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    Clinical Trial Results:
    BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis

    Summary
    EudraCT number
    2014-001076-58
    Trial protocol
    CZ   DK  
    Global end of trial date
    07 Mar 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    01 Apr 2017
    First version publication date
    01 Apr 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    191622-145
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02230956
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Allergan, Inc
    Sponsor organisation address
    2525 Dupont Drive, Irvine, United States, 92612
    Public contact
    Therapeutic Area Head,, Allergan, Inc, +1 7142464500, clinicaltrials@allergan.com
    Scientific contact
    Therapeutic Area Head,, Allergan, Inc, +1 7142464500, clinicaltrials@allergan.com
    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
    07 Mar 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Mar 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Mar 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study evaluated the efficacy and safety of a single intra-articular injection of 2 doses of BOTOX® (onabotulinumtoxinA) compared with placebo as treatment for knee osteoarthritis symptoms.
    Protection of trial subjects
    All participants were required to read and sign an informed consent form.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    28 Oct 2014
    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
    Czech Republic: 49
    Country: Number of subjects enrolled
    Denmark: 54
    Country: Number of subjects enrolled
    United States: 73
    Worldwide total number of subjects
    176
    EEA total number of subjects
    103
    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)
    108
    From 65 to 84 years
    68
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Participants with knee osteoarthritis were randomized in a 1:1:2 ratio to receive BOTOX 400 U, BOTOX 200 U, or placebo treatment.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    OnabotulinumtoxinA 400 U
    Arm description
    OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    botulinum toxin Type A
    Investigational medicinal product code
    Other name
    BOTOX® onabotulinumtoxinA
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Injection into the intra-articular space of the knee.

    Arm title
    OnabotulinumtoxinA 200 U
    Arm description
    OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    botulinum toxin Type A
    Investigational medicinal product code
    Other name
    BOTOX® onabotulinumtoxinA
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Injection into the intra-articular space of the knee.

    Arm title
    Placebo
    Arm description
    Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
    Arm type
    Placebo

    Investigational medicinal product name
    Normal Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Injection into the intra-articular space of the knee.

    Number of subjects in period 1
    OnabotulinumtoxinA 400 U OnabotulinumtoxinA 200 U Placebo
    Started
    44
    43
    89
    Completed
    39
    37
    82
    Not completed
    5
    6
    7
         Adverse event, non-fatal
    1
    1
    -
         Personal Reasons
    2
    1
    1
         Lost to follow-up
    1
    1
    2
         Other Miscellaneous Reason
    -
    1
    2
         Lack of efficacy
    1
    1
    1
         Protocol deviation
    -
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    OnabotulinumtoxinA 400 U
    Reporting group description
    OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.

    Reporting group title
    OnabotulinumtoxinA 200 U
    Reporting group description
    OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.

    Reporting group title
    Placebo
    Reporting group description
    Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.

    Reporting group values
    OnabotulinumtoxinA 400 U OnabotulinumtoxinA 200 U Placebo Total
    Number of subjects
    44 43 89 176
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0
        Newborns (0-27 days)
    0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0
        Children (2-11 years)
    0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0
        Adults (18-64 years)
    30 26 52 108
        From 65-84 years
    14 17 37 68
        85 years and over
    0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    60.7 ( 8.25 ) 60.2 ( 8.41 ) 61.1 ( 7.79 ) -
    Gender, Male/Female
    Units: Subjects
        Female
    30 26 51 107
        Male
    14 17 38 69

    End points

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    End points reporting groups
    Reporting group title
    OnabotulinumtoxinA 400 U
    Reporting group description
    OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.

    Reporting group title
    OnabotulinumtoxinA 200 U
    Reporting group description
    OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.

    Reporting group title
    Placebo
    Reporting group description
    Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.

    Primary: Change from Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale

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    End point title
    Change from Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale [1]
    End point description
    Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily pain scores over 7-days were averaged. A negative change from Baseline indicates improvement.
    End point type
    Primary
    End point timeframe
    Baseline, Week 8
    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: No statistical analysis is reported for this outcome measure
    End point values
    OnabotulinumtoxinA 400 U OnabotulinumtoxinA 200 U Placebo
    Number of subjects analysed
    44
    43
    89
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    5.92 ( 1.222 )
    6.09 ( 1.313 )
    6 ( 1.15 )
        Change from Baseline at Week 8
    -1.68 ( 1.641 )
    -2.07 ( 1.602 )
    -1.98 ( 1.793 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale

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    End point title
    Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale
    End point description
    The WOMAC Pain Score consisted of 5 questions about pain completed by the participant where: 0=no pain to 10=extreme pain for a total possible Pain Score of 0 (best) to 50 (worst). A negative change from Baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24
    End point values
    OnabotulinumtoxinA 400 U OnabotulinumtoxinA 200 U Placebo
    Number of subjects analysed
    44
    43
    89
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    5.84 ( 1.629 )
    5.41 ( 1.806 )
    5.34 ( 1.548 )
        Change from Baseline at Week 1 (n = 44, 43, 88)
    -1.75 ( 1.567 )
    -1.61 ( 1.666 )
    -1.62 ( 1.805 )
        Change from Baseline at Week 4 (n = 43, 43, 86)
    -1.82 ( 1.893 )
    -1.67 ( 1.763 )
    -1.81 ( 1.848 )
        Change from Baseline at Week 8 (n = 40, 39, 84)
    -2.02 ( 1.899 )
    -1.52 ( 1.907 )
    -1.76 ( 1.976 )
        Change from Baseline at Week 12 (n = 39, 39, 84)
    -1.81 ( 1.975 )
    -1.82 ( 1.87 )
    -1.75 ( 2.014 )
        Change from Baseline at Week 16 (n = 40, 38, 80)
    -1.67 ( 1.841 )
    -1.64 ( 2.174 )
    -1.62 ( 1.901 )
        Change from Baseline at Week 20 (n = 39, 38, 80)
    -1.79 ( 1.937 )
    -1.68 ( 2.066 )
    -1.78 ( 2.037 )
        Change from Baseline at Week 24 (n = 39, 37, 82)
    -1.93 ( 2.289 )
    -1.81 ( 2.181 )
    -1.69 ( 2.008 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale

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    End point title
    Change from Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale
    End point description
    The WOMAC Physical Function Score consisted of 17 questions about the difficulty of daily activities completed by the participant where: 0=no difficulty to 10=extreme difficulty for a total possible Physical Function Score of 0 (best) to 170 (worst). A negative change from Baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24
    End point values
    OnabotulinumtoxinA 400 U OnabotulinumtoxinA 200 U Placebo
    Number of subjects analysed
    44
    43
    89
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    5.56 ( 1.804 )
    5.35 ( 1.995 )
    4.99 ( 1.854 )
        Change from Baseline at Week 1 (n = 44, 43, 88)
    -1.33 ( 1.424 )
    -1.64 ( 1.87 )
    -1.44 ( 1.933 )
        Change from Baseline at Week 4 (n = 43, 43, 86)
    -1.26 ( 1.672 )
    -1.66 ( 1.908 )
    -1.35 ( 2.069 )
        Change from Baseline at Week 8 (n = 40, 39, 84)
    -1.54 ( 1.819 )
    -1.5 ( 2.043 )
    -1.27 ( 2.07 )
        Change from Baseline at Week 12 (n = 39, 39, 84)
    -1.3 ( 1.648 )
    -1.68 ( 1.781 )
    -1.4 ( 2.17 )
        Change from Baseline at Week 16 (n = 40, 38, 80)
    -1.29 ( 1.558 )
    -1.59 ( 2.127 )
    -1.09 ( 1.991 )
        Change from Baseline at Week 20 (n = 39, 38, 80)
    -1.34 ( 1.651 )
    -1.44 ( 2.172 )
    -1.18 ( 2.087 )
        Change from Baseline at Week 24 (n = 39, 37, 82)
    -1.48 ( 2.029 )
    -1.56 ( 2.232 )
    -1.12 ( 1.998 )
    No statistical analyses for this end point

    Secondary: Patient Global Impression of Change (GIC) Using a 7-Point Scale

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    End point title
    Patient Global Impression of Change (GIC) Using a 7-Point Scale
    End point description
    The participant rated the change in their health status since enrollment using a 7-point scale where: +3=very much improved, +2=much improved, +1=minimally improved, 0=no change, -1=minimally worse, -2=much worse and -3=very much worse. Negative scores indicate worsening and positive scores indicate improvement.
    End point type
    Secondary
    End point timeframe
    Weeks 1, 4, 8, 12, 16, 20 and 24
    End point values
    OnabotulinumtoxinA 400 U OnabotulinumtoxinA 200 U Placebo
    Number of subjects analysed
    44
    43
    89
    Units: score on a scale
    arithmetic mean (standard deviation)
        Week 1 (n = 44, 43, 87)
    0.9 ( 1 )
    1.2 ( 0.97 )
    1.1 ( 1.09 )
        Week 4 (n = 43, 43, 86)
    0.9 ( 1.24 )
    1.2 ( 1.23 )
    1.2 ( 1.1 )
        Week 8 (n = 40, 39, 84)
    1.1 ( 1.09 )
    0.9 ( 1.35 )
    1 ( 1 )
        Week 12 (n = 39, 39, 84)
    1.1 ( 1.35 )
    1.2 ( 1.3 )
    1 ( 1.14 )
        Week 16 (n = 40, 38, 80)
    1.1 ( 1.31 )
    1.1 ( 1.36 )
    1 ( 1.1 )
        Week 20 (n = 39, 38, 80)
    1.1 ( 1.24 )
    1 ( 1.42 )
    1 ( 1.2 )
        Week 24 (n = 39, 37, 82)
    0.8 ( 1.34 )
    1 ( 1.41 )
    0.9 ( 1.28 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in the 7-Day Average Daily Worst Pain Score Using an 11-Point Scale

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    End point title
    Change from Baseline in the 7-Day Average Daily Worst Pain Score Using an 11-Point Scale
    End point description
    Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to10= worst pain possible. The daily worst pain scores over 7-days were averaged. A negative change from Baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    OnabotulinumtoxinA 400 U OnabotulinumtoxinA 200 U Placebo
    Number of subjects analysed
    44
    43
    89
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    6.5 ( 1.243 )
    6.84 ( 1.342 )
    6.63 ( 1.157 )
        Week 24
    -1.48 ( 1.894 )
    -2.07 ( 2.126 )
    -1.8 ( 1.896 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Day 172
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    OnabotulinumtoxinA 400 U
    Reporting group description
    OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.

    Reporting group title
    OnabotulinumtoxinA 200 U
    Reporting group description
    OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.

    Reporting group title
    Placebo
    Reporting group description
    Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.

    Serious adverse events
    OnabotulinumtoxinA 400 U OnabotulinumtoxinA 200 U Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 44 (13.64%)
    4 / 43 (9.30%)
    6 / 89 (6.74%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Muscle strain
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 43 (2.33%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 43 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 43 (2.33%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 43 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dizziness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Basal ganglia infarction
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 43 (2.33%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Retinal detachment
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Constipation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nausea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 43 (2.33%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 43 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 43 (0.00%)
    2 / 89 (2.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Incision site infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 43 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    OnabotulinumtoxinA 400 U OnabotulinumtoxinA 200 U Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 44 (20.45%)
    15 / 43 (34.88%)
    26 / 89 (29.21%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 44 (2.27%)
    5 / 43 (11.63%)
    2 / 89 (2.25%)
         occurrences all number
    1
    5
    2
    Musculoskeletal and connective tissue disorders
    Joint swelling
         subjects affected / exposed
    0 / 44 (0.00%)
    4 / 43 (9.30%)
    4 / 89 (4.49%)
         occurrences all number
    0
    5
    5
    Osteoarthritis
         subjects affected / exposed
    1 / 44 (2.27%)
    2 / 43 (4.65%)
    5 / 89 (5.62%)
         occurrences all number
    1
    2
    6
    Arthralgia
         subjects affected / exposed
    4 / 44 (9.09%)
    9 / 43 (20.93%)
    9 / 89 (10.11%)
         occurrences all number
    5
    11
    12
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    3 / 44 (6.82%)
    2 / 43 (4.65%)
    8 / 89 (8.99%)
         occurrences all number
    3
    2
    8

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Sep 2014
    Amendment 1 added an assessment of the skin at the site of injection on day 1, at all follow-up visits, and at the exit visit. This amendment also added stopping criteria for the study.

    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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