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    Clinical Trial Results:
    A phase II, international, multi-centre, prospective, randomised, parallel-group, double-blind, dose-ranging, placebo-controlled, 12-week, princeps study to assess the efficacy and safety of a one injection cycle with either botulinum toxin Type-A (Dysport® 125, 250 or 500 Units) or placebo followed by an optional 6-month extension phase in the symptomatic treatment of micturition urgency and frequency in continent female subjects suffering from idiopathic overative bladder.

    Summary
    EudraCT number
    		 2007-002999-34
    Trial protocol
    		 GB   DE   NL   BE   FR   CZ   IT   ES  
    Global end of trial date
    15 Dec 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 May 2016
    First version publication date
    27 May 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    Y-79-52120-126
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ipsen Pharma
    Sponsor organisation address
    Ipsen Group, 190 Bath Road, Slough, Berkshire, United Kingdom, SL1 3XE
    Public contact
    Medical Director, Urology, Ipsen Pharma, clinical.trials@ipsen.com
    Scientific contact
    Medical Director, Urology, Ipsen Pharma, clinical.trials@ipsen.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
    25 Mar 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Dec 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Dec 2009
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the effect of treatment with three doses of botulinum toxin type-A (Dysport®) versus placebo on the number of episodes of urgency and frequency of micturition experienced in continent female subjects with idiopathic overactive bladder (iOAB) at Week 12 in comparison to Baseline.
    Protection of trial subjects
    This study was conducted in compliance with the IECs, informed consent regulations, the Declaration of Helsinki, International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines [1], and Food and Drug Administration (FDA) regulations [2, 3]. In addition, this study adhered to all local regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Mar 2008
    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
    Netherlands: 1
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Czech Republic: 22
    Country: Number of subjects enrolled
    France: 13
    Country: Number of subjects enrolled
    Germany: 22
    Worldwide total number of subjects
    63
    EEA total number of subjects
    63
    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)
    50
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited from 22 sites in 7 European countries (France, Germany, Czech Republic, Belgium, Italy, Netherlands, and Spain).

    Pre-assignment
    Screening details
    		 Screened subjects were 82 and 19 subjects were screen failures. Randomized subjects were 63. Two subjects have been randomized but not injected by IMP => Pure ITT Population = Safety Population = 61 subjects.

    Period 1
    Period 1 title
    Princeps Phase: Dysport and Placebo
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Investigators were to break the study blind for a subject only in cases of medical emergency, where treatment was dependent on knowledge of the study drug received. In the event of the study code for a subject being broken, the Investigator was to immediately notify the responsible Medical Representative or the Clinical Safety Committee. If possible, this notification was to take place before the treatment identification was made. Date and reason(s) for unblinding were to be recorded in CRF.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A: Dysport 125 units
    Arm description
    		 Intradetrusor Injection of Dysport, 125 units in total
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dysport
    Investigational medicinal product code
    Other name
    Botulinum Toxin Type A
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Dysport Intradetrusor Injection, 125 units in total

    Arm title
    		 Arm B: Dysport 250 units
    Arm description
    		 Intradetrusor Injection of Dysport, 250 units in total
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dysport
    Investigational medicinal product code
    Other name
    Botulinum Toxin Type A
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Dysport Intradetrusor Injection, 250 units in total

    Arm title
    		 Arm C: Dysport 500 units
    Arm description
    		 Intradetrusor Injection of Dysport, 500 units in total.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dysport
    Investigational medicinal product code
    Other name
    Botulinum Toxin Type A
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Dysport Intradetrusor Injection, 500 units in total

    Arm title
    		 Arm D: Placebo
    Arm description
    		 Intradetrusor injection of Placebo, 0 units in total
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Placebo Intradetrusor injection, 0 units in total

    Number of subjects in period 1
    		Arm A: Dysport 125 units Arm B: Dysport 250 units Arm C: Dysport 500 units Arm D: Placebo
    Started
    9
    19
    18
    17
    Completed
    8
    14
    14
    16
    Not completed
    1
    5
    4
    1
         Consent withdrawn by subject
    -
    1
    -
    1
         Adverse event, non-fatal
    -
    1
    -
    -
         Non-specific
    1
    2
    1
    -
         Lost to follow-up
    -
    -
    1
    -
         Protocol deviation
    -
    1
    1
    -
         Lack of efficacy
    -
    -
    1
    -
    Period 2
    Period 2 title
    Extension Phase: Dysport and Placebo
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Investigators were to break the study blind for a subject only in cases of medical emergency, where treatment was dependent on knowledge of the study drug received. In the event of the study code for a subject being broken, the Investigator was to immediately notify the responsible Medical Representative or the Clinical Safety Committee. If possible, this notification was to take place before the treatment identification was made. Date and reason(s) for unblinding were to be recorded in CRF.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A: Dysport 125 units
    Arm description
    		 Intradetrusor Injection of Dysport, 125 units in total.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dysport
    Investigational medicinal product code
    Other name
    Botulinum Toxin Type A
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Dysport Intradetrusor Injection, 125 units in total

    Arm title
    		 Arm B: Dysport 250 units
    Arm description
    		 Intradetrusor Injection of Dysport, 250 units in total
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dysport
    Investigational medicinal product code
    Other name
    Botulinum Toxin Type A
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Dysport Intradetrusor Injection, 250 units in total

    Arm title
    		 Arm C: Dysport 500 units
    Arm description
    		 Intradetrusor Injection of Dysport, 500 units in total.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dysport
    Investigational medicinal product code
    Other name
    Botulinum Toxin Type A
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Dysport Intradetrusor Injection, 500 units in total

    Arm title
    		 Arm D: Placebo
    Arm description
    		 Intradetrusor injection of Placebo, 0 units in total
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Placebo Intradetrusor injection, 0 units in total

    Number of subjects in period 2 [1]
    		Arm A: Dysport 125 units Arm B: Dysport 250 units Arm C: Dysport 500 units Arm D: Placebo
    Started
    6
    6
    6
    5
    Completed
    4
    2
    5
    2
    Not completed
    2
    4
    1
    3
         Consent withdrawn by subject
    -
    1
    -
    -
         Non-specific
    2
    2
    1
    1
         Lost to follow-up
    -
    1
    -
    1
         Lack of efficacy
    -
    -
    -
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: The number of subjects completed in period 1 (Princeps Phase) is not same as the number of subjects started in the period 2 (Extension Phase) as period 2 (Extension phase) was an optional phase. Of the 52 subjects who completed princeps phase, only 23 subjects were enrolled in the extension phase and 13 subjects completed the extension phase

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A: Dysport 125 units
    Reporting group description
    		 Intradetrusor Injection of Dysport, 125 units in total

    Reporting group title
    Arm B: Dysport 250 units
    Reporting group description
    		 Intradetrusor Injection of Dysport, 250 units in total

    Reporting group title
    Arm C: Dysport 500 units
    Reporting group description
    		 Intradetrusor Injection of Dysport, 500 units in total.

