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    Clinical Trial Results:
    Comprehensive Assessment of Erenumab Efficacy in Subjects With High Frequency Episodic Migraine With at Least 1 Previously Failed Preventive Treatment: a Global, Double-blind, Placebo-controlled Phase 4 Study

    Summary
    EudraCT number
    		 2019-003646-33
    Trial protocol
    		 PL   PT   HU   BG   CZ   IT   RO  
    Global end of trial date
    26 Oct 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Aug 2024
    First version publication date
    23 Aug 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    20190008
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04252742
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Amgen Inc.
    Sponsor organisation address
    One Amgen Center Drive, Thousand Oaks, CA, United States,
    Public contact
    IHQ Medical Info-Clinical Trials, Amgen Inc., MedInfoInternational@amgen.com
    Scientific contact
    IHQ Medical Info-Clinical Trials, Amgen Inc., 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
    26 Oct 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Oct 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study was to evaluate the treatment benefit of erenumab on headache duration of at least moderate pain intensity.
    Protection of trial subjects
    This study was conducted in accordance with the protocol and with consensus ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences International Ethical Guidelines, applicable International Council for Harmonisation (ICH) Good Clinical Practice and other applicable ICH laws and regulations/guidelines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Sep 2020
    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
    United States: 23
    Country: Number of subjects enrolled
    Bulgaria: 29
    Country: Number of subjects enrolled
    Czechia: 66
    Country: Number of subjects enrolled
    Hungary: 41
    Country: Number of subjects enrolled
    Italy: 53
    Country: Number of subjects enrolled
    Poland: 278
    Country: Number of subjects enrolled
    Portugal: 9
    Country: Number of subjects enrolled
    Romania: 2
    Country: Number of subjects enrolled
    Spain: 11
    Worldwide total number of subjects
    512
    EEA total number of subjects
    489
    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)
    501
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 61 study centers in North America and Europe from September 2020 to October 2023.

    Pre-assignment
    Screening details
    		 Eligible adult participants with high frequency episodic migraine (EP) who met specific eligibility criteria during a 2-week run-in period and 4-week baseline period entered the double-blind treatment period (DBTP). The DBTP included a 12-week main-DBTP (M-DBTP) and a 4-week exploratory DBTP (E-DBTP)

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants were randomized to receive matching placebo subcutaneously (SC) every 4 weeks (Q4W) for up to 16 weeks in the DBTP.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo was administered SC Q4W for up to 16 weeks.

    Arm title
    		 Erenumab 140 mg SC Q4W
    Arm description
    		 Participants were randomized to receive 140 mg erenumab SC Q4W for up to 16 weeks in the DBTP.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Erenumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Erenumab was administered SC Q4W for up to 16 weeks.

    Number of subjects in period 1
    		Placebo Erenumab 140 mg SC Q4W
    Started
    256
    256
    Received investigational product (IP)
    256
    254
    Completed
    241
    244
    Not completed
    15
    12
         Consent withdrawn by subject
    15
    9
         Lost to follow-up
    -
    1
         Decision by sponsor
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants were randomized to receive matching placebo subcutaneously (SC) every 4 weeks (Q4W) for up to 16 weeks in the DBTP.

    Reporting group title
    Erenumab 140 mg SC Q4W
    Reporting group description
    		 Participants were randomized to receive 140 mg erenumab SC Q4W for up to 16 weeks in the DBTP.

    Reporting group values
    		 Placebo Erenumab 140 mg SC Q4W Total
    Number of subjects
    		 256 256 512
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 250 251 501
        From 65-84 years
    		 6 5 11
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 42.5 ( 10.2 ) 41.9 ( 10.9 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 222 220 442
        Male
    		 34 36 70
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 7 7 14
        Not Hispanic or Latino
    		 248 249 497
        Unknown or Not Reported
    		 1 0 1
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 1 2 3
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 2 2 4
        White
    		 253 252 505
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0
    Monthly Hours of at Least Moderate Headache Pain Intensity
    At least moderate headache pain intensity was defined as headache pain intensity reported as 'Moderate' or 'Severe' based on the 3-level headache pain intensity scale. Worst or peak pain intensity during a headache was collected using the e-diary in 3-levels (mild, moderate or severe). The duration of headaches with at least moderate pain intensity was collected. Participants with observed data within the 4-week baseline period are included (N=255 for Placebo and N=256 for Erenumab 140 mg SC Q4W).
    Units: hours/month
        arithmetic mean (standard deviation)
    		 47.382 ( 29.302 ) 48.843 ( 29.502 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants were randomized to receive matching placebo subcutaneously (SC) every 4 weeks (Q4W) for up to 16 weeks in the DBTP.

    Reporting group title
    Erenumab 140 mg SC Q4W
    Reporting group description
    		 Participants were randomized to receive 140 mg erenumab SC Q4W for up to 16 weeks in the DBTP.

    Primary: Change from Baseline in Mean Monthly Hours of at Least Moderate Headache Pain Intensity Over Months 1, 2, and 3

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    End point title
    		 Change from Baseline in Mean Monthly Hours of at Least Moderate Headache Pain Intensity Over Months 1, 2, and 3
    End point description
    At least moderate headache pain intensity was defined as headache pain intensity reported as 'Moderate' or 'Severe' based on the 3-level headache pain intensity scale. Worst or peak pain intensity during a headache was collected using the e-diary in 3-levels (mild, moderate or severe). The duration of headaches with at least moderate pain intensity was collected. A negative change from baseline indicates a reduction in mean monthly hours of at least moderate headache pain intensity. Change from baseline in mean monthly measurement is the arithmetic mean of the monthly change from baseline values for the months considered with observed data, if there was at least one observed monthly value. The least squares mean (LSM) estimates of change from baseline in reported headache pain intensity utilized a linear mixed model which included treatment, visit, treatment-by-visit interaction, and baseline value as covariates and assumed a first-order auto regression covariance structure.
    End point type
    Primary
    End point timeframe
    Baseline, Month 1, Month 2, and Month 3
    End point values
    		 Placebo Erenumab 140 mg SC Q4W
    Number of subjects analysed
    251 [1]
    253 [2]
    Units: hours/month
        least squares mean (standard error)
    -23.38 ( 1.26 )
    -31.33 ( 1.25 )
    Notes
    [1] - The M-DBTP efficacy analysis set.
    [2] - The M-DBTP efficacy analysis set.
    Statistical analysis title
    		 LSM Difference: Erenumab - Placebo
    Comparison groups
    Placebo v Erenumab 140 mg SC Q4W
    Number of subjects included in analysis
    504
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001 [3]
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -7.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.45
         upper limit
    		 -4.46
    Notes
    [3] - Nominal p-value is presented without multiplicity adjustment.

    Secondary: Change from Baseline in Mean Monthly Physical Function Domain Score as Measured by the Migraine Functional Impact Questionnaire (MFIQ) Over Months 1, 2, and 3

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    End point title
    		 Change from Baseline in Mean Monthly Physical Function Domain Score as Measured by the Migraine Functional Impact Questionnaire (MFIQ) Over Months 1, 2, and 3
    End point description
    The MFIQ is a self-administered 26-item instrument measuring the impact of migraine on broader functioning including on Physical Functioning (5 items). Participants responded to items using a 5-point scale assigned scores from 1 to 5, with 5 representing the greatest burden. Each domain score was calculated as the sum of the item responses and rescaled to a 0 to 100 scale, with higher scores representing greater burden. The recall period was the past 7 days. A negative change from baseline indicates an improvement in burden. Change from baseline in mean monthly scores is the arithmetic mean of the monthly change from baseline values for the months considered with observed data, if there was at least one observed monthly value. The LSM estimates utilized a linear mixed model which included treatment, visit, treatment-by-visit interaction, and baseline value as covariates and assumed a first-order auto regression covariance structure.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1, Month 2, and Month 3
    End point values
    		 Placebo Erenumab 140 mg SC Q4W
    Number of subjects analysed
    239 [4]
    244 [5]
    Units: score on a scale
        least squares mean (standard error)
    -22.92 ( 1.25 )
    -30.28 ( 1.23 )
    Notes
    [4] - The M-DBTP efficacy analysis set.
    [5] - The M-DBTP efficacy analysis set.
    Statistical analysis title
    		 LSM Difference: Erenumab - Placebo
    Comparison groups
    Placebo v Erenumab 140 mg SC Q4W
    Number of subjects included in analysis
    483
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001 [6]
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -7.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.8
         upper limit
    		 -3.92
    Notes
    [6] - Nominal p-value is presented without multiplicity adjustment.

    Secondary: Change from Baseline in Mean Monthly Usual Activities Domain Score as Measured by the MFIQ Over Months 1, 2, and 3

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    End point title
    		 Change from Baseline in Mean Monthly Usual Activities Domain Score as Measured by the MFIQ Over Months 1, 2, and 3
    End point description
    The MFIQ is a self-administered 26-item instrument measuring the impact of migraine on broader functioning including Impact on Usual Activities (10 items). Participants responded to items using a 5-point scale assigned scores from 1 to 5, with 5 representing the greatest burden. Each domain score was calculated as the sum of the item responses and rescaled to a 0 to 100 scale, with higher scores representing greater burden. The recall period was the previous 7 days. A negative change from baseline indicates an improvement in burden. Change from baseline in mean monthly scores is the arithmetic mean of the monthly change from baseline values for the months considered with observed data, if there was at least one observed monthly value. The LSM estimates utilized a linear mixed model which included treatment, visit, treatment-by-visit interaction, and baseline value as covariates and assumed a first-order auto regression covariance structure.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1, Month 2, and Month 3
    End point values
    		 Placebo Erenumab 140 mg SC Q4W
    Number of subjects analysed
    239 [7]
    244 [8]
    Units: score on a scale
        least squares mean (standard error)
    -23.98 ( 1.17 )
    -31.08 ( 1.16 )
    Notes
    [7] - The M-DBTP efficacy analysis set.
    [8] - The M-DBTP efficacy analysis set.
    Statistical analysis title
    		 LSM Difference: Erenumab - Placebo
    Comparison groups
    Placebo v Erenumab 140 mg SC Q4W
    Number of subjects included in analysis
    483
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001 [9]
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -7.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.34
         upper limit
    		 -3.87
    Notes
    [9] - Nominal p-value is presented without multiplicity adjustment

    Secondary: Change from Baseline in Mean Monthly Emotional Functioning Domain Score as Measured by the MFIQ Over Months 1, 2, and 3

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    End point title
    		 Change from Baseline in Mean Monthly Emotional Functioning Domain Score as Measured by the MFIQ Over Months 1, 2, and 3
    End point description
    The MFIQ is a self-administered 26-item instrument measuring the impact of migraine on broader functioning including Impact on Emotional Functioning (5 items). Participants responded to items using a 5-point scale assigned scores from 1 to 5, with 5 representing the greatest burden. Each domain score was calculated as the sum of the item responses and rescaled to a 0 to 100 scale, with higher scores representing greater burden. The recall period was the previous 7 days. A negative change from baseline indicates an improvement in burden. Change from baseline in mean monthly scores is the arithmetic mean of the monthly change from baseline values for the months considered with observed data, if there was at least one observed monthly value. The LSM estimates utilized a linear mixed model which included treatment, visit, treatment-by-visit interaction, and baseline value as covariates and assumed a first-order auto regression covariance structure.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1, Month 2, and Month 3
    End point values
    		 Placebo Erenumab 140 mg SC Q4W
    Number of subjects analysed
    239 [10]
    244 [11]
    Units: score on a scale
        least squares mean (standard error)
    -22.77 ( 1.34 )
    -29.83 ( 1.33 )
    Notes
    [10] - The M-DBTP efficacy analysis set.
    [11] - The M-DBTP efficacy analysis set.
    Statistical analysis title
    		 LSM Difference: Erenumab - Placebo
    Comparison groups
    Placebo v Erenumab 140 mg SC Q4W
    Number of subjects included in analysis
    483
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001 [12]
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -7.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.76
         upper limit
    		 -3.34
    Notes
    [12] - Nominal p-value is presented without multiplicity adjustment

