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    Clinical Trial Results:
    Botulinum toxin type A block of the otic ganglion in chronic cluster headache. Safety issues.

    Summary
    EudraCT number
    		 2016-004213-28
    Trial protocol
    		 NO  
    Global end of trial date
    31 May 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jul 2021
    First version publication date
    29 Jul 2021
    Other versions
    Summary report(s)
    		 Published paper

    Trial information

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    Trial identification
    Sponsor protocol code
    OTOBLOCKCH2016
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03066635
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    NTNU
    Sponsor organisation address
    Edvard Griegs gt 8, Trondheim, Norway, 7030
    Public contact
    Lars Jacob Stovner, Department of Neuroscience, NTNU, 0047 72575070, erling.tronvik@ntnu.no
    Scientific contact
    Lars Jacob Stovner, Department of Neuroscience, NTNU, +47 40458528, erling.tronvik@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
    31 May 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 May 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    31 May 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate safety
    Protection of trial subjects
    All participants were given extensive information prior to participation on the experimental nature of this pilot trial and potential risks.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jun 2017
    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
    Norway: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    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)
    9
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruited from the out patient clinic, St. Olavs Hospital Trondheim from June 2017 to May 2019

    Pre-assignment
    Screening details
    		 11 patients were screened, one was screening failure due to too few headache attacks in the baseline period.

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

    Arms
    Arm title
    		 Treatment
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    botulinum toxin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    12,5 Allergan units Botox injected in 5 patients and 25 units Botox injected in 5 patients

    Number of subjects in period 1
    		Treatment
    Started
    10
    Completed
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 10 10
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 55 ± 12 -
    Gender categorical
    Units: Subjects
        Female
    		 5 5
        Male
    		 5 5

    End points

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

    Primary: Safety

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    End point title
    		 Safety [1]
    End point description
    End point type
    Primary
    End point timeframe
    June 2017 - May 2019
    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: The primary objective of this pilot trial in 10 patients was to evaluate safety. All safety data were given in full and no statistical analyses were performed on this parameter.
    End point values
    		 Treatment
    Number of subjects analysed
    10
    Units: Occurrence of adverse events
        number (not applicable)
    10
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    June 2017 - May 2019
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 WebCRF - NTNU
    Dictionary version
    2.0
    Reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 -

    Serious adverse events
    		 Treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (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
    		 Treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 10 (60.00%)
    Injury, poisoning and procedural complications
    Transient pain or swelling at site of injection
         subjects affected / exposed
    3 / 10 (30.00%)
         occurrences all number
    3
    Transient jaw stiffness or discomfort gaping at injection site
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Nervous system disorders
    Transient chin numbness
         subjects affected / exposed
    2 / 10 (20.00%)
         occurrences all number
    2
    Transient discomfort swallowing
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Transient articulation difficulties due to local discomfort
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Transient nasal voice
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Transient hyperacusis
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Transient tinnitus
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Transient ear fullness
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Endocrine disorders
    Transient dry mouth
         subjects affected / exposed
    3 / 10 (30.00%)
         occurrences all number
    3

    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 a small pilot trial in only 10 patients to evaluate safety of the intervention.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/32583902
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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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