Clinical Trial Results:
Cerebral effect of paracetamol measured by f-MRI
Summary
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EudraCT number |
2013-004908-20 |
Trial protocol |
BE |
Global end of trial date |
06 Aug 2024
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Results information
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Results version number |
v1(current) |
This version publication date |
10 May 2025
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First version publication date |
10 May 2025
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
PARAMRI
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
UZ Brussel
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Sponsor organisation address |
Laarbeeklaan, Brussel, Belgium,
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Public contact |
Datanurse, UZ Brussel, 32 24776001, virgini.vanbuggenhout@uzbrussel.be
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Scientific contact |
Datanurse, UZ Brussel, 32 24776001, virgini.vanbuggenhout@uzbrussel.be
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
30 Dec 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
22 Apr 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
06 Aug 2024
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Evaluation of the cerebral activity of paracetamol, assessed by f-MRI
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Protection of trial subjects |
All patients were followed up regarding safety from signing informed consent till end of study (second MRI).
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
02 Dec 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Belgium: 20
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Worldwide total number of subjects |
20
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EEA total number of subjects |
20
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
20
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||
Pre-assignment
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Screening details |
- | ||||||
Pre-assignment period milestones
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Number of subjects started |
20 | ||||||
Number of subjects completed |
20 | ||||||
Period 1
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Period 1 title |
study conduct (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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MRI - paracetamol | ||||||
Arm description |
- | ||||||
Arm type |
test | ||||||
Investigational medicinal product name |
paracetamol
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
1g of paracetamol was given once together with a glass of still water.
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Baseline characteristics reporting groups
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Reporting group title |
MRI - paracetamol
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
MRI - paracetamol
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Reporting group description |
- |
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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).
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End point type |
Primary
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End point timeframe |
Ventral Left cluster of the brain (cerebellum posterior lobe). Difference between first MRI and second MRI
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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). |
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No statistical analyses for this end point |
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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).
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End point type |
Primary
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End point timeframe |
Ventral Left cluster of the brain (middle temporal gyrus). Difference between first MRI and second MRI
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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). |
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No statistical analyses for this end point |
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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).
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End point type |
Primary
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End point timeframe |
Ventral Left cluster of the brain (posterior cingulate). Difference between first MRI and second MRI.
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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). |
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No statistical analyses for this end point |
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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).
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End point type |
Primary
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End point timeframe |
Ventral Left cluster of the brain (caudata). Difference between first MRI and second MRI.
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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). |
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No statistical analyses for this end point |
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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).
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End point type |
Primary
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End point timeframe |
Ventral right cluster of the brain (Temporal). Difference between first MRI and second MRI.
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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). |
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No statistical analyses for this end point |
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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).
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End point type |
Primary
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End point timeframe |
Ventral right cortex (posterior cingulate) difference between MRI before paracetamol and MRI after paracetamol.
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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). |
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No statistical analyses for this end point |
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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).
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End point type |
Primary
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End point timeframe |
Ventral right cortex (superior frontal gyrus). difference between MRI before paracetamol and MRI after paracetamol.
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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). |
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No statistical analyses for this end point |
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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).
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End point type |
Primary
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End point timeframe |
dorsal left cortex (temporal). Difference between MRI before paracetamol and MRI after paracetamol
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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). |
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No statistical analyses for this end point |
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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).
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End point type |
Primary
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End point timeframe |
dorsal left cortex inferior frontal gyrus. Difference between MRI before paracetamol and MRI after paracetamol.
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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). |
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No statistical analyses for this end point |
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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).
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End point type |
Primary
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End point timeframe |
dorsal right cortex postcentral gyrus. Difference between MRI before paracetamol and MRI after paracetamol.
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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). |
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No statistical analyses for this end point |
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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).
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End point type |
Primary
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End point timeframe |
ventral and dorsal left cortex insula. Difference between MRI before paracetamol and MRI after paracetamol.
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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). |
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No statistical analyses for this end point |
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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).
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End point type |
Primary
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End point timeframe |
ventral and dorsal left cortex middle frontal gyrus. Difference between MRI before paracetamol and MRI after paracetamol
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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). |
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No statistical analyses for this end point |
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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
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End point type |
Primary
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End point timeframe |
ventral and dorsal left cortex posterior cingulate. Difference between MRI before paracetamol and MRI after.
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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). |
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No statistical analyses for this end point |
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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
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End point type |
Primary
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End point timeframe |
ventral and dorsal left cortex precentral. Difference between MRI before paracetamol and MRI after.
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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). |
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No statistical analyses for this end point |
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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
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End point type |
Primary
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End point timeframe |
ventral and dorsal right cortex temporal. Difference between MRI before paracetamol and MRI after
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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). |
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No statistical analyses for this end point |
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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
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End point type |
Primary
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End point timeframe |
ventral and dorsal right cortex inferior frontal gyrus. Difference between MRI before paracetamol and MRI after
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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). |
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No statistical analyses for this end point |
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End point title |
ventral and dorsal right cortex precentral gyrus [17] | ||||||
End point description |
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End point type |
Primary
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End point timeframe |
ventral and dorsal right cortex precentral gyrus. Difference between MRI before paracetamol and MRI after.
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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). |
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No statistical analyses for this end point |
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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
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End point type |
Primary
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End point timeframe |
ventral and dorsal right cortex precentral. Difference between MRI before paracetamol and MRI after.
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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). |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
adverse events were reported from signing the informed consent till the second MRI was done.
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Assessment type |
Systematic | ||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||
Dictionary version |
22
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Reporting groups
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Reporting group title |
Study conduct
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Reporting group description |
- | ||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||
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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. |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |