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 were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    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

    Download PDF

    Clinical Trial Results:
    A 12-week double-blind, randomized, multicenter study comparing the efficacy and safety of once monthly subcutaneous 140 mg AMG334 against placebo in adult episodic migraine patients who have failed 2-4 prophylactic treatments (LIBERTY)

    Summary
    EudraCT number
    		 2016-002211-18
    Trial protocol
    		 CZ   GB   SE   DE   FI   ES   AT   DK   BE   GR   NL   FR   IT  
    Global end of trial date
    28 Jan 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Feb 2022
    First version publication date
    06 Feb 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CAMG334A2301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03096834
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    Novartis Campus, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.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
    28 Jan 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jan 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the effect of 140 mg AMG334 compared to placebo on the proportion of patients with at least 50% reduction from baseline in monthly migraine days (MMD).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Mar 2017
    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
    Australia: 2
    Country: Number of subjects enrolled
    Austria: 6
    Country: Number of subjects enrolled
    Belgium: 9
    Country: Number of subjects enrolled
    Czechia: 22
    Country: Number of subjects enrolled
    Denmark: 5
    Country: Number of subjects enrolled
    Finland: 8
    Country: Number of subjects enrolled
    France: 9
    Country: Number of subjects enrolled
    Germany: 66
    Country: Number of subjects enrolled
    Greece: 10
    Country: Number of subjects enrolled
    Italy: 16
    Country: Number of subjects enrolled
    Netherlands: 21
    Country: Number of subjects enrolled
    Norway: 21
    Country: Number of subjects enrolled
    Spain: 20
    Country: Number of subjects enrolled
    Sweden: 14
    Country: Number of subjects enrolled
    Switzerland: 8
    Country: Number of subjects enrolled
    United Kingdom: 9
    Worldwide total number of subjects
    246
    EEA total number of subjects
    227
    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)
    246
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 333 participants were screened for the trial

    Period 1
    Period 1 title
    Double-Blind Treatment Epoch
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AMG334 140 mg DB
    Arm description
    		 AMG334 140 mg subcutaneous injections administered every 4 weeks during Double-Blind Epoch
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMG334
    Investigational medicinal product code
    AMG334
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Two injections of AMG334 70 mg / 1 mL pre-filled syringe (equaling 140 mg total dose) were administered at Day 1 and Weeks 4 and 8 during DBTP

    Arm title
    		 Placebo DB
    Arm description
    		 Matching placebo subcutaneous injections administered every 4 weeks during Double-Blind Epoch
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Two injections of matching placebo were administered at Day 1 and Weeks 4 and 8 during DBTP

    Number of subjects in period 1
    		AMG334 140 mg DB Placebo DB
    Started
    121
    125
    Completed
    118
    122
    Not completed
    3
    3
         Protocol deviation
    2
    1
         Pregnancy
    -
    1
         Subject/guardian decision
    1
    1
    Period 2
    Period 2 title
    Open-Label Treatment Epoch
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AMG334 140 mg DB cont on AMG334 140 mg
    Arm description
    		 AMG334 140 mg subcutaneous injections during DB continued on AMG334 140 mg in Open-Label Epoch
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMG334
    Investigational medicinal product code
    AMG334
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Two injections of AMG334 70 mg / 1 mL pre-filled syringe (equaling 140 mg total dose) were administered at Week 12 and then every 4 weeks during OLTP and PTAP

    Arm title
    		 Placebo DB to AMG334 140 mg
    Arm description
    		 Placebo in Double-Blind Epoch (DB) switched to AMG334 140 mg in Open-Label Epoch
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMG334
    Investigational medicinal product code
    AMG334
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Two injections of AMG334 70 mg / 1 mL pre-filled syringe (equaling 140 mg total dose) were administered at Week 12 and then every 4 weeks during OLTP and PTAP

    Number of subjects in period 2
    		AMG334 140 mg DB cont on AMG334 140 mg Placebo DB to AMG334 140 mg
    Started
    118
    122
    Completed
    86
    83
    Not completed
    32
    39
         Physician decision
    1
    -
         Adverse event, non-fatal
    5
    6
         Pregnancy
    1
    -
         New therapy for study indication
    1
    1
         Subject/guardian decision
    9
    17
         Lack of efficacy
    15
    15
    Period 3
    Period 3 title
    Safety Follow-Up Epoch
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    No study treatment was administered during this safety follow-up.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AMG334 140 mg DB cont on AMG334 140 mg
    Arm description
    		 AMG334 140 mg subcutaneous injections during DB continued on AMG334 140 mg in Open-Label Epoch
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMG334
    Investigational medicinal product code
    AMG334
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Two injections of AMG334 70 mg / 1 mL pre-filled syringe (equaling 140 mg total dose) were administered at Week 12 and then every 4 weeks during OLTP and PTAP

    Arm title
    		 Placebo DB to AMG334 140 mg
    Arm description
    		 Placebo in Double-Blind Epoch (DB) switched to AMG334 140 mg in Open-Label Epoch
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMG334
    Investigational medicinal product code
    AMG334
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Two injections of AMG334 70 mg / 1 mL pre-filled syringe (equaling 140 mg total dose) were administered at Week 12 and then every 4 weeks during OLTP and PTAP

    Number of subjects in period 3 [1]
    		AMG334 140 mg DB cont on AMG334 140 mg Placebo DB to AMG334 140 mg
    Started
    66
    61
    Completed
    65
    59
    Not completed
    1
    2
         Protocol deviation
    -
    1
         Lost to follow-up
    1
    -
         New therapy for study indication
    -
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Not all participants continued into this Epoch.
    Period 4
    Period 4 title
    Post-Trial Access Epoch
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AMG334 140 mg DB cont on AMG334 140 mg
    Arm description
    		 AMG334 140 mg subcutaneous injections during DB continued on AMG334 140 mg in Open-Label Epoch
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMG334
    Investigational medicinal product code
    AMG334
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Two injections of AMG334 70 mg / 1 mL pre-filled syringe (equaling 140 mg total dose) were administered at Week 12 and then every 4 weeks during OLTP and PTAP

    Arm title
    		 Placebo DB to AMG334 140 mg
    Arm description
    		 Placebo in Double-Blind Epoch (DB) switched to AMG334 140 mg in Open-Label Epoch
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMG334
    Investigational medicinal product code
    AMG334
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Two injections of AMG334 70 mg / 1 mL pre-filled syringe (equaling 140 mg total dose) were administered at Week 12 and then every 4 weeks during OLTP and PTAP

    Number of subjects in period 4 [2]
    		AMG334 140 mg DB cont on AMG334 140 mg Placebo DB to AMG334 140 mg
    Started
    21
    15
    Completed
    21
    15
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Post-trial access to treatment was not available if commercially available.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    AMG334 140 mg DB
    Reporting group description
    		 AMG334 140 mg subcutaneous injections administered every 4 weeks during Double-Blind Epoch

    Reporting group title
    Placebo DB
    Reporting group description
    		 Matching placebo subcutaneous injections administered every 4 weeks during Double-Blind Epoch

    Reporting group values
    		 AMG334 140 mg DB Placebo DB Total
    Number of subjects
    		 121 125 246
    Age Categorical
    Participants who continued into Open-Label Epoch were the same participants in Double-Blind Treatment Epoch
    Units: Participants
        Between 18 and 65 years
    		 121 125 246
    Sex: Female, Male
    Units:
        Female
    		 97 103 200
        Male
    		 24 22 46
    Race/Ethnicity, Customized
    Units: Subjects
        Caucasian
    		 112 115 227
        Asian
    		 0 1 1
        Unknown
    		 0 1 1
        Other
    		 9 8 17
    Monthly Migraine Days at Baseline
    A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as: with/without aura, lasting ≥ 30 minutes with at least 1 criteria: 1. ≥ 2 of following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity, 2. ≥ 1 of the following symptoms: nausea and/or vomiting, photophobia and phonophobia. If a migraine-specific medication (ie, triptan or ergotamine) was taken during aura, or a headache, it was counted as a migraine day regardless of duration and pain features/associated symptoms.
    Units: Migraine days/month
        arithmetic mean (standard deviation)
    		 9.2 ( 2.56 ) 9.3 ( 2.72 ) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    AMG334 140 mg DB
    Reporting group description
    		 AMG334 140 mg subcutaneous injections administered every 4 weeks during Double-Blind Epoch

    Reporting group title
    Placebo DB
    Reporting group description
    		 Matching placebo subcutaneous injections administered every 4 weeks during Double-Blind Epoch
    Reporting group title
    AMG334 140 mg DB cont on AMG334 140 mg
    Reporting group description
    		 AMG334 140 mg subcutaneous injections during DB continued on AMG334 140 mg in Open-Label Epoch

    Reporting group title
    Placebo DB to AMG334 140 mg
    Reporting group description
    		 Placebo in Double-Blind Epoch (DB) switched to AMG334 140 mg in Open-Label Epoch
    Reporting group title
    AMG334 140 mg DB cont on AMG334 140 mg
    Reporting group description
    		 AMG334 140 mg subcutaneous injections during DB continued on AMG334 140 mg in Open-Label Epoch

    Reporting group title
    Placebo DB to AMG334 140 mg
    Reporting group description
    		 Placebo in Double-Blind Epoch (DB) switched to AMG334 140 mg in Open-Label Epoch
    Reporting group title
    AMG334 140 mg DB cont on AMG334 140 mg
    Reporting group description
    		 AMG334 140 mg subcutaneous injections during DB continued on AMG334 140 mg in Open-Label Epoch

    Reporting group title
    Placebo DB to AMG334 140 mg
    Reporting group description
    		 Placebo in Double-Blind Epoch (DB) switched to AMG334 140 mg in Open-Label Epoch

    Subject analysis set title
    AMG334 140 mg - All Patients
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All participants who received AMG334 during trial including participants who switched from placebo

    Primary: Percentage of participants with a 50% reduction from baseline of Monthly Migraine Days (MMD) in the last month (last 4 weeks of treatment)

    		 Close Top of page
    End point title
    		 Percentage of participants with a 50% reduction from baseline of Monthly Migraine Days (MMD) in the last month (last 4 weeks of treatment)
    End point description
    A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as: with/without aura, lasting ≥ 30 minutes with at least 1 criteria: 1. ≥ 2 of following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity, 2. ≥ 1 of the following symptoms: nausea and/or vomiting, photophobia and phonophobia. If a migraine-specific medication (ie, triptan or ergotamine) was taken during aura, or a headache, it was counted as a migraine day regardless of duration and pain features/associated symptoms.
    End point type
    Primary
    End point timeframe
    Baseline, Month 3 (last 4 weeks of treatment)
    End point values
    		 AMG334 140 mg DB Placebo DB
    Number of subjects analysed
    119
    124
    Units: Participants
        number (not applicable)
    30.3
    13.7
    Statistical analysis title
    		 Month 3 (last 4 weeks of treatment)
    Comparison groups
    Placebo DB v AMG334 140 mg DB
    Number of subjects included in analysis
    243
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.002
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.43
         upper limit
    		 5.19

    Secondary: Change from baseline in Monthly Migraine Days (MMD) in the last month (last 4 weeks of treatment)

    		 Close Top of page
    End point title
    		 Change from baseline in Monthly Migraine Days (MMD) in the last month (last 4 weeks of treatment)
    End point description
    A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as: with/without aura, lasting ≥ 30 minutes with at least 1 criteria: 1. ≥ 2 of following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity, 2. ≥ 1 of the following symptoms: nausea and/or vomiting, photophobia and phonophobia. If a migraine-specific medication (ie, triptan or ergotamine) was taken during aura, or a headache, it was counted as a migraine day regardless of duration and pain features/associated symptoms.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 3 (last 4 weeks of treatment)
    End point values
    		 AMG334 140 mg DB Placebo DB
    Number of subjects analysed
    118
    120
    Units: Monthly migraine days
    arithmetic mean (standard error)
        Month 3 n=118,120
    -1.75 ( 0.43 )
    -0.16 ( 0.41 )
    Statistical analysis title
    		 Month 3
    Comparison groups
    AMG334 140 mg DB v Placebo DB
    Number of subjects included in analysis
    238
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.004
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.67
         upper limit
    		 -0.51
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.55

    Secondary: Change from baseline in physical impairment and everyday activities as measured by the Migraine Physical Function Impact Diary (MPFID) at Month 3

    		 Close Top of page
    End point title
    		 Change from baseline in physical impairment and everyday activities as measured by the Migraine Physical Function Impact Diary (MPFID) at Month 3
    End point description
    MPFID has 2 domains: Everyday Activities, which consisted of 7 items and Physical Impairment with 5 items using a 5-point scale. Scores were summed across each domain and were then transformed and used for analyses. Transforming MPFID domain scores ranged from 0-100, where higher scores were indicative of greater migraine impact (ie, higher burden)
    End point type
    Secondary
    End point timeframe
    Baseline, Month 3 (last 4 weeks of treatment)
    End point values
    		 AMG334 140 mg DB Placebo DB
    Number of subjects analysed
    118
    120
    Units: scores on a scale
    arithmetic mean (standard error)
        Physical impairment domain n=118,120
    -1.85 ( 0.84 )
    1.61 ( 0.80 )
        Everyday activities domain n=118,120
    -3.36 ( 0.83 )
    0.55 ( 0.81 )
    Statistical analysis title
    		 Month 3
    Statistical analysis description
    Physical impairment domain
    Comparison groups
    AMG334 140 mg DB v Placebo DB
    Number of subjects included in analysis
    238
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.003
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.7
         upper limit
    		 -1.23
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.13
    Statistical analysis title
    		 Month 3
    Statistical analysis description
    Everyday activities domain
    Comparison groups
    AMG334 140 mg DB v Placebo DB
    Number of subjects included in analysis
    238
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.12
         upper limit
    		 -1.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.12

    Secondary: Change in the number of monthly acute migraine-specific medication treatment days at Month 3

    		 Close Top of page
    End point title
    		 Change in the number of monthly acute migraine-specific medication treatment days at Month 3
    End point description
    Number of days on which acute migraine-specific medications were used were recorded in eDiary between each monthly IP dose. Migraine-Specific medications included two categories of medications: triptan-based migraine medications and ergotamine-based migraine medications. Monthly migraine-specific medication use at baseline was the number of migraine-specific medication treatment days in the baseline period.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 3 (last 4 weeks of treatment)
    End point values
    		 AMG334 140 mg DB Placebo DB
    Number of subjects analysed
    118
    120
    Units: Migraine treatment specific days/month
        arithmetic mean (standard error)
    -1.25 ( 0.24 )
    0.46 ( 0.28 )
    Statistical analysis title
    		 Month 3
    Comparison groups
    AMG334 140 mg DB v Placebo DB
    Number of subjects included in analysis
    238
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.43
         upper limit
    		 -0.99
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.36

    Secondary: Percentage of participants with a 75% reduction from baseline of Monthly Migraine Days (MMD) in the last month (last 4 weeks of treatment)

    		 Close Top of page
    End point title
    		 Percentage of participants with a 75% reduction from baseline of Monthly Migraine Days (MMD) in the last month (last 4 weeks of treatment)
    End point description
    A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as: with/without aura, lasting ≥ 30 minutes with at least 1 criteria: 1. ≥ 2 of following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity, 2. ≥ 1 of the following symptoms: nausea and/or vomiting, photophobia and phonophobia. If a migraine-specific medication (ie, triptan or ergotamine) was taken during aura, or a headache, it was counted as a migraine day regardless of duration and pain features/associated symptoms.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 3 (last 4 weeks of treatment)
    End point values
    		 AMG334 140 mg DB Placebo DB
    Number of subjects analysed
    119
    124
    Units: Percentage of participants
        number (not applicable)
    11.8
    4.0
    Statistical analysis title
    		 Month 3
    Comparison groups
    AMG334 140 mg DB v Placebo DB
    Number of subjects included in analysis
    243
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.025
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.11
         upper limit
    		 9.01

