Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Voidaanko S1P-reseptoreihin vaikuttamalla vähentää mikroglia-solukon aktiivisuutta ms-potilaan aivoissa? PET-tutkimus käyttäen [11C]PK11195 radioligandia

    Summary
    EudraCT number
    		 2014-000296-12
    Trial protocol
    		 FI  
    Global end of trial date
    14 Jun 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Jun 2021
    First version publication date
    30 Jun 2021
    Other versions
    Summary report(s)
    		 2014-000296-12 results

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    T13/2014
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Turku University Hospital
    Sponsor organisation address
    kiinamyllynkatu 4-8, Turku, Finland, 20520
    Public contact
    Turku University Hospital, Turku University Hospital, +358 02 313 0000 , turkucrc@tyks.fi
    Scientific contact
    Turku University Hospital, Turku University Hospital, +358 02 313 0000 , turkucrc@tyks.fi
    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
    29 Aug 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Jun 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate weather fingolimodi-treatment has an effect on microglial activation
    Protection of trial subjects
    Subjects were taken care by health care professionals during the trial visits.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Feb 2014
    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
    Finland: 11
    Worldwide total number of subjects
    11
    EEA total number of subjects
    11
    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)
    11
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Number of screened patients: 11

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Fingolimod
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gilenya
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage and administration according to lable

    Number of subjects in period 1
    		Fingolimod
    Started
    11
    Completed
    11
    Period 2
    Period 2 title
    Week 6-8
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Fingolimod
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gilenya
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage and administration according to lable

    Number of subjects in period 2
    		Fingolimod
    Started
    11
    Completed
    11
    Period 3
    Period 3 title
    Week 24
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Fingolimod
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gilenya
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage and administration according to lable

    Number of subjects in period 3
    		Fingolimod
    Started
    11
    Completed
    11

    Baseline characteristics

    		 Close Top of page

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Fingolimod
    Reporting group description
    		 -
    Reporting group title
    Fingolimod
    Reporting group description
    		 -
    Reporting group title
    Fingolimod
    Reporting group description
    		 -

    Primary: Change in microglial activation between time points

    		 Close Top of page
    End point title
    		 Change in microglial activation between time points
    End point description
    End point type
    Primary
    End point timeframe
    Baseline, Week 6-8, Week 24
    End point values
    		 Fingolimod Fingolimod Fingolimod
    Number of subjects analysed
    11
    11
    11
    Units: Distribution volume ratio
        geometric mean (standard deviation)
    1.16 ( 0.18 )
    1.04 ( 0.20 )
    1.04 ( 0.13 )
    Statistical analysis title
    		 Repeated-measures ANOVA with Bonferroni adjustment
    Comparison groups
    Fingolimod v Fingolimod v Fingolimod
    Number of subjects included in analysis
    33
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    24.2.2014 - 29.8.2016
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Fingolimod
    Reporting group description
    		 -

    Serious adverse events
    		 Fingolimod
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 11 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Fingolimod
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 11 (9.09%)
    General disorders and administration site conditions
    Headache
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1

    More information

    		 Close Top of page

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 26 07:56:07 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA