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    Clinical Trial Results:
    Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Eptinezumab for the Preventive Treatment of Migraine in Patients with a Dual Diagnosis of Migraine and Medication Overuse Headache

    Summary
    EudraCT number
    		 2020-001669-35
    Trial protocol
    		 ES  
    Global end of trial date
    30 Sep 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Oct 2023
    First version publication date
    01 Oct 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    19139A
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04772742
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    H. Lundbeck A/S
    Sponsor organisation address
    Ottiliavej 9, Valby, Denmark, 2500
    Public contact
    H. Lundbeck A/S, LundbeckClinicalTrials@lundbeck.com, +45 36301311, LundbeckClinicalTrials@lundbeck.com
    Scientific contact
    H. Lundbeck A/S, LundbeckClinicalTrials@lundbeck.com, +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
    30 Sep 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 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 and medication overuse headache.
    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
    17 Feb 2021
    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
    China: 128
    Country: Number of subjects enrolled
    Spain: 28
    Country: Number of subjects enrolled
    Georgia: 9
    Country: Number of subjects enrolled
    Korea, Republic of: 18
    Country: Number of subjects enrolled
    Taiwan: 10
    Worldwide total number of subjects
    193
    EEA total number of subjects
    28
    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)
    184
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study included 2 periods: Placebo-controlled Period - 12-week double-blind treatment period with placebo or eptinezumab 100mg followed by an Open-label Period - 12-week period with eptinezumab 100mg. A safety follow-up visit was conducted 20 weeks after the last investigational medicinal product administration.

    Pre-assignment
    Screening details
    		 193 participants were enrolled at sites in 5 countries.

    Period 1
    Period 1 title
    Placebo-controlled (Weeks 1-12)
    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
    		 Eptinezumab
    Arm description
    		 Participants received 100 mg eptinezumab by intravenous (IV) infusion at Baseline (Day 0)
    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
    100mg at Baseline (Day 0)

    Arm title
    		 Placebo
    Arm description
    		 Participants received matching placebo by IV infusion at Baseline (Day 0)
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    100 mL 0.9% saline solution administered at Baseline (Day 0)

    Number of subjects in period 1
    		Eptinezumab Placebo
    Started
    93
    100
    Received at least 1 dose of study drug
    93
    100
    Completed
    81
    83
    Not completed
    12
    17
         Consent withdrawn by subject
    -
    2
         Adverse event, non-fatal
    2
    1
         Other reasons
    10
    14
    Period 2
    Period 2 title
    Open-label (Weeks 12-24)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Eptinezumab
    Arm description
    		 Participants received 100 mg eptinezumab by IV infusion at Primary Outcome Visit (Week 12)
    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
    100mg at Primary Outcome Visit (Week 12)

    Number of subjects in period 2
    		Eptinezumab
    Started
    164
    Received at least 1 dose of study drug
    162
    Completed
    137
    Not completed
    27
         Consent withdrawn by subject
    5
         Adverse event, non-fatal
    2
         Other reasons
    13
         Lost to follow-up
    2
         Lack of efficacy
    3
         Not treated
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Eptinezumab
    Reporting group description
    		 Participants received 100 mg eptinezumab by intravenous (IV) infusion at Baseline (Day 0)

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received matching placebo by IV infusion at Baseline (Day 0)

    Reporting group values
    		 Eptinezumab Placebo Total
    Number of subjects
    		 93 100 193
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 87 97 184
        From 65-84 years
    		 6 3 9
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        median (full range (min-max))
    		 44 (19 to 70) 43.5 (19 to 71) -
    Gender Categorical
    Units: Subjects
        Female
    		 69 82 151
        Male
    		 24 18 42
    Monthly Migraine Days (MMDs)
    The Full Analysis Set (FAS, n=190) included all participants who had a valid Baseline assessment and at least one valid post-baseline 4-week assessment of MMDs in Weeks 1-12.
    Units: days
        arithmetic mean (standard deviation)
    		 19.5 ( 3.6 ) 19.7 ( 3.8 ) -

    End points

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    End points reporting groups
    Reporting group title
    Eptinezumab
    Reporting group description
    		 Participants received 100 mg eptinezumab by intravenous (IV) infusion at Baseline (Day 0)

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received matching placebo by IV infusion at Baseline (Day 0)
    Reporting group title
    Eptinezumab
    Reporting group description
    		 Participants received 100 mg eptinezumab by IV infusion at Primary Outcome Visit (Week 12)

    Primary: Change from Baseline in Number of Monthly Migraine Days (MMDs)

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    End point title
    		 Change from Baseline in Number of Monthly Migraine Days (MMDs)
    End point description
    The Migraine Day definition was based on the International Headache Society (IHS) guidelines for controlled trials of preventive treatment of chronic migraine in adults and was defined as any day the participant reported a headache that met criterion A, B, or C: • Criterion A (all of the following criteria): – lasted ≥4 hours – had ≥2 of the following: unilateral location; pulsating quality; moderate/severe pain intensity; aggravation by or avoidance of routine physical activity – was accompanied by: nausea; vomiting; photophobia or phonophobia • Criterion B: – lasted ≥30 minutes and the participant had an aura • Criterion C: a day with a headache believed by the participant to be a migraine and for which he/she took migraine-specific acute medication (such as triptan, ergotamine, or other migraine-specific acute medication) The FAS included all participants who had a valid Baseline assessment and at least one 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
    		 Eptinezumab Placebo
    Number of subjects analysed
    90
    100
    Units: days
        arithmetic mean (standard error)
    -7.2 ( 0.73 )
    -5.9 ( 0.68 )
    Statistical analysis title
    		 Mean Difference from Placebo
    Comparison groups
    Eptinezumab v Placebo
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1484
    Method
    		 mixed model for repeated measures
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.9
         upper limit
    		 0.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.86

    Secondary: Change from Baseline in MMDs With Use of Acute Medication

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    End point title
    		 Change from Baseline in MMDs With Use of Acute Medication
    End point description
    The Migraine Day definition was based on the International Headache Society (IHS) guidelines for controlled trials of preventive treatment of chronic migraine in adults and was defined as any day the participant reported a headache that met criterion A, B, or C: • Criterion A (all of the following criteria): – lasted ≥4 hours – had ≥2 of the following: unilateral location; pulsating quality; moderate/severe pain intensity; aggravation by or avoidance of routine physical activity – was accompanied by: nausea; vomiting; photophobia or phonophobia • Criterion B: – lasted ≥30 minutes and the participant had an aura • Criterion C: a day with a headache believed by the participant to be a migraine and for which he/she took migraine-specific acute medication (such as triptan, ergotamine, or other migraine-specific acute medication) The FAS included all participants who had a valid Baseline assessment and at least one valid post-baseline 4-week assessment of MMDs in Weeks 1-12.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 1-12
    End point values
    		 Eptinezumab Placebo
    Number of subjects analysed
    90
    100
    Units: days
        arithmetic mean (standard error)
    -7.5 ( 0.73 )
    -6.2 ( 0.69 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants with At Least 50% Reduction in MMDs

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    End point title
    		 Percentage of Participants with At Least 50% Reduction in MMDs
    End point description
    The Migraine Day definition was based on the International Headache Society (IHS) guidelines for controlled trials of preventive treatment of chronic migraine in adults and was defined as any day the participant reported a headache that met criterion A, B, or C: • Criterion A (all of the following criteria): – lasted ≥4 hours – had ≥2 of the following: unilateral location; pulsating quality; moderate/severe pain intensity; aggravation by or avoidance of routine physical activity – was accompanied by: nausea; vomiting; photophobia or phonophobia • Criterion B: – lasted ≥30 minutes and the participant had an aura • Criterion C: a day with a headache believed by the participant to be a migraine and for which he/she took migraine-specific acute medication (such as triptan, ergotamine, or other migraine-specific acute medication) The FAS included all participants who had a valid Baseline assessment and at least one valid post-baseline 4-week assessment of MMDs in Weeks 1-12.
    End point type
    Secondary
    End point timeframe
    Weeks 1-12
    End point values
    		 Eptinezumab Placebo
    Number of subjects analysed
    90
    100
    Units: percentage of participants
        number (not applicable)
    31.1
    24.0
    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
    The FAS included all participants who had a valid Baseline assessment and at least one valid post-baseline 4-week assessment of MMDs in Weeks 1-12. Here, number of subjects analyzed refers to the number of participants in the analysis at the relevant timepoint.
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    		 Eptinezumab Placebo
    Number of subjects analysed
    90
    99
    Units: percentage of participants
        number (not applicable)
    44.2
    59.2
    No statistical analyses for this end point

    Secondary: Percentage of Participants with At Least 75% Reduction in MMDs (Weeks 1-4)

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    End point title
    		 Percentage of Participants with At Least 75% Reduction in MMDs (Weeks 1-4)
    End point description
    The Migraine Day definition was based on the International Headache Society (IHS) guidelines for controlled trials of preventive treatment of chronic migraine in adults and was defined as any day the participant reported a headache that met criterion A, B, or C: • Criterion A (all of the following criteria): – lasted ≥4 hours – had ≥2 of the following: unilateral location; pulsating quality; moderate/severe pain intensity; aggravation by or avoidance of routine physical activity – was accompanied by: nausea; vomiting; photophobia or phonophobia • Criterion B: – lasted ≥30 minutes and the participant had an aura • Criterion C: a day with a headache believed by the participant to be a migraine and for which he/she took migraine-specific acute medication (such as triptan, ergotamine, or other migraine-specific acute medication) The FAS included all participants who had a valid Baseline assessment and at least one valid post-baseline 4-week assessment of MMDs in Weeks 1-12.
    End point type
    Secondary
    End point timeframe
    Weeks 1-4
    End point values
    		 Eptinezumab Placebo
    Number of subjects analysed
    90
    99
    Units: percentage of participants
        number (not applicable)
    17.8
    1.0
    No statistical analyses for this end point

    Secondary: Change from Baseline in Number of Monthly Headache Days (MHDs)

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    End point title
    		 Change from Baseline in Number of Monthly Headache Days (MHDs)
    End point description
    A Headache Day was defined as a day with a headache of a minimum 30 minutes or a Migraine Day. The FAS included all participants who had a valid Baseline assessment and at least one valid post-baseline 4-week assessment of MMDs in Weeks 1-12.
    End point type
    Secondary
    End point timeframe
    Weeks 1-12
    End point values
    		 Eptinezumab Placebo
    Number of subjects analysed
    90
    100
    Units: days
        arithmetic mean (standard error)
    -7.1 ( 0.70 )
    -5.9 ( 0.67 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants with At Least 75% Reduction in MMDs (Weeks 1-12)

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    End point title
    		 Percentage of Participants with At Least 75% Reduction in MMDs (Weeks 1-12)
    End point description
    The Migraine Day definition was based on the International Headache Society (IHS) guidelines for controlled trials of preventive treatment of chronic migraine in adults and was defined as any day the participant reported a headache that met criterion A, B, or C: • Criterion A (all of the following criteria): – lasted ≥4 hours – had ≥2 of the following: unilateral location; pulsating quality; moderate/severe pain intensity; aggravation by or avoidance of routine physical activity – was accompanied by: nausea; vomiting; photophobia or phonophobia • Criterion B: – lasted ≥30 minutes and the participant had an aura • Criterion C: a day with a headache believed by the participant to be a migraine and for which he/she took migraine-specific acute medication (such as triptan, ergotamine, or other migraine-specific acute medication) The FAS included all participants who had a valid Baseline assessment and at least one valid post-baseline 4-week assessment of MMDs in Weeks 1-12.
    End point type
    Secondary
    End point timeframe
    Weeks 1-12
    End point values
    		 Eptinezumab Placebo
    Number of subjects analysed
    90
    100
    Units: percentage of participants
        number (not applicable)
    16.7
    2.0
    No statistical analyses for this end point

    Secondary: Percentage of Participants with At Least 75% Reduction in MHDs (Weeks 1-12)

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    End point title
    		 Percentage of Participants with At Least 75% Reduction in MHDs (Weeks 1-12)
    End point description
    A Headache Day was defined as a day with a headache of a minimum 30 minutes or a Migraine Day. The FAS included all participants who had a valid Baseline assessment and at least one valid post-baseline 4-week assessment of MMDs in Weeks 1-12.
    End point type
    Secondary
    End point timeframe
    Weeks 1-12
    End point values
    		 Eptinezumab Placebo
    Number of subjects analysed
    90
    100
    Units: percentage of participants
        number (not applicable)
    13.3
    1.0
    No statistical analyses for this end point

    Secondary: Percentage of Participants with At Least 75% Reduction in MHDs (Weeks 1-4)

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    End point title
    		 Percentage of Participants with At Least 75% Reduction in MHDs (Weeks 1-4)
    End point description
    A Headache Day was defined as a day with a headache of a minimum 30 minutes or a Migraine Day. The FAS included all participants who had a valid Baseline assessment and at least one valid post-baseline 4-week assessment of MMDs in Weeks 1-12. Here, number of subjects analyzed refers to the number of participants in the analysis at the relevant timepoint.
    End point type
    Secondary
    End point timeframe
    Weeks 1-4
    End point values
    		 Eptinezumab Placebo
    Number of subjects analysed
    90
    99
    Units: percentage of participants
        number (not applicable)
    10.0
    0
    No statistical analyses for this end point

    Secondary: Change from Baseline in MHDs With Use of Acute Medication

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    End point title
    		 Change from Baseline in MHDs With Use of Acute Medication
    End point description
    A Headache Day was defined as a day with a headache of a minimum 30 minutes or a Migraine Day. The FAS included all participants who had a valid Baseline assessment and at least one valid post-baseline 4-week assessment of MMDs in Weeks 1-12.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 1-12
    End point values
    		 Eptinezumab Placebo
    Number of subjects analysed
    90
    100
    Units: days
        arithmetic mean (standard error)
    -7.6 ( 0.71 )
    -6.3 ( 0.68 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Percentage of Migraine Attacks with Severe Pain Intensity

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    End point title
    		 Change from Baseline in Percentage of Migraine Attacks with Severe Pain Intensity
    End point description
    A migraine, occurring on a single day or lasting more days, that fulfils the criteria for a migraine, was also referred to as a Migraine Attack. The FAS included all participants who had a valid Baseline assessment and at least one valid post-baseline 4-week assessment of MMDs in Weeks 1-12.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 1-12
    End point values
    		 Eptinezumab Placebo
    Number of subjects analysed
    90
    100
    Units: percentage of migraine attacks
        arithmetic mean (standard error)
    -7.4 ( 2.25 )
    -5.8 ( 2.14 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Percentage of Headache Episodes with Severe Pain Intensity

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    End point title
    		 Change from Baseline in Percentage of Headache Episodes with Severe Pain Intensity
    End point description
    A headache, occurring on a single day or lasting more days, that either lasts at least 30 minutes or qualifies as a migraine, was also referred to as a Headache Episode. The FAS included all participants who had a valid Baseline assessment and at least one valid post-baseline 4-week assessment of MMDs in Weeks 1-12.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 1-12
    End point values
    		 Eptinezumab Placebo
    Number of subjects analysed
    90
    100
    Units: percentage of headache episodes
        arithmetic mean (standard error)
    -8.2 ( 2.09 )
    -6.0 ( 1.99 )
    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 patient-reported item reflecting the participant’s impression of change in their disease status since the start of the study (that is, in relation to activity limitations, symptoms, emotions, and overall quality of life). The item is rated on a 7-point scale, where a high score indicates improvement (very much improved; much improved; minimally improved; no change; minimally worse; much worse; very much worse). The FAS included all participants who had a valid Baseline assessment and at least one valid post-baseline 4-week assessment of MMDs in Weeks 1-12. Here, number of subjects analyzed refers to the number of participants in the analysis at the relevant timepoint.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Eptinezumab Placebo
    Number of subjects analysed
    86
    96
    Units: score on a scale
        arithmetic mean (standard error)
    2.6 ( 0.14 )
    3.1 ( 0.13 )
    No statistical analyses for this end point

    Secondary: Change from Screening at Week 12 in Most Bothersome Symptom (MBS) Score

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    End point title
    		 Change from Screening at Week 12 in Most Bothersome Symptom (MBS) Score
    End point description
    The Investigator verbally obtained the most bothersome symptom associated with the participant's migraines during the Screening Visit. Participants were asked to rate the improvement in this symptom from screening on a 7-point scale where a high score indicates improvement (very much improved; much improved; minimally improved; no change; minimally worse; much worse; very much worse). The MBS areas include: nausea, vomiting, sensitivity to light, sensitivity to sound, mental cloudiness, fatigue, pain with activity, mood changes, and other. The FAS included all participants who had a valid Baseline assessment and at least one valid post-baseline 4-week assessment of MMDs in Weeks 1-12. Here, number of subjects analyzed refers to the number of participants in the analysis at the relevant timepoint.
    End point type
    Secondary
    End point timeframe
    Screening, Week 12
    End point values
    		 Eptinezumab Placebo
    Number of subjects analysed
    86
    96
    Units: score on a scale
        arithmetic mean (standard error)
    2.7 ( 0.14 )
    3.2 ( 0.14 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 32 Weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Eptinezumab
    Reporting group description
    		 Placebo-controlled period (Weeks 1-12)

    Reporting group title
    Placebo to eptinezumab (Open-label period)
    Reporting group description
    		 Open-label period (Weeks 12-24) Participants received placebo during the placebo-controlled period and eptinezumab in the open-label period.

    Reporting group title
    Eptinezumab to eptinezumab (Open-label)
    Reporting group description
    		 Open-label period (Weeks 12-24) Participants received eptinezumab in both the placebo-controlled and open-label periods

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo-controlled period (Weeks 1-12)

