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    Clinical Trial Results:
    “Follow the sutures“. An open multicenter, multinational pilot study to explore tolerability, safety and effect of a new procedure for injecting botulinum toxin in the head against chronic migraine.

    Summary
    EudraCT number
    		 2017-002516-13
    Trial protocol
    		 NO  
    Global end of trial date
    31 Dec 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Nov 2021
    First version publication date
    19 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    FollowTheSutures
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03543254
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    St. Olavs Hospital HF
    Sponsor organisation address
    Olav kyrres gate, TRONDHEIM, Norway, 7006
    Public contact
    Gøril Bruvik Gravdahl, Nasjonal kompetansetjeneste for hodepine, St. Olavs hospital, 47 72575147, knut.hagen@ntnu.no
    Scientific contact
    Gøril Bruvik Gravdahl, Nasjonal kompetansetjeneste for hodepine, St. Olavs hospital, 95401579 72575147, knut.hagen@ntnu.no
    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 Oct 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Dec 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate whether the new injection procedure is safe and tolerable to the patients
    Protection of trial subjects
    Drug liability insurance payment for all trials subjects
    Background therapy
    		 Botulinum toxin injection given in a open-label, non-controlled single-center study
    Evidence for comparator
    		 non-controlled design
    Actual start date of recruitment
    15 May 2018
    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
    Norway: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    20
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Potential study patients were identified among regular outpatients at the Department of Neurology, St. Olavs Hospital in Trondheim, Norway. Planned recruitment of patients at the Mayo Clinic in USA cancelled due to the Covid 19 pandemic

    Pre-assignment
    Screening details
    		 Potential participants had been sent an email with the informed consent form which was signed at the screening visit

    Period 1
    Period 1 title
    Baseline period
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    The study was open-labelled

    Arms
    Arm title
    		 Baseline period of at least 28 days
    Arm description
    		 Headache diary
    Arm type
    		 Headache diary

    Investigational medicinal product name
    Headache diary
    Investigational medicinal product code
    Other name
    Headache diary
    Pharmaceutical forms
    Wound stick
    Routes of administration
    Topical
    Dosage and administration details
    Every days

    Number of subjects in period 1
    		Baseline period of at least 28 days
    Started
    20
    Completed
    20
    Period 2
    Period 2 title
    12 weeks follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Open-labelled

    Arms
    Arm title
    		 Botulinum toxin-A
    Arm description
    		 The participants (all women) with a negative pregnancy test got injection of 90 units of botulinum toxin A
    Arm type
    		 Active comparator

    Investigational medicinal product name
    botulinum toxin A
    Investigational medicinal product code
    Other name
    botulinum toxin A
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Solution for injection
    Dosage and administration details
    90 Unit

    Number of subjects in period 2
    		Botulinum toxin-A
    Started
    20
    Completed
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline period
    Reporting group description
    		 age and gender

    Reporting group values
    		 Baseline period Total
    Number of subjects
    		 20 20
    Age categorical
    The mean age was40 years (SD) 9, range 19-58
    Units: Subjects
        Adults (18-64 years)
    		 20 20
    Age continuous
    Units: years
        geometric mean (standard deviation)
    		 40 ± 9 -
    Gender categorical
    20 women, 0 men
    Units: Subjects
        Female
    		 20 20
        Male
    		 0 0
    Subject analysis sets

    Subject analysis set title
    Active tratment
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Moderate to severe headache days

    Subject analysis sets values
    		 Active tratment
    Number of subjects
    20
    Age categorical
    The mean age was40 years (SD) 9, range 19-58
    Units: Subjects
        Adults (18-64 years)
    20
    Age continuous
    Units: years
        geometric mean (standard deviation)
    40 ± 9
    Gender categorical
    20 women, 0 men
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    Baseline period of at least 28 days
    Reporting group description
    		 Headache diary
    Reporting group title
    Botulinum toxin-A
    Reporting group description
    		 The participants (all women) with a negative pregnancy test got injection of 90 units of botulinum toxin A

    Subject analysis set title
    Active tratment
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Moderate to severe headache days

    Primary: Moderate to severe headache at week 5-8 after injection compared to baseline

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    End point title
    		 Moderate to severe headache at week 5-8 after injection compared to baseline
    End point description
    Diary information
    End point type
    Primary
    End point timeframe
    Week 5-8 versus baseline
    End point values
    		 Botulinum toxin-A Active tratment
    Number of subjects analysed
    19
    20
    Units: Headache days
    arithmetic mean (standard deviation)
        Active
    11.7 ± 63.8
    11.7 ± 63.8
    Statistical analysis title
    		 Pared t-test
    Statistical analysis description
    Paired t test and p <0.05 considered statistic significant
    Comparison groups
    Botulinum toxin-A v Active tratment
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5
         upper limit
    		 95
    Variability estimate
    Standard deviation
    Dispersion value
    0.05
    Notes
    [1] - paired t test

    Secondary: Days with headache lasting at least 4 hours

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    End point title
    		 Days with headache lasting at least 4 hours
    End point description
    Days with headache lasting at lest 4 hours per days
    End point type
    Secondary
    End point timeframe
    5-8 weeks versus baseline
    End point values
    		 Botulinum toxin-A Active tratment
    Number of subjects analysed
    19
    19
    Units: Headache days
        arithmetic mean (standard deviation)
    13.8 ± 28.4
    13.8 ± 28.4
    Statistical analysis title
    		 Pared t-test
    Comparison groups
    Botulinum toxin-A v Active tratment
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5
         upper limit
    		 95
    Variability estimate
    Standard deviation
    Dispersion value
    0.01

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    12 weeks follow-up
    Adverse event reporting additional description
    AE during baseline and the first 3 moths after injection
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    12 weeks follow up
    Reporting group description
    		 One had reduced power of chewing and several short-lasting neck pain during injection

    Serious adverse events
    		 12 weeks follow up
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (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
    		 12 weeks follow up
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Noe AE reach 5%

    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.
    The pilot study should include 40 participants, but only 20 were included due to the Covid 19 pandemic
    For support, Contact us.
    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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