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    Clinical Trial Results:
    A multi-centre (UK) double-blind randomised parallel group placebo controlled trial to evaluate the efficacy, safety, and tolerability of Intravenous Immunoglobulin (IVIg) 0.5g/kg plus standard treatment, versus matched placebo plus standard treatment in patients with longstanding Complex Regional Pain Syndrome.

    Summary
    EudraCT number
    2012-000058-73
    Trial protocol
    GB  
    Global end of trial date
    19 Mar 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    21 Aug 2018
    First version publication date
    21 Aug 2018
    Other versions
    Summary report(s)
    Summary Trial Results

    Trial information

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    Trial identification
    Sponsor protocol code
    LIPS
    Additional study identifiers
    ISRCTN number
    ISRCTN42179756
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    University of Liverpool: UOL000773, REC Reference:: 12/EE/0164
    Sponsors
    Sponsor organisation name
    The Walton Centre NHS Foundation Trust
    Sponsor organisation address
    Lower Lane, Fazakerley, United Kingdom,
    Public contact
    Dr Andreas Goebel, The Walton Centre NHS Foundation Trust, 0151 5295666, rdi@thewaltoncentre.nhs.uk
    Scientific contact
    Dr Andreas Goebel, The Walton Centre NHS Foundation Trust, 0151 5295666, rdi@thewaltoncentre.nhs.uk
    Sponsor organisation name
    The University of Liverpool
    Sponsor organisation address
    Research Support Office, Waterhouse Building, 3 Brownlow Street, Liverpool, Liverpool, United Kingdom, L69 3GL
    Public contact
    Ms Karen Wilding, Research Support Office, 0151 7948385,
    Scientific contact
    Dr Andreas Goebel, The Walton Centre NHS Foundation Trust, 0151 5295666, rdi@thewaltoncentre.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
    22 Sep 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Mar 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Mar 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To gain, within 44 months, both definite proof of the clinical efficacy, and a more confident estimate of the effect size of low-dose IVIg treatment to reduce pain in patients with msCRPS.
    Protection of trial subjects
    Throughout the project measures were put in place to minimise any risk, pain or distress to trial participants.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    15 Aug 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: 111
    Worldwide total number of subjects
    111
    EEA total number of subjects
    111
    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)
    111
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Between 15 Aug 2013 - 8 Oct 2015, 111 were randomised to one of two trial arms. 56 were randomised to Placebo and 55 were randomised to IVIg. 8 participants were excluded from the primary analysis. The primary analysis was performed on 103 patients, with 53 in Placebo and 50 in IVIg.

    Pre-assignment
    Screening details
    Between 15 Aug 2013 - 8 Oct 2015, 121 patients were screened for eligibility into the trial. 10 participants did not meet the inclusion/exclusion criteria as follows; 4 no longer consenting, 1 not contactable, 1 ineligible pain scores, 2 ineligible blood results, 1 ineligible disease duration and 1 ineligible Budapest Criteria.

    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
    Investigator, Monitor, Carer, Assessor, Subject
    Blinding implementation details
    Patients, Providers, Researchers and Outcome Assessors were blinded to treatment assignment (ISRCTN42179756)

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Visually indistinguishable placebo of 0.1% albumin in saline
    Arm type
    Placebo

    Investigational medicinal product name
    visually indistinguishable placebo of 0.1% albumin in saline
    Investigational medicinal product code
    visually indistinguishable placebo of 0.1% albumin
    Other name
    visually indistinguishable placebo of 0.1% albumin in saline
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravascular use
    Dosage and administration details
    visually indistinguishable placebo of 0.1% albumin

    Arm title
    Study Drug
    Arm description
    0.5g/kg of body weight Human normal immunoglobulin for intravenous use (IVIg)
    Arm type
    Experimental

    Investigational medicinal product name
    Human normal immunoglobulin for intravenous use (IVIg)
    Investigational medicinal product code
    PR1
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Two blinded infusions 3 weeks apart (day 1 and day 22 post-randomisation) followed by two optional open label infusions 3 weeks apart (day 43 and day 64 post randomisation maximum dosage allowed - 80g (2.5ml/kg/hour)

    Number of subjects in period 1
    Placebo Study Drug
    Started
    56
    55
    Completed
    56
    55

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    Between 27th August 2013 and 28th October 2015, 111 patients were randomised to one of the two trial arms. 56 were randomised to Placebo and 55 were randomised to IVIg. Two of these patients did not receive their first infusion and supplied no outcome pain data. Three further patients did receive their first infusion but also did not supply any outcome pain data. All 5 of these patients are excluded from the primary analysis. In addition, three patients were randomised in error. Two of these had an average baseline pain score (over the first 7 days) below 5 and one patient had a disease duration of less than 12 months. These 3 patients (all randomised to IVIg) are excluded from the primary analysis. The primary analysis was performed on 103 patients, with 53 in Placebo and 50 in IVIg.

    Reporting group values
    overall trial Total
    Number of subjects
    111 111
    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)
    111 111
        From 65-84 years
    0 0
        85 years and over
    0 0
    Gender categorical
    Units: Subjects
        male
    34 34
        Female
    77 77

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Visually indistinguishable placebo of 0.1% albumin in saline

    Reporting group title
    Study Drug
    Reporting group description
    0.5g/kg of body weight Human normal immunoglobulin for intravenous use (IVIg)

    Primary: The primary outcome is the average 24h pain intensity over 15 days, recorded in pain diaries entries for the previous 24 hours collected on days 28 to 42 (day 1=day of first infusion).

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    End point title
    The primary outcome is the average 24h pain intensity over 15 days, recorded in pain diaries entries for the previous 24 hours collected on days 28 to 42 (day 1=day of first infusion). [1]
    End point description
    The primary outcome is the average 24h pain intensity over 15 days, recorded in pain diaries entries for the previous 24 hours collected on days 28 to 42 (day 1=day of first infusion).
    End point type
    Primary
    End point timeframe
    The primary outcome is the average 24h pain intensity over 15 days, recorded in pain diaries entries for the previous 24 hours collected on days 28 to 42 (day 1=day of first infusion).
    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: The primary outcome is the average 24h pain intensity over 15 days, recorded in pain diaries entries for the previous 24 hours collected on days 28 to 42 (day 1=day of first infusion). Summary Analysis has been uploaded as an additional PDF with the dataset
    End point values
    Placebo Study Drug
    Number of subjects analysed
    53
    50
    Units: Pain Inference/Quality of Life, worst 24
        arithmetic mean (full range (min-max))
    6.9 (0 to 10)
    7.2 (1 to 10)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events were reporting on an ongoing basis throughout the life of the project.
    Adverse event reporting additional description
    A total of 6 Serious Adverse Events were reported across the blinded and open label phases of the trial. 2 patients in the blinded phase (1 in the placebo and 1 in the IVIG group) and 4 in the open IVIg phase. 0 SUSARS were reported.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    Not Applicable
    Dictionary version
    NA
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Visually indistinguishable placebo of 0.1% albumin in saline

    Reporting group title
    Study Drug
    Reporting group description
    0.5g/kg of body weight Human normal immunoglobulin for intravenous use (IVIg)

    Serious adverse events
    Placebo Study Drug
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 56 (1.79%)
    5 / 104 (4.81%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    General disorders and administration site conditions
    Headache
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aseptic Meningitis
         subjects affected / exposed
    0 / 56 (0.00%)
    2 / 104 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Increased heart rate
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DVT
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo Study Drug
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    39 / 56 (69.64%)
    78 / 104 (75.00%)
    Vascular disorders
    Heart Flutter
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    4
    Exhaustion
    Additional description: Exhaustion
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Chest infection
         subjects affected / exposed
    1 / 56 (1.79%)
    3 / 104 (2.88%)
         occurrences all number
    1
    3
    consolidation in the lower left pulmonary lobe
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    Retching after coughing
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    Shortness of breath
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 104 (0.00%)
         occurrences all number
    2
    0
    Immune system disorders
    Flu Symptoms
    Additional description: Flu Symptoms
         subjects affected / exposed
    9 / 56 (16.07%)
    4 / 104 (3.85%)
         occurrences all number
    10
    4
    Cold symptoms
    Additional description: Cold symptoms
         subjects affected / exposed
    5 / 56 (8.93%)
    6 / 104 (5.77%)
         occurrences all number
    5
    6
    Raised temperature
    Additional description: Raised temperature
         subjects affected / exposed
    1 / 56 (1.79%)
    3 / 104 (2.88%)
         occurrences all number
    1
    3
    Sore Throat
    Additional description: Sore Throat
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 104 (0.96%)
         occurrences all number
    1
    1
    Sore sinuses
    Additional description: sore sinuses
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    Cough
    Additional description: Cough
         subjects affected / exposed
    1 / 56 (1.79%)
    2 / 104 (1.92%)
         occurrences all number
    1
    2
    Bleeding blisters on both legs
    Additional description: Bleeding blisters on both legs
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    Infected involution of nail on right halux
    Additional description: Infected involution of nail on right halux
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Eye pain
    Additional description: eye pain
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    watering eyes
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    Intermittent left eye blurred vision
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    ear ache
         subjects affected / exposed
    2 / 56 (3.57%)
    1 / 104 (0.96%)
         occurrences all number
    2
    1
    General disorders and administration site conditions
    Headache
    Additional description: Headache
         subjects affected / exposed
    18 / 56 (32.14%)
    48 / 104 (46.15%)
         occurrences all number
    22
    74
    Dizziness
    Additional description: DIzziness
         subjects affected / exposed
    5 / 56 (8.93%)
    8 / 104 (7.69%)
         occurrences all number
    5
    10
    Myoclonic jerks
    Additional description: Myoclonic jerks
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    3
    FIts (non-epileptic)
    Additional description: FIts (non-epileptic)
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    2
    Shaking/tremors
    Additional description: Shaking/tremors
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    3
    Paresthesia
    Additional description: Paresthesia
         subjects affected / exposed
    3 / 56 (5.36%)
    5 / 104 (4.81%)
         occurrences all number
    4
    5
    Lack of Concentration
    Additional description: Lack of Concentration
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    Word finding difficulties
    Additional description: Word finding difficulties
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    Photosensitivity reaction
    Additional description: Photosensitivity reaction
         subjects affected / exposed
    0 / 56 (0.00%)
    2 / 104 (1.92%)
         occurrences all number
    0
    2
    Burning pain all over
    Additional description: Burning pain all over
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    Feeling in scar returned
    Additional description: Feeling in scar returned
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    excruciating scar pain
    Additional description: excruciating scar pain
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    Left Hand Pain (2x fingers)
    Additional description: Left Hand Pain (2x fingers)
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    Burning left hand (2x fingers)
    Additional description: Burning left hand (2x fingers)
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    Lethargy/Tiredness
    Additional description: Lethargy/Tiredness
         subjects affected / exposed
    5 / 56 (8.93%)
    3 / 104 (2.88%)
         occurrences all number
    6
    4
    Depression
    Additional description: Depression
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    Trembling Spasm (left arm)
    Additional description: Trembling Spasm (left arm)
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    Forgetfulness
    Additional description: Forgetfulness
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    Nightmares
    Additional description: Nightmares
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    Tingling (right hand)
    Additional description: Tingling (right hand)
