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    Clinical Trial Results:
    Cerebral effect of paracetamol measured by f-MRI

    Summary
    EudraCT number
    		 2013-004908-20
    Trial protocol
    		 BE  
    Global end of trial date
    06 Aug 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 May 2025
    First version publication date
    10 May 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PARAMRI
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UZ Brussel
    Sponsor organisation address
    Laarbeeklaan, Brussel, Belgium,
    Public contact
    Datanurse, UZ Brussel, 32 24776001, virgini.vanbuggenhout@uzbrussel.be
    Scientific contact
    Datanurse, UZ Brussel, 32 24776001, virgini.vanbuggenhout@uzbrussel.be
    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
    30 Dec 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Apr 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Aug 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluation of the cerebral activity of paracetamol, assessed by f-MRI
    Protection of trial subjects
    All patients were followed up regarding safety from signing informed consent till end of study (second MRI).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Dec 2013
    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
    Belgium: 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
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 20
    Number of subjects completed
    		 20

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

    Arms
    Arm title
    		 MRI - paracetamol
    Arm description
    		 -
    Arm type
    		 test

    Investigational medicinal product name
    paracetamol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1g of paracetamol was given once together with a glass of still water.

    Number of subjects in period 1
    		MRI - paracetamol
    Started
    20
    Completed
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MRI - paracetamol
    Reporting group description
    		 -

    Reporting group values
    		 MRI - paracetamol Total
    Number of subjects
    		 20 20
    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 (full range (min-max))
    		 31 (22 to 55) -
    Gender categorical
    Units: Subjects
        Female
    		 11 11
        Male
    		 9 9
    weight
    Units: kilogram(s)
        median (full range (min-max))
    		 75 (48 to 120) -
    height
    Units: centimetre
        median (full range (min-max))
    		 176 (160 to 195) -

    End points

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    End points reporting groups
    Reporting group title
    MRI - paracetamol
    Reporting group description
    		 -

    Primary: Ventral left cortex cerebellum posterior lobe

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    End point title
    		 Ventral left cortex cerebellum posterior lobe [1]
    End point description
    Data were expressed as t-value subtraction versus baseline (before intake paracetamol).
    End point type
    Primary
    End point timeframe
    Ventral Left cluster of the brain (cerebellum posterior lobe). Difference between first MRI and second MRI
    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: Measurements were done in the same arm. Patient had a MRI before given paracetamol and one MRI after. Data were expressed as t-value subtraction versus baseline (before intake).
    End point values
    		 MRI - paracetamol
    Number of subjects analysed
    20
    Units: Kelvin
    117
    No statistical analyses for this end point

    Primary: ventral left cortex middle temporal gyrus

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    End point title
    		 ventral left cortex middle temporal gyrus [2]
    End point description
    Data were expressed as t-value subtraction versus baseline (before intake).
    End point type
    Primary
    End point timeframe
    Ventral Left cluster of the brain (middle temporal gyrus). Difference between first MRI and second MRI
    Notes
    [2] - 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: Measurements were done in the same arm. Patient had a MRI before given paracetamol and one MRI after. Data were expressed as t-value subtraction versus baseline (before intake).
    End point values
    		 MRI - paracetamol
    Number of subjects analysed
    20
    Units: Kelvin
    85
    No statistical analyses for this end point

    Primary: ventral left cortex posterior cingulate

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    End point title
    		 ventral left cortex posterior cingulate [3]
    End point description
    Data were expressed as t-value subtraction versus baseline (before intake).
    End point type
    Primary
    End point timeframe
    Ventral Left cluster of the brain (posterior cingulate). Difference between first MRI and second MRI.
    Notes
    [3] - 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: Measurements were done in the same arm. Patient had a MRI before given paracetamol and one MRI after. Data were expressed as t-value subtraction versus baseline (before intake).
    End point values
    		 MRI - paracetamol
    Number of subjects analysed
    20
    Units: Kelvin
    576
    No statistical analyses for this end point

    Primary: ventral left cortex caudata

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    End point title
    		 ventral left cortex caudata [4]
    End point description
    Data were expressed as t-value subtraction versus baseline (before intake).
    End point type
    Primary
    End point timeframe
    Ventral Left cluster of the brain (caudata). Difference between first MRI and second MRI.
    Notes
    [4] - 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: Measurements were done in the same arm. Patient had a MRI before given paracetamol and one MRI after. Data were expressed as t-value subtraction versus baseline (before intake).
    End point values
    		 MRI - paracetamol
    Number of subjects analysed
    20
    Units: Kelvin
    93
    No statistical analyses for this end point