    Secondary: Percentage of participants with a 100% reduction from baseline of Monthly Migraine Days (MMD) in the last month (last 4 weeks of treatment)

    		 Close Top of page
    End point title
    		 Percentage of participants with a 100% reduction from baseline of Monthly Migraine Days (MMD) in the last month (last 4 weeks of treatment)
    End point description
    A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as: with/without aura, lasting ≥ 30 minutes with at least 1 criteria: 1. ≥ 2 of following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity, 2. ≥ 1 of the following symptoms: nausea and/or vomiting, photophobia and phonophobia. If a migraine-specific medication (ie, triptan or ergotamine) was taken during aura, or a headache, it was counted as a migraine day regardless of duration and pain features/associated symptoms.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 3 (last 4 weeks of treatment)
    End point values
    		 AMG334 140 mg DB Placebo DB
    Number of subjects analysed
    119
    124
    Units: Percentage of participants
        number (not applicable)
    5.9
    0
    No statistical analyses for this end point

    Secondary: Number of participants who developed anti-AMG334 antibodies

    		 Close Top of page
    End point title
    		 Number of participants who developed anti-AMG334 antibodies
    End point description
    Blood samples for immunogenicity testing were collected for the measurement of anti-AMG334 binding antibodies.
    End point type
    Secondary
    End point timeframe
    Baseline up to 180 weeks
    End point values
    		 AMG334 140 mg - All Patients
    Number of subjects analysed
    238
    Units: participants
    0
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from the first dose of study treatment through the completion of the up to 196-week trial for a maximum treatment exposure of 199 weeks (includes 4 week follow-up).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    AMG334 140 mg DB
    Reporting group description
    		 AMG334 140 mg subcutaneous injections administered every 4 weeks during Double-Blind Epoch

    Reporting group title
    Placebo DB
    Reporting group description
    		 Matching placebo subcutaneous injections administered every 4 weeks during Double-Blind Epoch

    Reporting group title
    AMG334 140 mg DB cont on AMG334 140 mg
    Reporting group description
    		 AMG334 140 mg subcutaneous injections during DB continued on AMG334 140 mg in Open-Label Epoch

    Reporting group title
    Placebo DB to MG334 140mg
    Reporting group description
    		 Placebo in Double-Blind Epoch (DB) switched to AMG334 140 mg in Open-Label Epoch

    Serious adverse events
    		 AMG334 140 mg DB Placebo DB AMG334 140 mg DB cont on AMG334 140 mg Placebo DB to MG334 140mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 119 (1.68%)
    1 / 124 (0.81%)
    16 / 118 (13.56%)
    18 / 122 (14.75%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cervix carcinoma stage 0
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    1 / 118 (0.85%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myelofibrosis
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    1 / 118 (0.85%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pituitary tumour benign
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    0 / 118 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Allergy to arthropod sting
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    1 / 118 (0.85%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    0 / 118 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postmenopausal haemorrhage
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    0 / 118 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    0 / 118 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    0 / 118 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    0 / 118 (0.00%)
    2 / 122 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femoral neck fracture
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    1 / 118 (0.85%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    1 / 118 (0.85%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Traumatic fracture
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 124 (0.00%)
    0 / 118 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Extrasystoles
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    0 / 118 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Aura
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    1 / 118 (0.85%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    1 / 118 (0.85%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Medication overuse headache
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    1 / 118 (0.85%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 124 (0.00%)
    2 / 118 (1.69%)
    2 / 122 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Status migrainosus
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    0 / 118 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    0 / 118 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Dacryostenosis acquired
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    1 / 118 (0.85%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inflammation of lacrimal passage
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    1 / 118 (0.85%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal vein thrombosis
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    1 / 118 (0.85%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Anal fissure
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    0 / 118 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    0 / 118 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    0 / 118 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    0 / 118 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biliary colic
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    1 / 118 (0.85%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus urinary
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    0 / 118 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    1 / 118 (0.85%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    1 / 118 (0.85%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    0 / 118 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    0 / 118 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic sinusitis
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    0 / 118 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 124 (0.81%)
    0 / 118 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes simplex hepatitis
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    1 / 118 (0.85%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    0 / 118 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    1 / 118 (0.85%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 AMG334 140 mg DB Placebo DB AMG334 140 mg DB cont on AMG334 140 mg Placebo DB to MG334 140mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    44 / 119 (36.97%)
    43 / 124 (34.68%)
    94 / 118 (79.66%)
    101 / 122 (82.79%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 119 (0.84%)
    1 / 124 (0.81%)
    14 / 118 (11.86%)
    9 / 122 (7.38%)
         occurrences all number
    1
    1
    14
    13
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 119 (2.52%)
    2 / 124 (1.61%)
    5 / 118 (4.24%)
    7 / 122 (5.74%)
         occurrences all number
    3
    2
    8
    9
    Headache
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    5 / 118 (4.24%)
    7 / 122 (5.74%)
         occurrences all number
    0
    0
    5
    7
    Migraine
         subjects affected / exposed
    0 / 119 (0.00%)
    2 / 124 (1.61%)
    10 / 118 (8.47%)
    10 / 122 (8.20%)
         occurrences all number
    0
    2
    12
    22
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 119 (2.52%)
    2 / 124 (1.61%)
    9 / 118 (7.63%)
    8 / 122 (6.56%)
         occurrences all number
    3
    2
    11
    8
    Influenza like illness
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    11 / 118 (9.32%)
    6 / 122 (4.92%)
         occurrences all number
    0
    0
    14
    7
    Injection site haematoma
         subjects affected / exposed
    1 / 119 (0.84%)
    2 / 124 (1.61%)
    2 / 118 (1.69%)
    7 / 122 (5.74%)
         occurrences all number
    1
    3
    9
    14
    Injection site pain
         subjects affected / exposed
    7 / 119 (5.88%)
