Clinical Trial Results:
Cerebrospinal fluid levels of triamcinolone acetonide
Summary
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EudraCT number |
2019-001863-60 |
Trial protocol |
AT |
Global end of trial date |
08 Nov 2021
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Results information
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Results version number |
v1(current) |
This version publication date |
19 Apr 2023
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First version publication date |
19 Apr 2023
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Other versions |
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Summary report(s) |
Manuscript |
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 |
04/2019
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04658836 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Abteilung für Hals-, Nasen- und Ohrenkrankheiten MUW, AKH Wien
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Sponsor organisation address |
Spitalgasse 23, Vienna, Austria, 1090
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Public contact |
HNO Ambulanz 8J, Abteilung für Hals-, Nasen- und Ohrenkrankheiten MUW, AKH Wien, valerie.dahm@meduniwien.ac.at
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Scientific contact |
HNO Ambulanz 8J, Abteilung für Hals-, Nasen- und Ohrenkrankheiten MUW, AKH Wien, valerie.dahm@meduniwien.ac.at
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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 |
07 Feb 2023
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
10 Feb 2020
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Global end of trial reached? |
Yes
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Global end of trial date |
08 Nov 2021
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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 |
Primary Objective
Demonstrate presence of Triamcinolone acetonide in cerebrospinal fluid
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Protection of trial subjects |
Patients will be randomly assigned a three-digit number and the further data analysis will be carried out anonymously.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Sep 2019
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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 |
Austria: 21
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Worldwide total number of subjects |
21
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EEA total number of subjects |
21
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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) |
17
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From 65 to 84 years |
4
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85 years and over |
0
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Recruitment
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Recruitment details |
Patients were recruited over a time period of 2 years. The active phase of each patient lasted up to 9 days. | ||||||
Pre-assignment
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Screening details |
Patients were asked to be included in the study if they underwent a vestibular schwannoma resection | ||||||
Period 1
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Period 1 title |
Vestibular schwannoma (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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CSF Triamcinolone | ||||||
Arm description |
- | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Triamcinolone acetonide
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intratympanic use
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Dosage and administration details |
40mg/ml intratympanic injection
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Baseline characteristics reporting groups
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Reporting group title |
Vestibular schwannoma
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
CSF Triamcinolone
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Reporting group description |
- |
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End point title |
Triamcinolone levels in CSF [1] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
single measurement
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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: Due to the small sample size of seven (SCC), nine (RWM) and twenty-one (CSF) samples, results are reported as individual data, mean and median, where appropriate. Median values (interquartile range, IQR) are given for description of continuous variables. |
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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 |
2 years
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
1
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Frequency threshold for reporting non-serious adverse events: 1% | |||
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: No adverse events happened during the trial |
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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 | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/34864199 |