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    Blocked nose
    Additional description: Blocked nose
         subjects affected / exposed
    2 / 56 (3.57%)
    2 / 104 (1.92%)
         occurrences all number
    2
    3
    Blisters (sole of left foot)
    Additional description: Blisters (sole of left foot)
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    sore/bleeding gums
    Additional description: bleeding gums
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 104 (0.96%)
         occurrences all number
    1
    1
    Nose bleed
         subjects affected / exposed
    2 / 56 (3.57%)
    2 / 104 (1.92%)
         occurrences all number
    4
    2
    Tonsillitis
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    aversion to light
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    Taste of blood in mouth
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    sensitive to noise
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    Increased/exacerbation pain
         subjects affected / exposed
    2 / 56 (3.57%)
    12 / 104 (11.54%)
         occurrences all number
    2
    12
    Increased sensitivity
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 104 (0.96%)
         occurrences all number
    1
    1
    swollen arms
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    aching arms
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    intermittent pain
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    left knee pain
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    left foot pain
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    left thigh pain
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    exacerbation of allodynia
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    Pain on soles of feet
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    intermittent burning/sweating and cold sensations
    Additional description: intermittent burning/sweating and cold sensations
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    worsening intermittent burning/sweating and cold sensations
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    right foot pain
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    right leg pain
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    increased limb swelling
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    spreading of CRPS to other limb
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    skin rash (ISR)
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    2
    Pain in left hand
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    Hot flush
         subjects affected / exposed
    0 / 56 (0.00%)
    2 / 104 (1.92%)
         occurrences all number
    0
    2
    right facial swelling with trigeminal neuralgia
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    Vitamin D deficiency
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    Chills/sweating
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    weightloss (unintentional)
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 104 (0.96%)
         occurrences all number
    1
    1
    Infected cyst
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    Road traffic accident
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    taste of metal
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    Post menopausal bleeding
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    muscle pain
         subjects affected / exposed
    0 / 56 (0.00%)
    3 / 104 (2.88%)
         occurrences all number
    0
    6
    stiffness
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    2
    chest pain
         subjects affected / exposed
    0 / 56 (0.00%)
    2 / 104 (1.92%)
         occurrences all number
    0
    3
    back pain
         subjects affected / exposed
    0 / 56 (0.00%)
    2 / 104 (1.92%)
         occurrences all number
    0
    2
    shaking
         subjects affected / exposed
    0 / 56 (0.00%)
    2 / 104 (1.92%)
         occurrences all number
    0
    2
    burning pain
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    cramping
         subjects affected / exposed
    2 / 56 (3.57%)
    1 / 104 (0.96%)
         occurrences all number
    2
    2
    pain (localised)
         subjects affected / exposed
    1 / 56 (1.79%)
    6 / 104 (5.77%)
         occurrences all number
    1
    20
    stiffness (localised)
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 104 (0.96%)
         occurrences all number
    1
    1
    fatigability
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    2
    trapped nerve in right (unaffected) foot
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    bilateral knee swelling
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    left hand weakness
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    worsening pain of the anterior aspect of left foot
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    cold, white, numb middle finger left hand
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    left leg pain flared up
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    left side jaw pain
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    cold left foot
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    Falls
         subjects affected / exposed
    2 / 56 (3.57%)
    1 / 104 (0.96%)
         occurrences all number
    2
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    15 / 56 (26.79%)
    28 / 104 (26.92%)
         occurrences all number
    18
    35
    Diarrhoea
         subjects affected / exposed
    3 / 56 (5.36%)
    7 / 104 (6.73%)
         occurrences all number
    4
    9
    sickness/vomiting
         subjects affected / exposed
    6 / 56 (10.71%)
    15 / 104 (14.42%)
         occurrences all number
    7
    17
    Irritable bowel syndrome
         subjects affected / exposed
    2 / 56 (3.57%)
    1 / 104 (0.96%)
         occurrences all number
    2
    1
    worsening gastric reflux
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    Intermittent stomach pain
         subjects affected / exposed
    0 / 56 (0.00%)
    2 / 104 (1.92%)
         occurrences all number
    0
    2
    Constipation
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    weightloss
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    Pain in chest due to vomiting
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    Gallstones
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    Loss of appetite
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    abdominal pain
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    Sugar sensitivity
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Urinary tract infection
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    Kidney pain
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 104 (0.96%)
         occurrences all number
    1
    1
    Skin and subcutaneous tissue disorders
    Localised rash
    Additional description: Localised rash
         subjects affected / exposed
    4 / 56 (7.14%)
    13 / 104 (12.50%)
         occurrences all number
    5
    16
    Itchy Skin
    Additional description: Itchy Skin
         subjects affected / exposed
    2 / 56 (3.57%)
    3 / 104 (2.88%)
         occurrences all number
    3
    4
    Bilateral swollen feet/legs
    Additional description: Bilateral swollen feet/legs
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    3
    Hair loss/thinning
    Additional description: Hair loss/thinning
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    Dry skin patch
    Additional description: Dry skin patch
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 104 (0.96%)
         occurrences all number
    1
    1
    skin tender left inner thumb area
    Additional description: skin tender left inner thumb area
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    Burning sensation
    Additional description: Burning sensation
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 104 (0.96%)
         occurrences all number
    1
    1
    Skin infection
    Additional description: skin infection (cellulitis)
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    Foot ulcer
    Additional description: foot ulcer
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    Naval Discharge
    Additional description: Naval Discharge
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    lumps on toes
    Additional description: lumps on toes
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    abrasion left big toe
    Additional description: abrasion left big toe
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    hot bilateral knees
    Additional description: hot bilateral knees
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    Small weeping area at end of stump
    Additional description: Small weeping area at end of stump
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    aches
         subjects affected / exposed
    2 / 56 (3.57%)
    1 / 104 (0.96%)
         occurrences all number
    3
    1
    locking (localised)
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences all number
    3
    0
    ulcer (right leg)
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    Tremors
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    ligament damage (left ankle)
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    swollen left hand
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    wrist strain
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    muscle twitching
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    left leg trembling (spasm)
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    weak ankle (left)
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    jerking leg
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    feeling cold
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Dec 2012
    SA 1 (Protocol 2.0 19.10.12) Primary Outcome Measure - extended period for 24 hour diary from 15 to 37 days Secondary Outcome Measure -EQ-SD used as a measure of quality of life Exclusion Criteria - IgA levels redefined Screening Recruitment and consent - text added for clarification selection and timing of dose for each participant - text added to clarify inclusion packaging and labelling of IMP - study name and Eudract now included on label Concomitant Medications - additional information provided Biochemistry - Additional tests included Implementation Procedures - clarification of the implementation procedures Efficacy safety - treatment stopping rules agreed and included Sample size calculation Withdrawal of patients - clarification of discontinuation of participants in the study Monitoring Quality Control and Assurance Safety - changes made to representatives in the TSC and DMC Addition of PI video
    11 Apr 2013
    SA2 - Protocol V3.0 dated 11/04/2013 REC - updated REC address Secondary and exploratory outcome measures - removal of time trade off scale Inclusion criteria - rewording of inclusion criteria 4 Study medication - clarification of drug/placebo availability pregnancy - addition of urine pregnancy test PI video - addition of slides
    01 Jul 2013
    SA3 - Protocol V4.0 dated 14/06/2013 Secondary outcome measures - CRPS Questionnaire and Neglect-like symptoms added Statistical Considerations - allergy status and low baseline IgG plasma level added
    04 Oct 2013
    SA4 - PIS V3.0 dated 02/09/2013 Protocol - additional site (Leicester) PIS - amendment to common, occasional and rare side effect of IVIG
    28 Mar 2014
    SA5 - Interim Report for RLBUHT dated 20/02/2014 Selection and timing of dose for each participant

    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
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