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    Clinical Trial Results:
    A PHASE IIA, MULTICENTRE, DOUBLE BLIND, SINGLE DOSE, PARALLEL GROUP, PLACEBO CONTROLLED, CLINICAL PILOT STUDY TO ASSESS THE EFFICACY AND SAFETY OF SINGLE DOSE, INTRA-DETRUSOR INJECTIONS OF 750 UNITS OF DYSPORT IN SUBJECTS SUFFERING FROM NEUROGENIC DETRUSOR OVERACTIVITY FOLLOWING SPINAL CORD INJURY OR MULTIPLE SCLEROSIS

    Summary
    EudraCT number
    2010-023210-31
    Trial protocol
    DE   AT   IT   LT   CZ  
    Global end of trial date
    21 Mar 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    11 Mar 2016
    First version publication date
    11 Mar 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Y52-52120-155
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01357980
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Ipsen Pharma
    Sponsor organisation address
    65 quai Georges Gorse, Boulogne-Billancourt , France, 92100
    Public contact
    Christine Seymour, Ipsen Innovation, +33 (0)160 92 95 38, ct-application@ipsen.com
    Scientific contact
    Philippe Picaut, Ipsen Innovation, +33 (0)160 92 95 38, ct-application@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
    03 Oct 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Mar 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Mar 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary study objective is to assess the efficacy of a single dose of Dysport (750 U) compared to placebo for the improvement in the daily incontinence episode frequency (IEF) for each administration mode (15 or 30 injection sites).
    Protection of trial subjects
    The study was conducted under the provisions of the Declaration of Helsinki, IECs, informed consent regulations, International Conference on HarmonisationConsolidated Guideline on GCP [2] and also adhered to all applicable local regulatory requirements.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    23 May 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Efficacy, Safety
    Long term follow-up duration
    4 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Czech Republic: 4
    Country: Number of subjects enrolled
    France: 32
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    Poland: 3
    Worldwide total number of subjects
    47
    EEA total number of subjects
    47
    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)
    46
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Patients were planned to be recruited at 22 centres in six countries (Austria, the Czech Republic, Germany, France, Italy and Poland), and patients were actually enrolled at 17 centres in five countries (the Czech Republic, Germany, France, Italy and Poland)

    Pre-assignment
    Screening details
    A screening visit was performed four to seven days prior to Baseline (Day -7 to Day -4). At Baseline, 47 subjects were randomised in a ratio of 5:2:5:2 to one of the four treatment groups.

    Period 1
    Period 1 title
    Randomisation
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator
    Blinding implementation details
    The blind was maintained for the preparation of each subject’s study treatment for injection, maintaining the blind for the subject, the investigator and the remainder of the project team.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Dysport 750 U (15 Injection Sites)
    Arm description
    Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
    Arm type
    Experimental

    Investigational medicinal product name
    Dysport®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    750 U with 0.5 ml per injection site

    Arm title
    Placebo (15 Injection Sites)
    Arm description
    Placebo: Intra detrusor injection on day 1 (single dose)
    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
    0.5 ml per injection site

    Arm title
    Dysport 750 U (30 Injection Sites)
    Arm description
    Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
    Arm type
    Experimental

    Investigational medicinal product name
    Dysport®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    750 U with 0.5 ml per injection site

    Arm title
    Placebo (30 Injection Sites)
    Arm description
    Placebo: Intra detrusor injection on day 1 (single dose)
    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
    0.5 ml per injection site

    Number of subjects in period 1
    Dysport 750 U (15 Injection Sites) Placebo (15 Injection Sites) Dysport 750 U (30 Injection Sites) Placebo (30 Injection Sites)
    Started
    16
    7
    17
    7
    Completed
    16
    6
    16
    7
    Not completed
    0
    1
    1
    0
         Consent withdrawn by subject
    -
    -
    1
    -
         Lack of efficacy
    -
    1
    -
    -
    Period 2
    Period 2 title
    Intent To Treat (ITT) population
    Is this the baseline period?
    Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Dysport 750 U (15 Injection Sites)
    Arm description
    Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
    Arm type
    Experimental

    Investigational medicinal product name
    Dysport®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    750 U with 0.5 ml per injection site

    Arm title
    Placebo (15 Injection Sites)
    Arm description
    Placebo: Intra detrusor injection on day 1 (single dose)
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo (15 Injection Sites)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 ml per injection site

    Arm title
    Dysport 750 U (30 Injection Sites)
    Arm description
    Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
    Arm type
    Experimental

    Investigational medicinal product name
    Dysport®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    750 U with 0.5 ml per injection site

    Arm title
    Placebo (30 Injection Sites)
    Arm description
    Placebo: Intra detrusor injection on day 1 (single dose)
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo (30 Injection Sites)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 ml per injection site

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Baseline characteristics are assessed for ITT group. Period 1 is for all randomized subjects [Randomization group] Period 2 is for all Intent To Treat (ITT) population
    Number of subjects in period 2 [2] [3]
    Dysport 750 U (15 Injection Sites) Placebo (15 Injection Sites) Dysport 750 U (30 Injection Sites) Placebo (30 Injection Sites)
    Started
    14
    6
    16
    6
    Completed
    14
    6
    16
    6
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Worldwide numbers reported are per all randomized subjects (Randomization group) However, baseline and outcomes are reported per Intent To Treat (ITT) population
    [3] - 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: Subjects started in Period 2 (ITT subjects) are not dependent on subjects completed in Period 1 (randomized subjects). ITT population, which consisted of all randomized subjects who received at least one injection of study medication and completed assessment for the averaged daily IEF both at Baseline and at Day 84 (Visit 6). Of the 47 subjects randomized, 42 (89.4%) subjects were included in the ITT population. 5 subjects who did not have IEF data at Baseline and/or at Day 84 were excluded

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dysport 750 U (15 Injection Sites)
    Reporting group description
    Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)

    Reporting group title
    Placebo (15 Injection Sites)
    Reporting group description
    Placebo: Intra detrusor injection on day 1 (single dose)

    Reporting group title
    Dysport 750 U (30 Injection Sites)
    Reporting group description
    Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)

    Reporting group title
    Placebo (30 Injection Sites)
    Reporting group description
    Placebo: Intra detrusor injection on day 1 (single dose)

    Reporting group values
    Dysport 750 U (15 Injection Sites) Placebo (15 Injection Sites) Dysport 750 U (30 Injection Sites) Placebo (30 Injection Sites) Total
    Number of subjects
    14 6 16 6 42
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    41.1 ± 12.1 46.5 ± 10.7 50.5 ± 11.1 40.8 ± 10.6 -
    Gender categorical
    Units: Subjects
        Female
    7 2 12 2 23
        Male
    7 4 4 4 19
    Number of subjects with Spinal Cord Injury (SCI) or Multiple Sclerosis (MS)
    Units: Subjects
        SCI
    9 4 7 2 22
        MS
    5 2 9 4 20
    Number of Subjects Using Anticholinergics
    Units: Subjects
        Yes
    9 5 9 5 28
        No
    5 1 7 1 14

    End points

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    End points reporting groups
    Reporting group title
    Dysport 750 U (15 Injection Sites)
    Reporting group description
    Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)

    Reporting group title
    Placebo (15 Injection Sites)
    Reporting group description
    Placebo: Intra detrusor injection on day 1 (single dose)

    Reporting group title
    Dysport 750 U (30 Injection Sites)
    Reporting group description
    Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)

    Reporting group title
    Placebo (30 Injection Sites)
    Reporting group description
    Placebo: Intra detrusor injection on day 1 (single dose)
    Reporting group title
    Dysport 750 U (15 Injection Sites)
    Reporting group description
    Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)

    Reporting group title
    Placebo (15 Injection Sites)
    Reporting group description
    Placebo: Intra detrusor injection on day 1 (single dose)

    Reporting group title
    Dysport 750 U (30 Injection Sites)
    Reporting group description
    Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)

    Reporting group title
    Placebo (30 Injection Sites)
    Reporting group description
    Placebo: Intra detrusor injection on day 1 (single dose)

    Primary: Daily Incontinence Episode Frequency (IEF)

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    End point title
    Daily Incontinence Episode Frequency (IEF)
    End point description
    Analysis based on number of subjects in the Intent to Treat (ITT) population.
    End point type
    Primary
    End point timeframe
    Baseline and Day 84
    End point values
    Dysport 750 U (15 Injection Sites) Placebo (15 Injection Sites) Dysport 750 U (30 Injection Sites) Placebo (30 Injection Sites)
    Number of subjects analysed
    14
    6
    16
    6
    Units: episodes per day
    arithmetic mean (standard deviation)
        Baseline
    4.21 ± 2.32
    3.33 ± 2.87
    3.23 ± 1.26
    4.4 ± 1.55
        Change from baseline to Day 84
    -3.51 ± 2.8
    -1.05 ± 2.95
    -2.86 ± 1.43
    -3.4 ± 1.49
    Statistical analysis title
    Daily Incontinence Episode Frequency (IEF)
    Statistical analysis description
    Statistical Analysis 1 Comparison of the average Daily IEF change from baseline to DAY 84 using ANCOVA with the baseline average daily IEF value as covariate.
    Comparison groups
    Dysport 750 U (15 Injection Sites) v Placebo (15 Injection Sites)
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.11
    Method
    ANCOVA
    Confidence interval
    Statistical analysis title
    Daily Incontinence Episode Frequency (IEF)
    Statistical analysis description
    Statistical Analysis 2 Comparison of the average Daily IEF change from baseline to DAY 84 using ANCOVA with the baseline average daily IEF value as covariate.
    Comparison groups
    Placebo (30 Injection Sites) v Dysport 750 U (30 Injection Sites)
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.07
    Method
    ANCOVA
    Confidence interval

    Secondary: Urodynamics: Maximum Cystometric Capacity

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    End point title
    Urodynamics: Maximum Cystometric Capacity
    End point description
    Maximum Cystometric Capacity is an urodynamic parameter that indicates the volume at which a patient feels he (she) can no longer delay release of urine from the urinary bladder. Baseline urodynamics exams done at screening visit. Analysis based on number (n) of subjects with a valid value in the Intent-to-Treat (ITT) population for the respective treatment groups.
    End point type
    Secondary
    End point timeframe
    Baseline, Days 14, 42 and 84
    End point values
    Dysport 750 U (15 Injection Sites) Placebo (15 Injection Sites) Dysport 750 U (30 Injection Sites) Placebo (30 Injection Sites)
    Number of subjects analysed
    14
    6
    16
    6
    Units: mL
    arithmetic mean (standard deviation)
        Baseline (n=14,5,16,6)
    281 ± 186
    287 ± 112
    288 ± 144
    220 ± 55
        Change from baseline to D14 (n=14,5,16,6)
    186 ± 160
    -36 ± 140
    169 ± 92
    -33 ± 88
        Change from baseline to D42 (n=14,6,15,6)
    163 ± 208
    45 ± 64
    185 ± 174
    3 ± 94
        Change from baseline to D84 (n=14,5,16,6)
    150 ± 174
    12.5 ± 26
    196 ± 135
    50 ± 145
    Statistical analysis title
    Urodynamics: Maximum Cystometric Capacity
    Statistical analysis description
    Statistical Analysis 1 Comparison of the maximum Cystometric Capacity change from baseline to DAY 14 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.
    Comparison groups
    Dysport 750 U (15 Injection Sites) v Placebo (15 Injection Sites)
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.01
    Method
    ANCOVA
    Confidence interval
    Statistical analysis title
    Urodynamics: Maximum Cystometric Capacity
    Statistical analysis description
    Statistical Analysis 2 Comparison of the maximum Cystometric Capacity change from baseline to DAY 14 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.
    Comparison groups
    Dysport 750 U (30 Injection Sites) v Placebo (30 Injection Sites)
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.01
    Method
    ANCOVA
    Confidence interval
    Statistical analysis title
    Urodynamics: Maximum Cystometric Capacity
    Statistical analysis description
    Statistical Analysis 3 Comparison of the maximum Cystometric Capacity change from baseline to DAY 42 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.
    Comparison groups
    Dysport 750 U (15 Injection Sites) v Placebo (15 Injection Sites)
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.09
    Method
    ANCOVA
    Confidence interval
    Statistical analysis title
    Urodynamics: Maximum Cystometric Capacity
    Statistical analysis description
    Statistical Analysis 4 Comparison of the maximum Cystometric Capacity change from baseline to DAY 42 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.
    Comparison groups
    Dysport 750 U (30 Injection Sites) v Placebo (30 Injection Sites)
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.01
    Method
    ANCOVA
    Confidence interval
    Statistical analysis title
    Urodynamics: Maximum Cystometric Capacity
    Statistical analysis description
    Statistical Analysis 5 Comparison of the maximum Cystometric Capacity change from baseline to DAY 84 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.
    Comparison groups
    Dysport 750 U (15 Injection Sites) v Placebo (15 Injection Sites)
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.01
    Method
    ANCOVA
    Confidence interval
    Statistical analysis title
    Urodynamics: Maximum Cystometric Capacity
    Statistical analysis description
    Statistical Analysis 6 Comparison of the maximum Cystometric Capacity change from baseline to DAY 84 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.
    Comparison groups
    Dysport 750 U (30 Injection Sites) v Placebo (30 Injection Sites)
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.01
    Method
    ANCOVA
    Confidence interval

    Secondary: Urodynamics:Maximum Detrusor Pressure

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    End point title
    Urodynamics:Maximum Detrusor Pressure
    End point description
    Maximum Detrusor Pressure is an urodynamic parameter that is the maximum value of the pressure within the bladder which is measured during the filling phase of the urodynamic exam. Baseline urodynamics exams done at screening visit. Analysis based on number (n) of subjects with a valid value in the Intent-to-Treat (ITT) population for the respective treatment groups.
    End point type
    Secondary
    End point timeframe
    Baseline, Days 14, 42 and 84
    End point values
    Dysport 750 U (15 Injection Sites) Placebo (15 Injection Sites) Dysport 750 U (30 Injection Sites) Placebo (30 Injection Sites)
    Number of subjects analysed
    14
    6
    16
    6
    Units: cm water (cm H20)
    arithmetic mean (standard deviation)
        Baseline (n=14,5,15,6)
    59 ± 44
    53 ± 40
    46 ± 28
    70 ± 23
        Change from baseline to D14 (n=14,5,16,6)
    -24 ± 53
    -4 ± 18
    -27 ± 22
    27 ± 48
        Change from baseline to D42 (n=14,6,15,6)
    -41 ± 40
    0 ± 14
    -24 ± 24
    10 ± 42
        Change from baseline to D84 (n=13,5,16,6)
    -26 ± 46
    4 ± 18
    -20 ± 23
    12 ± 29
    Statistical analysis title
    Urodynamics:Maximum Detrusor Pressure
    Statistical analysis description
    Statistical Analysis 1 Comparison of the maximum Detrusor Pressure change from baseline to DAY 14 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.
    Comparison groups
    Placebo (15 Injection Sites) v Dysport 750 U (15 Injection Sites)
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.25
    Method
    ANCOVA
    Confidence interval
    Statistical analysis title
    Urodynamics:Maximum Detrusor Pressure
    Statistical analysis description
    Statistical Analysis 2 Comparison of the maximum Detrusor Pressure change from baseline to DAY 14 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.
    Comparison groups
    Dysport 750 U (30 Injection Sites) v Placebo (30 Injection Sites)
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.01
    Method
    ANCOVA
    Confidence interval
    Statistical analysis title
    Urodynamics:Maximum Detrusor Pressure
    Statistical analysis description
    Statistical Analysis 3 Comparison of the maximum Detrusor Pressure change from baseline to DAY 42 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.
    Comparison groups
    Dysport 750 U (15 Injection Sites) v Placebo (15 Injection Sites)
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.03
    Method
    ANCOVA
    Confidence interval
    Statistical analysis title
    Urodynamics:Maximum Detrusor Pressure
    Statistical analysis description
    Statistical Analysis 4 Comparison of the maximum Detrusor Pressure change from baseline to DAY 42 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.
    Comparison groups
    Dysport 750 U (30 Injection Sites) v Placebo (30 Injection Sites)
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.01
    Method
    ANCOVA
    Confidence interval
    Statistical analysis title
    Urodynamics:Maximum Detrusor Pressure
    Statistical analysis description
    Statistical Analysis 5 Comparison of the maximum Detrusor Pressure change from baseline to DAY 84 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.
    Comparison groups
    Dysport 750 U (15 Injection Sites) v Placebo (15 Injection Sites)
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.01
    Method
    ANCOVA
    Confidence interval
    Statistical analysis title
    Urodynamics:Maximum Detrusor Pressure
    Statistical analysis description
    Statistical Analysis 6 Comparison of the maximum Detrusor Pressure change from baseline to DAY 84 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.
    Comparison groups
    Dysport 750 U (30 Injection Sites) v Placebo (30 Injection Sites)
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.01
    Method
    ANCOVA
    Confidence interval

    Secondary: Physician's Global Assessment Score of Treatment Response

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    End point title
    Physician's Global Assessment Score of Treatment Response
    End point description
    The subject’s treatment response was assessed by the physician and graded as ‘markedly worse’, ‘much worse’, ‘worse’, ‘slightly worse’, ‘no change’, ‘slightly improved’, ‘improved’, ‘much improved’, or ‘markedly improved’. Analysis based on number of subjects in the Intent to Treat (ITT) population.
    End point type
    Secondary
    End point timeframe
    Day 14
    End point values
    Dysport 750 U (15 Injection Sites) Placebo (15 Injection Sites) Dysport 750 U (30 Injection Sites) Placebo (30 Injection Sites)
    Number of subjects analysed
    14
    6
    16
    6
    Units: participants
        Markedly worse
    0
    0
    0
    0
        Much worse
    0
    0
    0
    0
        Worse
    0
    0
    0
    0
        Slightly worse
    1
    1
    0
    1
        No change
    2
    3
    1
    3
        Slightly improved
    0
    0
    0
    0
        Improved
    3
    1
    4
    2
        Much improved
    4
    1
    8
    0
        Markedly improved
    4
    0
    3
    0
    Statistical analysis title
    PGA Score of Treatment Response
    Statistical analysis description
    Statistical Analysis 1
    Comparison groups
    Placebo (15 Injection Sites) v Dysport 750 U (15 Injection Sites)
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    [1]
    P-value
    = 0.05
    Method
    Satterthwaite-Welch’s t-test
    Confidence interval
    Notes
    [1] - Statistical Analysis 1 Comparison of the Physician's Global Assessment score at DAY 14 using a two sided Satterthwaite-Welch’s t-test for independent samples.
    Statistical analysis title
    PGA Score of Treatment Response
    Statistical analysis description
    Statistical Analysis 2 Comparison of the Physician's Global Assessment score at DAY 14 using a two sided Satterthwaite-Welch’s t-test for independent samples.
    Comparison groups
    Dysport 750 U (30 Injection Sites) v Placebo (30 Injection Sites)
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.01
    Method
    Satterthwaite-Welch’s t-test
    Confidence interval

    Secondary: Physician's Global Assessment Score of Treatment Response

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    End point title
    Physician's Global Assessment Score of Treatment Response
    End point description
    The subject’s treatment response was assessed by the physician and graded as ‘markedly worse’, ‘much worse’, ‘worse’, ‘slightly worse’, ‘no change’, ‘slightly improved’, ‘improved’, ‘much improved’, or ‘markedly improved’. Analysis based on number of subjects in the Intent to Treat (ITT) population.
    End point type
    Secondary
    End point timeframe
    Day 42
    End point values
    Dysport 750 U (15 Injection Sites) Placebo (15 Injection Sites) Dysport 750 U (30 Injection Sites) Placebo (30 Injection Sites)
    Number of subjects analysed
    14
    6
    16
    6
    Units: participants
        Markedly worse
    0
    0
    0
    0
        Much worse
    0
    0
    0
    0
        Worse
    0
    0
    0
    0
        Slightly worse
    0
    1
    1
    0
        No change
    1
    3
    0
    3
        Slightly improved
    0
    0
    0
    0
        Improved
    3
    1
    4
    3
        Much improved
    5
    1
    7
    0
        Markedly improved
    5
    0
    4
    0
    Statistical analysis title
    PGA Score of Treatment Response
    Statistical analysis description
    Statistical Analysis 1 Comparison of the Physician's Global Assessment score at DAY 42 using a two sided Satterthwaite-Welch’s t-test for independent samples.
    Comparison groups
    Dysport 750 U (15 Injection Sites) v Placebo (15 Injection Sites)
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.01
    Method
    Satterthwaite-Welch’s t-test
    Confidence interval
    Statistical analysis title
    PGA Score of Treatment Response
    Statistical analysis description
    Statistical Analysis 2 Comparison of the Physician's Global Assessment score at DAY 42 using a two sided Satterthwaite-Welch’s t-test for independent samples.
    Comparison groups
    Dysport 750 U (30 Injection Sites) v Placebo (30 Injection Sites)
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.01
    Method
    Satterthwaite-Welch’s t-test
    Confidence interval

    Secondary: Physician's Global Assessment Score of Treatment Response

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    End point title
    Physician's Global Assessment Score of Treatment Response
    End point description
    The subject’s treatment response was assessed by the physician and graded as ‘markedly worse’, ‘much worse’, ‘worse’, ‘slightly worse’, ‘no change’, ‘slightly improved’, ‘improved’, ‘much improved’, or ‘markedly improved’. Analysis based on number of subjects in the Intent to Treat (ITT) population.
    End point type
    Secondary
    End point timeframe
    Day 84
    End point values
    Dysport 750 U (15 Injection Sites) Placebo (15 Injection Sites) Dysport 750 U (30 Injection Sites) Placebo (30 Injection Sites)
    Number of subjects analysed
    14
    6
    16
    6
    Units: participants
        Markedly worse
    0
    0
    0
    0
        Much worse
    0
    0
    0
    0
        Worse
    0
    1
    0
    0
        Slightly worse
    0
    0
    0
    0
        No change
    1
    2
    1
    4
        Slightly improved
    2
    1
    0
    0
        Improved
    2
    1
    4
    2
        Much improved
    6
    1
    7
    0
        Markedly improved
    3
    0
    4
    0
    Statistical analysis title
    PGA Score of Treatment Response
    Statistical analysis description
    Statistical Analysis 1 Comparison of the Physician's Global Assessment score at DAY 84 using a two sided Satterthwaite-Welch's t-test for independent samples.
    Comparison groups
    Dysport 750 U (15 Injection Sites) v Placebo (15 Injection Sites)
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.05
    Method
    Satterthwaite-Welch’s t-test
    Confidence interval
    Statistical analysis title
    PGA Score of Treatment Response
    Statistical analysis description
    Statistical Analysis 2 Comparison of the Physician's Global Assessment score at DAY 84 using a two sided Satterthwaite-Welch's t-test for independent samples.
    Comparison groups
    Dysport 750 U (30 Injection Sites) v Placebo (30 Injection Sites)
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.01
    Method
    Satterthwaite-Welch’s t-test
    Confidence interval

    Secondary: Quality of Life (QoL) Total Summary Score

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    End point title
    Quality of Life (QoL) Total Summary Score
    End point description
    Mean Change from Baseline in Short Form (SF)-Qualiveen Questionnaire Calculated Total Score. The SF-Qualiveen questionnaire is a specific health related QoL questionnaire validated for urinary disorders in subjects with neurological conditions containing 8 items looking at four scales: limitations (2 items); constraints (2 items); fears (2 items) and feelings (2 items). The 8 items each having a 5-point Likert-type scale ranging from 0=“Not at all” to 4=“Extremely” for the first 6 items, from 0=“Never” to 4=“Always” for item 7 and from 0=”Always” to 4=”Never” for item 8. The score per scale has been calculated as the mean of the two items. In case of one missing item among the 2 items for a given scale, the score has not been calculated. Total score has been calculated as the mean of all the items completed among the 8 items. Lower scores indicate a better QoL (i.e. no limitations, fears, constraints, or negative feelings) and higher scores indicate poorer QoL. Analysis -ITT
    End point type
    Secondary
    End point timeframe
    Baseline, 14, 42 and 84
    End point values
    Dysport 750 U (15 Injection Sites) Placebo (15 Injection Sites) Dysport 750 U (30 Injection Sites) Placebo (30 Injection Sites)
    Number of subjects analysed
    14
    6
    16
    6
    Units: Score on scale
    arithmetic mean (standard deviation)
        Baseline
    2.4 ± 0.7
    2.7 ± 0.6
    2.4 ± 0.8
    2.3 ± 1
        Change from baseline to D14
    -1.1 ± 0.9
    -0.2 ± 1
    -0.8 ± 0.8
    -0.5 ± 1.3
        Change from baseline to D42
    -1 ± 0.8
    -0.6 ± 1.2
    -1.2 ± 0.8
    -0.6 ± 1.1
        Change from baseline to D84
    -1.3 ± 1
    -0.2 ± 0.7
    -1.2 ± 0.9
    -0.7 ± 1.1
    Statistical analysis title
    Quality of Life (QoL) Total Summary Score
    Statistical analysis description
    Statistical Analysis 1 Comparison of the Quality of Life Total Summary score change from baseline to DAY 14 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.
    Comparison groups
    Dysport 750 U (15 Injection Sites) v Placebo (15 Injection Sites)
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.01
    Method
    ANCOVA
    Confidence interval
    Statistical analysis title
    Quality of Life (QoL) Total Summary Score
    Statistical analysis description
    Statistical Analysis 2 Comparison of the Quality of Life Total Summary score change from baseline to DAY 14 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.
    Comparison groups
    Dysport 750 U (30 Injection Sites) v Placebo (30 Injection Sites)
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.7
    Method
    ANCOVA
    Confidence interval
    Statistical analysis title
    Quality of Life (QoL) Total Summary Score
    Statistical analysis description
    Statistical Analysis 3 Comparison of the Quality of Life Total Summary score change from baseline to DAY 42 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.
    Comparison groups
    Dysport 750 U (15 Injection Sites) v Placebo (15 Injection Sites)
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.3
    Method
    ANCOVA
    Confidence interval
    Statistical analysis title
    Quality of Life (QoL) Total Summary Score
    Statistical analysis description
    Statistical Analysis 4 Comparison of the Quality of Life Total Summary score change from baseline to DAY 42 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.
    Comparison groups
    Dysport 750 U (30 Injection Sites) v Placebo (30 Injection Sites)
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.3
    Method
    ANCOVA
    Confidence interval
    Statistical analysis title
    Quality of Life (QoL) Total Summary Score
    Statistical analysis description
    Statistical Analysis 5 Comparison of the Quality of Life Total Summary score change from baseline to DAY 84 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.
    Comparison groups
    Dysport 750 U (15 Injection Sites) v Placebo (15 Injection Sites)
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.01
    Method
    ANCOVA
    Confidence interval
    Statistical analysis title
    Quality of Life (QoL) Total Summary Score
    Statistical analysis description
    Statistical Analysis 6 Comparison of the Quality of Life Total Summary score change from baseline to DAY 84 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.
    Comparison groups
    Dysport 750 U (30 Injection Sites) v Placebo (30 Injection Sites)
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.4
    Method
    ANCOVA
    Confidence interval

    Secondary: Pain Visual Analogue Scale (VAS) Score: Before Treatment Injection

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    End point title
    Pain Visual Analogue Scale (VAS) Score: Before Treatment Injection
    End point description
    Analysis based on number of subjects in the Intent to Treat (ITT) population. Pain assessment using the VAS. The VAS is a 100-mm (10-cm) scoring scale. Score range on VAS is from 0 to 100 where zero [0]indicates no pain and 100 indicates worst possible pain.
    End point type
    Secondary
    End point timeframe
    Baseline
    End point values
    Dysport 750 U (15 Injection Sites) Placebo (15 Injection Sites) Dysport 750 U (30 Injection Sites) Placebo (30 Injection Sites)
    Number of subjects analysed
    14
    6
    16
    6
    Units: mm
        arithmetic mean (standard deviation)
    2.7 ± 9
    12.2 ± 21.5
    1.3 ± 2.6
    6.7 ± 16.3
    No statistical analyses for this end point

    Secondary: Pain Visual Analogue Scale (VAS) Score: During Treatment Injection Procedure

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    End point title
    Pain Visual Analogue Scale (VAS) Score: During Treatment Injection Procedure
    End point description
    Analysis based on number of subjects in the Intent to Treat (ITT) population. Pain assessment using the VAS. The VAS is a 100-mm (10-cm) scoring scale. Score range on VAS is from 0 to 100 where zero [0] indicates no pain and 100 indicates worst possible pain.
    End point type
    Secondary
    End point timeframe
    Baseline
    End point values
    Dysport 750 U (15 Injection Sites) Placebo (15 Injection Sites) Dysport 750 U (30 Injection Sites) Placebo (30 Injection Sites)
    Number of subjects analysed
    14
    6
    16
    6
    Units: mm
        arithmetic mean (standard deviation)
    13.7 ± 19.3
    11 ± 19.9
    15.8 ± 19.7
    10 ± 24.5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    98 days
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Dysport 750 U (15 Injection Sites)
    Reporting group description
    Botulinum type A toxin (Dysport®): 750 U using different administration regimen, intra detrusor injection on day 1 (single dose)

