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    Clinical Trial Results:
    An Open-label, Efficacy and Safety Study of Canakinumab (Anti-interleukin-1β Monoclonal Antibody) Administered for 6 Months (24 Weeks) in Japanese Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease, Followed by an Extension Phase to Provide Canakinumab to Study Patients Until it is Approved and Marketed in Japan

    Summary
    EudraCT number
    		 2015-003490-15
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    29 Feb 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Nov 2016
    First version publication date
    12 Nov 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CACZ885D2308
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00991146
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, +41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, +41 613241111,
    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 Feb 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Feb 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Feb 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the proportion of patients who were free of relapse at week 24 including those patients who have been up-titrated.
    Protection of trial subjects
    A rescue medication or adjustment medication scheme was applied to those patients who either did not achieve a complete response or relapsed prior to their next scheduled dose. Patients who did not achieve (or maintain) complete response following canakinumab injection in any treatment period, could have received a dose adjustment. Possible step-wise up-titration regimens: • 300 mg s.c. (or 4 mg/kg for patients with a body weight ≤40 kg) • 450 mg s.c. (or 6 mg/kg for patients with a body weight ≤40 kg) • 600 mg s.c. (or 8 mg/kg for patients with a body weight ≤40 kg)
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Oct 2009
    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
    Japan: 19
    Worldwide total number of subjects
    19
    EEA total number of subjects
    0
    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)
    8
    Adolescents (12-17 years)
    7
    Adults (18-64 years)
    4
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Patient’s informed consent for patients ≥20 years of age, or for patients <20 years of age, parent or legal guardian’s written informed consent and child’s assent was required before any assessment was performed.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 ACZ885
    Arm description
    		 CAPS patients with a body weight >40 kg received 150 mg of canakinumab administered s.c. per each injection, every 8 weeks. CAPS patients with a body weight ≤40 kg received an equivalent of 2 mg/kg administered s.c. per each injection, every 8 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ACZ885
    Investigational medicinal product code
    Other name
    canakinumab
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Investigational drug (active canakinumab) was provided in individual 6 mL glass vials each containing 150 mg canakinumab as a lyophilized cake. For patients with a body weight of ≥15 kg, canakinumab is reconstituted with 1.0 mL water for injection (WFI) to reach a concentration of 150mg/mL. For patients with a body weight < 15 kg, the 150 mg canakinumab lyophilized cake should be reconstituted with 2.2 mL WFI to get a canakinumab concentration of 75 mg/mL. CAPS patients with a body weight >40 kg received 150 mg of canakinumab administered s.c. per each injection, every 8 weeks. CAPS patients with a body weight ≤40 kg received an equivalent of 2 mg/kg administered s.c. per each injection, every 8 weeks.

    Number of subjects in period 1
    		ACZ885
    Started
    19
    Completed
    18
    Not completed
    1
         Consent withdrawn by subject
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ACZ885
    Reporting group description
    		 CAPS patients with a body weight >40 kg received 150 mg of canakinumab administered s.c. per each injection, every 8 weeks. CAPS patients with a body weight ≤40 kg received an equivalent of 2 mg/kg administered s.c. per each injection, every 8 weeks.

    Reporting group values
    		 ACZ885 Total
    Number of subjects
    		 19 19
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 8 8
        Adolescents (12-17 years)
    		 7 7
        Adults (18-64 years)
    		 4 4
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 14.8 ( 11.35 ) -
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 12 12

    End points

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    End points reporting groups
    Reporting group title
    ACZ885
    Reporting group description
    		 CAPS patients with a body weight >40 kg received 150 mg of canakinumab administered s.c. per each injection, every 8 weeks. CAPS patients with a body weight ≤40 kg received an equivalent of 2 mg/kg administered s.c. per each injection, every 8 weeks.

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Consisted of all 19 CAPS patients who were enrolled and received at least one dose of canakinumab during the study.

    Subject analysis set title
    Safety set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Consisted of all 19 CAPS patients who were enrolled and received at least one dose of canakinumab during the study.

