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    Clinical Trial Results:
    Worms for immune regulation of multiple sclerosis

    Summary
    EudraCT number
    		 2008-005008-24
    Trial protocol
    		 GB  
    Global end of trial date
    18 Jan 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Feb 2018
    First version publication date
    17 Feb 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    08126
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01470521
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Nottingham
    Sponsor organisation address
    Derby Rd, Nottingham, United Kingdom, NG7 2UH
    Public contact
    Clinical Neurology, University of Nottingham, 0115 8231443, cris.constantinescu@nottingham.ac.uk
    Scientific contact
    Clinical Neurology, University of Nottingham, 0115 8231443, cris.constantinescu@nottingham.ac.uk
    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
    21 Jul 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Jan 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Jan 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Whether controlled parasitic infection with N. americanus (25 larvae per patient) reduces the cumulative number of gadolinium enhancing (Gd+) lesions, new T2 lesions, and enlarging T2 lesions in MS at month 9 in comparison to baseline and placebo.
    Protection of trial subjects
    Minimal pain and distress (blood samples and MRI) in this trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Sep 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 71
    Worldwide total number of subjects
    71
    EEA total number of subjects
    71
    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)
    71
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment from NUH clinical database

    Pre-assignment
    Screening details
    		 73 screened. 2 screening failures. Inclusion: RR or SP MS, untreated. Exclusion: pregnant or planned pregnancy, younger than 18 or older than 65, comorbidities, anaemia, prior evidence of parasitic infection.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treated
    Arm description
    		 Patients treated with Necator americanus
    Arm type
    		 Experimental

    Investigational medicinal product name
    Necator americanus larvae
    Investigational medicinal product code
    3057
    Other name
    Pharmaceutical forms
    Concentrate for cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    25 larvae, single dose, in water solution, applied by patch applied to skin.

    Arm title
    		 Placebo
    Arm description
    		 Patients receiving no treatment
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo patch
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous patch
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Administered to arm

    Number of subjects in period 1
    		Treated Placebo
    Started
    35
    36
    Completed
    35
    36

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treated
    Reporting group description
    		 Patients treated with Necator americanus

    Reporting group title
    Placebo
    Reporting group description
    		 Patients receiving no treatment

    Reporting group values
    		 Treated Placebo Total
    Number of subjects
    		 35 36 71
    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)
    		 35 36 71
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
        Adults (18-65 years)
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 25 26 51
        Male
    		 10 10 20
    disease type
    RRMS or SPMS
    Units: Subjects
        RRMS
    		 31 27 58
        SPMS
    		 4 9 13

    End points

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    End points reporting groups
    Reporting group title
    Treated
    Reporting group description
    		 Patients treated with Necator americanus

    Reporting group title
    Placebo
    Reporting group description
    		 Patients receiving no treatment

    Primary: MRI disease activity

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    End point title
    		 MRI disease activity
    End point description
    Total number of new, enlarging, and enhancing lesions
    End point type
    Primary
    End point timeframe
    Visit 1 to Visit 13
    End point values
    		 Treated Placebo
    Number of subjects analysed
    31 [1]
    33 [2]
    Units: Lesions
    31
    33
    Attachments
    		 Untitled (Filename: Lesion dot plot.png)
    Notes
    [1] - Those with 2, or less, missing MRI
    [2] - Those with 2, or less, missing MRI
    Statistical analysis title
    		 Primary
    Statistical analysis description
    Comparison of lesion counts: treated v placebo
    Comparison groups
    Treated v Placebo
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 < 0.27 [4]
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2
         upper limit
    		 0
    Notes
    [3] - Hypothesis: there are there fewer new lesions in the treated than placebo group.
    [4] - Two tailed. Unfortunately there were many ties (zero detectable MRI activity) particularly in the treated group. Ultimately this has impaired the power of the planned analysis.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Visit 1 to visit 13.
    Adverse event reporting additional description
    Self reporting
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    2016
    Reporting groups
    Reporting group title
    Treated
    Reporting group description
    		 Patients treated with Necator americanus

    Reporting group title
    Placebo
    Reporting group description
    		 Patients receiving no treatment

    Serious adverse events
    		 Treated Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 35 (5.71%)
    4 / 36 (11.11%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Surgical and medical procedures
    Hysterectomy
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroidectomy
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Brain hypoxia
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Multiple sclerosis relapse
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Allergy to synthetic fabric
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Diabetes mellitus
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 36 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Treated Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    35 / 35 (100.00%)
    33 / 36 (91.67%)
    Cardiac disorders
    Chest pain
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 36 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 35 (2.86%)
    6 / 36 (16.67%)
         occurrences all number
    1
    6
    Dizziness
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    General disorders and administration site conditions
    reaction at plaster site
         subjects affected / exposed
    29 / 35 (82.86%)
    10 / 36 (27.78%)
         occurrences all number
    29
    10
    hay fever
         subjects affected / exposed
    1 / 35 (2.86%)
    3 / 36 (8.33%)
         occurrences all number
    1
    3
    Immune system disorders
    Multiple sclerosis relapse
         subjects affected / exposed
    4 / 35 (11.43%)
    9 / 36 (25.00%)
         occurrences all number
    4
    9
    Ear and labyrinth disorders
    Ear infection
         subjects affected / exposed
    0 / 35 (0.00%)
    3 / 36 (8.33%)
         occurrences all number
    0
    3
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    9 / 35 (25.71%)
    9 / 36 (25.00%)
         occurrences all number
    9
    9
    Abdominal discomfort
         subjects affected / exposed
    8 / 35 (22.86%)
    6 / 36 (16.67%)
         occurrences all number
    8
    6
    Gastroenteritis
         subjects affected / exposed
    4 / 35 (11.43%)
    5 / 36 (13.89%)
         occurrences all number
    4
    5
    Constipation
         subjects affected / exposed
    1 / 35 (2.86%)
    3 / 36 (8.33%)
         occurrences all number
    1
    3
    Nausea
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 36 (0.00%)
         occurrences all number
    3
    0
    Respiratory, thoracic and mediastinal disorders
    Upper respiratory tract infection
         subjects affected / exposed
    16 / 35 (45.71%)
    18 / 36 (50.00%)
         occurrences all number
    16
    18
    Lower respiratory tract infection
         subjects affected / exposed
    3 / 35 (8.57%)
    3 / 36 (8.33%)
         occurrences all number
    3
    3
    Cough
         subjects affected / exposed
    2 / 35 (5.71%)
    2 / 36 (5.56%)
         occurrences all number
    2
    2
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    3 / 35 (8.57%)
    3 / 36 (8.33%)
         occurrences all number
    3
    3
    Pain of skin
         subjects affected / exposed
    1 / 35 (2.86%)
    2 / 36 (5.56%)
         occurrences all number
    1
    2
    Renal and urinary disorders
    Urinary tract infection
         subjects affected / exposed
    7 / 35 (20.00%)
    6 / 36 (16.67%)
         occurrences all number
    7
    6
    Psychiatric disorders
    Depression
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 36 (2.78%)
         occurrences all number
    2
    1
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    2 / 35 (5.71%)
    7 / 36 (19.44%)
         occurrences all number
    2
    7
    Back pain
         subjects affected / exposed
    3 / 35 (8.57%)
    2 / 36 (5.56%)
         occurrences all number
    3
    2
    Nasopharyngitis
         subjects affected / exposed
    3 / 35 (8.57%)
    2 / 36 (5.56%)
         occurrences all number
    3
    2
    Infections and infestations
    Tooth abscess
         subjects affected / exposed
    3 / 35 (8.57%)
    3 / 36 (8.33%)
         occurrences all number
    3
    3

    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.
    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.

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