    Secondary: Change from Baseline in Mean Monthly Social Functioning Domain Score as Measured by the MFIQ Over Months 1, 2, and 3

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    End point title
    		 Change from Baseline in Mean Monthly Social Functioning Domain Score as Measured by the MFIQ Over Months 1, 2, and 3
    End point description
    The MFIQ is a self-administered 26-item instrument measuring the impact of migraine on broader functioning including Impact on Social Functioning (5 items). Participants responded to items using a 5-point scale assigned scores from 1 to 5, with 5 representing the greatest burden. Each domain score was calculated as the sum of the item responses and rescaled to a 0 to 100 scale, with higher scores representing greater burden. The recall period was the previous 7 days. A negative change from baseline indicates an improvement in burden. Change from baseline in mean monthly scores is the arithmetic mean of the monthly change from baseline values for the months considered with observed data, if there was at least one observed monthly value. The LSM estimates utilized a linear mixed model which included treatment, visit, treatment-by-visit interaction, and baseline value as covariates and assumed a first-order auto regression covariance structure.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1, Month 2, and Month 3
    End point values
    		 Placebo Erenumab 140 mg SC Q4W
    Number of subjects analysed
    239 [13]
    244 [14]
    Units: score on a scale
        least squares mean (standard error)
    -25.05 ( 1.28 )
    -31.87 ( 1.27 )
    Notes
    [13] - The M-DBTP efficacy analysis set.
    [14] - The M-DBTP efficacy analysis set.
    Statistical analysis title
    		 LSM Difference: Erenumab - Placebo
    Comparison groups
    Placebo v Erenumab 140 mg SC Q4W
    Number of subjects included in analysis
    483
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001 [15]
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -6.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.37
         upper limit
    		 -3.27
    Notes
    [15] - Nominal p-value is presented without multiplicity adjustment

    Secondary: Change from Baseline in Mean Monthly Average Duration of at Least Moderate Headache Pain Intensity in Migraine Attacks Occurring Over Months 1, 2, and 3

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    End point title
    		 Change from Baseline in Mean Monthly Average Duration of at Least Moderate Headache Pain Intensity in Migraine Attacks Occurring Over Months 1, 2, and 3
    End point description
    At least moderate headache pain intensity was defined as headache pain intensity reported as 'Moderate' or 'Severe' based on the 3-level headache pain intensity scale. Worst or peak pain intensity during a headache was collected using the e-diary in 3-levels (mild, moderate or severe). The duration of headaches with at least moderate pain intensity during a migraine attack was collected. A negative change from baseline indicates a reduction in mean monthly average duration of at least moderate headache pain intensity during a migraine attack. Change from baseline in mean monthly measurement is the arithmetic mean of the monthly change from baseline values for the months considered with observed data, if there was at least one observed monthly value. The LSM estimates utilized a linear mixed model which included treatment, visit, treatment-by-visit interaction, and baseline value as covariates and assumed a first-order auto regression covariance structure.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1, Month 2, and Month 3
    End point values
    		 Placebo Erenumab 140 mg SC Q4W
    Number of subjects analysed
    251 [16]
    253 [17]
    Units: hours
        least squares mean (standard error)
    -2.78 ( 0.31 )
    -3.86 ( 0.30 )
    Notes
    [16] - The M-DBTP efficacy analysis set.
    [17] - The M-DBTP efficacy analysis set.
    Statistical analysis title
    		 LSM Difference: Erenumab - Placebo
    Comparison groups
    Placebo v Erenumab 140 mg SC Q4W
    Number of subjects included in analysis
    504
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.013 [18]
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.92
         upper limit
    		 -0.22
    Notes
    [18] - Nominal p-value is presented without multiplicity adjustment.