    Primary: ventral right cortex temporal

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    End point title
    		 ventral right cortex temporal [5]
    End point description
    Data were expressed as t-value subtraction versus baseline (before intake).
    End point type
    Primary
    End point timeframe
    Ventral right cluster of the brain (Temporal). Difference between first MRI and second MRI.
    Notes
    [5] - 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: Measurements were done in the same arm. Patient had a MRI before given paracetamol and one MRI after. Data were expressed as t-value subtraction versus baseline (before intake).
    End point values
    		 MRI - paracetamol
    Number of subjects analysed
    20
    Units: Kelvin
    103
    No statistical analyses for this end point

    Primary: ventral right cortex posterior cingulate

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    End point title
    		 ventral right cortex posterior cingulate [6]
    End point description
    Data were expressed as t-value subtraction versus baseline (before intake).
    End point type
    Primary
    End point timeframe
    Ventral right cortex (posterior cingulate) difference between MRI before paracetamol and MRI after paracetamol.
    Notes
    [6] - 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: Measurements were done in the same arm. Patient had a MRI before given paracetamol and one MRI after. Data were expressed as t-value subtraction versus baseline (before intake).
    End point values
    		 MRI - paracetamol
    Number of subjects analysed
    20
    Units: Kelvin
    185
    No statistical analyses for this end point

    Primary: ventral right cortex superior frontal gyrus

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    End point title
    		 ventral right cortex superior frontal gyrus [7]
    End point description
    Data were expressed as t-value subtraction versus baseline (before intake).
    End point type
    Primary
    End point timeframe
    Ventral right cortex (superior frontal gyrus). difference between MRI before paracetamol and MRI after paracetamol.
    Notes
    [7] - 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: Measurements were done in the same arm. Patient had a MRI before given paracetamol and one MRI after. Data were expressed as t-value subtraction versus baseline (before intake).
    End point values
    		 MRI - paracetamol
    Number of subjects analysed
    20
    Units: Kelvin
    281
    No statistical analyses for this end point

    Primary: dorsal left cortex temporal

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    End point title
    		 dorsal left cortex temporal [8]
    End point description
    Data were expressed as t-value subtraction versus baseline (before intake).
    End point type
    Primary
    End point timeframe
    dorsal left cortex (temporal). Difference between MRI before paracetamol and MRI after paracetamol
    Notes
    [8] - 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: Measurements were done in the same arm. Patient had a MRI before given paracetamol and one MRI after. Data were expressed as t-value subtraction versus baseline (before intake).
    End point values
    		 MRI - paracetamol
    Number of subjects analysed
    20
    Units: Kelvin
    239
    No statistical analyses for this end point

    Primary: dorsal left cortex inferior frontal gyrus

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    End point title
    		 dorsal left cortex inferior frontal gyrus [9]
    End point description
    Data were expressed as t-value subtraction versus baseline (before intake).
    End point type
    Primary
    End point timeframe
    dorsal left cortex inferior frontal gyrus. Difference between MRI before paracetamol and MRI after paracetamol.
    Notes
    [9] - 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: Measurements were done in the same arm. Patient had a MRI before given paracetamol and one MRI after. Data were expressed as t-value subtraction versus baseline (before intake).
    End point values
    		 MRI - paracetamol
    Number of subjects analysed
    20
    Units: Kelvin
    165
    No statistical analyses for this end point

    Primary: dorsal right cortex- postcentral gyrus

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    End point title
    		 dorsal right cortex- postcentral gyrus [10]
    End point description
    Data were expressed as t-value subtraction versus baseline (before intake).
    End point type
    Primary
    End point timeframe
    dorsal right cortex postcentral gyrus. Difference between MRI before paracetamol and MRI after paracetamol.
    Notes
    [10] - 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: Measurements were done in the same arm. Patient had a MRI before given paracetamol and one MRI after. Data were expressed as t-value subtraction versus baseline (before intake).
    End point values
    		 MRI - paracetamol
    Number of subjects analysed
    20
    Units: Kelvin
    102
    No statistical analyses for this end point

    Primary: ventral and dorsal left cortex insula

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    End point title
    		 ventral and dorsal left cortex insula [11]
    End point description
    Data were expressed as t-value subtraction versus baseline (before intake).
    End point type
    Primary
    End point timeframe
    ventral and dorsal left cortex insula. Difference between MRI before paracetamol and MRI after paracetamol.
    Notes
    [11] - 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: Measurements were done in the same arm. Patient had a MRI before given paracetamol and one MRI after. Data were expressed as t-value subtraction versus baseline (before intake).
    End point values
    		 MRI - paracetamol
    Number of subjects analysed
    20
    Units: Kelvin
    212
    No statistical analyses for this end point

    Primary: ventral and dorsal left cortex middle frontal gyrus

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    End point title
    		 ventral and dorsal left cortex middle frontal gyrus [12]
    End point description
    Data were expressed as t-value subtraction versus baseline (before intake).
    End point type
    Primary
    End point timeframe
    ventral and dorsal left cortex middle frontal gyrus. Difference between MRI before paracetamol and MRI after paracetamol
    Notes
    [12] - 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: Measurements were done in the same arm. Patient had a MRI before given paracetamol and one MRI after. Data were expressed as t-value subtraction versus baseline (before intake).
    End point values
    		 MRI - paracetamol
    Number of subjects analysed
    20
    Units: Kelvin
    85
    No statistical analyses for this end point

    Primary: ventral and dorsal left cortex posterior cingulate

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    End point title
    		 ventral and dorsal left cortex posterior cingulate [13]
    End point description
    Data were expressed as t-value subtraction versus baseline (before intake
    End point type
    Primary
    End point timeframe
    ventral and dorsal left cortex posterior cingulate. Difference between MRI before paracetamol and MRI after.
    Notes
    [13] - 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: Measurements were done in the same arm. Patient had a MRI before given paracetamol and one MRI after. Data were expressed as t-value subtraction versus baseline (before intake).
    End point values
    		 MRI - paracetamol
    Number of subjects analysed
    20
    Units: Kelvin
    149
    No statistical analyses for this end point

    Primary: ventral and dorsal left cortex precentral

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    End point title
    		 ventral and dorsal left cortex precentral [14]
    End point description
    Data were expressed as t-value subtraction versus baseline (before intake
    End point type
    Primary
    End point timeframe
    ventral and dorsal left cortex precentral. Difference between MRI before paracetamol and MRI after.
    Notes
    [14] - 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: Measurements were done in the same arm. Patient had a MRI before given paracetamol and one MRI after. Data were expressed as t-value subtraction versus baseline (before intake).
    End point values
    		 MRI - paracetamol
    Number of subjects analysed
    20
    Units: Kelvin
    880
    No statistical analyses for this end point

    Primary: ventral and dorsal right cortex temporal

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    End point title
    		 ventral and dorsal right cortex temporal [15]
    End point description
    Data were expressed as t-value subtraction versus baseline (before intake
    End point type
    Primary
    End point timeframe
    ventral and dorsal right cortex temporal. Difference between MRI before paracetamol and MRI after
    Notes
    [15] - 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: Measurements were done in the same arm. Patient had a MRI before given paracetamol and one MRI after. Data were expressed as t-value subtraction versus baseline (before intake).
    End point values
    		 MRI - paracetamol
    Number of subjects analysed
    20
    Units: Kelvin
    88
    No statistical analyses for this end point

    Primary: ventral and dorsal right cortex inferior frontal gyrus

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    End point title
    		 ventral and dorsal right cortex inferior frontal gyrus [16]
    End point description
    Data were expressed as t-value subtraction versus baseline (before intake
    End point type
    Primary
    End point timeframe
    ventral and dorsal right cortex inferior frontal gyrus. Difference between MRI before paracetamol and MRI after
    Notes
    [16] - 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: Measurements were done in the same arm. Patient had a MRI before given paracetamol and one MRI after. Data were expressed as t-value subtraction versus baseline (before intake).
    End point values
    		 MRI - paracetamol
    Number of subjects analysed
    20
    Units: Kelvin
    86
    No statistical analyses for this end point

    Primary: ventral and dorsal right cortex precentral gyrus

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    End point title
    		 ventral and dorsal right cortex precentral gyrus [17]
    End point description
    End point type
    Primary
    End point timeframe
    ventral and dorsal right cortex precentral gyrus. Difference between MRI before paracetamol and MRI after.
    Notes
    [17] - 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: Measurements were done in the same arm. Patient had a MRI before given paracetamol and one MRI after. Data were expressed as t-value subtraction versus baseline (before intake).
    End point values
    		 MRI - paracetamol
    Number of subjects analysed
    20
    Units: Kelvin
    105
    No statistical analyses for this end point

    Primary: ventral and dorsal right cortex precentral

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    End point title
    		 ventral and dorsal right cortex precentral [18]
    End point description
    Data were expressed as t-value subtraction versus baseline (before intake
    End point type
    Primary
    End point timeframe
    ventral and dorsal right cortex precentral. Difference between MRI before paracetamol and MRI after.
    Notes
    [18] - 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: Measurements were done in the same arm. Patient had a MRI before given paracetamol and one MRI after. Data were expressed as t-value subtraction versus baseline (before intake).
    End point values
    		 MRI - paracetamol
    Number of subjects analysed
    20
    Units: Kelvin
    708
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    adverse events were reported from signing the informed consent till the second MRI was done.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    Study conduct
    Reporting group description
    		 -

    Serious adverse events
    		 Study conduct
    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
    		 Study conduct
    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: safety was assessed after ICF was signed. However, patients only had to come in for the study one day, they had to perform a MRI, take a paracetamol afterwards and did another MRI. After that they've reached the end of the study.

    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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