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    Clinical Trial Results:
    Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study With an Extension Period to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Patients With Unsuccessful Prior Preventive Treatments

    Summary
    EudraCT number
    2019-004497-25
    Trial protocol
    DE   CZ   DK   FI   BE   PL   GB   SK   HU   SE   BG   IT  
    Global end of trial date
    15 Sep 2022

    Results information
    Results version number
    v1(current)
    This version publication date
    21 Feb 2024
    First version publication date
    21 Feb 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    18898A
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04418765
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    H. Lundbeck A/S
    Sponsor organisation address
    Ottiliavej 9, Valby, Denmark, 2500
    Public contact
    LundbeckClinicalTrials@lundbeck.com, H. Lundbeck A/S, +45 36301311, LundbeckClinicalTrials@lundbeck.com
    Scientific contact
    LundbeckClinicalTrials@lundbeck.com, H. Lundbeck A/S, +45 36301311, LundbeckClinicalTrials@lundbeck.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
    15 Sep 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Sep 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to evaluate the efficacy of eptinezumab for the prevention of migraine in participants with unsuccessful prior preventive treatments.
    Protection of trial subjects
    This study was conducted in compliance with Good Clinical Practice and in accordance with the ethical principles described in the Declaration of Helsinki.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Jun 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 17
    Country: Number of subjects enrolled
    Bulgaria: 33
    Country: Number of subjects enrolled
    Czechia: 218
    Country: Number of subjects enrolled
    Germany: 21
    Country: Number of subjects enrolled
    Denmark: 12
    Country: Number of subjects enrolled
    Spain: 25
    Country: Number of subjects enrolled
    Finland: 13
    Country: Number of subjects enrolled
    France: 22
    Country: Number of subjects enrolled
    United Kingdom: 20
    Country: Number of subjects enrolled
    Georgia: 176
    Country: Number of subjects enrolled
    Hungary: 19
    Country: Number of subjects enrolled
    Italy: 5
    Country: Number of subjects enrolled
    Poland: 256
    Country: Number of subjects enrolled
    Russian Federation: 13
    Country: Number of subjects enrolled
    Slovakia: 34
    Country: Number of subjects enrolled
    Sweden: 2
    Country: Number of subjects enrolled
    United States: 6
    Worldwide total number of subjects
    892
    EEA total number of subjects
    677
    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)
    867
    From 65 to 84 years
    25
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This study included 2 periods: Placebo-controlled Period – 24-week double-blind treatment period with placebo or eptinezumab and Extension Period – 48-week dose-blinded period with eptinezumab after completion of the Placebo-controlled Period.

    Pre-assignment
    Screening details
    Participants assigned to placebo in the Placebo-controlled Period were randomized 1:1 to treatment with either eptinezumab 100 milligrams (mg) or eptinezumab 300 mg. Participants assigned to eptinezumab 100 mg or 300 mg in the Placebo-controlled Period continued their treatment.

    Period 1
    Period 1 title
    Placebo-controlled Period (24 Weeks)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Participants received placebo matched to eptinezumab by intravenous (IV) infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo was administered per schedule specified in the arm description.

    Arm title
    Eptinezumab 100 mg
    Arm description
    Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
    Arm type
    Experimental

    Investigational medicinal product name
    Eptinezumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Eptinezumab was administered per schedule specified in the arm description.

    Arm title
    Eptinezumab 300 mg
    Arm description
    Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
    Arm type
    Experimental

    Investigational medicinal product name
    Eptinezumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Eptinezumab was administered per schedule specified in the arm description.

    Number of subjects in period 1
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Started
    299
    299
    294
    Received at least 1 dose of study drug
    298
    299
    294
    Completed
    293
    288
    284
    Not completed
    6
    11
    10
         Consent withdrawn by subject
    1
    5
    2
         Adverse event, non-fatal
    1
    1
    6
         Randomized but not treated
    1
    -
    -
         Other than specified
    2
    -
    1
         Lost to follow-up
    -
    1
    -
         Lack of efficacy
    1
    3
    -
         Protocol deviation
    -
    1
    1
    Period 2
    Period 2 title
    Extension Period (48 Weeks)
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Eptinezumab 100 mg
    Arm description
    Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
    Arm type
    Experimental

    Investigational medicinal product name
    Eptinezumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Eptinezumab was administered per schedule specified in the arm description.

    Arm title
    Eptinezumab 300 mg
    Arm description
    Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
    Arm type
    Experimental

    Investigational medicinal product name
    Eptinezumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Eptinezumab was administered per schedule specified in the arm description.

    Number of subjects in period 2
    Eptinezumab 100 mg Eptinezumab 300 mg
    Started
    433
    432
    Received at least 1 dose of study drug
    433
    432
    Completed
    392
    390
    Not completed
    41
    42
         Consent withdrawn by subject
    21
    14
         Adverse event, non-fatal
    2
    9
         Non-compliance with study drug
    -
    2
         Other than specified
    5
    2
         Lack of efficacy
    13
    13
         Protocol deviation
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo matched to eptinezumab by intravenous (IV) infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.

    Reporting group title
    Eptinezumab 100 mg
    Reporting group description
    Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).

    Reporting group title
    Eptinezumab 300 mg
    Reporting group description
    Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).

    Reporting group values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg Total
    Number of subjects
    299 299 294 892
    Age categorical
    Units: Subjects
    Age Continuous
    Here N = 298 (placebo), 299 (Eptinezumab 100 mg), and 293 (Eptinezumab 300 mg).
    Units: years
        arithmetic mean (standard deviation)
    43.8 ± 10.83 44.6 ± 10.76 43.1 ± 10.2 -
    Sex: Female, Male
    Units: participants
        Female
    264 277 261 802
        Male
    35 22 33 90
    Monthly Migraine Days (MMDs)
    A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D as defined in the outcome measure 1. Here N = 298 (placebo), 299 (Eptinezumab 100 mg), and 293 (Eptinezumab 300 mg).
    Units: days/month
        arithmetic mean (standard deviation)
    13.9 ± 5.72 13.8 ± 5.58 13.7 ± 5.44 -
    Monthly Headache Days (MHDs)
    A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D in outcome measure 1). Here N = 298 (placebo), 299 (Eptinezumab 100 mg), and 293 (Eptinezumab 300 mg).
    Units: days/month
        arithmetic mean (standard deviation)
    14.5 ± 5.79 14.5 ± 5.63 14.4 ± 5.45 -
    Headache Impact Test (HIT-6) Score
    The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49). Here N = 288 (placebo), 281 (Eptinezumab 100 mg), and 287 (Eptinezumab 300 mg).
    Units: units on a scale
        arithmetic mean (standard deviation)
    66.2 ± 4.38 66.6 ± 4.7 66.5 ± 4.41 -
    Percentage of Migraine Attacks With Severe Pain Intensity
    A migraine attack was defined as a headache that occurred on a single day or lasted >1 day and that met the criteria for a migraine day (as defined in criterion A, B, C, or D in outcome measure 1). Here N = 298 (placebo), 299 (Eptinezumab 100 mg), and 293 (Eptinezumab 300 mg).
    Units: percentage of migraine attacks
        arithmetic mean (standard deviation)
    40.4 ± 29.74 47.1 ± 29.82 43.9 ± 28.4 -
    Percentage of Headache Episodes With Severe Pain Intensity
    A headache episode was defined as a headache lasted ≥30 minutes or that met the criteria for a migraine (as defined in criterion A, B, C, or D in outcome measure 1). Here N = 298 (placebo), 299 (Eptinezumab 100 mg), and 293 (Eptinezumab 300 mg).
    Units: percentage of headache episodes
        arithmetic mean (standard deviation)
    38.5 ± 29.29 44.2 ± 28.56 41 ± 27.01 -
    Acute Migraine Medication Days
    Here N = 298 (placebo), 299 (Eptinezumab 100 mg), and 292 (Eptinezumab 300 mg).
    Units: days
        arithmetic mean (standard deviation)
    11.2 ± 5.93 11.2 ± 5.47 11 ± 5.29 -
    MMDs With Use of Acute Medication
    Here N = 298 (placebo), 299 (Eptinezumab 100 mg), and 293 (Eptinezumab 300 mg).
    Units: days/month
        arithmetic mean (standard deviation)
    12.5 ± 5.62 12.7 ± 5.48 12.4 ± 5.38 -
    Migraine-Specific Quality of Life (MSQ) Subscores - MSQ role function-restrictive
    The MSQ is a participant-reported outcome designed to assess the quality of life in participants with migraine. It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores were summed and transformed to a 0- to 100-point scale. Higher scores indicated better quality of life. Here N = 288 (placebo), 276 (Eptinezumab 100 mg), and 287 (Eptinezumab 300 mg).
    Units: units on a scale
        arithmetic mean (standard deviation)
    35.1 ± 17.14 35.7 ± 17.33 35.7 ± 16.68 -
    Migraine-Specific Quality of Life (MSQ) Subscores - MSQ role function-preventive
    The MSQ is a participant-reported outcome designed to assess the quality of life in participants with migraine. It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores were summed and transformed to a 0- to 100-point scale. Higher scores indicated better quality of life. Here N = 288 (placebo), 276 (Eptinezumab 100 mg), and 287 (Eptinezumab 300 mg).
    Units: units on a scale
        arithmetic mean (standard deviation)
    50.5 ± 22.14 50.2 ± 21.39 51 ± 21.47 -
    Migraine-Specific Quality of Life (MSQ) Subscores - MSQ emotional function
    The MSQ is a participant-reported outcome designed to assess the quality of life in participants with migraine. It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores were summed and transformed to a 0- to 100-point scale. Higher scores indicated better quality of life. Here N = 288 (placebo), 276 (Eptinezumab 100 mg), and 287 (Eptinezumab 300 mg).
    Units: units on a scale
        arithmetic mean (standard deviation)
    48.4 ± 26.63 50.3 ± 24.7 48.6 ± 23.8 -
    Health-Related Quality of Life (EQ-5D-5L) Visual Analog Scale (VAS) Score
    The EQ-5D-5L is a participant-reported assessment designed to measure the participant’s well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a VAS of the overall health state. Each descriptive item was rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The VAS ranged from 0 (worst imaginable health state) to 100 (best imaginable health state). Here N = 287 (placebo), 276 (Eptinezumab 100 mg), and 285 (Eptinezumab 300 mg).
    Units: units on a scale
        arithmetic mean (standard deviation)
    74 ± 20.36 75.9 ± 19.01 74.5 ± 20.72 -
    WPAI Questionnaire Subscore (Absenteeism)
    It contains 6 items that measure: 1) employment status, 2) hours missed from work due to specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. 4 scores calculated from responses to 6 items: absenteeism, presenteeism, work productivity loss, activity impairment. Scores were calculated as impairment percentages (0-100). Higher Scores = greater impairment. N = 218 (placebo), 196 (Eptinezumab 100 mg), and 209 (Eptinezumab 300 mg).
    Units: units on a scale
        arithmetic mean (standard deviation)
    12.8 ± 20.7 11.4 ± 19.4 12 ± 19.31 -
    WPAI Questionnaire Subscores (Presenteeism)
    It contains 6 items that measure: 1) employment status, 2) hours missed from work due to specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. 4 scores calculated from responses to 6 items: absenteeism, presenteeism, work productivity loss, activity impairment. Scores were calculated as impairment percentages (0-100). Higher Scores = greater impairment. N = 212 (placebo), 191 (Eptinezumab 100 mg), and 206 (Eptinezumab 300 mg).
    Units: units on a scale
        arithmetic mean (standard deviation)
    51.7 ± 24.22 50.8 ± 25.61 53.3 ± 24.01 -
    WPAI Questionnaire Subscores (Work Productivity Loss)
    It contains 6 items that measure: 1) employment status, 2) hours missed from work due to specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. 4 scores calculated from responses to 6 items: absenteeism, presenteeism, work productivity loss, activity impairment. Scores were calculated as impairment percentages (0-100). Higher Scores = greater impairment. N = 212 (placebo), 191 (Eptinezumab 100 mg), and 206 (Eptinezumab 300 mg).
    Units: units on a scale
        arithmetic mean (standard deviation)
    55.6 ± 24.7 53.7 ± 26.17 57 ± 24.1 -
    WPAI Questionnaire Subscores (Activity Impairment)
    It contains 6 items that measure: 1) employment status, 2) hours missed from work due to specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. 4 scores calculated from responses to 6 items: absenteeism, presenteeism, work productivity loss, activity impairment. Scores were calculated as impairment percentages (0-100). Higher Scores = greater impairment. N = 286 (placebo), 274 (Eptinezumab 100 mg), and 285 (Eptinezumab 300 mg).
    Units: units on a scale
        arithmetic mean (standard deviation)
    58.7 ± 23.52 58.5 ± 23.47 59.1 ± 23.37 -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo matched to eptinezumab by intravenous (IV) infusion on Baseline (Day 0) and on Week 12 in the double-blind treatment period.

    Reporting group title
    Eptinezumab 100 mg
    Reporting group description
    Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).

    Reporting group title
    Eptinezumab 300 mg
    Reporting group description
    Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).
    Reporting group title
    Eptinezumab 100 mg
    Reporting group description
    Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).

    Reporting group title
    Eptinezumab 300 mg
    Reporting group description
    Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0); and thereafter, every 12 weeks up to Week 60 (2 doses in the double-blind treatment period and 4 doses in the dose-blinded extension period).

    Subject analysis set title
    Placebo to Eptinezumab 100 mg
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants who received placebo in the double-blind placebo-controlled period, received eptinezumab 100 mg in the dose-blinded extension period.

    Subject analysis set title
    Placebo to Eptinezumab 300 mg
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants who received placebo in the double-blind placebo-controlled period, received eptinezumab 300 mg in the dose-blinded extension period.

    Subject analysis set title
    Eptinezumab 100 mg to Eptinezumab 100 mg
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants who received eptinezumab 100 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.

    Subject analysis set title
    Eptinezumab 300 mg to Eptinezumab 300 mg
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.

    Primary: Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1 to 12

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    End point title
    Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1 to 12
    End point description
    A migraine day defined as any day participant reported a headache that met criterion A, B, C, or D: A (all of following): lasted ≥4 hours, had ≥2 of following: unilateral location; pulsating quality; moderate/severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and accompanied by ≥1 of following: nausea; vomiting; photophobia and phonophobia. B: lasted ≥30 minutes and participant had an aura with headache. C: lasted ≥30 minutes and met ≥2 of following criteria: lasted ≥4 hours, had ≥2 of following: unilateral location; pulsating quality; moderate/severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of following: nausea; vomiting; photophobia and phonophobia. D: participant took medication to treat headache because he/she believed as having a migraine. FAS: all randomized participants who had a valid baseline and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1-12.
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 1 - 12
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    298
    299
    293
    Units: days/month
        arithmetic mean (standard error)
    -2.1 ± 0.38
    -4.8 ± 0.37
    -5.3 ± 0.37
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    Analysis was performed using an REML-based MMRM with month (Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20, Weeks 21-24), country, stratification factor (monthly MHDs at baseline: ≤14/>14) and treatment as factors, baseline score as a continuous covariate, treatment-by-month interaction, baseline score-by-month interaction, and stratum-by-month interaction. A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.
    Comparison groups
    Placebo v Eptinezumab 100 mg
    Number of subjects included in analysis
    597
    Analysis specification
    Pre-specified
    Analysis type
    other [1]
    P-value
    < 0.0001 [2]
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -2.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.4
         upper limit
    -2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.36
    Notes
    [1] - Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.
    [2] - Testing continued only, if the previous comparison was statistically significant. Threshold for significance: p-value <α, where α = 0.05. Here it is test no. 3 of testing order.
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    Analysis was performed using a restricted maximum likelihood (REML)-based mixed model for repeated measurements (MMRM) with month (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, 21-24), country, stratification factor (monthly MHDs at baseline: ≤14/>14) and treatment as factors, baseline score as a continuous covariate, treatment-by-month interaction, baseline score-by-month interaction, and stratum-by-month interaction. A testing strategy was applied to ensure protection of the type 1 error.
    Comparison groups
    Placebo v Eptinezumab 300 mg
    Number of subjects included in analysis
    591
    Analysis specification
    Pre-specified
    Analysis type
    other [3]
    P-value
    < 0.0001 [4]
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -3.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.9
         upper limit
    -2.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.36
    Notes
    [3] - Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.
    [4] - Testing continued only, if the previous comparison was statistically significant. Threshold for significance: p-value <α, where α = 0.05. Here it is test no. 1 of testing order.

    Secondary: Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12

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    End point title
    Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12
    End point description
    A migraine day defined as any day participant reported a headache that met criterion A, B, C, or D: A (all of following): lasted ≥4 hours, had ≥2 of following: unilateral location; pulsating quality; moderate/severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and accompanied by ≥1 of following: nausea; vomiting; photophobia and phonophobia. B: lasted ≥30 minutes and participant had an aura with headache. C: lasted ≥30 minutes and met ≥2 of following criteria: lasted ≥4 hours, had ≥2 of following: unilateral location; pulsating quality; moderate/severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of following: nausea; vomiting; photophobia and phonophobia. D: participant took medication to treat headache because he/she believed as having a migraine. FAS: all randomized participants who had a valid baseline and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1-12.
    End point type
    Secondary
    End point timeframe
    Baseline to Weeks 1 - 12
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    298
    299
    293
    Units: percentage of participants
        number (not applicable)
    13.1
    42.1
    49.5
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    Analysis was performed using logistic regression model including baseline MMDs as a continuous covariate, and treatment and stratification factor (MHD at baseline: ≤14/>14) as factors. A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.
    Comparison groups
    Placebo v Eptinezumab 100 mg
    Number of subjects included in analysis
    597
    Analysis specification
    Pre-specified
    Analysis type
    other [5]
    P-value
    < 0.0001 [6]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    4.91
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.29
         upper limit
    7.47
    Notes
    [5] - Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.
    [6] - Testing continued only, if the previous comparison was statistically significant. Threshold for significance: p-value <α, where α = 0.05. Here it is test no. 4 of testing order.
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    Analysis was performed using logistic regression model including baseline MMDs as a continuous covariate, and treatment and stratification factor (MHD at baseline: ≤14/>14) as factors. A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.
    Comparison groups
    Placebo v Eptinezumab 300 mg
    Number of subjects included in analysis
    591
    Analysis specification
    Pre-specified
    Analysis type
    other [7]
    P-value
    < 0.0001 [8]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    6.58
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    4.41
         upper limit
    10.01
    Notes
    [7] - Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.
    [8] - Testing continued only, if the previous comparison was statistically significant. Threshold for significance: p-value <α, where α = 0.05. Here it is test no. 2 of testing order.

    Secondary: Change From Baseline in the Number of MMDs Averaged Over Weeks 13 to 24

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    End point title
    Change From Baseline in the Number of MMDs Averaged Over Weeks 13 to 24
    End point description
    A migraine day defined as any day participant reported headache that met criterion A, B, C, or D: A (all of following): lasted ≥4 hours, had ≥2 of following: unilateral location; pulsating quality; moderate/severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; with ≥1 of following: nausea; vomiting; photophobia and phonophobia. B: lasted ≥30 minutes and participant had an aura with headache. C: lasted ≥30 minutes and met ≥2 of following: lasted ≥4 hours, had ≥2 of following: unilateral location; pulsating quality; moderate/severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, with ≥1 of following: nausea; vomiting; photophobia and phonophobia. D: participant took medication to treat headache because he/she believed as having migraine. FAS: all randomized participants who had a valid baseline and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1-12. N= participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 13 - 24
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    295
    287
    286
    Units: days/month
        arithmetic mean (standard error)
    -2.4 ± 0.39
    -5.4 ± 0.39
    -6.1 ± 0.39
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    Analysis was performed using an REML-based MMRM with month (Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20, Weeks 21-24), country, stratification factor (monthly MHDs at baseline: ≤14/>14) and treatment as factors, baseline score as a continuous covariate, treatment-by-month interaction, baseline score-by-month interaction, and stratum-by-month interaction. A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.
    Comparison groups
    Placebo v Eptinezumab 100 mg
    Number of subjects included in analysis
    582
    Analysis specification
    Pre-specified
    Analysis type
    other [9]
    P-value
    < 0.0001 [10]
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.8
         upper limit
    -2.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.39
    Notes
    [9] - Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.
    [10] - Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be <α/3, <α/2, and <α, where α = 0.05. Here it is test no. 6a of testing order.
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    Analysis was performed using an REML-based MMRM with month (Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20, Weeks 21-24), country, stratification factor (monthly MHDs at baseline: ≤14/>14) and treatment as factors, baseline score as a continuous covariate, treatment-by-month interaction, baseline score-by-month interaction, and stratum-by-month interaction. A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.
    Comparison groups
    Placebo v Eptinezumab 300 mg
    Number of subjects included in analysis
    581
    Analysis specification
    Pre-specified
    Analysis type
    other [11]
    P-value
    < 0.0001 [12]
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -3.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.5
         upper limit
    -3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.39
    Notes
    [11] - Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.
    [12] - Threshold for significance: p-value <α, where α = 0.05. Here it is test no. 5a of testing order.

    Secondary: Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12

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    End point title
    Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12
    End point description
    A migraine day defined as any day participant reported a headache that met criterion A, B, C, or D: A (all of following): lasted ≥4 hours, had ≥2 of following: unilateral location; pulsating quality; moderate/severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and accompanied by ≥1 of following: nausea; vomiting; photophobia and phonophobia. B: lasted ≥30 minutes and participant had an aura with headache. C: lasted ≥30 minutes and met ≥2 of following criteria: lasted ≥4 hours, had ≥2 of following: unilateral location; pulsating quality; moderate/severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of following: nausea; vomiting; photophobia and phonophobia. D: participant took medication to treat headache because he/she believed as having a migraine. FAS: all randomized participants who had a valid baseline and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1-12.
    End point type
    Secondary
    End point timeframe
    Baseline to Weeks 1 - 12
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    298
    299
    293
    Units: percentage of participants
        number (not applicable)
    2.0
    15.7
    18.8
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    Analysis was performed using logistic regression model including baseline MMDs as a continuous covariate, and treatment and stratification factor (MHD at baseline: ≤14/>14) as factors. A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error. Testing continued only, if the previous comparison was statistically significant.
    Comparison groups
    Placebo v Eptinezumab 300 mg
    Number of subjects included in analysis
    591
    Analysis specification
    Pre-specified
    Analysis type
    other [13]
    P-value
    < 0.0001 [14]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    11.43
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    5.22
         upper limit
    30.15
    Notes
    [13] - Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.
    [14] - Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be <α/3, <α/2, and <α, where α = 0.05. Here it is test no. 5b of testing order.
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    Analysis was performed using logistic regression model including baseline MMDs as a continuous covariate, and treatment and stratification factor (MHD at baseline: ≤14/>14) as factors. A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error. Testing continued only, if the previous comparison was statistically significant.
    Comparison groups
    Placebo v Eptinezumab 100 mg
    Number of subjects included in analysis
    597
    Analysis specification
    Pre-specified
    Analysis type
    other [15]
    P-value
    < 0.0001 [16]
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    9.19
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    4.16
         upper limit
    24.35
    Notes
    [15] - Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.
    [16] - Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be <α/3, <α/2, and <α, where α = 0.05. Here it is test no. 6b of testing order.

    Secondary: Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24

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    End point title
    Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24
    End point description
    A migraine day defined as any day participant reported headache that met criterion A, B, C, or D: A (all of following): lasted ≥4 hours, had ≥2 of following: unilateral location; pulsating quality; moderate/severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; with ≥1 of following: nausea; vomiting; photophobia and phonophobia. B: lasted ≥30 minutes and participant had an aura with headache. C: lasted ≥30 minutes and met ≥2 of following: lasted ≥4 hours, had ≥2 of following: unilateral location; pulsating quality; moderate/severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, with ≥1 of following: nausea; vomiting; photophobia and phonophobia. D: participant took medication to treat headache because he/she believed as having migraine. FAS: all randomized participants who had a valid baseline and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1-12. N= participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline to Weeks 13 - 24
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    295
    287
    286
    Units: percentage of participants
        number (not applicable)
    23.7
    52.3
    59.1
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Headache Impact Test (HIT-6) Score at Week 12

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    End point title
    Change From Baseline in the Headache Impact Test (HIT-6) Score at Week 12
    End point description
    The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49). FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, N= participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    288
    277
    283
    Units: units on a scale
        arithmetic mean (standard error)
    -3.1 ± 0.61
    -6.9 ± 0.61
    -8.5 ± 0.60
    Statistical analysis title
    Statistical Analysis 2
    Statistical analysis description
    Analysis was performed using MMRM with the following fixed effects: visit, country, stratification factor (MHDs at baseline: ≤14/>14) and treatment as factors, baseline HIT-6 Total Score as a continuous covariate, baseline score-by-visit interaction, treatment-by-visit interaction, and stratum-by-visit interaction. A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error. Testing continued only, if the previous comparison was statistically significant.
    Comparison groups
    Placebo v Eptinezumab 100 mg
    Number of subjects included in analysis
    565
    Analysis specification
    Pre-specified
    Analysis type
    other [17]
    P-value
    < 0.0001 [18]
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -3.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5
         upper limit
    -2.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.63
    Notes
    [17] - Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.
    [18] - Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be <α/3, <α/2, and <α, where α = 0.05. Here it is test no. 6c of testing order.
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    Analysis was performed using MMRM with the following fixed effects: visit, country, stratification factor (MHDs at baseline: ≤14/>14) and treatment as factors, baseline HIT-6 Total Score as a continuous covariate, baseline score-by-visit interaction, treatment-by-visit interaction, and stratum-by-visit interaction. A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error. Testing continued only, if the previous comparison was statistically significant.
    Comparison groups
    Placebo v Eptinezumab 300 mg
    Number of subjects included in analysis
    571
    Analysis specification
    Pre-specified
    Analysis type
    other [19]
    P-value
    < 0.0001 [20]
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -5.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.7
         upper limit
    -4.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.63
    Notes
    [19] - Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.
    [20] - Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be <α/3, <α/2, and <α, where α = 0.05. Here it is test no. 5c of testing order.

    Secondary: Percentage of Participants With 100% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12

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    End point title
    Percentage of Participants With 100% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12
    End point description
    A migraine day defined as any day participant reported a headache that met criterion A, B, C, or D: A (all of following): lasted ≥4 hours, had ≥2 of following: unilateral location; pulsating quality; moderate/severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and accompanied by ≥1 of following: nausea; vomiting; photophobia and phonophobia. B: lasted ≥30 minutes and participant had an aura with headache. C: lasted ≥30 minutes and met ≥2 of following criteria: lasted ≥4 hours, had ≥2 of following: unilateral location; pulsating quality; moderate/severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of following: nausea; vomiting; photophobia and phonophobia. D: participant took medication to treat headache because he/she believed as having a migraine. FAS: all randomized participants who had a valid baseline and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1-12.
    End point type
    Secondary
    End point timeframe
    Baseline to Weeks 1 - 12
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    298
    299
    293
    Units: percentage of participants
        number (not applicable)
    1.1
    5.9
    7.7
    No statistical analyses for this end point

    Secondary: Percentage of Participants With ≥50% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12

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    End point title
    Percentage of Participants With ≥50% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12
    End point description
    A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1). FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.
    End point type
    Secondary
    End point timeframe
    Baseline to Weeks 1 - 12
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    298
    299
    293
    Units: percentage of participants
        number (not applicable)
    12.8
    39.5
    45.7
    No statistical analyses for this end point

    Secondary: Percentage of Participants With ≥75% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12

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    End point title
    Percentage of Participants With ≥75% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12
    End point description
    A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1). FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.
    End point type
    Secondary
    End point timeframe
    Baseline to Weeks 1 - 12
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    298
    299
    293
    Units: percentage of participants
        number (not applicable)
    2.3
    15.1
    16.4
    No statistical analyses for this end point

    Secondary: Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24

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    End point title
    Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24
    End point description
    A migraine day defined as any day participant reported headache that met criterion A, B, C, or D: A (all of following): lasted ≥4 hours, had ≥2 of following: unilateral location; pulsating quality; moderate/severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; with ≥1 of following: nausea; vomiting; photophobia and phonophobia. B: lasted ≥30 minutes and participant had an aura with headache. C: lasted ≥30 minutes and met ≥2 of following: lasted ≥4 hours, had ≥2 of following: unilateral location; pulsating quality; moderate/severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, with ≥1 of following: nausea; vomiting; photophobia and phonophobia. D: participant took medication to treat headache because he/she believed as having migraine. FAS: all randomized participants who had a valid baseline and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1-12. N= participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline to Weeks 13 - 24
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    295
    287
    293
    Units: percentage of participants
        number (not applicable)
    6.8
    21.3
    27.6
    No statistical analyses for this end point

    Secondary: Percentage of Participants With 100% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12

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    End point title
    Percentage of Participants With 100% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12
    End point description
    A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1). FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.
    End point type
    Secondary
    End point timeframe
    Baseline to Weeks 1 - 12
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    298
    299
    293
    Units: percentage of participants
        number (not applicable)
    1.1
    4.1
    5.3
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Number of MHDs Averaged Over Weeks 1 to 12

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    End point title
    Change From Baseline in the Number of MHDs Averaged Over Weeks 1 to 12
    End point description
    A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1). FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 1 - 12
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    298
    299
    293
    Units: days/month
        arithmetic mean (standard error)
    -2.1 ± 0.38
    -4.6 ± 0.37
    -5.1 ± 0.37
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Percentage of Migraine Attacks With Severe Pain Intensity Averaged Over Weeks 1 to 12

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    End point title
    Change From Baseline in the Percentage of Migraine Attacks With Severe Pain Intensity Averaged Over Weeks 1 to 12
    End point description
    A migraine attack was defined as a headache that occurred on a single day or lasted >1 day and that met the criteria for a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1). FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 1 - 12
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    298
    299
    293
    Units: percentage of migraine attacks
        arithmetic mean (standard error)
    -10.2 ± 1.91
    -17.9 ± 1.87
    -21.3 ± 1.87
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 13 to 24

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    End point title
    Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 13 to 24
    End point description
    In the evening eDiary, participants were asked each day to fill out whether they used any of the following medications during that day: Ergotamine, triptan, analgesic, opioid, or combination analgesic. A day where the participant answered that they took any of those in the evening eDiary was considered a day with use of acute migraine medication. FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, N = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 13- 24
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    294
    287
    285
    Units: days/month
        arithmetic mean (standard error)
    -1.7 ± 0.36
    -4.6 ± 0.36
    -5.2 ± 0.36
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 1 to 12

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    End point title
    Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 1 to 12
    End point description
    Number of MMDs with acute medication usage was derived using the answer to “Did you take any medications to treat this headache?” in the headache diary. The question was asked when a participant was ending a headache. Thus, a migraine day with acute medication usage was defined as a migraine day with the extra condition that this question was answered as “Yes”. FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 1 - 12
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    298
    299
    293
    Units: days/month
        arithmetic mean (standard error)
    -2.0 ± 0.36
    -4.6 ± 0.36
    -5.2 ± 0.36
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Percentage of Headache Episodes With Severe Pain Intensity Averaged Over Weeks 1 to 12

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    End point title
    Change From Baseline in the Percentage of Headache Episodes With Severe Pain Intensity Averaged Over Weeks 1 to 12
    End point description
    A headache episode was defined as a headache lasted ≥30 minutes or that met the criteria for a migraine (as defined in criterion A, B, C, or D above in outcome measure 1). FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 1 - 12
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    298
    299
    293
    Units: percentage of headache episodes
        arithmetic mean (standard error)
    -8.8 ± 1.85
    -16.2 ± 1.81
    -19.5 ± 1.81
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 1 to 12

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    End point title
    Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 1 to 12
    End point description
    In the evening eDiary, participants were asked each day to fill out whether they used any of the following medications during that day: Ergotamine, triptan, analgesic, opioid, or combination analgesic. A day where the participant answered that they took any of those in the evening eDiary was considered a day with use of acute migraine medication. FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, N = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 1 - 12
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    298
    298
    290
    Units: days/month
        arithmetic mean (standard error)
    -1.6 ± 0.34
    -4.1 ± 0.33
    -4.6 ± 0.34
    No statistical analyses for this end point

    Secondary: Patient Global Impression of Change (PGIC) Score at Week 12

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    End point title
    Patient Global Impression of Change (PGIC) Score at Week 12
    End point description
    The PGIC is a single, participant-reported item reflecting the participant's impression of change in his/her disease status since the start of the study (that is, in relation to activity limitations, symptoms, emotions, and overall quality of life). Participants rated their impression of change in disease status on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a higher score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status. FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, N= participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    297
    292
    289
    Units: units on a scale
        arithmetic mean (standard error)
    3.6 ± 0.09
    2.6 ± 0.09
    2.5 ± 0.09
    No statistical analyses for this end point

    Secondary: PGIC Score at Week 24

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    End point title
    PGIC Score at Week 24
    End point description
    The PGIC is a single, participant-reported item reflecting the participant's impression of change in his/her disease status since the start of the study (that is, in relation to activity limitations, symptoms, emotions, and overall quality of life). Participants rated their impression of change in disease status on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a higher score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status. FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, N= participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    286
    280
    281
    Units: units on a scale
        arithmetic mean (standard error)
    3.5 ± 0.09
    2.5 ± 0.09
    2.4 ± 0.09
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 13 to 24

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    End point title
    Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 13 to 24
    End point description
    Number of MMDs with acute medication usage was derived using the answer to “Did you take any medications to treat this headache?” in the headache diary. The question was asked when a participant was ending a headache. Thus, a migraine day with acute medication usage was defined as a migraine day with the extra condition that this question was answered as “Yes”. FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, N= participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 13 - 24
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    295
    287
    286
    Units: days/month
        arithmetic mean (standard error)
    -2.1 ± 0.39
    -4.9 ± 0.39
    -5.8 ± 0.38
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Migraine on the Day After First Dosing

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    End point title
    Percentage of Participants With Migraine on the Day After First Dosing
    End point description
    FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    298
    299
    293
    Units: percentage of participants
        number (not applicable)
    43.7
    27.2
    24.4
    No statistical analyses for this end point

    Secondary: Change From Baseline in the HIT-6 Score at Week 24

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    End point title
    Change From Baseline in the HIT-6 Score at Week 24
    End point description
    The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49). FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, N= participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    278
    266
    276
    Units: units on a scale
        arithmetic mean (standard error)
    -3.9 ± 0.63
    -8.9 ± 0.63
    -9.9 ± 0.62
    No statistical analyses for this end point

    Secondary: Most Bothersome Symptom (MBS) Score at Week 12

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    End point title
    Most Bothersome Symptom (MBS) Score at Week 12
    End point description
    Participants were asked about their most bothersome symptom associated with their migraines during the Baseline Visit. Participants were asked to rate the improvement in this symptom from baseline on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a high score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status. The MBS areas included: nausea, vomiting, sensitivity to light, sensitivity to sound, mental cloudiness, fatigue, pain with activity, mood changes, and other symptoms. FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, N= participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    293
    289
    287
    Units: units on a scale
        arithmetic mean (standard error)
    3.7 ± 0.09
    2.8 ± 0.09
    2.7 ± 0.09
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Number of MMDs in Participants With Medication Overuse Headache (MOH) Averaged Over Weeks 1 to 12

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    End point title
    Change From Baseline in the Number of MMDs in Participants With Medication Overuse Headache (MOH) Averaged Over Weeks 1 to 12
    End point description
    FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, N= participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 1 - 12
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    37
    38
    35
    Units: days/month
        arithmetic mean (standard error)
    -2.3 ± 1.12
    -5.6 ± 1.07
    -7.3 ± 1.18
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analog Scale (VAS) Score at Week 12

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    End point title
    Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analog Scale (VAS) Score at Week 12
    End point description
    The EQ-5D-5L is a participant-reported assessment designed to measure the participant’s well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a VAS of the overall health state. Each descriptive item was rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The VAS ranged from 0 (worst imaginable health state) to 100 (best imaginable health state). FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, N= participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    287
    271
    281
    Units: units on a scale
        arithmetic mean (standard error)
    -3.1 ± 1.39
    2.0 ± 1.40
    4.4 ± 1.38
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Migraine-Specific Quality of Life (MSQ) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 12

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    End point title
    Change From Baseline in the Migraine-Specific Quality of Life (MSQ) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 12
    End point description
    The MSQ is a participant-reported outcome designed to assess the quality of life in participants with migraine. It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores were summed and transformed to a 0- to 100-point scale. Higher scores indicated better quality of life. FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, N= participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    288
    271
    283
    Units: units on a scale
    arithmetic mean (standard error)
        MSQ Role Function-Restrictive
    13.7 ± 1.75
    25.0 ± 1.75
    28.7 ± 1.72
        MSQ Role Function-Preventive
    11.6 ± 1.63
    22.7 ± 1.64
    25.0 ± 1.61
        MSQ Emotional Function
    9.6 ± 1.83
    20.6 ± 1.84
    23.1 ± 1.80
    No statistical analyses for this end point

    Secondary: Change From Baseline in the MSQ Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 24

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    End point title
    Change From Baseline in the MSQ Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 24
    End point description
    The MSQ is a participant-reported outcome designed to assess the quality of life in participants with migraine. It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores were summed and transformed to a 0- to 100-point scale. Higher scores indicated better quality of life. FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, N= participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    278
    259
    275
    Units: units on a scale
    arithmetic mean (standard error)
        MSQ Role Function-Restrictive
    15.0 ± 1.76
    30.1 ± 1.78
    30.0 ± 1.73
        MSQ Role Function-Preventive
    13.1 ± 1.63
    25.7 ± 1.65
    26.3 ± 1.61
        MSQ Emotional Function
    9.9 ± 1.84
    24.1 ± 1.86
    24.1 ± 1.81
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) VAS Score at Week 24

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    End point title
    Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) VAS Score at Week 24
    End point description
    The EQ-5D-5L is a participant-reported assessment designed to measure the participant’s well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a VAS of the overall health state. Each descriptive item was rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The VAS ranged from 0 (worst imaginable health state) to 100 (best imaginable health state). FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, N= participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    276
    258
    273
    Units: units on a scale
        arithmetic mean (standard error)
    -2.8 ± 1.38
    2.0 ± 1.40
    5.2 ± 1.37
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12

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    End point title
    Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12
    End point description
    WPAI Questionnaire contains 6 items that measure: 1) employment status, 2) hours missed from work due to the specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. Four scores were calculated from the responses to these 6 items: absenteeism, presenteeism, work productivity loss, and activity impairment. Scores were calculated as impairment percentages (0-100%), with higher numbers indicating greater impairment and less productivity, i.e, worse outcomes. FAS: all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, N= participants evaluable for this endpoint. n = participants evaluable for specified categories.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    286
    268
    280
    Units: units on a scale
    arithmetic mean (standard error)
        Absenteeism (n= 196,174,183)
    -0.1 ± 1.49
    -5.8 ± 1.53
    -3.8 ± 1.50
        Presenteeism (n= 188,169,179)
    -9.9 ± 2.42
    -19.0 ± 2.46
    -23.3 ± 2.40
        Work productivity loss (n= 188,169,179)
    -9.7 ± 2.56
    -19.5 ± 2.61
    -24.0 ± 2.54
        Activity impairment (n= 286,268,280)
    -11.2 ± 2.07
    -21.3 ± 2.07
    -23.8 ± 2.05
    No statistical analyses for this end point

    Secondary: Change From Baseline in the WPAI Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 24

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    End point title
    Change From Baseline in the WPAI Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 24
    End point description
    WPAI Questionnaire contains 6 items that measure: 1) employment status, 2) hours missed from work due to the specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. Four scores were calculated from the responses to these 6 items: absenteeism, presenteeism, work productivity loss, and activity impairment. Scores were calculated as impairment percentages (0-100%), with higher numbers indicating greater impairment and less productivity, i.e, worse outcomes. FAS: all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, N= participants evaluable for this endpoint. n = participants evaluable for specified categories.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    275
    256
    273
    Units: units on a scale
    arithmetic mean (standard error)
        Absenteeism (n= 180,151,168)
    -0.7 ± 1.46
    -5.2 ± 1.53
    -5.4 ± 1.47
        Presenteeism (n= 173,145,166)
    -7.5 ± 2.49
    -22.2 ± 2.59
    -19.3 ± 2.46
        Work productivity loss (n= 173,145,166)
    -7.2 ± 2.62
    -22.6 ± 2.73
    -20.2 ± 2.60
        Activity impairment (n= 275,256,273)
    -10.1 ± 2.07
    -24.7 ± 2.09
    -22.6 ± 2.04
    No statistical analyses for this end point

    Secondary: Percentage of Participants With ≥5-Point Reduction From Baseline to Week 12 in HIT-6 Score

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    End point title
    Percentage of Participants With ≥5-Point Reduction From Baseline to Week 12 in HIT-6 Score
    End point description
    The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49). FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, N = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    288
    280
    284
    Units: percentage of participants
        number (not applicable)
    39.9
    62.1
    62.0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With ≥5-Point Reduction From Baseline to Week 24 in HIT-6 Score

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    End point title
    Percentage of Participants With ≥5-Point Reduction From Baseline to Week 24 in HIT-6 Score
    End point description
    The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49). FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, N = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 24
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    288
    280
    285
    Units: percentage of participants
        number (not applicable)
    46.2
    72.1
    71.6
    No statistical analyses for this end point

    Secondary: Health Care Resource Utilization (HCRU): Visits to a Family Doctor/General Practitioner

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    End point title
    Health Care Resource Utilization (HCRU): Visits to a Family Doctor/General Practitioner
    End point description
    Number of participants who visited to a family doctor/general practitioner has been reported. FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, N = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    297
    291
    289
    Units: participants
        0 Visit
    244
    259
    256
        1 Visit
    35
    22
    22
        2 Visits
    6
    5
    6
        3 Visits
    7
    2
    3
        4 Visits
    1
    1
    1
        5 Visits
    1
    2
    1
        6 Visits
    2
    0
    0
        8 Visits
    1
    0
    0
    No statistical analyses for this end point

    Secondary: HCRU: Visits to a Specialist

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    End point title
    HCRU: Visits to a Specialist
    End point description
    Number of participants who visited to a specialist has been reported. FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, N = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    297
    291
    289
    Units: participants
        0 Visit
    249
    256
    257
        1 Visit
    33
    31
    24
        2 Visits
    2
    2
    4
        3 Visits
    7
    2
    4
        5 Visits
    1
    0
    0
        6 Visits
    4
    0
    0
        8 Visits
    1
    0
    0
    No statistical analyses for this end point

    Secondary: HCRU: Number of Emergency Department Visits Due to Your Migraine

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    End point title
    HCRU: Number of Emergency Department Visits Due to Your Migraine
    End point description
    Number of participants who visited to emergency department due to your migraine has been reported. FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, N = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    297
    291
    289
    Units: participants
        0 Visit
    289
    289
    285
        1 Visit
    6
    1
    3
        2 Visits
    0
    1
    1
        3 Visits
    1
    0
    0
        8 Visits
    1
    0
    0
    No statistical analyses for this end point

    Secondary: HCRU: Total Number of Overnight Hospital Stays Due to Migraine

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    End point title
    HCRU: Total Number of Overnight Hospital Stays Due to Migraine
    End point description
    Number of participants who had total number of overnight hospital stays due to migraine has been reported. FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, N = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    297
    291
    289
    Units: participants
        0 Visit
    295
    290
    289
        1 Visit
    1
    0
    0
        3 Visits
    1
    1
    0
    No statistical analyses for this end point

    Secondary: HCRU: Number of Hospital Admissions Due to Migraine

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    End point title
    HCRU: Number of Hospital Admissions Due to Migraine
    End point description
    Number of participants who admitted in the hospital due to migraine has been reported. FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, N = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Placebo Eptinezumab 100 mg Eptinezumab 300 mg
    Number of subjects analysed
    297
    291
    289
    Units: participants
        0 Visit
    295
    289
    287
        1 Visit
    1
    1
    2
        2 Visits
    0
    1
    0
        4 Visits
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Number of MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72

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    End point title
    Change From Baseline in the Number of MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72
    End point description
    A migraine day was defined in endpoint #1. Full-analysis-long-term set (FAS_LT) included all randomized participants who received at least 1 infusion of study drug, had a visit in the Extension Period, and who had a valid baseline assessment and a valid assessment of monthly migraine days in the Extension Period. Here, 'N' = participants evaluable for this endpoint. 'n' = participants evaluable at specified timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 72
    End point values
    Placebo to Eptinezumab 100 mg Placebo to Eptinezumab 300 mg Eptinezumab 100 mg to Eptinezumab 100 mg Eptinezumab 300 mg to Eptinezumab 300 mg
    Number of subjects analysed
    144
    146
    282
    282
    Units: days/month
    arithmetic mean (standard error)
        Change at Weeks 25-36 (n=144,146,282,282)
    -4.7 ± 0.49
    -6.1 ± 0.49
    -5.8 ± 0.39
    -5.9 ± 0.39
        Change at Weeks 37-48 (n=140,146,282,273)
    -5.0 ± 0.50
    -6.0 ± 0.50
    -5.8 ± 0.40
    -6.0 ± 0.40
        Change at Weeks 49-60 (n=134,140,270,265)
    -5.6 ± 0.51
    -6.6 ± 0.51
    -5.8 ± 0.41
    -6.0 ± 0.41
        Change at Weeks 61-72 (n=126,136,252,246)
    -5.9 ± 0.51
    -6.8 ± 0.51
    -6.6 ± 0.41
    -6.5 ± 0.41
    No statistical analyses for this end point

    Secondary: Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72

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    End point title
    Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72
    End point description
    A migraine day was defined in endpoint #1. FAS_LT included all randomized participants who received at least 1 infusion of study drug, had a visit in the Extension Period, and who had a valid baseline assessment and a valid assessment of monthly migraine days in the Extension Period. Here, 'N' = participants evaluable for this endpoint. 'n' = participants evaluable at specified timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline to Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 72
    End point values
    Placebo to Eptinezumab 100 mg Placebo to Eptinezumab 300 mg Eptinezumab 100 mg to Eptinezumab 100 mg Eptinezumab 300 mg to Eptinezumab 300 mg
    Number of subjects analysed
    144
    146
    282
    282
    Units: percentage of participants
    number (not applicable)
        Weeks 25-36 (n=144,146,282,282)
    48.6
    63.0
    59.6
    61.0
        Weeks 37-48 (n=140,146,282,273)
    49.3
    60.3
    60.6
    61.9
        Weeks 49-60 (n=134,140,270,265)
    59.7
    68.6
    62.6
    62.3
        Weeks 61-72 (n=126,136,252,246)
    63.5
    69.9
    68.3
    65.9
    No statistical analyses for this end point

    Secondary: Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72

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    End point title
    Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72
    End point description
    A migraine day was defined in endpoint #1. FAS_LT included all randomized participants who received at least 1 infusion of study drug, had a visit in the Extension Period, and who had a valid baseline assessment and a valid assessment of monthly migraine days in the Extension Period. Here, 'N' = participants evaluable for this endpoint. 'n' = participants evaluable at specified timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline to Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 72
    End point values
    Placebo to Eptinezumab 100 mg Placebo to Eptinezumab 300 mg Eptinezumab 100 mg to Eptinezumab 100 mg Eptinezumab 300 mg to Eptinezumab 300 mg
    Number of subjects analysed
    144
    146
    282
    282
    Units: percentage of participants
    number (not applicable)
        Weeks 25-36 (n=144,146,282,282)
    19.4
    28.1
    25.9
    31.2
        Weeks 37-48 (n=140,146,282,273)
    27.9
    30.8
    31.6
    32.6
        Weeks 49-60 (n=134,140,270,265)
    32.1
    33.6
    29.3
    38.9
        Weeks 61-72 (n=126,136,252,246)
    36.5
    39.0
    37.7
    44.7
    No statistical analyses for this end point

    Secondary: Change From Baseline in HIT-6 Score at Weeks 36, 48, 60, and 72

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    End point title
    Change From Baseline in HIT-6 Score at Weeks 36, 48, 60, and 72
    End point description
    The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49). FAS_LT included all randomized participants who received at least 1 infusion of study drug, had a visit in the Extension Period, and who had a valid baseline assessment and a valid assessment of monthly migraine days in the Extension Period. Here, 'N' = participants evaluable for this endpoint. 'n' = participants evaluable at specified timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 36, 48, 60, and 72
    End point values
    Placebo to Eptinezumab 100 mg Placebo to Eptinezumab 300 mg Eptinezumab 100 mg to Eptinezumab 100 mg Eptinezumab 300 mg to Eptinezumab 300 mg
    Number of subjects analysed
    138
    139
    265
    272
    Units: units on a scale
    arithmetic mean (standard error)
        Change at Week 36 (n=138,137,265,272)
    -10.01 ± 0.69
    -12.15 ± 0.73
    -10.99 ± 0.57
    -12.0 ± 0.56
        Change at Week 48 (n=134,139,260,260)
    -10.71 ± 0.77
    -12.71 ± 0.75
    -12.55 ± 0.59
    -12.68 ± 0.60
        Change at Week 60 (n=128,136,249,258)
    -12.54 ± 0.80
    -13.21 ± 0.71
    -12.57 ± 0.56
    -13.15 ± 0.59
        Change at Week 72 (n=124,131,239,237)
    -12.68 ± 0.87
    -15.02 ± 0.78
    -13.28 ± 0.63
    -14.13 ± 0.63
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to Week 72
    Adverse event reporting additional description
    All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug. All-patients-treated-long-term set (APTS_LT) included all randomized participants who received at least 1 infusion of the study drug and had a visit in the Extension Period.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Placebo-controlled Period: Placebo
    Reporting group description
    Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.

    Reporting group title
    Placebo-controlled Period: Eptinezumab 300 mg
    Reporting group description
    Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.

    Reporting group title
    Placebo-controlled Period: Eptinezumab 100 mg
    Reporting group description
    Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.

    Reporting group title
    Extension Period: Eptinezumab 300 mg to Eptinezumab 300 mg
    Reporting group description
    Participants who received eptinezumab 300 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.

    Reporting group title
    Extension Period: Placebo to Eptinezumab 100 mg
    Reporting group description
    Participants who received placebo in the double-blind placebo-controlled period, received eptinezumab 100 mg in the dose-blinded extension period.

    Reporting group title
    Extension Period: Placebo to Eptinezumab 300 mg
    Reporting group description
    Participants who received placebo in the double-blind placebo-controlled period, received eptinezumab 300 mg in the dose-blinded extension period.

    Reporting group title
    Extension Period: Eptinezumab 100 mg to Eptinezumab 100 mg
    Reporting group description
    Participants who received eptinezumab 100 mg in the double-blind placebo-controlled period, continued to receive the same dose of eptinezumab in the dose-blinded extension period.

