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    Clinical Trial Results:
    Interventional, Open-label, Fixed-dose Multiple Administration Study to Evaluate Long-term Treatment With Eptinezumab in Patients With Chronic Cluster Headache

    Summary
    EudraCT number
    		 2020-001968-28
    Trial protocol
    		 DE   DK   NL   FI   ES   IT  
    Global end of trial date
    29 Jun 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Jul 2024
    First version publication date
    10 Jul 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    19385A
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05064397
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    H. Lundbeck A/S
    Sponsor organisation address
    Ottiliavej 9, Valby, Denmark, 2500
    Public contact
    Email contact via H. Lundbeck A/S, H. Lundbeck A/S, +45 36301311, LundbeckClinicalTrials@Lundbeck.com
    Scientific contact
    Email contact via H. Lundbeck A/S, 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
    29 Jun 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jun 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main goal of this trial was to inform about long-term safety and tolerability of eptinezumab in participants with chronic cluster headache.
    Protection of trial subjects
    This trial 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 Sep 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Denmark: 19
    Country: Number of subjects enrolled
    Spain: 13
    Country: Number of subjects enrolled
    Finland: 4
    Country: Number of subjects enrolled
    France: 51
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    Italy: 26
    Country: Number of subjects enrolled
    Netherlands: 10
    Country: Number of subjects enrolled
    United States: 4
    Worldwide total number of subjects
    131
    EEA total number of subjects
    125
    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)
    127
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 131 participants were enrolled in 9 countries.

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

    Arms
    Arm title
    		 Eptinezumab
    Arm description
    		 Participants received 4 intravenous (IV) infusions of 400 milligrams (mg) eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eptinezumab
    Investigational medicinal product code
    Other name
    Vyepti
    Pharmaceutical forms
    Solution for injection/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
    		Eptinezumab
    Started
    131
    Received at least 1 dose of study drug
    131
    Completed
    108
    Not completed
    23
         Consent withdrawn by subject
    3
         Adverse event, non-fatal
    4
         Other reasons
    3
         Lost to follow-up
    1
         Lack of efficacy
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Eptinezumab
    Reporting group description
    		 Participants received 4 intravenous (IV) infusions of 400 milligrams (mg) eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.

    Reporting group values
    		 Eptinezumab Total
    Number of subjects
    		 131 131
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 127 127
        From 65-84 years
    		 4 4
        85 years and over
    		 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 45.2 ( 10.79 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 47 47
        Male
    		 84 84
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0
        Asian
    		 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Black or African American
    		 0 0
        White
    		 76 76
        More than one race
    		 4 4
        Unknown or Not Reported
    		 51 51

    End points

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    End points reporting groups
    Reporting group title
    Eptinezumab
    Reporting group description
    		 Participants received 4 intravenous (IV) infusions of 400 milligrams (mg) eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.

    Primary: Number of Participants With Treatment-emergent Adverse Events (AEs)

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    End point title
    		 Number of Participants With Treatment-emergent Adverse Events (AEs) [1]
    End point description
    A treatment-emergent AE was defined as any on-treatment untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A summary of non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. Measured in the all-participants-treated set (APTS), which included all participants who received infusion with eptinezumab.
    End point type
    Primary
    End point timeframe
    From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only summary statistics were planned for this endpoint.
    End point values
    		 Eptinezumab
    Number of subjects analysed
    131
    Units: participants
    106
    No statistical analyses for this end point

    Secondary: Conversion From Chronic Cluster Headache (cCH) to Episodic Cluster Headache (eCH): Number of Participants With No Cluster Headache (CH) Attacks for ≥3 Consecutive Months (≥12 consecutive weeks)

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    End point title
    		 Conversion From Chronic Cluster Headache (cCH) to Episodic Cluster Headache (eCH): Number of Participants With No Cluster Headache (CH) Attacks for ≥3 Consecutive Months (≥12 consecutive weeks)
    End point description
    Participants counted as converting from cCH to eCH if they had no CH attacks for at least 3 months. The Full Analysis Set (FAS) included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks.
    End point type
    Secondary
    End point timeframe
    Week 1 to Week 48
    End point values
    		 Eptinezumab
    Number of subjects analysed
    131
    Units: participants
    7
    No statistical analyses for this end point

    Secondary: Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used

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    End point title
    		 Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used
    End point description
    Abortive therapy was defined as oxygen and/or triptans, where it counted as 2 times if oxygen and triptans were used for the same attack. The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
    End point values
    		 Eptinezumab
    Number of subjects analysed
    127
    Units: Abortive therapy use per week
    least squares mean (standard error)
        Week 1
    -3.63 ( 0.53 )
        Week 2
    -4.24 ( 0.70 )
        Week 3
    -4.90 ( 0.76 )
        Week 4
    -4.99 ( 0.94 )
        Week 13
    -7.22 ( 0.84 )
        Week 14
    -6.83 ( 0.85 )
        Week 15
    -6.06 ( 0.84 )
        Week 16
    -6.42 ( 0.96 )
        Week 25
    -6.18 ( 0.99 )
        Week 26
    -6.56 ( 0.86 )
        Week 27
    -7.56 ( 0.82 )
        Week 28
    -7.12 ( 0.83 )
        Week 37
    -6.55 ( 0.98 )
        Week 38
    -6.97 ( 0.84 )
        Week 39
    -6.71 ( 1.04 )
        Week 40
    -7.09 ( 0.84 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used

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    End point title
    		 Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used
    End point description
    The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
    End point values
    		 Eptinezumab
    Number of subjects analysed
    127
    Units: Oxygen use per week
    least squares mean (standard error)
        Week 1
    -1.72 ( 0.33 )
        Week 2
    -2.43 ( 0.40 )
        Week 3
    -3.17 ( 0.48 )
        Week 4
    -3.23 ( 0.59 )
        Week 13
    -3.97 ( 0.57 )
        Week 14
    -3.93 ( 0.56 )
        Week 15
    -3.09 ( 0.53 )
        Week 16
    -3.78 ( 0.61 )
        Week 25
    -3.56 ( 0.67 )
        Week 26
    -3.75 ( 0.58 )
        Week 27
    -4.06 ( 0.52 )
        Week 28
    -4.02 ( 0.54 )
        Week 37
    -3.60 ( 0.64 )
        Week 38
    -3.74 ( 0.52 )
        Week 39
    -3.99 ( 0.66 )
        Week 40
    -3.82 ( 0.55 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used

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    End point title
    		 Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used
    End point description
    The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
    End point values
    		 Eptinezumab
    Number of subjects analysed
    127
    Units: Triptans use per week
    least squares mean (standard error)
        Week 1
    -1.75 ( 0.33 )
        Week 2
    -1.73 ( 0.42 )
        Week 3
    -1.74 ( 0.44 )
        Week 4
    -1.90 ( 0.45 )
        Week 13
    -2.94 ( 0.46 )
        Week 14
    -2.78 ( 0.50 )
        Week 15
    -2.81 ( 0.49 )
        Week 16
    -2.50 ( 0.51 )
        Week 25
    -2.05 ( 0.52 )
        Week 26
    -2.48 ( 0.48 )
        Week 27
    -3.06 ( 0.45 )
        Week 28
    -2.86 ( 0.46 )
        Week 37
    -2.55 ( 0.50 )
        Week 38
    -2.54 ( 0.49 )
        Week 39
    -2.52 ( 0.58 )
        Week 40
    -2.95 ( 0.54 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Average Number of Weekly Attacks

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    End point title
    		 Change From Baseline in the Average Number of Weekly Attacks
    End point description
    The participant completed a CH eDiary, daily, and record for each day/week whether he/she had any CH attacks. The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
    End point values
    		 Eptinezumab
    Number of subjects analysed
    127
    Units: Attacks per week
    least squares mean (standard error)
        Week 1
    -3.00 ( 0.54 )
        Week 2
    -3.92 ( 0.79 )
        Week 3
    -4.51 ( 0.93 )
        Week 4
    -4.98 ( 1.18 )
        Week 13
    -6.18 ( 1.20 )
        Week 14
    -6.31 ( 1.15 )
        Week 15
    -5.81 ( 1.08 )
        Week 16
    -6.63 ( 1.24 )
        Week 25
    -5.56 ( 1.26 )
        Week 26
    -5.95 ( 1.27 )
        Week 27
    -7.09 ( 1.22 )
        Week 28
    -6.51 ( 1.31 )
        Week 37
    -6.25 ( 1.27 )
        Week 38
    -6.57 ( 1.14 )
        Week 39
    -5.99 ( 1.23 )
        Week 40
    -6.39 ( 1.15 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Number of Weekly Attacks (Weeks 1-4)

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    End point title
    		 Change from Baseline in the Number of Weekly Attacks (Weeks 1-4)
    End point description
    The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 1-4
    End point values
    		 Eptinezumab
    Number of subjects analysed
    127
    Units: Attacks per week
        least squares mean (standard error)
    -4.11 ( 0.79 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Number of Weekly Attacks (Weeks 1-2)

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    End point title
    		 Change from Baseline in the Number of Weekly Attacks (Weeks 1-2)
    End point description
    The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 1-2
    End point values
    		 Eptinezumab
    Number of subjects analysed
    127
    Units: Attacks per week
        least squares mean (standard error)
    -3.46 ( 0.61 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Number of Monthly Attacks

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    End point title
    		 Change from Baseline in the Number of Monthly Attacks
    End point description
    The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Months 1-12
    End point values
    		 Eptinezumab
    Number of subjects analysed
    129
    Units: Attacks per month
        least squares mean (standard error)
    -22.65 ( 4.39 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Average Attack Related Daily Pain (including days with no attacks), as Assessed Using the 5-point Self-rating Pain Severity Scale

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    End point title
    		 Change from Baseline in the Average Attack Related Daily Pain (including days with no attacks), as Assessed Using the 5-point Self-rating Pain Severity Scale
    End point description
    The severity of pain for each attack was rated on an ordinal scale that ranged from 0 to 4 with higher scores indicating more headache pain (headache pain ratings: 0 = none/barely any pain; 1 = mild; 2 = moderate; 3 = severe; 4 = excruciating). The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
    End point values
    		 Eptinezumab
    Number of subjects analysed
    127
    Units: score on a scale
    least squares mean (standard error)
        Week 1
    -0.47 ( 0.06 )
        Week 2
    -0.51 ( 0.07 )
        Week 3
    -0.58 ( 0.07 )
        Week 4
    -0.59 ( 0.08 )
        Week 13
    -0.78 ( 0.09 )
        Week 14
    -0.75 ( 0.09 )
        Week 15
    -0.82 ( 0.08 )
        Week 16
    -0.90 ( 0.09 )
        Week 25
    -0.80 ( 0.09 )
        Week 26
    -0.79 ( 0.09 )
        Week 27
    -0.88 ( 0.09 )
        Week 28
    -0.84 ( 0.09 )
        Week 37
    -0.77 ( 0.09 )
        Week 38
    -0.79 ( 0.10 )
        Week 39
    -0.70 ( 0.10 )
        Week 40
    -0.79 ( 0.10 )
    No statistical analyses for this end point

    Secondary: Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks

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    End point title
    		 Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks
    End point description
    The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
    End point values
    		 Eptinezumab
    Number of subjects analysed
    127
    Units: participants
        Week 1
    49
        Week 2
    52
        Week 3
    55
        Week 4
    55
        Week 13
    54
        Week 14
    63
        Week 15
    58
        Week 16
    62
        Week 25
    60
        Week 26
    60
        Week 27
    62
        Week 28
    48
        Week 37
    57
        Week 38
    51
        Week 39
    43
        Week 40
    44
    No statistical analyses for this end point

    Secondary: Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks

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    End point title
    		 Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks
    End point description
    The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
    End point values
    		 Eptinezumab
    Number of subjects analysed
    127
    Units: participants
        Week 1
    30
        Week 2
    36
        Week 3
    42
        Week 4
    40
        Week 13
    35
        Week 14
    45
        Week 15
    43
        Week 16
    48
        Week 25
    43
        Week 26
    45
        Week 27
    45
        Week 28
    39
        Week 37
    40
        Week 38
    41
        Week 39
    34
        Week 40
    38
    No statistical analyses for this end point

    Secondary: Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks

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    End point title
    		 Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks
    End point description
    The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
    End point values
    		 Eptinezumab
    Number of subjects analysed
    127
    Units: participants
        Week 1
    11
        Week 2
    13
        Week 3
    21
        Week 4
    20
        Week 13
    23
        Week 14
    25
        Week 15
    23
        Week 16
    29
        Week 25
    29
        Week 26
    24
        Week 27
    28
        Week 28
    24
        Week 37
    27
        Week 38
    28
        Week 39
    21
        Week 40
    25
    No statistical analyses for this end point

    Secondary: cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks)

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    End point title
    		 cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks)
    End point description
    Participants counted as being in remission if they had no cluster headache attacks for at least 1 month. The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks.
    End point type
    Secondary
    End point timeframe
    Week 1 to Week 48
    End point values
    		 Eptinezumab
    Number of subjects analysed
    131
    Units: participants
    19
    No statistical analyses for this end point

    Secondary: cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks between the First and Second Infusion)

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    End point title
    		 cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks between the First and Second Infusion)
    End point description
    The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks.
    End point type
    Secondary
    End point timeframe
    Week 1 to Week 12
    End point values
    		 Eptinezumab
    Number of subjects analysed
    129
    Units: participants
    8
    No statistical analyses for this end point

    Secondary: cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks between the Second and Third Infusion)

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    End point title
    		 cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks between the Second and Third Infusion)
    End point description
    The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks.
    End point type
    Secondary
    End point timeframe
    Week 13 to Week 24
    End point values
    		 Eptinezumab
    Number of subjects analysed
    119
    Units: participants
    10
    No statistical analyses for this end point

    Secondary: Patient Global Impression of Change (PGIC) Score

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    End point title
    		 Patient Global Impression of Change (PGIC) Score
    End point description
    The PGIC is a patient-reported measure of improvement in pain sensation and quality of life scored on a scale from 1 (very much improved) to 7 (very much worse). Lower scores indicate better health status. The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
    End point values
    		 Eptinezumab
    Number of subjects analysed
    118
    Units: score on a scale
    least squares mean (standard error)
        Week 4
    2.74 ( 0.12 )
        Week 8
    2.69 ( 0.13 )
        Week 12
    2.69 ( 0.13 )
        Week 16
    2.58 ( 0.13 )
        Week 20
    2.72 ( 0.14 )
        Week 24
    2.58 ( 0.13 )
        Week 28
    2.54 ( 0.13 )
        Week 32
    2.64 ( 0.13 )
        Week 36
    2.58 ( 0.12 )
        Week 40
    2.73 ( 0.14 )
        Week 44
    2.67 ( 0.13 )
        Week 48
    2.65 ( 0.13 )
    No statistical analyses for this end point

    Secondary: cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Between the Third and Fourth Infusion)

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    End point title
    		 cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Between the Third and Fourth Infusion)
    End point description
    The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks.
    End point type
    Secondary
    End point timeframe
    Week 25 to Week 36
    End point values
    		 Eptinezumab
    Number of subjects analysed
    111
    Units: participants
    9
    No statistical analyses for this end point

    Secondary: cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Within the First 12 Weeks After the Fourth Infusion)

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    End point title
    		 cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Within the First 12 Weeks After the Fourth Infusion)
    End point description
    The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks.
    End point type
    Secondary
    End point timeframe
    Week 37 to Week 48
    End point values
    		 Eptinezumab
    Number of subjects analysed
    104
    Units: participants
    10
    No statistical analyses for this end point

    Secondary: Number of Participants who Received a Transitional Therapy During the Treatment Period

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    End point title
    		 Number of Participants who Received a Transitional Therapy During the Treatment Period
    End point description
    Transitional treatments were defined as greater occipital nerve (GON) block or oral steroids. The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks.
    End point type
    Secondary
    End point timeframe
    Week 1 to Week 48
    End point values
    		 Eptinezumab
    Number of subjects analysed
    131
    Units: participants
    17
    No statistical analyses for this end point

    Secondary: Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time

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    End point title
    		 Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
    End point description
    The SIS is a patient-reported clinical outcome assessment used to assess quality of life resulting from sleep disturbance. The SIS questionnaire includes 35 items belonging to 7 domains to assess sleep impact on: daily activities (5 items); emotional well-being (4 items); emotional impact (4 items); energy/fatigue (5 items); social well-being (6 items); mental fatigue (3 items); and satisfaction with sleep (8 items). Each item, for 6 out of the 7 domains, is rated on a 5-point scale ranging from 1 (always or all of the time) to 5 (never or none of the time), whereas satisfaction with sleep is rated on a 5-point scale ranging from 1 (very satisfied) to 5 (very dissatisfied). Each domain yields a score ranging from 0 to 100; items within each domain are summed and transformed using a formula. A higher score indicates better quality of life (reverse scoring for the satisfaction with sleep domain).
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 4, 12, 16, 24, 28, 36, 40, 48
    End point values
    		 Eptinezumab
    Number of subjects analysed
    109
    Units: score on a scale
    arithmetic mean (standard deviation)
        Daily Activities - Week 4
    14.98 ( 2.05 )
        Daily Activities - Week 12
    15.26 ( 2.36 )
        Daily Activities - Week 16
    16.36 ( 2.48 )
        Daily Activities - Week 24
    15.54 ( 2.33 )
        Daily Activities - Week 28
    16.17 ( 2.42 )
        Daily Activities - Week 36
    14.51 ( 2.39 )
        Daily Activities - Week 40
    17.83 ( 2.15 )
        Daily Activities - Week 48
    13.29 ( 2.34 )
        Emotional Well-being - Week 4
    17.63 ( 2.19 )
        Emotional Well-being - Week 12
    16.28 ( 2.32 )
        Emotional Well-being - Week 16
    15.72 ( 2.37 )
        Emotional Well-being - Week 24
    14.04 ( 2.47 )
        Emotional Well-being - Week 28
    17.98 ( 2.51 )
        Emotional Well-being - Week 36
    15.75 ( 2.34 )
        Emotional Well-being - Week 40
    15.40 ( 2.35 )
        Emotional Well-being - Week 48
    14.61 ( 2.53 )
        Emotional Impact - Week 4
    17.41 ( 2.42 )
        Emotional Impact - Week 12
    17.00 ( 2.48 )
        Emotional Impact - Week 16
    18.34 ( 2.59 )
        Emotional Impact - Week 24
    17.01 ( 2.42 )
        Emotional Impact - Week 28
    20.78 ( 2.53 )
        Emotional Impact - Week 36
    16.53 ( 2.53 )
        Emotional Impact - Week 40
    17.21 ( 2.57 )
        Emotional Impact - Week 48
    15.61 ( 2.58 )
        Energy/Fatigue - Week 4
    16.00 ( 2.35 )
        Energy/Fatigue - Week 12
    16.67 ( 2.50 )
        Energy/Fatigue - Week 16
    16.87 ( 2.63 )
        Energy/Fatigue - Week 24
    16.59 ( 2.71 )
        Energy/Fatigue - Week 28
    19.67 ( 2.73 )
        Energy/Fatigue - Week 36
    15.93 ( 2.62 )
        Energy/Fatigue - Week 40
    19.16 ( 2.53 )
        Energy/Fatigue - Week 48
    17.65 ( 2.62 )
        Social Well-being - Week 4
    14.73 ( 2.06 )
        Social Well-being - Week 12
    15.28 ( 2.31 )
        Social Well-being - Week 16
    14.68 ( 2.55 )
        Social Well-being - Week 24
    14.59 ( 2.46 )
        Social Well-being - Week 28
    17.30 ( 2.64 )
        Social Well-being - Week 36
    13.27 ( 2.43 )
        Social Well-being - Week 40
    15.59 ( 2.42 )
        Social Well-being - Week 48
    14.13 ( 2.59 )
        Mental Fatigue - Week 4
    13.00 ( 2.23 )
        Mental Fatigue - Week 12
    15.00 ( 2.34 )
        Mental Fatigue - Week 16
    15.15 ( 2.27 )
        Mental Fatigue - Week 24
    13.57 ( 2.39 )
        Mental Fatigue - Week 28
    14.86 ( 2.36 )
        Mental Fatigue - Week 36
    13.64 ( 2.49 )
        Mental Fatigue - Week 40
    13.98 ( 2.39 )
        Mental Fatigue - Week 48
    13.55 ( 2.42 )
        Satisfaction With Sleep - Week 4
    -13.86 ( 2.25 )
        Satisfaction With Sleep - Week 12
    -13.47 ( 2.29 )
        Satisfaction With Sleep - Week 16
    -14.50 ( 2.40 )
        Satisfaction With Sleep - Week 24
    -12.30 ( 2.20 )
        Satisfaction With Sleep - Week 28
    -16.67 ( 2.39 )
        Satisfaction With Sleep - Week 36
    -13.95 ( 2.43 )
        Satisfaction With Sleep - Week 40
    -14.99 ( 2.60 )
        Satisfaction With Sleep - Week 48
    -14.19 ( 2.59 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48

