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    Clinical Trial Results:
    Inhibition of complement activation (eculizumab®) in Guillain-Barré Syndrome study

    Summary
    EudraCT number
    		 2013-000228-33
    Trial protocol
    		 GB  
    Global end of trial date
    30 Jul 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Feb 2020
    First version publication date
    27 Feb 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GN12NE462
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02029378
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Glasgow
    Sponsor organisation address
    126 University Place, Glasgow, United Kingdom, G12 8TA
    Public contact
    Prof. Hugh J. Willison, University of Glasgow, 0044 141 330 8384, Hugh.Willison@glasgow.ac.uk
    Scientific contact
    Prof. Hugh J. Willison, University of Glasgow, 0044 141 330 8384, Hugh.Willison@glasgow.ac.uk
    Sponsor organisation name
    NHS Greater Glasgow and Clyde
    Sponsor organisation address
    Grahamston Road, Paisley, United Kingdom, PA2 7DE
    Public contact
    Maureen Travers, NHS Greater Glasgow and Clyde, Maureen.Travers@ggc.scot.nhs.uk
    Scientific contact
    Maureen Travers, NHS Greater Glasgow and Clyde, Maureen.Travers@ggc.scot.nhs.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
    30 Jul 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jul 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jul 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate safety and tolerability, of eculizumab in patients with GBS.
    Protection of trial subjects
    All the patients with GBS receive standard treatment either IVIg or Plasma exchange. Only those patients who would be eligible for IVIg treatment will be screened for the study. Patient’s participation will not delay the commencement of standard IVIg treatment. All the patients will be recruited within 14 days of onset of weakness, provided that the study drug can be started within this 14 day time period.
    Background therapy
    		 All participants received ciprofloxacin as a prophylactic antibiotic for 10 weeks.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2013
    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: 8
    Worldwide total number of subjects
    8
    EEA total number of subjects
    8
    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)
    6
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants recruited between Aug 2014 to Jul 2016.

    Pre-assignment
    Screening details
    		 All patients diagnosed with GBS and unable to walk within 2 weeks were screened.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Eculizumab
    Arm description
    		 Following consent, participants will be randomly assigned in a ratio of 2:1 to receive either Eculizumab or matching placebo by contacting the interactive webresponse system (IWRS). Drug treatment will be commenced as soon as is practical, after consent is obtained.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eculizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    administered intravenously at a dose of 900mg weekly for 4 weeks (day 0, week 1, week 2 and week 3)

    Arm title
    		 Placebo
    Arm description
    		 Following consent, participants will be randomly assigned in a ratio of 2:1 to receive either Eculizumab or matching placebo by contacting the interactive webresponse system (IWRS). Drug treatment will be commenced as soon as is practical, after consent is obtained
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    administered intravenously at a dose of 900mg weekly for 4 weeks (day 0, week 1, week 2 and week 3)

    Number of subjects in period 1
    		Eculizumab Placebo
    Started
    5
    3
    Completed
    5
    2
    Not completed
    0
    1
         Physician decision
    -
    1

    Baseline characteristics

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

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 8 8
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 6 6
        From 65-84 years
    		 2 2
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 4 4

    End points

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    End points reporting groups
    Reporting group title
    Eculizumab
    Reporting group description
    		 Following consent, participants will be randomly assigned in a ratio of 2:1 to receive either Eculizumab or matching placebo by contacting the interactive webresponse system (IWRS). Drug treatment will be commenced as soon as is practical, after consent is obtained.

    Reporting group title
    Placebo
    Reporting group description
    		 Following consent, participants will be randomly assigned in a ratio of 2:1 to receive either Eculizumab or matching placebo by contacting the interactive webresponse system (IWRS). Drug treatment will be commenced as soon as is practical, after consent is obtained

    Primary: Functional outcome on the GBS disability scale at set time intervals

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    End point title
    		 Functional outcome on the GBS disability scale at set time intervals [1]
    End point description
    End point type
    Primary
    End point timeframe
    Assessed from week 0 to week 4
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Because of the relevantly small number of participants and the primary end endpoint being an improvement in a scale, there was no statistical analysis formed and the improvement in the GBS scale for each participant simply reported.
    End point values
    		 Eculizumab Placebo
    Number of subjects analysed
    5
    2
    Units: GB Improvement over 4 weeks
    2
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From time of consent to 30 days following the last study visit.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    Eculizaumab
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Eculizaumab Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 5 (40.00%)
    0 / 2 (0.00%)
         number of deaths (all causes)
    1
    1
         number of deaths resulting from adverse events
    1
    0
    Injury, poisoning and procedural complications
    Toxicity to various agents
    Additional description: Toxicity to Opioid
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Aspiration
    Additional description: Aspiration Pneumonia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Eculizaumab Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 5 (100.00%)
    2 / 2 (100.00%)
    Investigations
    liver function test abnormal
         subjects affected / exposed
    2 / 5 (40.00%)
    1 / 2 (50.00%)
         occurrences all number
    2
    1
    Transaminases increased
         subjects affected / exposed
    3 / 5 (60.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0
    Cardiac disorders
    Ventricular extrasystoles
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Facial paresis
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Pneumothorax
    Additional description: HydroPneumothorax
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    2 / 5 (40.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    Psychiatric disorders
    Depressed mood
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Limb discomfort
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Lower respiratory tract infection
         subjects affected / exposed
    3 / 5 (60.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Jan 2016
    Protocol change and updated patient alert card

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/27801990
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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
    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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