    7 / 124 (5.65%)
    8 / 118 (6.78%)
    8 / 122 (6.56%)
         occurrences all number
    21
    7
    55
    16
    Pyrexia
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 124 (0.00%)
    8 / 118 (6.78%)
    7 / 122 (5.74%)
         occurrences all number
    1
    0
    10
    9
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    8 / 118 (6.78%)
    6 / 122 (4.92%)
         occurrences all number
    0
    0
    12
    7
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    2 / 119 (1.68%)
    2 / 124 (1.61%)
    11 / 118 (9.32%)
    5 / 122 (4.10%)
         occurrences all number
    2
    2
    11
    5
    Diarrhoea
         subjects affected / exposed
    2 / 119 (1.68%)
    1 / 124 (0.81%)
    8 / 118 (6.78%)
    7 / 122 (5.74%)
         occurrences all number
    2
    1
    11
    11
    Nausea
         subjects affected / exposed
    3 / 119 (2.52%)
    2 / 124 (1.61%)
    6 / 118 (5.08%)
    9 / 122 (7.38%)
         occurrences all number
    3
    2
    6
    12
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 119 (0.84%)
    1 / 124 (0.81%)
    10 / 118 (8.47%)
    10 / 122 (8.20%)
         occurrences all number
    1
    1
    13
    12
    Oropharyngeal pain
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 124 (0.00%)
    13 / 118 (11.02%)
    6 / 122 (4.92%)
         occurrences all number
    1
    0
    16
    7
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    2 / 119 (1.68%)
    1 / 124 (0.81%)
    3 / 118 (2.54%)
    9 / 122 (7.38%)
         occurrences all number
    2
    2
    3
    9
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 119 (1.68%)
    4 / 124 (3.23%)
    9 / 118 (7.63%)
    12 / 122 (9.84%)
         occurrences all number
    2
    5
    15
    20
    Back pain
         subjects affected / exposed
    5 / 119 (4.20%)
    2 / 124 (1.61%)
    15 / 118 (12.71%)
    18 / 122 (14.75%)
         occurrences all number
    6
    2
    23
    24
    Neck pain
         subjects affected / exposed
    3 / 119 (2.52%)
    0 / 124 (0.00%)
    9 / 118 (7.63%)
    6 / 122 (4.92%)
         occurrences all number
    3
    0
    11
    11
    Pain in extremity
         subjects affected / exposed
    0 / 119 (0.00%)
    3 / 124 (2.42%)
    5 / 118 (4.24%)
    7 / 122 (5.74%)
         occurrences all number
    0
    3
    5
    8
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    2 / 119 (1.68%)
    1 / 124 (0.81%)
    8 / 118 (6.78%)
    9 / 122 (7.38%)
         occurrences all number
    2
    1
    9
    11
    Cystitis
         subjects affected / exposed
    1 / 119 (0.84%)
    2 / 124 (1.61%)
    7 / 118 (5.93%)
    8 / 122 (6.56%)
         occurrences all number
    1
    3
    11
    12
    Gastroenteritis
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 124 (0.00%)
    13 / 118 (11.02%)
    10 / 122 (8.20%)
         occurrences all number
    1
    0
    16
    12
    Influenza
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    15 / 118 (12.71%)
    26 / 122 (21.31%)
         occurrences all number
    0
    0
    20
    36
    Nasopharyngitis
         subjects affected / exposed
    6 / 119 (5.04%)
    12 / 124 (9.68%)
    45 / 118 (38.14%)
    68 / 122 (55.74%)
         occurrences all number
    6
    12
    93
    164
    Rhinitis
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    6 / 118 (5.08%)
    5 / 122 (4.10%)
         occurrences all number
    0
    0
    6
    6
    Sinusitis
         subjects affected / exposed
    1 / 119 (0.84%)
    1 / 124 (0.81%)
    10 / 118 (8.47%)
    13 / 122 (10.66%)
         occurrences all number
    1
    1
    11
    15
    Tonsillitis
         subjects affected / exposed
    1 / 119 (0.84%)
    1 / 124 (0.81%)
    6 / 118 (5.08%)
    2 / 122 (1.64%)
         occurrences all number
    1
    1
    9
    2
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 119 (3.36%)
    0 / 124 (0.00%)
    9 / 118 (7.63%)
    7 / 122 (5.74%)
         occurrences all number
    5
    0
    23
    12
    Urinary tract infection
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 124 (0.81%)
    8 / 118 (6.78%)
    16 / 122 (13.11%)
         occurrences all number
    0
    1
    13
    19

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Dec 2016
    The purpose of this amendment was to change the AMG 334 dose from 70 mg to 140 mg per administration, and to update the sample size based on new assumptions using 140 mg. The definitions of the formal end of trial (EoT) and final clinical study report (CSR) were expanded upon, in addition to the clarification of various protocol sections based on feedback received from sites and regulatory authorities.
    26 Oct 2017
    The purpose of this amendment was to incorporate an additional exploratory analysis based on a consultation with a health technology assessment (HTA) body and due to the fact that amitriptyline was approved in Europe as an additional therapy for migraine prophylaxis.
    02 Mar 2018
    The purpose of this amendment was to expand the duration of the Open-Label Treatment Epoch from 52 weeks (1 year) to 156 weeks (3 years), intended to collect further long-term safety and efficacy data on AMG 334 in episodic migraine patients who had previously failed 2 to 4 prophylactic migraine treatments.
    27 May 2020
    The purpose of this amendment was to provide Post-Trial Access (PTA) for patients who had completed the 3 year Open-Label Treatment Epoch and had demonstrated clinical benefit in the opinion of the Investigator, to ensure continued drug access until erenumab had received country-level launch and subsequent reimbursement decision or until December 2020 whichever came first.

    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
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Sat Apr 27 17:40:04 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA