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    Clinical Trial Results:
    An open label study to evaluate the efficacy and tolerability of erenumab in the prophylactic treatment of persistent headache attributed to mild traumatic injury to the head

    Summary
    EudraCT number
    		 2018-003943-46
    Trial protocol
    		 DK  
    Global end of trial date
    09 Mar 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Mar 2021
    First version publication date
    28 Mar 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    081018
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Danish Headache Center
    Sponsor organisation address
    V, Valdemar Hansensvej 5, Glostrup, Denmark, 2600
    Public contact
    Henrik Schytz, Danish Headache Center, 45 28761824, henrik.winther.schytz.01@regionh.dk
    Scientific contact
    Henrik Schytz, Danish Headache Center, 38633863 28761824, henrik.winther.schytz.01@regionh.dk
    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
    06 Apr 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Mar 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Mar 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the effect of ERENUMAB on change in the monthly average number of headache days with moderate or severe intensity from baseline to week 9-12 in patients with persistent post-traumatic headache (PPTH) To evaluate the effect of ERENUMAB on change in the monthly average number of headache days from baseline to week 9-12 in PPTH patients
    Protection of trial subjects
    The study consisted of treatment of post-traumatic headache patients
    Background therapy
    		 The same as investigated
    Evidence for comparator
    		 N.A:
    Actual start date of recruitment
    01 Feb 2019
    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
    Denmark: 100
    Worldwide total number of subjects
    100
    EEA total number of subjects
    100
    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)
    100
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited from the outpatient clinic of the Danish Headache Center and from neurological departments and rehabilitation centers in the Capital Region of Denmark as well as the Region of Southern Denmark.

    Pre-assignment
    Screening details
    		 Patients included males and females aged 18 to 65 years with a history of persistent headache attributed to mild TBI.

    Period 1
    Period 1 title
    4 weeks
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Active
    Arm description
    		 -
    Arm type
    		 Active

    Investigational medicinal product name
    Erenumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    140 mg s.c.

    Number of subjects in period 1
    		Active
    Started
    100
    Completed
    100
    Period 2
    Period 2 title
    Week 12
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Week 9-12

    Arms
    Arm title
    		 Week 9-12
    Arm description
    		 -
    Arm type
    		 Open label

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Week 9-12
    Started
    100
    Completed
    100

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Active
    Reporting group description
    		 -
    Reporting group title
    Week 9-12
    Reporting group description
    		 -

    Primary: Primary

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    End point title
    		 Primary
    End point description
    Mean change in number of monthly headache days of moderate to severe intensity
    End point type
    Primary
    End point timeframe
    from baseline (4-week pretreatment period) to week 9–12
    End point values
    		 Active Week 9-12
    Number of subjects analysed
    89 [1]
    89
    Units: headache days
    89
    89
    Notes
    [1] - None
    Statistical analysis title
    		 Descriptive
    Statistical analysis description
    See article
    Comparison groups
    Active v Week 9-12
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 < 0.05
    Method
    		 descriptive
    Parameter type
    		 Descriptive
    Confidence interval
    Notes
    [2] - see article

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from first injection to week 9–12.
    Adverse event reporting additional description
    Overall, 100 patients received at least one dose of erenumab and were included in the tolerability and safety analyses. Seventy-eight patients reported at least one adverse event, with the most common ones being constipation (n = 30) and injection-site reactions (n = 15). Of the former, nine patients reported recurrent episodes of constipation
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Oxford
    Dictionary version
    1
    Reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 -

    Serious adverse events
    		 All patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 100 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 All patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 100 (30.00%)
    Gastrointestinal disorders
    Constiptation
         subjects affected / exposed
    30 / 100 (30.00%)
         occurrences all number
    30

    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.
    This was an open label study

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/32493206
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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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