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    End point title
    		 Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48
    End point description
    The EQ-5D-5L is a patient-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). Each descriptive item is rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 4, 16, 28, 40, 48
    End point values
    		 Eptinezumab
    Number of subjects analysed
    97
    Units: score on a scale
    arithmetic mean (standard deviation)
        Mobility - Week 4
    0.1 ( 0.89 )
        Self Care - Week 4
    0.0 ( 0.47 )
        Usual Activities - Week 4
    -0.2 ( 1.13 )
        Pain/Discomfort - Week 4
    -0.1 ( 1.28 )
        Anxiety/Depression - Week 4
    -0.1 ( 0.70 )
        Mobility - Week 16
    0.1 ( 1.02 )
        Self Care - Week 16
    0.0 ( 0.69 )
        Usual Activities - Week 16
    -0.2 ( 1.07 )
        Pain/Discomfort - Week 16
    -0.2 ( 1.48 )
        Anxiety/Depression - Week 16
    -0.1 ( 0.98 )
        Mobility - Week 28
    0.1 ( 0.92 )
        Self Care - Week 28
    0.1 ( 0.65 )
        Usual Activities - Week 28
    -0.1 ( 1.14 )
        Pain/Discomfort - Week 28
    -0.1 ( 1.26 )
        Anxiety/Depression - Week 28
    -0.1 ( 0.98 )
        Mobility - Week 40
    0.0 ( 0.96 )
        Self Care - Week 40
    0.0 ( 0.49 )
        Usual Activities - Week 40
    -0.4 ( 1.04 )
        Pain/Discomfort - Week 40
    -0.3 ( 1.42 )
        Anxiety/Depression - Week 40
    -0.1 ( 0.97 )
        Mobility - Week 48
    -0.0 ( 0.90 )
        Self Care - Week 48
    0.0 ( 0.53 )
        Usual Activities - Week 48
    -0.2 ( 1.17 )
        Pain/Discomfort - Week 48
    -0.1 ( 1.24 )
        Anxiety/Depression - Week 48
    -0.0 ( 1.04 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Work Productivity Activity Impairment: General Health Second Version (WPAI:GH2.0) Sub-Scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Weeks 4, 16, 28, 40 and 48

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    End point title
    		 Change From Baseline in the Work Productivity Activity Impairment: General Health Second Version (WPAI:GH2.0) Sub-Scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Weeks 4, 16, 28, 40 and 48
    End point description
    The WPAI:GH2.0 is a patient self-rated clinical outcome assessment designed to provide a quantitative measure of the work productivity and activity impairment due to a health condition. The WPAI:GH2.0 assesses activities over the preceding 7 days and consists of 6 items: 1 item assesses employment (yes/no); 3 items assess the number of hours worked, the number of hours missed from work due to the participant’s condition, or due to other reasons; and 2 visual numerical scales assess how much the participant’s condition affects his/her productivity at work and his/her ability to complete normal daily activities. Scores were calculated as impairment percentages (0-100%), with higher numbers indicating greater impairment and less productivity, i.e, worse outcomes. The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 4, 16, 28, 40, 48
    End point values
    		 Eptinezumab
    Number of subjects analysed
    95
    Units: score on a scale
    arithmetic mean (standard deviation)
        Absenteeism - Week 4
    -12.03 ( 2.82 )
        Absenteeism - Week 16
    -8.19 ( 2.98 )
        Absenteeism - Week 28
    -12.73 ( 1.70 )
        Absenteeism - Week 40
    -12.05 ( 2.29 )
        Absenteeism - Week 48
    -5.30 ( 2.99 )
        Presenteeism - Week 4
    -14.29 ( 3.23 )
        Presenteeism - Week 16
    -14.54 ( 3.74 )
        Presenteeism - Week 28
    -11.86 ( 3.78 )
        Presenteeism - Week 40
    -9.88 ( 3.58 )
        Presenteeism - Week 48
    -12.70 ( 3.53 )
        Work productivity loss - Week 4
    -17.28 ( 3.34 )
        Work productivity loss - Week 16
    -16.53 ( 3.98 )
        Work productivity loss - Week 28
    -14.60 ( 3.96 )
        Work productivity loss - Week 40
    -12.50 ( 3.78 )
        Work productivity loss - Week 48
    -12.16 ( 3.77 )
        Activity impairment - Week 4
    -15.99 ( 2.56 )
        Activity impairment - Week 16
    -15.64 ( 2.84 )
        Activity impairment - Week 28
    -17.37 ( 2.74 )
        Activity impairment - Week 40
    -18.73 ( 2.79 )
        Activity impairment - Week 48
    -14.35 ( 2.95 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in the EQ-5D-5L Visual Analog Scale (VAS) Score at Weeks 4, 16, 28, 40 and 48

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    End point title
    		 Change from Baseline in the EQ-5D-5L Visual Analog Scale (VAS) Score at Weeks 4, 16, 28, 40 and 48
    End point description
    The EQ-5D-5L VAS is a participant-reported assessment designed to measure the participant's well-being and ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 4, 16, 28, 40, 48
    End point values
    		 Eptinezumab
    Number of subjects analysed
    97
    Units: score on a scale
    least squares mean (standard error)
        Week 4
    9.03 ( 2.07 )
        Week 16
    9.26 ( 2.30 )
        Week 28
    6.99 ( 2.39 )
        Week 40
    8.61 ( 2.11 )
        Week 48
    6.90 ( 2.31 )
    No statistical analyses for this end point

    Secondary: Health Care Resource Utilization - Number of visits to a family doctor/general practitioner

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    End point title
    		 Health Care Resource Utilization - Number of visits to a family doctor/general practitioner
    End point description
    Number of participants who visited a family doctor/general practitioner has been reported. The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 4, 16, 28, 40, 48
    End point values
    		 Eptinezumab
    Number of subjects analysed
    112
    Units: participants
        Week 0 - 0 visits
    81
        Week 0 - 1 visit
    18
        Week 0 - 2 visits
    10
        Week 0 - 3 visits
    1
        Week 0 - 4 visits
    2
        Week 4 - 0 visits
    82
        Week 4 - 1 visit
    17
        Week 4 - 2 visits
    5
        Week 4 - 3 visits
    1
        Week 16 - 0 visits
    80
        Week 16 - 1 visit
    15
        Week 16 - 2 visits
    2
        Week 16 - 3 visits
    2
        Week 16 - 4 visits
    1
        Week 16 - 5 visits
    1
        Week 28 - 0 visits
    76
        Week 28 - 1 visit
    14
        Week 28 - 2 visits
    6
        Week 28 - 3 visits
    4
        Week 40 - 0 visits
    67
        Week 40 - 1 visit
    13
        Week 40 - 2 visits
    8
        Week 40 - 3 visits
    1
        Week 40 - 6 visits
    2
        Week 48 - 0 visits
    78
        Week 48 - 1 visit
    9
        Week 48 - 2 visits
    5
        Week 48 - 3 visits
    1
        Week 48 - 6 visits
    1
    No statistical analyses for this end point

    Secondary: Health Care Resource Utilization - Number of visits to a specialist

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    End point title
    		 Health Care Resource Utilization - Number of visits to a specialist
    End point description
    Number of participants who visited a specialist has been reported. The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 4, 16, 28, 40, 48
    End point values
    		 Eptinezumab
    Number of subjects analysed
    112
    Units: participants
        Week 0 - 0 visits
    51
        Week 0 - 1 visit
    40
        Week 0 - 2 visits
    18
        Week 0 - 3 visits
    2
        Week 0 - 6 visits
    1
        Week 4 - 0 visits
    74
        Week 4 - 1 visit
    28
        Week 4 - 2 visits
    1
        Week 4 - 3 visits
    1
        Week 4 - 4 visits
    1
        Week 16 - 0 visits
    64
        Week 16 - 1 visit
    23
        Week 16 - 2 visits
    9
        Week 16 - 3 visits
    2
        Week 16 - 4 visits
    1
        Week 16 - 5 visits
    1
        Week 16 - 7 visits
    1
        Week 28 - 0 visits
    68
        Week 28 - 1 visit
    25
        Week 28 - 2 visits
    4
        Week 28 - 4 visits
    2
        Week 28 - 5 visits
    1
        Week 40 - 0 visits
    62
        Week 40 - 1 visit
    22
        Week 40 - 2 visits
    4
        Week 40 - 3 visits
    1
        Week 40 - 4 visits
    1
        Week 40 - 6 visits
    1
        Week 48 - 0 visits
    72
        Week 48 - 1 visit
    17
        Week 48 - 2 visits
    3
        Week 48 - 3 visits
    1
        Week 48 - 6 visits
    1
    No statistical analyses for this end point

    Secondary: Health Care Resource Utilization - Number of emergency department visits due to cluster headache

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    End point title
    		 Health Care Resource Utilization - Number of emergency department visits due to cluster headache
    End point description
    Number of participants who visited an emergency department due to CH has been reported. The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 4, 16, 28, 40, 48
    End point values
    		 Eptinezumab
    Number of subjects analysed
    112
    Units: participants
        Week 0 - 0 visits
    108
        Week 0 - 1 visit
    1
        Week 0 - 2 visits
    1
        Week 0 - 4 visits
    2
        Week 4 - 0 visits
    102
        Week 4 - 1 visit
    2
        Week 4 - 4 visits
    1
        Week 16 - 0 visits
    97
        Week 16 - 1 visit
    2
        Week 16 - 2 visits
    1
        Week 16 - 4 visits
    1
        Week 28 - 0 visits
    96
        Week 28 - 1 visit
    2
        Week 28 - 2 visits
    1
        Week 28 - 4 visits
    1
        Week 40 - 0 visits
    88
        Week 40 - 1 visit
    1
        Week 40 - 2 visits
    2
        Week 48 - 0 visits
    91
        Week 48 - 1 visit
    1
        Week 48 - 2 visits
    1
        Week 48 - 3 visits
    1
    No statistical analyses for this end point

    Secondary: Health Care Resource Utilization - Number of hospital admissions due to cluster headache

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    End point title
    		 Health Care Resource Utilization - Number of hospital admissions due to cluster headache
    End point description
    Number of participants admitted to the hospital due to CH has been reported. The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 4, 16, 28, 40, 48
    End point values
    		 Eptinezumab
    Number of subjects analysed
    112
    Units: participants
        Week 0 - 0 admissions
    110
        Week 0 - 1 admission
    2
        Week 4 - 0 admissions
    103
        Week 4 - 1 admission
    2
        Week 16 - 0 admissions
    98
        Week 16 - 1 admission
    2
        Week 16 - 5 admissions
    1
        Week 28 - 0 admissions
    97
        Week 28 - 1 admission
    3
        Week 40 - 0 admissions
    89
        Week 40 - 1 admission
    1
        Week 40 - 5 admissions
    1
        Week 48 - 0 admissions
    92
        Week 48 - 1 admission
    2
    No statistical analyses for this end point

    Secondary: Health Care Resource Utilization - Total number of overnight hospital stays due to cluster headache

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    End point title
    		 Health Care Resource Utilization - Total number of overnight hospital stays due to cluster headache
    End point description
    Number of participants who had overnight hospital stays due to CH has been reported. The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 4, 16, 28, 40, 48
    End point values
    		 Eptinezumab
    Number of subjects analysed
    112
    Units: participants
        Week 0 - 0 visits
    109
        Week 0 - 1 visit
    2
        Week 0 - 2 visits
    1
        Week 4 - 0 visits
    105
        Week 16 - 0 visits
    98
        Week 16 - 1 visit
    1
        Week 16 - 7 visits
    1
        Week 16 - 10 visits
    1
        Week 28 - 0 visits
    99
        Week 28 - 1 visit
    1
        Week 40 - 0 visits
    90
        Week 40 - 1 visit
    1
        Week 48 - 0 visits
    92
        Week 48 - 1 visit
    1
        Week 48 - 5 visits
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
    Adverse event reporting additional description
    The APTS included all participants who received infusion with eptinezumab
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Eptinezumab
    Reporting group description
    		 Participants received 4 IV infusions of 400 mg eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.

    Serious adverse events
    		 Eptinezumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 131 (8.40%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Investigations
    Weight decreased
         subjects affected / exposed
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Jaw fracture
         subjects affected / exposed
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Cluster headache
         subjects affected / exposed
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Impaired gastric emptying
         subjects affected / exposed
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Suicide attempt
         subjects affected / exposed
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Endocrine disorders
    Thyroiditis acute
         subjects affected / exposed
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Eptinezumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    96 / 131 (73.28%)
    Vascular disorders
    Orthostatic hypotension
         subjects affected / exposed
    3 / 131 (2.29%)
         occurrences all number
    3
    Hypertension
         subjects affected / exposed
    4 / 131 (3.05%)
         occurrences all number
    4
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    22 / 131 (16.79%)
         occurrences all number
    30
    Influenza like illness
         subjects affected / exposed
    3 / 131 (2.29%)
         occurrences all number
    4
    Oedema peripheral
         subjects affected / exposed
    5 / 131 (3.82%)
         occurrences all number
    7
    Asthenia
         subjects affected / exposed
    6 / 131 (4.58%)
         occurrences all number
    11
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 131 (3.05%)
         occurrences all number
    4
    Dyspnoea
         subjects affected / exposed
    3 / 131 (2.29%)
         occurrences all number
    3
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    8 / 131 (6.11%)
         occurrences all number
    9
    Nightmare
         subjects affected / exposed
    3 / 131 (2.29%)
         occurrences all number
    3
    Sleep disorder
         subjects affected / exposed
    3 / 131 (2.29%)
         occurrences all number
    3
    Suicidal ideation
         subjects affected / exposed
    3 / 131 (2.29%)
         occurrences all number
    3
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    3 / 131 (2.29%)
         occurrences all number
    4
    Blood triglycerides increased
         subjects affected / exposed
    3 / 131 (2.29%)
         occurrences all number
    3
    Weight increased
         subjects affected / exposed
    8 / 131 (6.11%)
         occurrences all number
    8
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    3 / 131 (2.29%)
         occurrences all number
    3
    Fall
         subjects affected / exposed
    4 / 131 (3.05%)
         occurrences all number
    5
    Cardiac disorders
    Atrioventricular block first degree
         subjects affected / exposed
    3 / 131 (2.29%)
         occurrences all number
    5
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    7 / 131 (5.34%)
         occurrences all number
    7
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    4 / 131 (3.05%)
         occurrences all number
    4
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    8 / 131 (6.11%)
         occurrences all number
    8
    Constipation
         subjects affected / exposed
    6 / 131 (4.58%)
         occurrences all number
    9
    Abdominal pain upper
         subjects affected / exposed
    4 / 131 (3.05%)
         occurrences all number
    6
    Vomiting
         subjects affected / exposed
    7 / 131 (5.34%)
         occurrences all number
    7
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    9 / 131 (6.87%)
         occurrences all number
    9
    Alopecia
         subjects affected / exposed
    4 / 131 (3.05%)
         occurrences all number
    4
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 131 (2.29%)
         occurrences all number
    5
    Back pain
         subjects affected / exposed
    9 / 131 (6.87%)
         occurrences all number
    9
    Neck pain
         subjects affected / exposed
    3 / 131 (2.29%)
         occurrences all number
    5
    Infections and infestations
    Influenza
         subjects affected / exposed
    10 / 131 (7.63%)
         occurrences all number
    10
    Bronchitis
         subjects affected / exposed
    3 / 131 (2.29%)
         occurrences all number
    3
    COVID-19
         subjects affected / exposed
    29 / 131 (22.14%)
         occurrences all number
    31
    Gastroenteritis
         subjects affected / exposed
    3 / 131 (2.29%)
         occurrences all number
    3
    Sinusitis
         subjects affected / exposed
    3 / 131 (2.29%)
         occurrences all number
    3
    Rhinitis
         subjects affected / exposed
    6 / 131 (4.58%)
         occurrences all number
    6
    Pneumonia
         subjects affected / exposed
    3 / 131 (2.29%)
         occurrences all number
    4
    Pharyngitis
         subjects affected / exposed
    5 / 131 (3.82%)
         occurrences all number
    5
    Nasopharyngitis
         subjects affected / exposed
    24 / 131 (18.32%)
         occurrences all number
    33
    Urinary tract infection
         subjects affected / exposed
    4 / 131 (3.05%)
         occurrences all number
    5
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    6 / 131 (4.58%)
         occurrences all number
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Nov 2021
    Updated inclusion criteria and allowable concomitant medications.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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