Clinical Trial Results:
ROLE OF ENDOTHELIAL INFLAMMATION IN DEMYELINATING DISEASES OF THE CENTRAL NERVOUS SYSTEM
Summary
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EudraCT number |
2014-000254-11 |
Trial protocol |
DK |
Global end of trial date |
15 Aug 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
07 Apr 2021
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First version publication date |
07 Apr 2021
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Other versions |
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Summary report(s) |
Article |
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 |
33375
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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 |
Odense University Hospital
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Sponsor organisation address |
J.B. Winslows vej 4, Odense C, Denmark, 5000
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Public contact |
MS clinic, prof Illes, Department of Neurology, zsolt.illes@rsyd.dk
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Scientific contact |
MS clinic, prof Illes, Department of Neurology, 0045 53379541, zsolt.illes@rsyd.dk
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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 |
28 Sep 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
15 Aug 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
15 Aug 2018
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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 |
Screening for a prognostic biomarker regarding MS
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Protection of trial subjects |
We followed international and national guidelines, when collecting blood and CSF.
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Background therapy |
None | ||
Evidence for comparator |
No comparators | ||
Actual start date of recruitment |
30 Apr 2014
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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 |
Denmark: 104
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Worldwide total number of subjects |
104
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EEA total number of subjects |
104
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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) |
104
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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 |
April 2014 until August 2016, untreated newly diagnosed patients with multiple sclerosis | |||||||||
Pre-assignment
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Screening details |
To be eligible to participate in this study, candidates must meet the following eligibility criteria at the Screening/Baseline Visit: Patients with relapsing remitting multiple sclerosis (RRMS) fulfilling the McDonald criteria. Treatment-naïve patients and patients treated with first-line disease modifying treatment (DMTs); Age 18-60 | |||||||||
Period 1
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Period 1 title |
overall trial (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 | |||||||||
Blinding implementation details |
not blinded
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Baseline | |||||||||
Arm description |
pretreatment | |||||||||
Arm type |
untreated | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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1-year treatment | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
dimethyl fumarate
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
240 mg twice a day
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Baseline characteristics reporting groups
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Reporting group title |
Baseline
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Reporting group description |
pretreatment | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
1-year treatment
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Patients
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
We included untreated (naïve) newly diagnosed MS patients with RRMS according to the McDonald 2010 criteria. All patients had oligoclonal bands (OCBs) in the CSF (n=52).
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End points reporting groups
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Reporting group title |
Baseline
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Reporting group description |
pretreatment | ||
Reporting group title |
1-year treatment
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Reporting group description |
- | ||
Subject analysis set title |
Patients
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
We included untreated (naïve) newly diagnosed MS patients with RRMS according to the McDonald 2010 criteria. All patients had oligoclonal bands (OCBs) in the CSF (n=52).
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End point title |
neurofilament light chain | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
1 year
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Statistical analysis title |
Statistics | ||||||||||||
Statistical analysis description |
We described baseline characteristics with means and SDs for
continuous variables and percentages for binary variables.
Linear fit regression was performed using Spearman linear fit
regression to calculate coefficients and linearity between NFL in
CSF, plasma and serum. Data was checked for normality using
D'Agostino & Pearson normality test.
Receiver operating characteristic (ROC) analysis was
performed to identify cut-offs of NFL concentration in blood
and CSF that differentiate health
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Comparison groups |
Baseline v 1-year treatment
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Number of subjects included in analysis |
104
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Analysis specification |
Pre-specified
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Analysis type |
other [1] | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
Regression, Linear | ||||||||||||
Confidence interval |
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Notes [1] - comparing to the pre-treatment period |
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Adverse events information
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Timeframe for reporting adverse events |
April 30 2014 till august 14 2018
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||
Dictionary version |
2.1
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Reporting groups
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Reporting group title |
Adverse Events
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Reporting group description |
- | ||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||
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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. | |||
Results are published in Journal of Neurology, Neurosurgery and Psychiatry attached |