Clinical Trial Results:
Voidaanko S1P-reseptoreihin vaikuttamalla vähentää mikroglia-solukon aktiivisuutta ms-potilaan aivoissa? PET-tutkimus käyttäen [11C]PK11195 radioligandia
Summary
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EudraCT number |
2014-000296-12 |
Trial protocol |
FI |
Global end of trial date |
14 Jun 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
30 Jun 2021
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First version publication date |
30 Jun 2021
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Other versions |
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Summary report(s) |
2014-000296-12 results |
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 |
T13/2014
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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 |
Turku University Hospital
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Sponsor organisation address |
kiinamyllynkatu 4-8, Turku, Finland, 20520
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Public contact |
Turku University Hospital, Turku University Hospital, +358 02 313 0000 , turkucrc@tyks.fi
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Scientific contact |
Turku University Hospital, Turku University Hospital, +358 02 313 0000 , turkucrc@tyks.fi
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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 |
29 Aug 2016
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
14 Jun 2016
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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 |
To evaluate weather fingolimodi-treatment has an effect on microglial activation
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Protection of trial subjects |
Subjects were taken care by health care professionals during the trial visits.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
24 Feb 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 |
Finland: 11
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Worldwide total number of subjects |
11
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EEA total number of subjects |
11
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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) |
11
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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 |
Number of screened patients: 11 | ||||||
Period 1
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Period 1 title |
Baseline
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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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Fingolimod | ||||||
Arm description |
- | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Gilenya
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule, hard
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Routes of administration |
Oral use
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Dosage and administration details |
Dosage and administration according to lable
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Period 2
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Period 2 title |
Week 6-8
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Is this the baseline period? |
No | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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Fingolimod | ||||||
Arm description |
- | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Gilenya
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule, hard
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Routes of administration |
Oral use
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Dosage and administration details |
Dosage and administration according to lable
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Period 3
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Period 3 title |
Week 24
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Is this the baseline period? |
No | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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Fingolimod | ||||||
Arm description |
- | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Gilenya
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule, hard
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Routes of administration |
Oral use
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Dosage and administration details |
Dosage and administration according to lable
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End points reporting groups
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Reporting group title |
Fingolimod
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Reporting group description |
- | ||
Reporting group title |
Fingolimod
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Reporting group description |
- | ||
Reporting group title |
Fingolimod
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Reporting group description |
- |
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End point title |
Change in microglial activation between time points | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Baseline, Week 6-8, Week 24
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Statistical analysis title |
Repeated-measures ANOVA with Bonferroni adjustment | ||||||||||||||||
Comparison groups |
Fingolimod v Fingolimod v Fingolimod
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Number of subjects included in analysis |
33
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Analysis specification |
Post-hoc
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Analysis type |
other | ||||||||||||||||
P-value |
< 0.05 | ||||||||||||||||
Method |
ANOVA | ||||||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
24.2.2014 - 29.8.2016
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Assessment type |
Non-systematic | ||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||
Dictionary version |
18.0
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Reporting groups
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Reporting group title |
Fingolimod
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Reporting group description |
- | ||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||||||
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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 |