocol text
    31 Mar 2016
    - clarified language regarding length of time surrounding excluded treatments - aligned current protocol template language (Sections 9 and 12) - updated pregnancy and lactation notification worksheets - clarifications made to product complaints section - review of adverse events and serious adverse events added to Open-label treatment phase - serious adverse events collection added for CHU substudy - correct typographical, grammatical, and formatting errors throughout the protocol

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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