    Reporting group title
    Arm D: Placebo
    Reporting group description
    		 Intradetrusor injection of Placebo, 0 units in total

    Reporting group values
    		 Arm A: Dysport 125 units Arm B: Dysport 250 units Arm C: Dysport 500 units Arm D: Placebo Total
    Number of subjects
    		 9 19 18 17 63
    Age categorical
    Units: Subjects
    Age continuous
    Dysport 125 units: N=7, Dysport 250 units: N=16, Dysport 500 units: N=14, Placebo: N=16
    Units: years
        arithmetic mean (standard deviation)
    		 56.4 ± 11.27 54.1 ± 14.15 56.9 ± 10.34 49.1 ± 16.2 -
    Gender categorical
    Units: Subjects
        Female
    		 9 19 18 17 63
    Height
    Dysport 125 units: N=7, Dysport 250 units: N=16, Dysport 500 units: N=14, Placebo: N=16
    Units: CM
        arithmetic mean (standard deviation)
    		 163.4 ± 6.45 164.4 ± 6.91 163.5 ± 6.53 162.4 ± 5.98 -
    Number of Episodes of Urgency
    Dysport 125 units: N=7, Dysport 250 units: N=16, Dysport 500 units: N=14, Placebo: N=16
    Units: Number of Episodes
        arithmetic mean (standard deviation)
    		 35.8 ± 18.7 34.9 ± 18.9 29.8 ± 20.8 28.7 ± 16.7 -
    Number of Episodes of Micturitions
    Dysport 125 units: N=7, Dysport 250 units: N=16, Dysport 500 units: N=14, Placebo: N=16
    Units: Number of Episodes
        arithmetic mean (standard deviation)
    		 40.6 ± 11.3 44.2 ± 12.5 41.1 ± 14 41.1 ± 11.2 -
    Number of Episodes of Nocturia
    Dysport 125 units: N=7, Dysport 250 units: N=16, Dysport 500 units: N=14, Placebo: N=16
    Units: Number of Episodes
        arithmetic mean (standard deviation)
    		 9.3 ± 3.7 9.9 ± 5.7 6.4 ± 5.2 10 ± 6.2 -
    Severity of urgency using Overactive Bladder Questionnaire short form (OAB-Q SF)
    Dysport 125 units: N=7, Dysport 250 units: N=16, Dysport 500 units: N=14, Placebo: N=16
    Units: Unit on a scale
        arithmetic mean (standard deviation)
    		 35.7 ± 9.9 42.5 ± 11.8 38.8 ± 10 44.4 ± 13.5 -
    Urine flow rate
    Dysport 125 units: N=7, Dysport 250 units: N=16, Dysport 500 units: N=14, Placebo: N=16
    Units: mL/sec
        arithmetic mean (standard deviation)
    		 19.1 ± 10.5 20.3 ± 17.5 19.6 ± 7.8 22.1 ± 24.2 -
    Post-micturition residual volume (PMRV) assessed by ultrasound
    Dysport 125 units: N=7, Dysport 250 units: N=16, Dysport 500 units: N=14, Placebo: N=16
    Units: mL
        arithmetic mean (standard deviation)
    		 15.7 ± 31.9 13.5 ± 26.6 15.5 ± 18.5 14.3 ± 23.5 -
    Maximum Flow Rate
    Dysport 125 units: N=7, Dysport 250 units: N=16, Dysport 500 units: N=14, Placebo: N=16
    Units: mL/sec
        arithmetic mean (standard deviation)
    		 19.1 ± 10.54 20.3 ± 17.53 19.6 ± 7.82 22.1 ± 24.18 -
    Volume at First Desire to Void
    Dysport 125 units: N=7, Dysport 250 units: N=16, Dysport 500 units: N=14, Placebo: N=16
    Units: mL
        arithmetic mean (standard deviation)
    		 81.6 ± 48.7 85.9 ± 60.24 114.1 ± 63.28 72.5 ± 40.2 -
    Volume at Urgency
    Dysport 125 units: N=7, Dysport 250 units: N=16, Dysport 500 units: N=14, Placebo: N=16
    Units: mL
        arithmetic mean (standard deviation)
    		 181 ± 83.12 149.8 ± 93.94 199.5 ± 79.76 151 ± 60.36 -
    Maximum Cystometric Capacity (MCC)
    Dysport 125 units: N=7, Dysport 250 units: N=16, Dysport 500 units: N=14, Placebo: N=16
    Units: mL
        arithmetic mean (standard deviation)
    		 240.3 ± 106.9 182.7 ± 144 242.5 ± 88.49 241.9 ± 96.29 -
    Maximum Detrusor Pressure during Filling
    Dysport 125 units: N=7, Dysport 250 units: N=16, Dysport 500 units: N=14, Placebo: N=16
    Units: cm H2O
        arithmetic mean (standard deviation)
    		 39.6 ± 26.08 35.9 ± 23.16 33.6 ± 30.22 35.8 ± 26.07 -
    Detrusor Pressure at Maximum Flow Rate
    Dysport 125 units: N=7, Dysport 250 units: N=16, Dysport 500 units: N=14, Placebo: N=16
    Units: cm H2O
        arithmetic mean (standard deviation)
    		 42.4 ± 32.41 39.6 ± 28.2 41.2 ± 29.75 34.2 ± 20.26 -
    Bladder Compliance
    Dysport 125 units: N=4, Dysport 250 units: N=16, Dysport 500 units: N=14, Placebo: N=14
    Units: mL/cm H2O
        arithmetic mean (standard deviation)
    		 33.8 ± 37.38 26.5 ± 42.77 57.5 ± 54.73 37.2 ± 28.5 -
    Quality of Life (QoL) using EQ-5D: Mobility
    Dysport 125 units: N=7, Dysport 250 units: N=16, Dysport 500 units: N=14, Placebo: N=16 EuroQol-5D (EQ-5D)
    Units: Units on a scale
        arithmetic mean (standard deviation)
    		 1 ± 0 1.2 ± 0.4 1.3 ± 0.5 1.2 ± 0.4 -
    QoL using EQ-5D: Self-care
    Dysport 125 units: N=7, Dysport 250 units: N=16, Dysport 500 units: N=13, Placebo: N=16
    Units: Units on a scale
        arithmetic mean (standard deviation)
    		 1 ± 0 1.1 ± 0.3 1.1 ± 0.3 1 ± 0 -
    QoL using EQ-5D: Usual activities
    Dysport 125 units: N=7, Dysport 250 units: N=16, Dysport 500 units: N=14, Placebo: N=16
    Units: Units on a scale
        arithmetic mean (standard deviation)
    		 1 ± 0 1.3 ± 0.4 1.1 ± 0.3 1.1 ± 0.3 -
    QoL using EQ-5D: Pain/Discomfort
    Dysport 125 units: N=7, Dysport 250 units: N=16, Dysport 500 units: N=14, Placebo: N=16
    Units: Units on a scale
        arithmetic mean (standard deviation)
    		 1.3 ± 0.5 1.4 ± 0.5 1.4 ± 0.5 1.5 ± 0.6 -
    QoL using EQ-5D: Anxiety/Depression
    Dysport 125 units: N=7, Dysport 250 units: N=16, Dysport 500 units: N=14, Placebo: N=16
    Units: Units on a scale
        arithmetic mean (standard deviation)
    		 1.1 ± 0.4 1.4 ± 0.6 1.3 ± 0.5 1.5 ± 0.5 -

    End points

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    End points reporting groups
    Reporting group title
    Arm A: Dysport 125 units
    Reporting group description
    		 Intradetrusor Injection of Dysport, 125 units in total

    Reporting group title
    Arm B: Dysport 250 units
    Reporting group description
    		 Intradetrusor Injection of Dysport, 250 units in total

    Reporting group title
    Arm C: Dysport 500 units
    Reporting group description
    		 Intradetrusor Injection of Dysport, 500 units in total.

    Reporting group title
    Arm D: Placebo
    Reporting group description
    		 Intradetrusor injection of Placebo, 0 units in total
    Reporting group title
    Arm A: Dysport 125 units
    Reporting group description
    		 Intradetrusor Injection of Dysport, 125 units in total.

    Reporting group title
    Arm B: Dysport 250 units
    Reporting group description
    		 Intradetrusor Injection of Dysport, 250 units in total

    Reporting group title
    Arm C: Dysport 500 units
    Reporting group description
    		 Intradetrusor Injection of Dysport, 500 units in total.

    Reporting group title
    Arm D: Placebo
    Reporting group description
    		 Intradetrusor injection of Placebo, 0 units in total

    Primary: Mean change from baseline in number of episodes of Urgency (Princeps phase)

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    End point title
    		 Mean change from baseline in number of episodes of Urgency (Princeps phase)
    End point description
    Intention-to-Treat (ITT) population
    End point type
    Primary
    End point timeframe
    From Day 1 (baseline) to Visit 5 (week 12)
    End point values
    		 Arm A: Dysport 125 units Arm B: Dysport 250 units Arm C: Dysport 500 units Arm D: Placebo
    Number of subjects analysed
    7
    16
    14
    16
    Units: Number of Episodes
        arithmetic mean (standard deviation)
    -24.5 ± 17.2
    -12.8 ± 13.5
    -16.7 ± 21.4
    -13.5 ± 15.2
    Statistical analysis title
    		 Q1: Dysport 125 units vs Placebo
    Comparison groups
    Arm D: Placebo v Arm A: Dysport 125 units
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7426
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Q1: Dysport 250 units vs Placebo
    Comparison groups
    Arm D: Placebo v Arm B: Dysport 250 units
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9007
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Q1: Dysport 500 units vs Placebo
    Comparison groups
    Arm C: Dysport 500 units v Arm D: Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.009
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Median: Dysport 125 units vs Placebo
    Comparison groups
    Arm A: Dysport 125 units v Arm D: Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6741
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Median: Dysport 250 units vs Placebo
    Comparison groups
    Arm B: Dysport 250 units v Arm D: Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8347
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Median: Dysport 500 units vs Placebo
    Comparison groups
    Arm C: Dysport 500 units v Arm D: Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3684
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Q3: Dysport 125 units vs Placebo
    Comparison groups
    Arm A: Dysport 125 units v Arm D: Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4339
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Q3: Dysport 250 units vs Placebo
    Comparison groups
    Arm B: Dysport 250 units v Arm D: Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7455
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Q3: Dysport 500 units vs Placebo
    Comparison groups
    Arm C: Dysport 500 units v Arm D: Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.831
    Method
    		 ANCOVA
    Confidence interval

    Primary: Mean change from baseline in number of Episodes of Micturitions (Princeps phase)

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    End point title
    		 Mean change from baseline in number of Episodes of Micturitions (Princeps phase)
    End point description
    ITT population
    End point type
    Primary
    End point timeframe
    From Day 1 (baseline) to Visit 5 (week 12)
    End point values
    		 Arm A: Dysport 125 units Arm B: Dysport 250 units Arm C: Dysport 500 units Arm D: Placebo
    Number of subjects analysed
    7
    14
    14
    16
    Units: Number of Episodes
        arithmetic mean (standard deviation)
    -18.9 ± 7.6
    -10 ± 10.2
    -14.3 ± 12.5
    -10.7 ± 10.3
    Statistical analysis title
    		 Dysport 125 units vs Placebo
    Comparison groups
    Arm A: Dysport 125 units v Arm D: Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0319
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Dysport 250 units vs Placebo
    Comparison groups
    Arm B: Dysport 250 units v Arm D: Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.604
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Dysport 500 units vs Placebo
    Comparison groups
    Arm C: Dysport 500 units v Arm D: Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.257
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Mean change from baseline in number of episodes of urgency and frequency of micturition (Princeps phase)

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    End point title
    		 Mean change from baseline in number of episodes of urgency and frequency of micturition (Princeps phase)
    End point description
    ITT population
    End point type
    Secondary
    End point timeframe
    Baseline (day 1) to Week 6 (Visit 4)
    End point values
    		 Arm A: Dysport 125 units Arm B: Dysport 250 units Arm C: Dysport 500 units Arm D: Placebo
    Number of subjects analysed
    7
    15
    13
    15
    Units: Number of Episodes
    arithmetic mean (standard deviation)
        Episodes of Urgency
    -22 ± 18.2
    -14 ± 10.1
    -15.4 ± 17.1
    -11 ± 9
        Frequency of Micturition
    -14.4 ± 7.9
    -8.2 ± 16.3
    -10.9 ± 10.3
    -10.7 ± 7.5
    Statistical analysis title
    		 Q1-Urgency: Placebo vs Dysport 125 units
    Comparison groups
    Arm A: Dysport 125 units v Arm D: Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2765
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Q1-Urgency: Placebo vs Dysport 250 units
    Comparison groups
    Arm B: Dysport 250 units v Arm D: Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3282
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Q1-Urgency: Placebo vs Dysport 500 units
    Comparison groups
    Arm C: Dysport 500 units v Arm D: Placebo
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1463
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Median-Urgency: Placebo vs Dysport 125 units
    Comparison groups
    Arm A: Dysport 125 units v Arm D: Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7059
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Median-Urgency: Placebo vs Dysport 250 units
    Comparison groups
    Arm B: Dysport 250 units v Arm D: Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4906
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Median-Urgency: Placebo vs Dysport 500 units
    Comparison groups
    Arm C: Dysport 500 units v Arm D: Placebo
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9228
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Q3-Urgency: Placebo vs Dysport 125 units
    Comparison groups
    Arm A: Dysport 125 units v Arm D: Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2353
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Q3-Urgency: Placebo vs Dysport 250 units
    Comparison groups
    Arm B: Dysport 250 units v Arm D: Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7289
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Q3-Urgency: Placebo vs Dysport 500 units
    Comparison groups
    Arm C: Dysport 500 units v Arm D: Placebo
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5278
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Micturition: Placebo vs Dysport 125 units
    Comparison groups
    Arm A: Dysport 125 units v Arm D: Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4551
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Micturition: Placebo vs Dysport 250 units
    Comparison groups
    Arm D: Placebo v Arm B: Dysport 250 units
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3873
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Micturition: Placebo vs Dysport 500 units
    Comparison groups
    Arm C: Dysport 500 units v Arm D: Placebo
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9517
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Mean change from baseline in Frequency of Nocturia (Princeps Phase)

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    End point title
    		 Mean change from baseline in Frequency of Nocturia (Princeps Phase)
    End point description
    ITT population
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) to Week 6 (visit 4) and Week 12 (visit 5)
    End point values
    		 Arm A: Dysport 125 units Arm B: Dysport 250 units Arm C: Dysport 500 units Arm D: Placebo
    Number of subjects analysed
    7
    15 [1]
    13 [2]
    15 [3]
    Units: Number of Episodes
    arithmetic mean (standard deviation)
        Baseline to Week 6
    -4.6 ± 3.6
    -3.2 ± 5.8
    -1.2 ± 3.4
    -5.5 ± 3.9
        Baseline to Week 12
    -5.3 ± 4.3
    -3.4 ± 6.7
    -2.4 ± 4.7
    -4.9 ± 4.7
    Notes
    [1] - Week 12: N=14
    [2] - Week 12: N=14
    [3] - Week 12: N=16
    Statistical analysis title
    		 Nocturia: Placebo vs Dysport 125 units (Week 6)
    Comparison groups
    Arm A: Dysport 125 units v Arm D: Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4645
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Nocturia: Placebo vs Dysport 250 units (Week 6)
    Comparison groups
    Arm B: Dysport 250 units v Arm D: Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1253
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Nocturia: Placebo vs Dysport 500 units (Week 6)
    Comparison groups
    Arm D: Placebo v Arm C: Dysport 500 units
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0351
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Nocturia: Placebo vs Dysport 125 units (Week 12)
    Statistical analysis description
    Number of subjects included in analysis=23
    Comparison groups
    Arm A: Dysport 125 units v Arm D: Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8193
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Nocturia: Placebo vs Dysport 250 units (Week 12)
    Comparison groups
    Arm B: Dysport 250 units v Arm D: Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5102
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Nocturia: Placebo vs Dysport 500 units (Week 12)
    Statistical analysis description
    Number of subjects included in analysis=30
    Comparison groups
    Arm D: Placebo v Arm C: Dysport 500 units
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6737
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Mean Change from baseline in severity of urgency using OAB-Q SF

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    End point title
    		 Mean Change from baseline in severity of urgency using OAB-Q SF
    End point description
    ITT population. The Overactive Bladder Questionnaire-Short Form (OAB-q SF) is a brief, self-administered patient-reported outcomes tool with two scales assessing symptom bother and health-related quality of life (HR-QOL) in patients with OAB. OAB-q SF consists of a 6-item symptom-bother scale & a 13-item HRQOL scale. HRQOL scale is divided into 3 subscales: Coping (5 items), Sleep (3 items), and Emotional social (5 items). Items are transformed and summarized into 2 domain scores: Symptom Severity and Total HRQOL. Symptom Severity score (average of items 1 through 6) ranged from 0 to 100, with higher scores reflecting greater symptom severity or bother. Total HRQOL score (average of items 1 through 13) ranged from 0 to 100, with higher scores reflecting better HRQOL.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) to Week 6 (visit 4), Week 12 (visit 5), Month 6 (Visit 6) and Month 9 (Visit 7)
    End point values
    		 Arm A: Dysport 125 units Arm B: Dysport 250 units Arm C: Dysport 500 units Arm D: Placebo
    Number of subjects analysed
    7
    16
    14
    16
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Baseline to Week 6 (n=7, 16, 14, 16)
    -10.5 ± 9.3
    -11.2 ± 12.1
    -17.1 ± 14.1
    -9 ± 19.4
        Baseline to Week 12 (n=6, 15, 14, 16)
    -17.8 ± 12.2
    -12.4 ± 14.4
    -15 ± 16
    -8 ± 25.8
        Baseline to Month 6 (n=6, 3, 6, 4)
    -17.8 ± 13.8
    -22.2 ± 10.2
    -23.9 ± 8.3
    -20.8 ± 19.1
        Baseline to Month 9 (n=4, 5, 6, 3)
    -26.7 ± 8.6
    -18 ± 8.4
    -17.8 ± 9.3
    -16.7 ± 17.6
    No statistical analyses for this end point

    Secondary: Mean Change from baseline in urine flow rate

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    End point title
    		 Mean Change from baseline in urine flow rate
    End point description
    ITT population.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) to Week 2 (visit 3) and Week 6 (visit 4)
    End point values
    		 Arm A: Dysport 125 units Arm B: Dysport 250 units Arm C: Dysport 500 units Arm D: Placebo
    Number of subjects analysed
    7
    14 [4]
    13 [5]
    16
    Units: mL/sec
    arithmetic mean (standard deviation)
        Baseline to Week 2
    2.3 ± 5.3
    -0.2 ± 12
    -2.2 ± 11.4
    -4.2 ± 26.9
        Baseline to Week 6
    -4 ± 6.5
    0.5 ± 22.4
    0.6 ± 21.1
    1.3 ± 29.5
    Notes
    [4] - Week 6: N=15
    [5] - Week 6: N=14
    Statistical analysis title
    		 Q1: Placebo vs Dysport 125 units (Week 2)
    Comparison groups
    Arm A: Dysport 125 units v Arm D: Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4212
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Q1: Placebo vs Dysport 250 units (Week 2)
    Comparison groups
    Arm B: Dysport 250 units v Arm D: Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6019
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Q1: Placebo vs Dysport 500 units (Week 2)
    Comparison groups
    Arm D: Placebo v Arm C: Dysport 500 units
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1861
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Median: Placebo vs Dysport 125 units (Week 2)
    Comparison groups
    Arm A: Dysport 125 units v Arm D: Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6296
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Median: Placebo vs Dysport 250 units (Week 2)
    Comparison groups
    Arm B: Dysport 250 units v Arm D: Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6741
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Median: Placebo vs Dysport 500 units (Week 2)
    Comparison groups
    Arm C: Dysport 500 units v Arm D: Placebo
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6413
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Q3: Placebo vs Dysport 125 units (Week 2)
    Comparison groups
    Arm A: Dysport 125 units v Arm D: Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1122
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Q3: Placebo vs Dysport 250 units (Week 2)
    Comparison groups
    Arm B: Dysport 250 units v Arm D: Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8201
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Q3: Placebo vs Dysport 500 units (Week 2)
    Comparison groups
    Arm C: Dysport 500 units v Arm D: Placebo
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5478
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Placebo vs Dysport 125 units (Week 6)
    Comparison groups
    Arm A: Dysport 125 units v Arm D: Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2587
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Placebo vs Dysport 250 units (Week 6)
    Statistical analysis description
    Number of subjects included in analysis=31
    Comparison groups
    Arm D: Placebo v Arm B: Dysport 250 units
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.759
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Placebo vs Dysport 500 units (Week 6)
    Statistical analysis description
    Number of subjects included in analysis=30
    Comparison groups
    Arm C: Dysport 500 units v Arm D: Placebo
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5971
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Mean Change from baseline in PMRV assessed by ultrasound Assessment

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    End point title
    		 Mean Change from baseline in PMRV assessed by ultrasound Assessment
    End point description
    ITT population.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) to Week 2 (Visit 3) and Week 6 (Visit 4)
    End point values
    		 Arm A: Dysport 125 units Arm B: Dysport 250 units Arm C: Dysport 500 units Arm D: Placebo
    Number of subjects analysed
    7
    16 [6]
    14
    16
    Units: mL
    arithmetic mean (standard deviation)
        Baseline to Week 2
    5.9 ± 40.3
    37.8 ± 80.5
    30 ± 56.8
    18.4 ± 47.8
        Baseline to Week 6
    -4.9 ± 18.2
    31.5 ± 77.7
    44.5 ± 75.2
    26.1 ± 64.2
    Notes
    [6] - Week 6: N=15
    Statistical analysis title
    		 Q1: Placebo vs Dysport 125 units (Week 2)
    Comparison groups
    Arm A: Dysport 125 units v Arm D: Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6042
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Q1: Placebo vs Dysport 250 units (Week 2)
    Comparison groups
    Arm B: Dysport 250 units v Arm D: Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.073
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Q1: Placebo vs Dysport 500 units (Week 2)
    Comparison groups
    Arm C: Dysport 500 units v Arm D: Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9536
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Median: Placebo vs Dysport 125 units (Week 2)
    Comparison groups
    Arm A: Dysport 125 units v Arm D: Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6042
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Median: Placebo vs Dysport 250 units (Week 2)
    Comparison groups
    Arm B: Dysport 250 units v Arm D: Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.073
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Median: Placebo vs Dysport 500 units (Week 2)
    Comparison groups
    Arm C: Dysport 500 units v Arm D: Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9536
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Q3: Placebo vs Dysport 125 units (Week 2)
    Comparison groups
    Arm D: Placebo v Arm A: Dysport 125 units
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5968
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Q3: Placebo vs Dysport 250 units (Week 2)
    Comparison groups
    Arm B: Dysport 250 units v Arm D: Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0098
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Q3: Placebo vs Dysport 500 units (Week 2)
    Comparison groups
    Arm C: Dysport 500 units v Arm D: Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3338
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Q1: Placebo vs Dysport 125 units (Week 6)
    Comparison groups
    Arm A: Dysport 125 units v Arm D: Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1379
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Q1: Placebo vs Dysport 250 units (Week 6)
    Comparison groups
    Arm B: Dysport 250 units v Arm D: Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0265
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Q1: Placebo vs Dysport 500 units (Week 6)
    Comparison groups
    Arm C: Dysport 500 units v Arm D: Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1464
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Median: Placebo vs Dysport 125 units (Week 6)
    Comparison groups
    Arm A: Dysport 125 units v Arm D: Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1379
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Median: Placebo vs Dysport 250 units (Week 6)
    Comparison groups
    Arm B: Dysport 250 units v Arm D: Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0265
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Median: Placebo vs Dysport 500 units (Week 6)
    Comparison groups
    Arm C: Dysport 500 units v Arm D: Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1464
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Q3: Placebo vs Dysport 125 units (Week 6)
    Comparison groups
    Arm A: Dysport 125 units v Arm D: Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2735
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Q3: Placebo vs Dysport 250 units (Week 6)
    Statistical analysis description
    Number of subjects included in analysis = 31
    Comparison groups
    Arm B: Dysport 250 units v Arm D: Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1578
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Q3: Placebo vs Dysport 500 units (Week 6)
    Comparison groups
    Arm C: Dysport 500 units v Arm D: Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.43
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Urodynamic Parameters: Mean Change from baseline in Maximum Flow Rate

