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    Clinical Trial Results:
    Botulinum toxin type A block of the sphenopalatine ganglion in chronic migraine. Safety issues

    Summary
    EudraCT number
    		 2014-001852-43
    Trial protocol
    		 NO  
    Global end of trial date
    01 Feb 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Sep 2021
    First version publication date
    03 Sep 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BTACM2014
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02259075
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    NTNU
    Sponsor organisation address
    Edvard Griegs Gate 8, Trondheim, Norway, 7030
    Public contact
    Lars Jacob Stovner, Department of Neuroscience, NTNU, lars.stovner@ntnu.no
    Scientific contact
    Lars Jacob Stovner, Department of Neuroscience, NTNU, lars.stovner@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
    02 May 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Feb 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Feb 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety
    Protection of trial subjects
    - Respect: All patients were treated with respected - Beneficence: Care taken to protect participants from inadvertent risk - The trial was reviewed by IRB - The trial was monitored by Data Safety Monitoring Board
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2014
    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
    		 -

    Pre-assignment
    Screening details
    		 Ten patients with chronic migraine were recruited from the Neurology Department and by referrals from collaborating headache experts within Norway.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    None

    Arms
    Arm title
    		 Treatment
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    botulinum toxin type A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    Aided by surgical navigation and MultiGuide, BTA was injected towards the SPG. All patients received 25 IU BTA suspended in 0.5 ml isotonic saline on each side for a total dose of 50 IU

    Number of subjects in period 1
    		Treatment
    Started
    10
    Completed
    9
    Not completed
    1
         Protocol deviation
    1

    Baseline characteristics

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    End points

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

    Primary: Adverse events

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    End point title
    		 Adverse events [1]
    End point description
    End point type
    Primary
    End point timeframe
    Assessed through tabulation from the treatment procedure to the end of the study.
    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: Data on adverse event where provided in full in this single arm no blinded pilot study and no statistical analyses were performed on this parameter.
    End point values
    		 Treatment
    Number of subjects analysed
    10
    Units: Number of adverse events
    25
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During the whole study post treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NTNU WEB CRF
    Dictionary version
    3.0
    Reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Serious adverse events
    		 Overall trial
    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
    		 Overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 10 (100.00%)
    Surgical and medical procedures
    Pain,swelling and numbness
         subjects affected / exposed
    10 / 10 (100.00%)
         occurrences all number
    8
    Jaw problems
         subjects affected / exposed
    7 / 10 (70.00%)
         occurrences all number
    7
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Eye disorders
    Tearing
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Visual disturbances
         subjects affected / exposed
    3 / 10 (30.00%)
         occurrences all number
    3
    Dry eye
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Gastrointestinal disorders
    Dysphagia
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Nasal obstruction
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Temporomandibular joint dysfunction
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    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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    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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