    Serious adverse events
    Placebo-controlled Period: Placebo Placebo-controlled Period: Eptinezumab 300 mg Placebo-controlled Period: Eptinezumab 100 mg Extension Period: Eptinezumab 300 mg to Eptinezumab 300 mg Extension Period: Placebo to Eptinezumab 100 mg Extension Period: Placebo to Eptinezumab 300 mg Extension Period: Eptinezumab 100 mg to Eptinezumab 100 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 298 (1.01%)
    7 / 294 (2.38%)
    6 / 299 (2.01%)
    9 / 284 (3.17%)
    2 / 145 (1.38%)
    7 / 148 (4.73%)
    9 / 288 (3.13%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 294 (0.34%)
    0 / 299 (0.00%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    1 / 148 (0.68%)
    0 / 288 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colorectal adenocarcinoma
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    0 / 284 (0.00%)
    1 / 145 (0.69%)
    0 / 148 (0.00%)
    0 / 288 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer in situ
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    1 / 288 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intraductal papilloma of breast
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    1 / 288 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal carcinoma
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    1 / 284 (0.35%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    0 / 288 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngeal neoplasm
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    1 / 288 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 298 (0.00%)
    2 / 294 (0.68%)
    0 / 299 (0.00%)
    1 / 284 (0.35%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    0 / 288 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    1 / 148 (0.68%)
    0 / 288 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    1 / 288 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nasal turbinate hypertrophy
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    1 / 288 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    0 / 288 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Road traffic accident
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    0 / 288 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    1 / 299 (0.33%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    0 / 288 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    0 / 288 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    0 / 288 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    1 / 284 (0.35%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    0 / 288 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Seizure
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 294 (0.34%)
    0 / 299 (0.00%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    0 / 288 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychogenic seizure
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 294 (0.34%)
    0 / 299 (0.00%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    0 / 288 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    1 / 284 (0.35%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    0 / 288 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervical radiculopathy
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    1 / 299 (0.33%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    0 / 288 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intracranial aneurysm
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    1 / 288 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radiculopathy
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    1 / 288 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Conductive deafness
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    1 / 288 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Retinal detachment
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    1 / 299 (0.33%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    0 / 288 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye pain
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    1 / 148 (0.68%)
    0 / 288 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    1 / 288 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    1 / 299 (0.33%)
    1 / 284 (0.35%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    0 / 288 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    1 / 288 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    1 / 284 (0.35%)
    1 / 145 (0.69%)
    0 / 148 (0.00%)
    0 / 288 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    1 / 299 (0.33%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    1 / 148 (0.68%)
    0 / 288 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Lichen planus
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    1 / 148 (0.68%)
    0 / 288 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Bladder prolapse
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    1 / 288 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    1 / 284 (0.35%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    0 / 288 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 294 (0.34%)
    0 / 299 (0.00%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    1 / 148 (0.68%)
    0 / 288 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Periarthritis
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    1 / 148 (0.68%)
    0 / 288 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diastasis recti abdominis
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    1 / 284 (0.35%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    0 / 288 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 298 (0.00%)
    2 / 294 (0.68%)
    1 / 299 (0.33%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    0 / 288 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis intestinal perforated
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    1 / 284 (0.35%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    0 / 288 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic sinusitis
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    1 / 148 (0.68%)
    0 / 288 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    1 / 288 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    1 / 284 (0.35%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    0 / 288 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pilonidal disease
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    1 / 148 (0.68%)
    0 / 288 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    1 / 284 (0.35%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    0 / 288 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    Placebo-controlled Period: Placebo Placebo-controlled Period: Eptinezumab 300 mg Placebo-controlled Period: Eptinezumab 100 mg Extension Period: Eptinezumab 300 mg to Eptinezumab 300 mg Extension Period: Placebo to Eptinezumab 100 mg Extension Period: Placebo to Eptinezumab 300 mg Extension Period: Eptinezumab 100 mg to Eptinezumab 100 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    85 / 298 (28.52%)
    90 / 294 (30.61%)
    95 / 299 (31.77%)
    118 / 284 (41.55%)
    57 / 145 (39.31%)
    62 / 148 (41.89%)
    133 / 288 (46.18%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 298 (1.01%)
    4 / 294 (1.36%)
    4 / 299 (1.34%)
    2 / 284 (0.70%)
    3 / 145 (2.07%)
    0 / 148 (0.00%)
    3 / 288 (1.04%)
         occurrences all number
    3
    4
    4
    2
    4
    0
    4
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    4 / 298 (1.34%)
    6 / 294 (2.04%)
    2 / 299 (0.67%)
    2 / 284 (0.70%)
    0 / 145 (0.00%)
    1 / 148 (0.68%)
    5 / 288 (1.74%)
         occurrences all number
    4
    6
    2
    3
    0
    1
    5
    Pyrexia
         subjects affected / exposed
    4 / 298 (1.34%)
    4 / 294 (1.36%)
    0 / 299 (0.00%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    0 / 288 (0.00%)
         occurrences all number
    5
    4
    0
    0
    0
    0
    0
    Asthenia
         subjects affected / exposed
    2 / 298 (0.67%)
    3 / 294 (1.02%)
    3 / 299 (1.00%)
    1 / 284 (0.35%)
    1 / 145 (0.69%)
    0 / 148 (0.00%)
    1 / 288 (0.35%)
         occurrences all number
    2
    3
    3
    1
    1
    0
    3
    Immune system disorders
    Immunisation reaction
         subjects affected / exposed
    2 / 298 (0.67%)
    3 / 294 (1.02%)
    0 / 299 (0.00%)
    2 / 284 (0.70%)
    0 / 145 (0.00%)
    1 / 148 (0.68%)
    2 / 288 (0.69%)
         occurrences all number
    3
    4
    0
    3
    0
    1
    2
    Social circumstances
    Menopause
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 294 (0.00%)
    1 / 299 (0.33%)
    0 / 284 (0.00%)
    1 / 145 (0.69%)
    3 / 148 (2.03%)
    1 / 288 (0.35%)
         occurrences all number
    1
    0
    1
    0
    1
    3
    1
    Reproductive system and breast disorders
    Menstruation irregular
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    1 / 284 (0.35%)
    0 / 145 (0.00%)
    1 / 148 (0.68%)
    3 / 288 (1.04%)
         occurrences all number
    1
    0
    0
    1
    0
    1
    3
    Menopausal symptoms
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    1 / 299 (0.33%)
    1 / 284 (0.35%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    3 / 288 (1.04%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    3
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 298 (0.00%)
    3 / 294 (1.02%)
    2 / 299 (0.67%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    3 / 288 (1.04%)
         occurrences all number
    0
    3
    2
    0
    0
    0
    3
    Cough
         subjects affected / exposed
    2 / 298 (0.67%)
    0 / 294 (0.00%)
    2 / 299 (0.67%)
    1 / 284 (0.35%)
    0 / 145 (0.00%)
    2 / 148 (1.35%)
    2 / 288 (0.69%)
         occurrences all number
    2
    0
    3
    1
    0
    2
    5
    Nasal congestion
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    1 / 299 (0.33%)
    3 / 284 (1.06%)
    1 / 145 (0.69%)
    0 / 148 (0.00%)
    2 / 288 (0.69%)
         occurrences all number
    0
    0
    1
    4
    1
    0
    2
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 298 (0.00%)
    3 / 294 (1.02%)
    2 / 299 (0.67%)
    2 / 284 (0.70%)
    0 / 145 (0.00%)
    1 / 148 (0.68%)
    4 / 288 (1.39%)
         occurrences all number
    0
    3
    2
    3
    0
    1
    4
    Depressive symptom
         subjects affected / exposed
    3 / 298 (1.01%)
    1 / 294 (0.34%)
    0 / 299 (0.00%)
    0 / 284 (0.00%)
    1 / 145 (0.69%)
    0 / 148 (0.00%)
    1 / 288 (0.35%)
         occurrences all number
    3
    1
    0
    0
    1
    0
    1
    Anxiety
         subjects affected / exposed
    2 / 298 (0.67%)
    1 / 294 (0.34%)
    1 / 299 (0.33%)
    2 / 284 (0.70%)
    0 / 145 (0.00%)
    1 / 148 (0.68%)
    3 / 288 (1.04%)
         occurrences all number
    2
    1
    1
    2
    0
    1
    3
    Depression
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 294 (0.00%)
    1 / 299 (0.33%)
    0 / 284 (0.00%)
    2 / 145 (1.38%)
    0 / 148 (0.00%)
    2 / 288 (0.69%)
         occurrences all number
    1
    0
    1
    0
    2
    0
    2
    Investigations
    Weight decreased
         subjects affected / exposed
    0 / 298 (0.00%)
    2 / 294 (0.68%)
    0 / 299 (0.00%)
    2 / 284 (0.70%)
    0 / 145 (0.00%)
    2 / 148 (1.35%)
    1 / 288 (0.35%)
         occurrences all number
    0
    2
    0
    2
    0
    2
    1
    Blood pressure increased
         subjects affected / exposed
    3 / 298 (1.01%)
    0 / 294 (0.00%)
    2 / 299 (0.67%)
    1 / 284 (0.35%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    1 / 288 (0.35%)
         occurrences all number
    4
    0
    2
    1
    0
    0
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    2 / 298 (0.67%)
    1 / 294 (0.34%)
    3 / 299 (1.00%)
    1 / 284 (0.35%)
    0 / 145 (0.00%)
    1 / 148 (0.68%)
    3 / 288 (1.04%)
         occurrences all number
    2
    1
    3
    1
    0
    1
    3
    Weight increased
         subjects affected / exposed
    2 / 298 (0.67%)
    1 / 294 (0.34%)
    1 / 299 (0.33%)
    2 / 284 (0.70%)
    2 / 145 (1.38%)
    2 / 148 (1.35%)
    3 / 288 (1.04%)
         occurrences all number
    2
    1
    1
    2
    2
    2
    3
    Blood cholesterol increased
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    1 / 284 (0.35%)
    0 / 145 (0.00%)
    2 / 148 (1.35%)
    0 / 288 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    2
    0
    Injury, poisoning and procedural complications
    Post vaccination syndrome
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    4 / 299 (1.34%)
    5 / 284 (1.76%)
    0 / 145 (0.00%)
    1 / 148 (0.68%)
    0 / 288 (0.00%)
         occurrences all number
    0
    0
    4
    6
    0
    1
    0
    Procedural pain
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    2 / 148 (1.35%)
    0 / 288 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    3
    0
    Ligament sprain
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 294 (0.00%)
    2 / 299 (0.67%)
    1 / 284 (0.35%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    3 / 288 (1.04%)
         occurrences all number
    1
    0
    2
    1
    0
    0
    3
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    5 / 298 (1.68%)
    5 / 294 (1.70%)
    2 / 299 (0.67%)
    4 / 284 (1.41%)
    1 / 145 (0.69%)
    1 / 148 (0.68%)
    2 / 288 (0.69%)
         occurrences all number
    5
    5
    2
    5
    1
    1
    3
    Migraine
         subjects affected / exposed
    3 / 298 (1.01%)
    3 / 294 (1.02%)
    1 / 299 (0.33%)
    2 / 284 (0.70%)
    0 / 145 (0.00%)
    1 / 148 (0.68%)
    7 / 288 (2.43%)
         occurrences all number
    3
    5
    1
    4
    0
    1
    7
    Sciatica
         subjects affected / exposed
    1 / 298 (0.34%)
    3 / 294 (1.02%)
    1 / 299 (0.33%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    2 / 288 (0.69%)
         occurrences all number
    1
    3
    1
    0
    0
    0
    2
    Somnolence
         subjects affected / exposed
    4 / 298 (1.34%)
    0 / 294 (0.00%)
    1 / 299 (0.33%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    1 / 148 (0.68%)
    0 / 288 (0.00%)
         occurrences all number
    4
    0
    2
    0
    0
    1
    0
    Headache
         subjects affected / exposed
    3 / 298 (1.01%)
    3 / 294 (1.02%)
    3 / 299 (1.00%)
    1 / 284 (0.35%)
    2 / 145 (1.38%)
    2 / 148 (1.35%)
    3 / 288 (1.04%)
         occurrences all number
    4
    3
    4
    1
    3
    3
    3
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 294 (0.00%)
    1 / 299 (0.33%)
    0 / 284 (0.00%)
    1 / 145 (0.69%)
    0 / 148 (0.00%)
    3 / 288 (1.04%)
         occurrences all number
    1
    0
    1
    0
    1
    0
    3
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    5 / 298 (1.68%)
    5 / 294 (1.70%)
    0 / 299 (0.00%)
    2 / 284 (0.70%)
    0 / 145 (0.00%)
    2 / 148 (1.35%)
    0 / 288 (0.00%)
         occurrences all number
    5
    5
    0
    2
    0
    2
    0
    Constipation
         subjects affected / exposed
    3 / 298 (1.01%)
    1 / 294 (0.34%)
    3 / 299 (1.00%)
    2 / 284 (0.70%)
    1 / 145 (0.69%)
    1 / 148 (0.68%)
    3 / 288 (1.04%)
         occurrences all number
    3
    2
    3
    2
    1
    2
    3
    Abdominal pain upper
         subjects affected / exposed
    2 / 298 (0.67%)
    4 / 294 (1.36%)
    5 / 299 (1.67%)
    3 / 284 (1.06%)
    1 / 145 (0.69%)
    3 / 148 (2.03%)
    4 / 288 (1.39%)
         occurrences all number
    3
    5
    5
    4
    1
    4
    5
    Abdominal pain
         subjects affected / exposed
    2 / 298 (0.67%)
    2 / 294 (0.68%)
    4 / 299 (1.34%)
    2 / 284 (0.70%)
    0 / 145 (0.00%)
    1 / 148 (0.68%)
    3 / 288 (1.04%)
         occurrences all number
    2
    2
    4
    2
    0
    1
    3
    Nausea
         subjects affected / exposed
    4 / 298 (1.34%)
    5 / 294 (1.70%)
    4 / 299 (1.34%)
    3 / 284 (1.06%)
    1 / 145 (0.69%)
    5 / 148 (3.38%)
    2 / 288 (0.69%)
         occurrences all number
    5
    5
    4
    3
    2
    5
    2
    Haemorrhoids
         subjects affected / exposed
    2 / 298 (0.67%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    2 / 284 (0.70%)
    2 / 145 (1.38%)
    1 / 148 (0.68%)
    2 / 288 (0.69%)
         occurrences all number
    3
    0
    0
    2
    2
    1
    2
    Dyspepsia
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 294 (0.34%)
    1 / 299 (0.33%)
    5 / 284 (1.76%)
    0 / 145 (0.00%)
    1 / 148 (0.68%)
    1 / 288 (0.35%)
         occurrences all number
    0
    1
    1
    6
    0
    1
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    4 / 299 (1.34%)
    0 / 284 (0.00%)
    1 / 145 (0.69%)
    1 / 148 (0.68%)
    1 / 288 (0.35%)
         occurrences all number
    0
    0
    4
    0
    1
    1
    1
    Pruritus
         subjects affected / exposed
    0 / 298 (0.00%)
    2 / 294 (0.68%)
    2 / 299 (0.67%)
    6 / 284 (2.11%)
    1 / 145 (0.69%)
    0 / 148 (0.00%)
    2 / 288 (0.69%)
         occurrences all number
    0
    2
    2
    6
    1
    0
    2
    Rash
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    3 / 284 (1.06%)
    1 / 145 (0.69%)
    0 / 148 (0.00%)
    0 / 288 (0.00%)
         occurrences all number
    1
    0
    0
    3
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 298 (0.00%)
    4 / 294 (1.36%)
    6 / 299 (2.01%)
    6 / 284 (2.11%)
    1 / 145 (0.69%)
    2 / 148 (1.35%)
    6 / 288 (2.08%)
         occurrences all number
    0
    5
    7
    6
    1
    3
    6
    Back pain
         subjects affected / exposed
    4 / 298 (1.34%)
    3 / 294 (1.02%)
    6 / 299 (2.01%)
    2 / 284 (0.70%)
    1 / 145 (0.69%)
    2 / 148 (1.35%)
    8 / 288 (2.78%)
         occurrences all number
    4
    3
    6
    2
    1
    2
    8
    Neck pain
         subjects affected / exposed
    1 / 298 (0.34%)
    3 / 294 (1.02%)
    1 / 299 (0.33%)
    0 / 284 (0.00%)
    1 / 145 (0.69%)
    0 / 148 (0.00%)
    1 / 288 (0.35%)
         occurrences all number
    1
    3
    1
    0
    1
    0
    1
    Pain in extremity
         subjects affected / exposed
    3 / 298 (1.01%)
    1 / 294 (0.34%)
    3 / 299 (1.00%)
    3 / 284 (1.06%)
    0 / 145 (0.00%)
    1 / 148 (0.68%)
    2 / 288 (0.69%)
         occurrences all number
    3
    1
    3
    3
    0
    1
    2
    Myalgia
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 294 (0.34%)
    2 / 299 (0.67%)
    1 / 284 (0.35%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    3 / 288 (1.04%)
         occurrences all number
    0
    1
    2
    1
    0
    0
    3
    Osteoarthritis
         subjects affected / exposed
    0 / 298 (0.00%)
    2 / 294 (0.68%)
    0 / 299 (0.00%)
    2 / 284 (0.70%)
    2 / 145 (1.38%)
    1 / 148 (0.68%)
    4 / 288 (1.39%)
         occurrences all number
    0
    2
    0
    2
    2
    1
    4
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    3 / 298 (1.01%)
    9 / 294 (3.06%)
    5 / 299 (1.67%)
    27 / 284 (9.51%)
    7 / 145 (4.83%)
    13 / 148 (8.78%)
    19 / 288 (6.60%)
         occurrences all number
    3
    11
    7
    38
    8
    15
    25
    COVID-19
         subjects affected / exposed
    16 / 298 (5.37%)
    15 / 294 (5.10%)
    19 / 299 (6.35%)
    63 / 284 (22.18%)
    25 / 145 (17.24%)
    31 / 148 (20.95%)
    63 / 288 (21.88%)
         occurrences all number
    16
    15
    19
    63
    26
    33
    69
    Urinary tract infection
         subjects affected / exposed
    5 / 298 (1.68%)
    5 / 294 (1.70%)
    1 / 299 (0.33%)
    4 / 284 (1.41%)
    3 / 145 (2.07%)
    4 / 148 (2.70%)
    3 / 288 (1.04%)
         occurrences all number
    6
    5
    1
    5
    4
    4
    4
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 298 (0.34%)
    2 / 294 (0.68%)
    4 / 299 (1.34%)
    8 / 284 (2.82%)
    4 / 145 (2.76%)
    6 / 148 (4.05%)
    13 / 288 (4.51%)
         occurrences all number
    1
    2
    4
    8
    4
    8
    14
    Sinusitis
         subjects affected / exposed
    3 / 298 (1.01%)
    1 / 294 (0.34%)
    0 / 299 (0.00%)
    5 / 284 (1.76%)
    2 / 145 (1.38%)
    2 / 148 (1.35%)
    4 / 288 (1.39%)
         occurrences all number
    3
    1
    0
    5
    2
    2
    4
    Gastroenteritis
         subjects affected / exposed
    3 / 298 (1.01%)
    2 / 294 (0.68%)
    0 / 299 (0.00%)
    5 / 284 (1.76%)
    1 / 145 (0.69%)
    1 / 148 (0.68%)
    2 / 288 (0.69%)
         occurrences all number
    3
    2
    0
    6
    1
    1
    2
    Bronchitis
         subjects affected / exposed
    1 / 298 (0.34%)
    3 / 294 (1.02%)
    0 / 299 (0.00%)
    3 / 284 (1.06%)
    1 / 145 (0.69%)
    3 / 148 (2.03%)
    4 / 288 (1.39%)
         occurrences all number
    1
    3
    0
    3
    1
    3
    4
    Pharyngitis
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 294 (0.34%)
    1 / 299 (0.33%)
    4 / 284 (1.41%)
    0 / 145 (0.00%)
    3 / 148 (2.03%)
    3 / 288 (1.04%)
         occurrences all number
    1
    1
    1
    5
    0
    3
    3
    Oral herpes
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    1 / 299 (0.33%)
    0 / 284 (0.00%)
    2 / 145 (1.38%)
    1 / 148 (0.68%)
    1 / 288 (0.35%)
         occurrences all number
    0
    0
    1
    0
    2
    1
    1
    Influenza
         subjects affected / exposed
    1 / 298 (0.34%)
    0 / 294 (0.00%)
    0 / 299 (0.00%)
    1 / 284 (0.35%)
    2 / 145 (1.38%)
    1 / 148 (0.68%)
    4 / 288 (1.39%)
         occurrences all number
    1
    0
    0
    1
    2
    1
    4
    Herpes zoster
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 294 (0.34%)
    1 / 299 (0.33%)
    0 / 284 (0.00%)
    1 / 145 (0.69%)
    0 / 148 (0.00%)
    3 / 288 (1.04%)
         occurrences all number
    0
    1
    1
    0
    1
    0
    3
    Cystitis
         subjects affected / exposed
    1 / 298 (0.34%)
    2 / 294 (0.68%)
    0 / 299 (0.00%)
    3 / 284 (1.06%)
    0 / 145 (0.00%)
    5 / 148 (3.38%)
    1 / 288 (0.35%)
         occurrences all number
    1
    2
    0
    3
    0
    5
    1
    Rhinitis
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 294 (0.34%)
    0 / 299 (0.00%)
    3 / 284 (1.06%)
    1 / 145 (0.69%)
    0 / 148 (0.00%)
    1 / 288 (0.35%)
         occurrences all number
    0
    1
    0
    3
    1
    0
    1
    Tonsillitis
         subjects affected / exposed
    0 / 298 (0.00%)
    2 / 294 (0.68%)
    0 / 299 (0.00%)
    4 / 284 (1.41%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    2 / 288 (0.69%)
         occurrences all number
    0
    2
    0
    5
    0
    0
    2
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    1 / 299 (0.33%)
    4 / 284 (1.41%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    0 / 288 (0.00%)
         occurrences all number
    0
    0
    1
    5
    0
    0
    0
    Metabolism and nutrition disorders
    Hyperlipidaemia
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 294 (0.00%)
    3 / 299 (1.00%)
    2 / 284 (0.70%)
    1 / 145 (0.69%)
    2 / 148 (1.35%)
    0 / 288 (0.00%)
         occurrences all number
    0
    0
    3
    2
    1
    2
    0
    Vitamin B12 deficiency
         subjects affected / exposed
    0 / 298 (0.00%)
    1 / 294 (0.34%)
    0 / 299 (0.00%)
    0 / 284 (0.00%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    3 / 288 (1.04%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    3
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 298 (0.34%)
    1 / 294 (0.34%)
    2 / 299 (0.67%)
    2 / 284 (0.70%)
    2 / 145 (1.38%)
    1 / 148 (0.68%)
    4 / 288 (1.39%)
         occurrences all number
    1
    1
    2
    2
    2
    1
    4
    Dyslipidaemia
         subjects affected / exposed
    2 / 298 (0.67%)
    2 / 294 (0.68%)
    1 / 299 (0.33%)
    2 / 284 (0.70%)
    0 / 145 (0.00%)
    0 / 148 (0.00%)
    3 / 288 (1.04%)
         occurrences all number
    2
    2
    1
    2
    0
    0
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Jan 2021
    It included following changes: - Added section describing how to manage reactions to investigational medicinal product; - Added withdrawal criteria for participants who have: • anaphylactic reactions or other severe and/or serious hypersensitivity reactions; • significant risk of suicide according to Columbia Suicide Severity Rating Scale (C-SSRS). - Made changes to the statistical methodology: • Primary analysis: MMRM replaced analysis of covariance (ANCOVA); • Key secondary responder endpoint analyses: logistic regression replaced the Cochran–Mantel–Haenszel (CMH) test; • Analysis of MMDs (Weeks 13-24): MMRM replaced ANCOVA • Added: that participants with a migraine on the day after the first dose and that 100% responder endpoints will be analysed using an extended CMH test.
    30 Nov 2021
    It included following changes: - Cancelled the planned interim analysis; - Clarified definitions for eligibility: migraine day, headache day, and eDiary compliant day. - Updated sections that described: • randomization stratified by MHDs and by country; • timing of exit interviews for participants who withdrew prior to Week 24; • definitions for calculating the number of episodic migraine (EM)/chronic migraine (CM) participants and low/high frequency EM participants for subgroup analyses; • unscheduled visits - Added that: • participants could attend up to two Screening Visits to complete all screening assessments; • vaccination against COVID-19 is allowed during the study; • following the database lock for the Placebo-controlled Period, Sponsor personnel involved in the development of the Clinical Study Report were unblinded to individual treatment codes.

    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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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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