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    Clinical Trial Results:
    A multicentre, randomised controlled Trial of Exenatide versus standard care in Acute Ischemic Stroke (TEXAIS)

    Summary
    EudraCT number
    		 2018-004325-88
    Trial protocol
    		 FI  
    Global end of trial date
    02 Oct 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 May 2024
    First version publication date
    18 May 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NTA1127
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03287076
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Australian New Zealand Clinical Trials Registry: ACTRN12617000409370
    Sponsors
    Sponsor organisation name
    Monash University
    Sponsor organisation address
    26 Sports Walk, Clayton Campus, Wellington Road, Clayton, Australia, 3800
    Public contact
    Maddalena Borromeo, Neuroscience Trials Australia, Maddalena.borromeo@florey.edu.au
    Scientific contact
    Maddalena Borromeo, Neuroscience Trials Australia, Maddalena.borromeo@florey.edu.au
    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
    27 Nov 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Oct 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Oct 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare neurological impairment (NIHSS) at 7 days in treated and untreated patients.
    Protection of trial subjects
    Informed consent
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jan 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
    Finland: 85
    Country: Number of subjects enrolled
    Australia: 265
    Worldwide total number of subjects
    350
    EEA total number of subjects
    85
    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)
    350
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Modified intention to treat

    Pre-assignment period milestones
    Number of subjects started
    		 350
    Number of subjects completed
    		 346

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Consent withdrawn by subject: 4
    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [1]

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Exenatide
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Exenatide
    Investigational medicinal product code
    ATC A10BJ01
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Exenatide 5μg subcutaneously twice daily for 5 days or discharge, whichever is sooner

    Arm title
    		 Standard care
    Arm description
    		 -
    Arm type
    		 Standard care

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: PROBE-design
    Number of subjects in period 1 [2]
    		Exenatide Standard care
    Started
    174
    172
    Completed
    174
    172
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 4 patients withdrew consent
    Period 2
    Period 2 title
    7 days or discharge
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [3]
    Blinding implementation details
    PROBE

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Exenatide
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Exenatide
    Investigational medicinal product code
    ATC A10BJ01
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Exenatide 5μg subcutaneously twice daily for 5 days or discharge, whichever is sooner

    Arm title
    		 Standard care
    Arm description
    		 -
    Arm type
    		 Standard care

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Notes
    [3] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: PROBE-design
    Number of subjects in period 2
    		Exenatide Standard care
    Started
    174
    172
    Completed
    174
    172

    Baseline characteristics

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

    Reporting group title
    Standard care
    Reporting group description
    		 -

    Reporting group values
    		 Exenatide Standard care Total
    Number of subjects
    		 174 172 346
    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
        median (inter-quartile range (Q1-Q3))
    		 72 (61 to 80) 71 (63 to 78) -
    Gender categorical
    Units: Subjects
        Female
    		 50 55 105
        Male
    		 124 117 241

    End points

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

    Reporting group title
    Standard care
    Reporting group description
    		 -
    Reporting group title
    Exenatide
    Reporting group description
    		 -

    Reporting group title
    Standard care
    Reporting group description
    		 -

    Primary: More than 8 point improvement on NIHSS or a score of 0-1

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    End point title
    		 More than 8 point improvement on NIHSS or a score of 0-1
    End point description
    End point type
    Primary
    End point timeframe
    7 days or time of discharge, whichever earliest
    End point values
    		 Exenatide Standard care
    Number of subjects analysed
    174
    172
    Units: 1
    104
    97
    Statistical analysis title
    		 Primary outcome
    Comparison groups
    Exenatide v Standard care
    Number of subjects included in analysis
    346
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.38
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 1.88

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    90 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NA
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Exenatide
    Reporting group description
    		 -

    Reporting group title
    Standard care
    Reporting group description
    		 -

    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: Not available.
    Serious adverse events
    		 Exenatide Standard care
    Total subjects affected by serious adverse events
         subjects affected / exposed
    26 / 174 (14.94%)
    29 / 172 (16.86%)
         number of deaths (all causes)
    10
    8
         number of deaths resulting from adverse events
    Investigations
    All other SAE
         subjects affected / exposed
    16 / 174 (9.20%)
    21 / 172 (12.21%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    10 / 174 (5.75%)
    8 / 172 (4.65%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 8
         deaths causally related to treatment / all
    0 / 10
    0 / 8
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Exenatide Standard care
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 174 (0.00%)
    0 / 172 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Oct 2018
    Version 3: 9 October 2018

    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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