    Secondary: Change from Baseline in Mean Monthly Average Peak Migraine Pain Intensity as Assessed by the 11-point Numeric Rating Scale (NRS) Over Months 1, 2, and 3

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    End point title
    		 Change from Baseline in Mean Monthly Average Peak Migraine Pain Intensity as Assessed by the 11-point Numeric Rating Scale (NRS) Over Months 1, 2, and 3
    End point description
    The NRS assesses headache pain intensity ranging from 0 to 10 with a higher score indicating more severe pain. Participants recorded the pain intensity using the e-diary at the headache end-time or in an evening diary entry on a daily basis for an ongoing headache. A negative change from baseline indicates an improvement in pain intensity. Change from baseline in mean monthly scores is the arithmetic mean of the monthly change from baseline values for the months considered with observed data, if there was at least one observed monthly value. The LSM estimates utilized a linear mixed model which included treatment, visit, treatment-by-visit interaction, and baseline value as covariates and assumed a first-order auto regression covariance structure.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1, Month 2, and Month 3
    End point values
    		 Placebo Erenumab 140 mg SC Q4W
    Number of subjects analysed
    251 [19]
    253 [20]
    Units: score on a scale
        least squares mean (standard error)
    -1.48 ( 0.13 )
    -1.96 ( 0.13 )
    Notes
    [19] - The M-DBTP efficacy analysis set.
    [20] - The M-DBTP efficacy analysis set.
    Statistical analysis title
    		 LSM Difference: Erenumab - Placebo
    Comparison groups
    Placebo v Erenumab 140 mg SC Q4W
    Number of subjects included in analysis
    504
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.011 [21]
    Method
    		 Mixed models analysis
    Parameter type
    		 LSM difference
    Point estimate
    -0.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.85
         upper limit
    		 -0.11
    Notes
    [21] - Nominal p-value is presented without multiplicity adjustment

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Day 1 to end of the DBTP (up to 16 weeks)
    Adverse event reporting additional description
    Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Erenumab 140 mg SC Q4W
    Reporting group description
    		 Participants were randomized to receive 140 mg erenumab SC Q4W for up to 16 weeks in the DBTP.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants were randomized to receive matching placebo SC QW4 for up to 16 weeks in the DBTP.

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No participants experienced any non-serious adverse events above the indicated threshold.
    Serious adverse events
    		 Erenumab 140 mg SC Q4W Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 254 (0.00%)
    2 / 256 (0.78%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Psychiatric disorders
    Psychogenic tremor
         subjects affected / exposed
    0 / 254 (0.00%)
    1 / 256 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 254 (0.00%)
    1 / 256 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Erenumab 140 mg SC Q4W Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 254 (0.00%)
    0 / 256 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Apr 2022
    - Updated the secondary and exploratory objectives and endpoints language. - Updated overall design language to incorporate the qualifying oral triptan-treated migraine attack definition; updated eligibility criteria for the end of the run-in period. - Updated the key eligibility criteria language. - Updated schedule of activities language. - Clarified IP background language. - Updated the benefit/risk assessment section. - Updated the prohibited medications section and prior treatment section. - Clarified that the run-in and baseline periods could not be extended for more than 18 days and 35 days, respectively. - Updated the subgroup language for the primary and secondary endpoints. - Updated the statistical analysis methods language.
    29 Jun 2022
    Updated the language in the endpoints.

    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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