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    Clinical Trial Results:
    Botulinum neurotoxin type A treatment for sialorrhea in central nervous system diseases

    Summary
    EudraCT number
    		 2015-000682-30
    Trial protocol
    		 EE  
    Global end of trial date
    12 Nov 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Apr 2022
    First version publication date
    07 Apr 2022
    Other versions
    Summary report(s)
    		 Does Botulinum neurotoxin type A treatment for sialorrhea 2017
    Saliva changes in Parkinson’s disease patients 2018
    Use of botulinum neurotoxin A 2012

    Trial information

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    Trial identification
    Sponsor protocol code
    01-09.02.15.
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Tartu University Hospital
    Sponsor organisation address
    Puusepa 1A, Tartu, Estonia, 50406
    Public contact
    Tartu University Hospital Clinic , Tartu University Hospital Clinic , janne.tiigimae-saar@kliinikum.ee
    Scientific contact
    Tartu University Hospital Clinic , Tartu University Hospital Clinic , janne.tiigimae-saar@kliinikum.ee
    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
    12 Nov 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Nov 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Nov 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1.Evaluate and compare salivary compositions and microflora change after BNT-A injections describing the status of caries and periodontal health. 2. Evaluate the BNT-A efficiency in treatment of average and hard sialorrhea patients. 3. Evaluate the BNT-A effect on patients life-quality.
    Protection of trial subjects
    Ethics commitee approval obtained. Informed consent obtained.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Mar 2015
    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
    Estonia: 80
    Worldwide total number of subjects
    80
    EEA total number of subjects
    80
    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)
    12
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    25
    From 65 to 84 years
    43
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Totally 67 patients were enrolled to the study group. In the control group there were 13 patients

    Pre-assignment
    Screening details
    		 Informed consent from the patient and/or caregiver was needed.

    Period 1
    Period 1 title
    Study group (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Experimental
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Botulinum neurotoxin type A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intraglandular use
    Dosage and administration details
    250 units

    Arm title
    		 Control group
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Experimental Control group
    Started
    67
    13
    Completed
    67
    13

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Study group
    Reporting group description
    		 -

    Reporting group values
    		 Study group Total
    Number of subjects
    		 80 80
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 14 14
        Adults (18-64 years)
    		 23 23
        From 65-84 years
    		 43 43
    Gender categorical
    Units: Subjects
        Female
    		 36 36
        Male
    		 44 44
    Subject analysis sets

    Subject analysis set title
    Per protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subject analysis set is described in the articles

    Subject analysis sets values
    		 Per protocol
    Number of subjects
    80
    Age categorical
    Units: Subjects
        Children (2-11 years)
    14
        Adults (18-64 years)
    23
        From 65-84 years
    43
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    44
        Male
    36

    End points

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

    Reporting group title
    Control group
    Reporting group description
    		 -

    Subject analysis set title
    Per protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subject analysis set is described in the articles

    Primary: Salivary flow rate

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    End point title
    		 Salivary flow rate
    End point description
    End point type
    Primary
    End point timeframe
    Resting saliva time, seconds
    End point values
    		 Experimental Control group Per protocol
    Number of subjects analysed
    67
    13
    13
    Units: second
    67
    13
    13
    Statistical analysis title
    		 Study result analysis
    Comparison groups
    Experimental v Control group
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 1-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Starting from study medication injection
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    All study subjects
    Reporting group description
    		 All study subjects

    Serious adverse events
    		 All study subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 67 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 All study subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 67 (1.49%)
    Gastrointestinal disorders
    Difficulties with swallowing
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 67 (1.49%)
         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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