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    Clinical Trial Results:
    Trichuris suis Oozyten (TSO®) in remittent-recurrent Multiple Sclerosis (MS) and Clinically Isolated Syndrom (CIS)

    Summary
    EudraCT number
    		 2009-015319-41
    Trial protocol
    		 DE  
    Global end of trial date
    02 Mar 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 May 2022
    First version publication date
    28 May 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TSO-MS
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Charité-Universitätsmedizin Berlin
    Sponsor organisation address
    Lindenberger Weg 80, Berlin, Germany, 13125
    Public contact
    the Department of Neurology and the NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin, 0049 30450560284, friedemann.paul@charite.de
    Scientific contact
    the Department of Neurology and the NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin, 0049 30450560284, friedemann.paul@charite.de
    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
    02 Mar 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Mar 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To test the efficacy of TSO® in MS and CIS patients, measured as number of new T2 lesions in cMRI after a 12 months treatment - compared to placebo.
    Protection of trial subjects
    The study was approved by the local ethics committee and the German Federal Institute for Drugs and Medical Devices (BfArM).Visitation at V1-4.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Feb 2011
    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
    Germany: 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

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    Recruitment
    Recruitment details
    		 Individuals were recruited between September 2012 and March 2015.

    Pre-assignment
    Screening details
    		 Eleven patients diagnosed with relapsing-remitting multiple sclerosis (RRMS) according to the revised McDonald criteria [17] (CIS) with clinical activity were recruited for experimental treatment with T. suis ova (TRIOMS).

    Period 1
    Period 1 title
    Treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 TSO Group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    TSO
    Investigational medicinal product code
    TSO
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    2500 Trichuris suis ova every 2 week for 12 months

    Arm title
    		 Placebo Group
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    every 2 weeks for 12 months

    Number of subjects in period 1
    		TSO Group Placebo Group
    Started
    5
    6
    Completed
    5
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    TSO Group
    Reporting group description
    		 -

    Reporting group title
    Placebo Group
    Reporting group description
    		 -

    Reporting group values
    		 TSO Group Placebo Group Total
    Number of subjects
    		 5 6 11
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 5 6 11
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 4 4 8
        Male
    		 1 2 3
    Months since diagnosis
    Units: Months
        median (full range (min-max))
    		 25 (13 to 187) 64.5 (5 to 165) -
    EDSS score
    Units: Score
        arithmetic mean (full range (min-max))
    		 1.8 (0 to 3.5) 2.08 (0 to 4) -
    hyperintense lesions identified on T2-weighted brain MRI
    Units: T2 lesions
        arithmetic mean (full range (min-max))
    		 66.75 (32 to 107) 94 (14 to 268) -
    Gd enhancing lesions
    Units: Gd lesions
        median (full range (min-max))
    		 1 (0 to 1) 1 (0 to 4) -

    End points

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    End points reporting groups
    Reporting group title
    TSO Group
    Reporting group description
    		 -

    Reporting group title
    Placebo Group
    Reporting group description
    		 -

    Primary: T2 lesions (after final treatment)

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    End point title
    		 T2 lesions (after final treatment)
    End point description
    for more details see attached PMID (table 1, page 5)
    End point type
    Primary
    End point timeframe
    12 months
    End point values
    		 TSO Group Placebo Group
    Number of subjects analysed
    5
    6
    Units: Score
        median (full range (min-max))
    53 (15 to 268)
    67.5 (36 to 105)
    Statistical analysis title
    		 Lesion change over 12 months
    Comparison groups
    TSO Group v Placebo Group
    Number of subjects included in analysis
    11
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Gd enhancing lesions (after final treatment)

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    End point title
    		 Gd enhancing lesions (after final treatment)
    End point description
    For more detail see attached PMID
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 TSO Group Placebo Group
    Number of subjects analysed
    5
    6
    Units: Score
        median (full range (min-max))
    0 (0 to 1)
    0 (0 to 2)
    No statistical analyses for this end point

    Secondary: Number of relapses

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    End point title
    		 Number of relapses
    End point description
    End point type
    Secondary
    End point timeframe
    12 months (V0-V4)
    End point values
    		 TSO Group Placebo Group
    Number of subjects analysed
    5
    6
    Units: Count
        median (full range (min-max))
    0 (0 to 3)
    1 (0 to 2)
    No statistical analyses for this end point

    Secondary: EDSS score (after final treatment)

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    End point title
    		 EDSS score (after final treatment)
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 TSO Group Placebo Group
    Number of subjects analysed
    5
    6
    Units: Score
        median (full range (min-max))
    1.5 (0 to 2)
    2.75 (0 to 4)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    12 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 own
    Dictionary version
    1
    Reporting groups
    Reporting group title
    TSO Group
    Reporting group description
    		 -

    Reporting group title
    Placebo Group
    Reporting group description
    		 -

    Serious adverse events
    		 TSO Group Placebo Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 TSO Group Placebo Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    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 AEs were reported

    More information

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    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.
    Recruitment problems due to considerable reservations about worm egg therapy by patients in some cases and because of the considerable expansion of therapy options in the treatment of MS with orally available substances within the recruitment period.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/33572978
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    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
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