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    End point title
    		 Urodynamic Parameters: Mean Change from baseline in Maximum Flow Rate
    End point description
    ITT population
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) to Week 12 (Visit 5)
    End point values
    		 Arm A: Dysport 125 units Arm B: Dysport 250 units Arm C: Dysport 500 units Arm D: Placebo
    Number of subjects analysed
    7
    12
    13
    15
    Units: mL/sec
        arithmetic mean (standard deviation)
    -0.9 ± 9.06
    25.6 ± 79.07
    1.1 ± 10.78
    2.5 ± 8.81
    Statistical analysis title
    		 Placebo vs Dysport 125 units
    Comparison groups
    Arm A: Dysport 125 units v Arm D: Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9808
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Placebo vs Dysport 250 units
    Comparison groups
    Arm B: Dysport 250 units v Arm D: Placebo
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1542
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Placebo vs Dysport 500 units
    Comparison groups
    Arm C: Dysport 500 units v Arm D: Placebo
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8905
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Urodynamic Parameters: Mean Change from baseline in PMRV

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    End point title
    		 Urodynamic Parameters: Mean Change from baseline in PMRV
    End point description
    ITT population
    End point type
    Secondary
    End point timeframe
    Baseline(Day 1) to Week 12 (Visit 5)
    End point values
    		 Arm A: Dysport 125 units Arm B: Dysport 250 units Arm C: Dysport 500 units Arm D: Placebo
    Number of subjects analysed
    7
    13
    13
    15
    Units: mL
        arithmetic mean (standard deviation)
    -2 ± 41.19
    59.6 ± 91.86
    50.5 ± 67.29
    -1.6 ± 35.01
    Statistical analysis title
    		 Q1: Placebo vs Dysport 125 units
    Comparison groups
    Arm A: Dysport 125 units v Arm D: Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8791
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Q1: Placebo vs Dysport 250 units
    Comparison groups
    Arm B: Dysport 250 units v Arm D: Placebo
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5791
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Q1: Placebo vs Dysport 500 units
    Comparison groups
    Arm C: Dysport 500 units v Arm D: Placebo
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1101
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Median: Placebo vs Dysport 125 units
    Comparison groups
    Arm A: Dysport 125 units v Arm D: Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8791
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Median: Placebo vs Dysport 250 units
    Comparison groups
    Arm B: Dysport 250 units v Arm D: Placebo
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5791
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Median: Placebo vs Dysport 500 units
    Comparison groups
    Arm D: Placebo v Arm C: Dysport 500 units
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1101
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Q3: Placebo vs Dysport 125 units
    Comparison groups
    Arm A: Dysport 125 units v Arm D: Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9631
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Q3: Placebo vs Dysport 250 units
    Comparison groups
    Arm B: Dysport 250 units v Arm D: Placebo
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Q3: Placebo vs Dysport 500 units
    Comparison groups
    Arm C: Dysport 500 units v Arm D: Placebo
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0109
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Urodynamic Parameters: Mean change from baseline in Volume at First Desire to Void

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    End point title
    		 Urodynamic Parameters: Mean change from baseline in Volume at First Desire to Void
    End point description
    ITT population
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) to Week 12 (visit 5)
    End point values
    		 Arm A: Dysport 125 units Arm B: Dysport 250 units Arm C: Dysport 500 units Arm D: Placebo
    Number of subjects analysed
    7
    11
    13
    14
    Units: mL
        arithmetic mean (standard deviation)
    23.1 ± 21.63
    49.7 ± 79.89
    40.9 ± 74.42
    17.1 ± 54.27
    Statistical analysis title
    		 Placebo vs Dysport 125 units
    Comparison groups
    Arm A: Dysport 125 units v Arm D: Placebo
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6565
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Placebo vs Dysport 250 units
    Comparison groups
    Arm B: Dysport 250 units v Arm D: Placebo
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1284
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Placebo vs Dysport 500 units
    Comparison groups
    Arm C: Dysport 500 units v Arm D: Placebo
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0153
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Urodynamic Parameters: Mean change from Baseline in Volume at Urgency

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    End point title
    		 Urodynamic Parameters: Mean change from Baseline in Volume at Urgency
    End point description
    ITT population
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) to Week 12 (Visit 5)
    End point values
    		 Arm A: Dysport 125 units Arm B: Dysport 250 units Arm C: Dysport 500 units Arm D: Placebo
    Number of subjects analysed
    7
    12
    13
    14
    Units: mL
        arithmetic mean (standard deviation)
    25.4 ± 80.11
    48.5 ± 119.17
    112.2 ± 128.93
    21.6 ± 90.85
    Statistical analysis title
    		 Placebo vs Dysport 125 units
    Comparison groups
    Arm D: Placebo v Arm A: Dysport 125 units
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7295
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Placebo vs Dysport 250 units
    Comparison groups
    Arm B: Dysport 250 units v Arm D: Placebo
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8225
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Placebo vs Dysport 500 units
    Comparison groups
    Arm C: Dysport 500 units v Arm D: Placebo
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0055
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Urodynamic Parameters: Mean Change from baseline in MCC

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    End point title
    		 Urodynamic Parameters: Mean Change from baseline in MCC
    End point description
    ITT population
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) to Week 12 (Visit 5)
    End point values
    		 Arm A: Dysport 125 units Arm B: Dysport 250 units Arm C: Dysport 500 units Arm D: Placebo
    Number of subjects analysed
    7
    12
    13
    14
    Units: mL
        arithmetic mean (standard deviation)
    -26.6 ± 79.31
    53.6 ± 92.14
    101.8 ± 96.19
    -19 ± 79.32
    Statistical analysis title
    		 Placebo vs Dysport 125 units
    Comparison groups
    Arm D: Placebo v Arm A: Dysport 125 units
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8341
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Placebo vs Dysport 250 units
    Comparison groups
    Arm B: Dysport 250 units v Arm D: Placebo
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2712
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Placebo vs Dysport 500 units
    Comparison groups
    Arm C: Dysport 500 units v Arm D: Placebo
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Urodynamic Parameters: Mean change from baseline in Maximum Detrusor Pressure during Filling (Pdetmax)

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    End point title
    		 Urodynamic Parameters: Mean change from baseline in Maximum Detrusor Pressure during Filling (Pdetmax)
    End point description
    ITT population.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) to Week 12 (Visit 5)
    End point values
    		 Arm A: Dysport 125 units Arm B: Dysport 250 units Arm C: Dysport 500 units Arm D: Placebo
    Number of subjects analysed
    7
    12
    13
    14
    Units: cm H2O
        arithmetic mean (standard deviation)
    -6.3 ± 16.55
    -7.4 ± 30.62
    -9.5 ± 25.57
    -12.2 ± 27.6
    Statistical analysis title
    		 Placebo vs Dysport 125 units
    Comparison groups
    Arm A: Dysport 125 units v Arm D: Placebo
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4844
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Placebo vs Dysport 250 units
    Comparison groups
    Arm B: Dysport 250 units v Arm D: Placebo
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5393
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Placebo vs Dysport 500 units
    Comparison groups
    Arm C: Dysport 500 units v Arm D: Placebo
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8337
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Urodynamic Parameters: Mean change from baseline in Detrusor Pressure at Maximum Flow Rate

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    End point title
    		 Urodynamic Parameters: Mean change from baseline in Detrusor Pressure at Maximum Flow Rate
    End point description
    ITT population
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) to Week 12 (Visit 5)
    End point values
    		 Arm A: Dysport 125 units Arm B: Dysport 250 units Arm C: Dysport 500 units Arm D: Placebo
    Number of subjects analysed
    7
    11
    13
    14
    Units: cm H2O
        arithmetic mean (standard deviation)
    -4 ± 16.05
    -13 ± 34.81
    1.4 ± 26.61
    0.9 ± 16.99
    Statistical analysis title
    		 Placebo vs Dysport 125 units
    Comparison groups
    Arm A: Dysport 125 units v Arm D: Placebo
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9703
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Placebo vs Dysport 250 units
    Comparison groups
    Arm B: Dysport 250 units v Arm D: Placebo
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8713
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Placebo vs Dysport 500 units
    Comparison groups
    Arm C: Dysport 500 units v Arm D: Placebo
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6378
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Urodynamic Parameters: Mean change from baseline in Bladder Compliance

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    End point title
    		 Urodynamic Parameters: Mean change from baseline in Bladder Compliance
    End point description
    ITT population
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) to Week 12 (Visit 5)
    End point values
    		 Arm A: Dysport 125 units Arm B: Dysport 250 units Arm C: Dysport 500 units Arm D: Placebo
    Number of subjects analysed
    4
    11
    12
    11
    Units: mL/cm H2O
        arithmetic mean (standard deviation)
    21 ± 12.57
    27.3 ± 54.77
    33.3 ± 129.45
    0.7 ± 19.78
    Statistical analysis title
    		 Placebo vs Dysport 125 units
    Comparison groups
    Arm A: Dysport 125 units v Arm D: Placebo
    Number of subjects included in analysis
    15
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6866
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Placebo vs Dysport 250 units
    Comparison groups
    Arm B: Dysport 250 units v Arm D: Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.511
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Placebo vs Dysport 500 units
    Comparison groups
    Arm C: Dysport 500 units v Arm D: Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2322
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Mean change from baseline in QoL using EQ-5D

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    End point title
    		 Mean change from baseline in QoL using EQ-5D
    End point description
    ITT population EuroQol-5D (EQ-5D): Self-reported health outcome measure, consisting of Part I: Descriptive system & Part II: Visual Analogue Scale (VAS). Part I has 5 single-item dimensions: Mobility, Self-care, Usual activities, Pain/Discomfort, & Anxiety/Depression. Each dimension has a 5 point response scale indicating problem level, where 5=Best health & 25=Worst health. Part II uses a vertical graduated VAS (thermometer), ranging from 0 (Worst health) to 100 (Best health).
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) to Week 6 (Visit 4) and Week 12 (Visit 5)
    End point values
    		 Arm A: Dysport 125 units Arm B: Dysport 250 units Arm C: Dysport 500 units Arm D: Placebo
    Number of subjects analysed
    7 [7]
    16 [8]
    14 [9]
    16
    Units: Unit on a scale
    arithmetic mean (standard deviation)
        Mobility (Week 6)
    0 ± 0
    0 ± 0.4
    -0.1 ± 0.3
    -0.1 ± 0.3
        Self-care (Week 6)
    0 ± 0
    0 ± 0
    0 ± 0
    0 ± 0
        Usual Activities (Week 6)
    0 ± 0
    0 ± 0
    0.1 ± 0.4
    0 ± 0
        Pain/Discomfort (Week 6)
    -0.3 ± 0.5
    0.1 ± 0.3
    -0.2 ± 0.4
    -0.3 ± 0.7
        Anxious/Depressed (Week 6)
    0 ± 0
    0 ± 0.4
    0 ± 0.4
    -0.1 ± 0.5
        Mobility (Week 12)
    0 ± 0
    0 ± 0.4
    -0.1 ± 0.4
    0 ± 0
        Self-care (Week 12)
    0 ± 0
    0 ± 0
    0 ± 0
    0 ± 0
        Usual Activities (Week 12)
    0 ± 0
    0.1 ± 0.3
    0.1 ± 0.3
    0.1 ± 0.4
        Pain/Discomfort (Week 12)
    -0.3 ± 0.5
    0.1 ± 0.5
    0.1 ± 0.7
    -0.2 ± 0.7
        Anxious/Depressed (Week 12)
    0 ± 0
    -0.1 ± 0.5
    0.1 ± 0.5
    -0.1 ± 0.6
    Notes
    [7] - Week 12 (Visit 5): N=6
    [8] - Week 12 (Visit 5): N=15. Anxious/Depressed Week 12: N=14.
    [9] - Pain/Discomfort Week 6: N=13
    No statistical analyses for this end point

    Secondary: Number of subjects who are normalised

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    End point title
    		 Number of subjects who are normalised
    End point description
    ITT population Normalised defined as micturitions <8 per 24 h
    End point type
    Secondary
    End point timeframe
    Week 6 and Week 12
    End point values
    		 Arm A: Dysport 125 units Arm B: Dysport 250 units Arm C: Dysport 500 units Arm D: Placebo
    Number of subjects analysed
    7
    16
    14
    16
    Units: Number of subjects
        Week 6
    4
    3
    5
    5
        Week 12
    6
    2
    4
    4
    Statistical analysis title
    		 Normalized: Placebo vs Dysport 125 units (Week 6)
    Comparison groups
    Arm A: Dysport 125 units v Arm D: Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2967
    Method
    		 Regression, Logistic
    Confidence interval
    Statistical analysis title
    		 Normalized: Placebo vs Dysport 250 units (Week 6)
    Comparison groups
    Arm B: Dysport 250 units v Arm D: Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4129
    Method
    		 Regression, Logistic
    Confidence interval
    Statistical analysis title
    		 Normalized: Placebo vs Dysport 500 units (Week 6)
    Comparison groups
    Arm C: Dysport 500 units v Arm D: Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7777
    Method
    		 Regression, Logistic
    Confidence interval
    Statistical analysis title
    		 Normalized: Placebo vs Dysport 125 units (Week 12)
    Comparison groups
    Arm A: Dysport 125 units v Arm D: Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0183
    Method
    		 Regression, Logistic
    Confidence interval
    Statistical analysis title
    		 Normalized: Placebo vs Dysport 250 units (Week 12)
    Comparison groups
    Arm B: Dysport 250 units v Arm D: Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4691
    Method
    		 Regression, Logistic
    Confidence interval
    Statistical analysis title
    		 Normalized: Placebo vs Dysport 500 units (Week 12)
    Comparison groups
    Arm C: Dysport 500 units v Arm D: Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8254
    Method
    		 Regression, Logistic
    Confidence interval

    Secondary: Number of subjects who Reported No Incidence of Urgencies

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    End point title
    		 Number of subjects who Reported No Incidence of Urgencies
    End point description
    ITT population.
    End point type
    Secondary
    End point timeframe
    At Week 6 and Week 12
    End point values
    		 Arm A: Dysport 125 units Arm B: Dysport 250 units Arm C: Dysport 500 units Arm D: Placebo
    Number of subjects analysed
    7
    16
    14
    16
    Units: Number of subjects
        Week 6
    0
    0
    0
    0
        Week 12
    0
    3
    1
    1
    Statistical analysis title
    		 Placebo vs Dysport 125 units (Week 12)
    Comparison groups
    Arm A: Dysport 125 units v Arm D: Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9709
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Placebo vs Dysport 250 units (Week 12)
    Comparison groups
    Arm B: Dysport 250 units v Arm D: Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2182
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Placebo vs Dysport 500 units (Week 12)
    Comparison groups
    Arm C: Dysport 500 units v Arm D: Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9297
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Number of subjects who are Responders with Respect to Both Urgency and Micturitions

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    End point title
    		 Number of subjects who are Responders with Respect to Both Urgency and Micturitions
    End point description
    ITT population Responders defined as decrease of at least 25% of the number of urgency and micturition episodes from Baseline Positive response is defined as >= 25% reduction compared to baseline in both urgency and micturitions
    End point type
    Secondary
    End point timeframe
    At week 6 and week 12
    End point values
    		 Arm A: Dysport 125 units Arm B: Dysport 250 units Arm C: Dysport 500 units Arm D: Placebo
    Number of subjects analysed
    7
    16
    14
    16
    Units: Number of subjects
        Week 6
    5
    7
    6
    5
        Week 12
    6
    6
    8
    7
    Statistical analysis title
    		 Placebo vs Dysport 125 units (Week 6)
    Comparison groups
    Arm A: Dysport 125 units v Arm D: Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1075
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Placebo vs Dysport 250 units (Week 6)
    Comparison groups
    Arm B: Dysport 250 units v Arm D: Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4577
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Placebo vs Dysport 500 units (Week 6)
    Comparison groups
    Arm C: Dysport 500 units v Arm D: Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.49
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Placebo vs Dysport 125 units (Week 12)
    Comparison groups
    Arm A: Dysport 125 units v Arm D: Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0865
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Placebo vs Dysport 250 units (Week 12)
    Comparison groups
    Arm B: Dysport 250 units v Arm D: Placebo
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9607
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Placebo vs Dysport 500 units (Week 12)
    Comparison groups
    Arm C: Dysport 500 units v Arm D: Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4656
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Safety: Number of subjects reporting adverse events (AEs) - Princeps and Extension phases

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    End point title
    		 Safety: Number of subjects reporting adverse events (AEs) - Princeps and Extension phases
    End point description
    Safety population. Treatment Emergent Adverse Event (TEAE) Serious Adverse Events (SAEs)
    End point type
    Secondary
    End point timeframe
    Up to Month 9 (Visit 7E)
    End point values
    		 Arm A: Dysport 125 units Arm B: Dysport 250 units Arm C: Dysport 500 units Arm D: Placebo
    Number of subjects analysed
    9
    17
    18
    17
    Units: Number of subjects
        Adverse Events
    2
    7
    7
    5
        TEAEs
    2
    7
    7
    4
        Mild (TEAEs)
    0
    0
    5
    3
        Moderate (TEAEs)
    1
    5
    2
    1
        Severe (TEAEs)
    1
    2
    0
    0
        Related (TEAEs)
    1
    4
    3
    2
        Not Related (TEAEs)
    1
    3
    4
    2
        TEAEs Leading to Drug Withdrawal
    0
    0
    0
    0
        TEAEs Leading to Death
    0
    0
    0
    0
        SAEs
    1
    1
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Month 9 (Visit 7E)
    Adverse event reporting additional description
    Safety population
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    Arm A: Dysport 125 units
    Reporting group description
    		 Dysport 125 units single injection

    Reporting group title
    Arm B: Dysport 250 units
    Reporting group description
    		 Dysport 250 units single injection

    Reporting group title
    Arm C: Dysport 500 units
    Reporting group description
    		 Dysport 500 units single injection

    Reporting group title
    Arm D: Placebo
    Reporting group description
    		 Placebo 0 units single injection

    Serious adverse events
    		 Arm A: Dysport 125 units Arm B: Dysport 250 units Arm C: Dysport 500 units Arm D: Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder cancer
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Arm A: Dysport 125 units Arm B: Dysport 250 units Arm C: Dysport 500 units Arm D: Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 9 (22.22%)
    7 / 17 (41.18%)
    7 / 18 (38.89%)
    4 / 17 (23.53%)
    Investigations
    Residual urine volume increased
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Headache
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Injection site pain
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastrointestinal disorders
    Defaecation urgency
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 17 (5.88%)
    1 / 18 (5.56%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    1
    1
    Abdominal discomfort
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Abdominal distension
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    1
    Abdominal pain
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Cough
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Renal and urinary disorders
    Micturition urgency
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Urethral pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Urinary incontinence
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 17 (5.88%)
    1 / 18 (5.56%)
    2 / 17 (11.76%)
         occurrences all number
    0
    2
    1
    2
    Bladder pain
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dysuria
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    1
    Urethral stenosis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Urge incontinence
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    1
    Urinary retention
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Tendonitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Infections and infestations
    Viral infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 17 (0.00%)
    2 / 18 (11.11%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 17 (11.76%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
         occurrences all number
    1
    3
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Jan 2008
    Addition of following exclusion criterion: - The subject has any relevant neurological conditions or history of dysphagia or history of aspiration pneumonia.

    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.
    Due to insufficient subject enrolment, the study was stopped prematurely.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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