    Serious adverse events
    		 Eptinezumab Placebo to eptinezumab (Open-label period) Eptinezumab to eptinezumab (Open-label) Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 93 (2.15%)
    0 / 81 (0.00%)
    4 / 81 (4.94%)
    0 / 100 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Rib fracture
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 93 (1.08%)
    0 / 81 (0.00%)
    0 / 81 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 93 (1.08%)
    0 / 81 (0.00%)
    0 / 81 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 81 (0.00%)
    1 / 81 (1.23%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radiculopathy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 81 (0.00%)
    1 / 81 (1.23%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermal cyst
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 81 (0.00%)
    1 / 81 (1.23%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 81 (0.00%)
    1 / 81 (1.23%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 81 (0.00%)
    1 / 81 (1.23%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 81 (0.00%)
    1 / 81 (1.23%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Eptinezumab Placebo to eptinezumab (Open-label period) Eptinezumab to eptinezumab (Open-label) Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 93 (21.51%)
    24 / 81 (29.63%)
    20 / 81 (24.69%)
    17 / 100 (17.00%)
    Investigations
    Protein urine present
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 93 (2.15%)
    0 / 81 (0.00%)
    0 / 81 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Glycosylated haemoglobin increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 93 (2.15%)
    0 / 81 (0.00%)
    1 / 81 (1.23%)
    1 / 100 (1.00%)
         occurrences all number
    2
    0
    1
    1
    Nervous system disorders
    Migraine
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 93 (1.08%)
    1 / 81 (1.23%)
    5 / 81 (6.17%)
    1 / 100 (1.00%)
         occurrences all number
    1
    1
    5
    1
    Dizziness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 93 (2.15%)
    3 / 81 (3.70%)
    1 / 81 (1.23%)
    2 / 100 (2.00%)
         occurrences all number
    2
    3
    1
    2
    General disorders and administration site conditions
    Fatigue
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 93 (0.00%)
    2 / 81 (2.47%)
    0 / 81 (0.00%)
    4 / 100 (4.00%)
         occurrences all number
    0
    2
    0
    5
    Influenza like illness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 93 (1.08%)
    1 / 81 (1.23%)
    0 / 81 (0.00%)
    2 / 100 (2.00%)
         occurrences all number
    1
    1
    0
    2
    Pyrexia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 93 (1.08%)
    0 / 81 (0.00%)
    3 / 81 (3.70%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    3
    0
    Gastrointestinal disorders
    Abdominal pain upper
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 93 (1.08%)
    2 / 81 (2.47%)
    0 / 81 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    1
    2
    0
    1
    Diarrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 93 (2.15%)
    2 / 81 (2.47%)
    0 / 81 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    2
    2
    0
    1
    Nausea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 93 (2.15%)
    0 / 81 (0.00%)
    1 / 81 (1.23%)
    2 / 100 (2.00%)
         occurrences all number
    2
    0
    1
    2
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 93 (2.15%)
    0 / 81 (0.00%)
    0 / 81 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Renal and urinary disorders
    Proteinuria
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 93 (0.00%)
    2 / 81 (2.47%)
    0 / 81 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Musculoskeletal and connective tissue disorders
    Muscle spasms
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 93 (2.15%)
    0 / 81 (0.00%)
    0 / 81 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Myalgia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 81 (1.23%)
    2 / 81 (2.47%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    2
    1
    Infections and infestations
    Urinary tract infection bacterial
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 93 (0.00%)
    1 / 81 (1.23%)
    0 / 81 (0.00%)
    3 / 100 (3.00%)
         occurrences all number
    0
    1
    0
    3
    COVID-19
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 93 (0.00%)
    3 / 81 (3.70%)
    3 / 81 (3.70%)
    1 / 100 (1.00%)
         occurrences all number
    0
    3
    3
    1
    Nasopharyngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 93 (2.15%)
    1 / 81 (1.23%)
    1 / 81 (1.23%)
    0 / 100 (0.00%)
         occurrences all number
    3
    2
    1
    0
    Pharyngotonsillitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 81 (0.00%)
    2 / 81 (2.47%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Upper respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 93 (3.23%)
    11 / 81 (13.58%)
    0 / 81 (0.00%)
    2 / 100 (2.00%)
         occurrences all number
    3
    14
    0
    2
    Urinary tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 93 (2.15%)
    0 / 81 (0.00%)
    3 / 81 (3.70%)
    1 / 100 (1.00%)
         occurrences all number
    2
    0
    3
    1
    Metabolism and nutrition disorders
    Hyperlipidaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 93 (0.00%)
    3 / 81 (3.70%)
    0 / 81 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    3
    0
    1
    Glucose tolerance impaired
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 93 (0.00%)
    0 / 81 (0.00%)
    2 / 81 (2.47%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Sep 2020
    Deleted: the maximum number of White patients
    25 Jan 2021
    Deleted: exit interviews Made changes to the statistical methodology: • added: efficacy analyses will be based on the FAS • included estimands Added: • withdrawal criteria for patients who have anaphylactic reactions or other severe and/or serious hypersensitivity reactions • information on how to manage anaphylactic/hypersensitivity reactions • the possibility to collect additional blood specimens using immune response laboratory kits • follow-up of patients with elevated AST or ALT values Clarified: • the acute medication allowed • the possibility for re-screening of patients affected by COVID-19
    23 Apr 2021
    Added that, per investigator judgement, it can be considered to perform additional immune response tests in accordance with local clinical practice, such as histamine, tryptase, immunoglobulin E, and complement components C3 and C4
    29 Oct 2021
    Updated the definition of a migraine day Made changes to the statistical methodology: • updated: the definition of the FAS to reflect an update in the statistical methodology • primary analysis: updated to include estimands • exploratory analysis: replaced ANCOVA with MMRM, replaced the CMH test with logistic regression

    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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