    Subject analysis set title
    Absent
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Assessment of auto-inflammatory disease activity: Severity = Absent

    Subject analysis set title
    Minimal
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Assessment of auto-inflammatory disease activity: Severity = Minimal

    Subject analysis set title
    Mild
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Assessment of auto-inflammatory disease activity: Severity = Mild

    Subject analysis set title
    Moderate
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Assessment of auto-inflammatory disease activity: Severity = Moderate

    Subject analysis set title
    Severe
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Assessment of auto-inflammatory disease activity: Severity = Severe

    Primary: Percentage of patients who do not experience a relapse (clinical and serological relapse) at Week 24

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    End point title
    		 Percentage of patients who do not experience a relapse (clinical and serological relapse) at Week 24 [1]
    End point description
    For complete responders, relapse was defined as the following criteria: A relapse consisted of clinical and serological relapse defined as follows: • Clinical relapse: Physician’s global assessment of auto-inflammatory disease >minimal or Physician’s global assessment of auto-inflammatory disease ≥minimal and assessment of skin disease >minimal and • Serological relapse: Serum CRP >3 mg/dL and/or 2. SAA >30 µg/mL
    End point type
    Primary
    End point timeframe
    Week 24
    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: Statistical analyses have not been performed for this primary end point.
    End point values
    		 Full Analysis Set (FAS)
    Number of subjects analysed
    Units: percent
    number (not applicable)
        Clinical relapse
    66.7
        Serological relapse
    66.7
        Complete response
    94.7
    No statistical analyses for this end point

    Secondary: Number of complete responder patients

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    End point title
    		 Number of complete responder patients
    End point description
    Complete response will consist of clinical and serological remission.
    End point type
    Secondary
    End point timeframe
    Day 15 and Day 29
    End point values
    		 Full Analysis Set (FAS)
    Number of subjects analysed
    19
    Units: participants
    number (not applicable)
        Day 15
    9
        Day 29
    1
    No statistical analyses for this end point

    Secondary: Overall assessment of physician’s global assessment of auto-inflammatory disease activity

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    End point title
    		 Overall assessment of physician’s global assessment of auto-inflammatory disease activity
    End point description
    The physician’s global assessment of autoinflammatory disease activity including component scores for skin disease (urticarial skin rash), arthralgia, myalgia, headache/migraine, conjunctivitis, fatigue/malaise, other symptoms related to autoinflammatory syndrome, and symptoms not related to autoinflammatory syndrome from start of study to the end of the study.
    End point type
    Secondary
    End point timeframe
    Baseline through end of study (24 months)
    End point values
    		 Absent Minimal Mild Moderate Severe
    Number of subjects analysed
    19
    19
    19
    19
    19
    Units: percent
    number (not applicable)
        Baseline (N=19)
    10.5
    31.6
    36.8
    15.8
    5.3
        Week 24 (N=18)
    33.3
    38.9
    27.8
    0
    0
        End of core phase (N=19)
    31.6
    36.8
    31.6
    0
    0
        Week 48 (N=18)
    50
    33.3
    11.1
    5.6
    0
        End of first extension (N=19)
    47.4
    31.6
    15.8
    5.3
    0
        End of study (N=19)
    57.9
    36.8
    5.3
    0
    0
    No statistical analyses for this end point

    Secondary: Overall assessment of skin disease

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    End point title
    		 Overall assessment of skin disease
    End point description
    The physician’s global assessment of autoinflammatory disease activity including component scores for skin disease (urticarial skin rash), arthralgia, myalgia, headache/migraine, conjunctivitis, fatigue/malaise, other symptoms related to autoinflammatory syndrome, and symptoms not related to autoinflammatory syndrome from start of study to the end of the study.
    End point type
    Secondary
    End point timeframe
    Baseline through end of study (24 months)
    End point values
    		 Absent Minimal Mild Moderate Severe
    Number of subjects analysed
    19
    19
    19
    19
    19
    Units: percent
    number (not applicable)
        Baseline (N=19)
    31.6
    26.3
    15.8
    15.8
    10.5
        Week 24 (N=18)
    61.1
    27.8
    11.1
    0
    0
        End of core phase (N=19)
    57.9
    26.3
    15.8
    0
    0
        Week 48 (N=18)
    94.4
    5.6
    0
    0
    0
        End of first extension (N=19)
    89.5
    5.3
    5.3
    0
    0
        End of study (N=19)
    84.2
    10.5
    5.3
    0
    0
    No statistical analyses for this end point

    Secondary: Overall assessment of arthralgia

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    End point title
    		 Overall assessment of arthralgia
    End point description
    The physician’s global assessment of autoinflammatory disease activity including component scores for skin disease (urticarial skin rash), arthralgia, myalgia, headache/migraine, conjunctivitis, fatigue/malaise, other symptoms related to autoinflammatory syndrome, and symptoms not related to autoinflammatory syndrome from start of study to the end of the study.
    End point type
    Secondary
    End point timeframe
    Baseline through end of study (24 months)
    End point values
    		 Absent Minimal Mild Moderate Severe
    Number of subjects analysed
    19
    19
    19
    19
    19
    Units: percent
    number (not applicable)
        Baseline (N=19)
    84.2
    10.5
    5.3
    0
    0
        Week 24 (N=18)
    83.3
    11.1
    5.6
    0
    0
        End of core phase (N=19)
    84.2
    10.5
    5.3
    0
    0
        Week 48 (N=18)
    88.9
    11.1
    0
    0
    0
        End of first extension (N=19)
    89.5
    10.5
    0
    0
    0
        End of study (N=19)
    100
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Overall assessment of myalgia

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    End point title
    		 Overall assessment of myalgia
    End point description
    The physician’s global assessment of autoinflammatory disease activity including component scores for skin disease (urticarial skin rash), arthralgia, myalgia, headache/migraine, conjunctivitis, fatigue/malaise, other symptoms related to autoinflammatory syndrome, and symptoms not related to autoinflammatory syndrome from start of study to the end of the study.
    End point type
    Secondary
    End point timeframe
    Baseline through end of study (24 months)
    End point values
    		 Absent Minimal Mild Moderate Severe
    Number of subjects analysed
    19
    19
    19
    19
    19
    Units: percent
    number (not applicable)
        Baseline (N=19)
    100
    0
    0
    0
    0
        Week 24 (N=18)
    94.4
    5.6
    0
    0
    0
        End of core phase (N=19)
    94.7
    5.3
    0
    0
    0
        Week 48 (N=18)
    94.4
    5.6
    0
    0
    0
        End of first extension (N=19)
    94.7
    5.3
    0
    0
    0
        End of study (N=19)
    100
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Overall assessment of headache/migraine

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    End point title
    		 Overall assessment of headache/migraine
    End point description
    The physician’s global assessment of autoinflammatory disease activity including component scores for skin disease (urticarial skin rash), arthralgia, myalgia, headache/migraine, conjunctivitis, fatigue/malaise, other symptoms related to autoinflammatory syndrome, and symptoms not related to autoinflammatory syndrome from start of study to the end of the study.
    End point type
    Secondary
    End point timeframe
    Baseline through end of study (24 months)
    End point values
    		 Absent Minimal Mild Moderate Severe
    Number of subjects analysed
    19
    19
    19
    19
    19 [2]
    Units: percent
    number (not applicable)
        Baseline (N=19)
    42.1
    42.1
    5.3
    10.5
    0
        Week 24 (N=18)
    55.6
    27.8
    11.1
    5.6
    0
        End of core phase (N=19)
    52.6
    26.3
    15.8
    5.3
    0
        Week 48 (N=18)
    61.1
    22.2
    11.1
    5.6
    0
        End of first extension (N=19)
    57.9
    21.1
    15.8
    5.3
    0
        End of study (N=19)
    73.7
    21.1
    5.3
    0
    0
    Notes
    [2] - 1 patient had severe symptoms at V7 (Day 57)
    No statistical analyses for this end point

    Secondary: Overall assessment of conjunctivitis

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    End point title
    		 Overall assessment of conjunctivitis
    End point description
    The physician’s global assessment of autoinflammatory disease activity including component scores for skin disease (urticarial skin rash), arthralgia, myalgia, headache/migraine, conjunctivitis, fatigue/malaise, other symptoms related to autoinflammatory syndrome, and symptoms not related to autoinflammatory syndrome from start of study to the end of the study.
    End point type
    Secondary
    End point timeframe
    Baseline through end of study (24 months)
    End point values
    		 Absent Minimal Mild Moderate Severe
    Number of subjects analysed
    19
    19
    19
    19
    19
    Units: percent
    number (not applicable)
        Baseline (N=19)
    68.4
    10.5
    10.5
    10.5
    0
        Week 24 (N=18)
    83.3
    16.7
    0
    0
    0
        End of core phase (N=19)
    78.9
    21.1
    0
    0
    0
        Week 48 (N=18)
    100
    0
    0
    0
    0
        End of first extension (N=19)
    94.7
    5.3
    0
    0
    0
        End of study (N=19)
    94.7
    5.3
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Overall assessment of fatigue/malaise

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    End point title
    		 Overall assessment of fatigue/malaise
    End point description
    The physician’s global assessment of autoinflammatory disease activity including component scores for skin disease (urticarial skin rash), arthralgia, myalgia, headache/migraine, conjunctivitis, fatigue/malaise, other symptoms related to autoinflammatory syndrome, and symptoms not related to autoinflammatory syndrome from start of study to the end of the study.
    End point type
    Secondary
    End point timeframe
    Baseline through end of study (24 months)
    End point values
    		 Absent Minimal Mild Moderate Severe
    Number of subjects analysed
    19
    19
    19
    19
    19
    Units: percent
    number (not applicable)
        Baseline (N=19)
    52.6
    31.6
    15.8
    0
    0
        Week 24 (N=18)
    88.9
    5.6
    0
    5.6
    0
        End of core phase (N=19)
    89.5
    5.3
    0
    5.3
    0
        Week 48 (N=18)
    94.4
    0
    5.6
    0
    0
        End of first extension (N=19)
    94.7
    0
    5.3
    0
    0
        End of study (N=19)
    100
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Overall assessment of other symptoms related to auto-inflammatory syndrome

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    End point title
    		 Overall assessment of other symptoms related to auto-inflammatory syndrome
    End point description
    The physician’s global assessment of autoinflammatory disease activity including component scores for skin disease (urticarial skin rash), arthralgia, myalgia, headache/migraine, conjunctivitis, fatigue/malaise, other symptoms related to autoinflammatory syndrome, and symptoms not related to autoinflammatory syndrome from start of study to the end of the study.
    End point type
    Secondary
    End point timeframe
    Baseline through end of study (24 months)
    End point values
    		 Absent Minimal Mild Moderate Severe
    Number of subjects analysed
    19
    19
    19
    19 [3]
    19 [4]
    Units: percent
    number (not applicable)
        Baseline (N=19)
    94.7
    5.3
    0
    0
    0
        Week 24 (N=18)
    100
    0
    0
    0
    0
        End of core phase (N=19)
    100
    0
    0
    0
    0
        Week 48 (N=18)
    94.4
    0
    5.6
    0
    0
        End of first extension (N=19)
    94.7
    0
    5.3
    0
    0
        End of study (N=19)
    94.7
    5.3
    0
    0
    0
    Notes
    [3] - 5 patients had moderate symptoms at following visits: 1 at V4 (Day 8), 2 at V5 (Day 15), 1 at V22
    [4] - 5 patients had moderate symptoms at following visits: 1 at V4 (Day 8), 2 at V5 (Day 15), 1 at V22
    No statistical analyses for this end point

    Secondary: Overall assessment of other symptoms not related to auto-inflammatory syndrome

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    End point title
    		 Overall assessment of other symptoms not related to auto-inflammatory syndrome
    End point description
    The physician’s global assessment of autoinflammatory disease activity including component scores for skin disease (urticarial skin rash), arthralgia, myalgia, headache/migraine, conjunctivitis, fatigue/malaise, other symptoms related to autoinflammatory syndrome, and symptoms not related to autoinflammatory syndrome from start of study to the end of the study.
    End point type
    Secondary
    End point timeframe
    Baseline through end of study (24 months)
    End point values
    		 Absent Minimal Mild Moderate Severe
    Number of subjects analysed
    19
    19
    19
    19 [5]
    19 [6]
    Units: percent
    number (not applicable)
        Baseline (N=19)
    100
    0
    0
    0
    0
        Week 24 (N=18)
    94.4
    0
    5.6
    0
    0
        End of core phase (N=19)
    94.7
    0
    5.3
    0
    0
        Week 48 (N=18)
    83.3
    11.1
    5.6
    0
    0
        End of first extension (N=19)
    84.2
    10.5
    5.3
    0
    0
        End of study (N=19)
    89.5
    10.5
    0
    0
    0
    Notes
    [5] - 1 patient had moderate symptoms at V8 (Day 85)
    [6] - 1 patient had severe symptoms at V4 (Day 8)
    No statistical analyses for this end point

