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    Clinical Trial Results:
    The effect of anti-calcitonin gene-related peptide (CGRP) receptor antibodies on the headache inducing properties of CGRP and cilostazol in migraine patients

    Summary
    EudraCT number
    		 2020-000661-16
    Trial protocol
    		 DK  
    Global end of trial date
    17 Jan 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 May 2023
    First version publication date
    16 May 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CGRP2020
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04452929
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Rigshospitalet Glostrup
    Sponsor organisation address
    Valdemar Hansens Vej 5, Glostrup, Denmark,
    Public contact
    Thien Phu Do, Rigshospitalet Glostrup, thiendo@gmail.com
    Scientific contact
    Thien Phu Do, Rigshospitalet Glostrup, thiendo@gmail.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
    Interim
    Date of interim/final analysis
    04 Jul 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Jan 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Jan 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    (1) To investigate the effect of anti-CGRP receptor monoclonal antibody (mAb), erenumab, in prevention of CGRP-induced and cilostazol-induced migraine-like attacks in patients with migraine (2) To investigate the effect of anti-CGRP receptor mAb, erenumab, in prevention of CGRP-induced and cilostazol-induced dilation of extracerebral arteries in patients with migraine (3) To investigate the effect of anti-CGRP receptor mAb, erenumab, in preventing CGRP-induced and cilostazol-induced facial flushing in patients with migraine (4) To investigate the effect of anti-CGRP receptor mAb, erenumab, on peptide blood levels in patients with migraine
    Protection of trial subjects
    The protocol was approved by the Regional Health Research Ethics Committee of the Capital Region of Denmark (identifier: H-19073983), the Danish Data Protection Agency (P-2020-652), and the Danish Medicines Agency (identifier: 2020033418). We obtained a signed consent form at the time of screening before any protocol-related procedures or assessments. All study-related procedures complied with the Declaration of Helsinki, with later revisions. The study is registered in ClinicalTrials.gov (identifier: NCT04452929).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Jul 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 75
    Worldwide total number of subjects
    75
    EEA total number of subjects
    75
    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)
    75
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 75
    Number of subjects completed
    		 75

    Period 1
    Period 1 title
    Erenumab or placebo
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor
    Blinding implementation details
    We enrolled participants in a randomized, double-blind, placebo-controlled, parallel trial at a single center in Denmark. Participants were randomly allocated to a subcutaneous administration of 140mg of erenumab or placebo (isotonic saline). Erenumab was provided by Novartis Pharma AG (Basel, Switzerland) and sorted in blinded packaging by Nomeco A/S (Copenhagen, Denmark). Independent pharmacy staff were responsible for randomization and allocation concealment.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Erenumab
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    erenumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    140mg

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Isotonic saline

    Number of subjects in period 1
    		Erenumab Placebo
    Started
    37
    38
    Completed
    37
    38
    Period 2
    Period 2 title
    CGRP
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor, Carer, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Erenumab
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    calcitonin gene-related peptide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1.5μg/min of CGRP over 20 minutes

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    calcitonin gene-related peptide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1.5μg/min of CGRP over 20 minutes

    Number of subjects in period 2
    		Erenumab Placebo
    Started
    37
    38
    Completed
    37
    38
    Period 3
    Period 3 title
    Cilostazol
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor, Carer, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Erenumab
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    cilostazol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200mg

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    cilostazol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200mg

    Number of subjects in period 3
    		Erenumab Placebo
    Started
    37
    38
    Completed
    37
    38

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Erenumab or placebo
    Reporting group description
    		 -

    Reporting group values
    		 Erenumab or placebo Total
    Number of subjects
    		 75 75
    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)
    		 75 75
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 33.4 ( 11.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 66 66
        Male
    		 9 9

    End points

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    End points reporting groups
    Reporting group title
    Erenumab
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -
    Reporting group title
    Erenumab
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -
    Reporting group title
    Erenumab
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Migraine attack following cilostazol

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    End point title
    		 Migraine attack following cilostazol
    End point description
    End point type
    Primary
    End point timeframe
    Incidence of migraine attacks in a 12-hour observational period after administration of experimental triggers
    End point values
    		 Erenumab Placebo
    Number of subjects analysed
    37
    38
    Units: Migraine attack
    28
    31
    Statistical analysis title
    		 Migraine attack induction rate
    Comparison groups
    Placebo v Erenumab
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.024
    Method
    		 Chi-squared
    Confidence interval

    Primary: Migraine attack following calcitonin gene-related peptide

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    End point title
    		 Migraine attack following calcitonin gene-related peptide
    End point description
    End point type
    Primary
    End point timeframe
    Incidence of migraine attacks in a 12-hour observational period after administration of experimental triggers
    End point values
    		 Erenumab Placebo
    Number of subjects analysed
    37
    38
    Units: Migraine attack
    28
    31
    Statistical analysis title
    		 Migraine attack induction rate
    Comparison groups
    Erenumab v Placebo
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.24
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Headache following cilostazol

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    End point title
    		 Headache following cilostazol
    End point description
    End point type
    Secondary
    End point timeframe
    Incidence of headache in a 12-hour observational period after administration of experimental triggers
    End point values
    		 Erenumab Placebo
    Number of subjects analysed
    37
    38
    Units: Headache
    33
    37
    No statistical analyses for this end point

    Secondary: Headache following calcitonin gene-related peptide

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    End point title
    		 Headache following calcitonin gene-related peptide
    End point description
    End point type
    Secondary
    End point timeframe
    Incidence of headache in a 12-hour observational period after administration of experimental triggers
    End point values
    		 Erenumab Placebo
    Number of subjects analysed
    37
    38
    Units: Headache
    24
    35
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Incidence of adverse events in a 12-hour observational period after administration of experimental triggers
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Erenumab - Cilostazol
    Reporting group description
    		 -

    Reporting group title
    Erenumab - Calcitonin gene-related peptide
    Reporting group description
    		 -

    Reporting group title
    Placebo - Cilostazol
    Reporting group description
    		 -

    Reporting group title
    Placebo - Calcitonin gene-related peptide
    Reporting group description
    		 -

    Serious adverse events
    		 Erenumab - Cilostazol Erenumab - Calcitonin gene-related peptide Placebo - Cilostazol Placebo - Calcitonin gene-related peptide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Erenumab - Cilostazol Erenumab - Calcitonin gene-related peptide Placebo - Cilostazol Placebo - Calcitonin gene-related peptide
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 37 (40.54%)
    15 / 37 (40.54%)
    13 / 38 (34.21%)
    37 / 38 (97.37%)
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    9 / 37 (24.32%)
    6 / 37 (16.22%)
    6 / 38 (15.79%)
    31 / 38 (81.58%)
         occurrences all number
    9
    6
    6
    31
    General disorders and administration site conditions
    Cold sensations
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 37 (0.00%)
    1 / 38 (2.63%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Warm sensations
         subjects affected / exposed
    15 / 37 (40.54%)
    15 / 37 (40.54%)
    13 / 38 (34.21%)
    37 / 38 (97.37%)
         occurrences all number
    15
    15
    13
    37
    Ear and labyrinth disorders
    Dizziness
         subjects affected / exposed
    2 / 37 (5.41%)
    1 / 37 (2.70%)
    2 / 38 (5.26%)
    1 / 38 (2.63%)
         occurrences all number
    2
    1
    2
    1
    Ear fullness
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
    2 / 38 (5.26%)
         occurrences all number
    0
    0
    0
    2
    Eye disorders
    Dry eyes
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 37 (2.70%)
    0 / 38 (0.00%)
    4 / 38 (10.53%)
         occurrences all number
    0
    1
    0
    4
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 37 (0.00%)
    1 / 38 (2.63%)
    2 / 38 (5.26%)
         occurrences all number
    1
    0
    1
    2
    Skin and subcutaneous tissue disorders
    Flushing
         subjects affected / exposed
    0 / 37 (0.00%)
    4 / 37 (10.81%)
    0 / 38 (0.00%)
    34 / 38 (89.47%)
         occurrences all number
    0
    4
    0
    34
    Itch
         subjects affected / exposed
    0 / 37 (0.00%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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