    Secondary: Percentage of participants experiencing a relapse at week 24

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    End point title
    		 Percentage of participants experiencing a relapse at week 24
    End point description
    For complete responders, relapse was defined as the following criteria: A relapse consisted of clinical and serological relapse defined as follows: • Clinical relapse: Physician’s global assessment of auto-inflammatory disease >minimal or Physician’s global assessment of auto-inflammatory disease ≥minimal and assessment of skin disease >minimal and • Serological relapse: Serum CRP >3 mg/dL and/or 2. SAA >30 μg/mL
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Full Analysis Set (FAS)
    Number of subjects analysed
    19
    Units: percent
    number (not applicable)
        Relapse at week 24
    22.2
        Clinical relapse at week 24
    33.3
        Serological relapse at week 24
    33.3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Enter new text: Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    ACZ885
    Reporting group description
    		 ACZ885

    Serious adverse events
    		 ACZ885
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 19 (26.32%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Cardiac disorders
    Sinoatrial block
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Epstein-Barr virus infection
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Meningitis mumps
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Parvovirus infection
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ACZ885
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 19 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign breast neoplasm
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Vascular disorders
    Diffuse vasculitis
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Flushing
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Hypertension
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    General disorders and administration site conditions
    Device dislocation
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Gait disturbance
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Injection site reaction
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    4
    Pyrexia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    3 / 19 (15.79%)
         occurrences all number
    3
    Respiratory, thoracic and mediastinal disorders
    Allergic cough
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Asthma
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Cough
         subjects affected / exposed
    3 / 19 (15.79%)
         occurrences all number
    5
    Epistaxis
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Nasal congestion
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    3
    Nasal obstruction
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Oropharyngeal pain
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    5
    Pulmonary oedema
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Rhinitis allergic
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Rhinorrhoea
         subjects affected / exposed
    3 / 19 (15.79%)
         occurrences all number
    6
    Psychiatric disorders
    Head banging
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Investigations
    Electrocardiogram T wave amplitude decreased
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    2
    Contusion
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Excoriation
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Joint injury
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Ligament sprain
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Limb injury
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Nervous system disorders
    Cerebral artery stenosis
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Cerebral hypoperfusion
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Dizziness
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Intracranial hypotension
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Ear and labyrinth disorders
    Deafness
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Deafness neurosensory
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Deafness unilateral
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Ear pruritus
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Eye disorders
    Chalazion
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Conjunctivitis
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Conjunctivitis allergic
         subjects affected / exposed
    3 / 19 (15.79%)
         occurrences all number
    3
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Abdominal pain upper
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Aphthous stomatitis
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Constipation
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Dental caries
         subjects affected / exposed
    3 / 19 (15.79%)
         occurrences all number
    3
    Diarrhoea
         subjects affected / exposed
    4 / 19 (21.05%)
         occurrences all number
    4
    Dyspepsia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Enteritis
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    2
    Gastritis atrophic
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Irritable bowel syndrome
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Lip dry
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Lip erosion
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Stomatitis
         subjects affected / exposed
    5 / 19 (26.32%)
         occurrences all number
    6
    Tooth impacted
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    3
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Dermatitis contact
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Dry skin
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Dyshidrosis
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Eczema
         subjects affected / exposed
    3 / 19 (15.79%)
         occurrences all number
    3
    Erythema multiforme
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Heat rash
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Pruritus
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Rash pruritic
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Urticaria
         subjects affected / exposed
    3 / 19 (15.79%)
         occurrences all number
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Back pain
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Musculoskeletal pain
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Osteochondrosis
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Pain in extremity
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    3 / 19 (15.79%)
         occurrences all number
    5
    Eczema infected
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    7 / 19 (36.84%)
         occurrences all number
    10
    Hand-foot-and-mouth disease
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Herpes simplex
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    2
    Hordeolum
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    3
    Influenza
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Impetigo
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Meningitis aseptic
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Molluscum contagiosum
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Nail candida
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    10 / 19 (52.63%)
         occurrences all number
    16
    Otitis externa
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Otitis media acute
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Otitis media
         subjects affected / exposed
    4 / 19 (21.05%)
         occurrences all number
    4
    Parotitis
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Pneumonia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Respiratory tract infection
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Sinusitis
         subjects affected / exposed
    5 / 19 (26.32%)
         occurrences all number
    7
    Skin infection
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Upper respiratory tract infection
         subjects affected / exposed
    14 / 19 (73.68%)
         occurrences all number
    41
    Varicella
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Mar 2010
    The protocol was amended to add central reading of audiograms by an independent reader and CSF-PK analysis. In addition, the amendment clarified the handling of patients for the 24-week analysis and the patients who discontinued or completed the core phase but did not continue into the extension phase.

    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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    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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