    Reporting group title
    Placebo (15 Injection Sites)
    Reporting group description
    Placebo: Intra detrusor injection on day 1 (single dose)

    Reporting group title
    Dysport 750 U (30 Injection Sites)
    Reporting group description
    Botulinum type A toxin (Dysport®): 750 U using different administration regimen, intra detrusor injection on day 1 (single dose)

    Reporting group title
    Placebo (30 Injection Sites)
    Reporting group description
    Placebo: Intra detrusor injection on day 1 (single dose)

    Serious adverse events
    Dysport 750 U (15 Injection Sites) Placebo (15 Injection Sites) Dysport 750 U (30 Injection Sites) Placebo (30 Injection Sites)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 16 (31.25%)
    0 / 7 (0.00%)
    1 / 17 (5.88%)
    0 / 7 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Nervous system disorders
    Multiple sclerosis relapse
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 7 (0.00%)
    0 / 17 (0.00%)
    0 / 7 (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
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 7 (0.00%)
    1 / 17 (5.88%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscular weakness
         subjects affected / exposed
    3 / 16 (18.75%)
    0 / 7 (0.00%)
    0 / 17 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 7 (0.00%)
    0 / 17 (0.00%)
    0 / 7 (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
    Dysport 750 U (15 Injection Sites) Placebo (15 Injection Sites) Dysport 750 U (30 Injection Sites) Placebo (30 Injection Sites)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 16 (43.75%)
    3 / 7 (42.86%)
    11 / 17 (64.71%)
    4 / 7 (57.14%)
    Investigations
    Blood urine present
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 7 (0.00%)
    0 / 17 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 7 (0.00%)
    1 / 17 (5.88%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Neutrophil count increased
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 7 (0.00%)
    0 / 17 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 7 (0.00%)
    1 / 17 (5.88%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 7 (14.29%)
    0 / 17 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 7 (0.00%)
    2 / 17 (11.76%)
    2 / 7 (28.57%)
         occurrences all number
    0
    0
    2
    2
    Influenza like illness
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 7 (0.00%)
    1 / 17 (5.88%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 7 (0.00%)
    0 / 17 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Renal and urinary disorders
    Bladder Pain
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 7 (14.29%)
    0 / 17 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Haematuria
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 7 (14.29%)
    0 / 17 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 7 (0.00%)
    0 / 17 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Muscular weakness
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 7 (0.00%)
    1 / 17 (5.88%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Infections and infestations
    Acute tonsillitis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 7 (0.00%)
    1 / 17 (5.88%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Bacteriuria
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 7 (0.00%)
    0 / 17 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Escherichia sepsis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 7 (0.00%)
    0 / 17 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Fungal infection
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 7 (0.00%)
    1 / 17 (5.88%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 7 (0.00%)
    0 / 17 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 7 (0.00%)
    3 / 17 (17.65%)
    1 / 7 (14.29%)
         occurrences all number
    1
    0
    3
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Jan 2012
    Protocol version 5.0 Changes: The protocol was amended due to questions released by the German Federal Institute for Drugs and Medical Devices (BfArM) on 09 December 2011 and the German Ethics Committee (EC) on 04 January 2012. As the new protocol was submitted in other countries, inclusion criterion #6 was updated, inclusion criterion #12 and exclusion criterion #2 were clarified and exclusion criterion #21 was added at the same time. Inclusion criterion 6 was changed: • From: Have documented SCI or MS with urodynamic measurement abnormalities within 6 months (both complete and incomplete SCIs and relevant MS with confirmed NDO as defined by ICS guidelines will be included in this study) • To: Have documented SCI or MS (both complete and incomplete SCIs and relevant MS with confirmed NDO as defined by ICS guidelines will be included in this study). Inclusion criterion 12 was changed: • From: Female subjects of childbearing potential must have a negative pregnancy test result and be willing to use reliable contraceptive measures for the duration of the study • To: Female subjects of childbearing potential must have had a negative pregnancy test result and have been willing to use reliable contraceptive measures for the duration the study (i.e. oral contraceptives and spermicide, when used in combination with condoms, etc. as a ‘double barrier method’) Exclusion criterion 2 was changed • From: Previous or current requirement for/diagnosis of bladder or and urethral disease or surgery, or disease/prostate cancer (PSA of >10 ng/mL). Subjects with serum PSA concentrations >4 ng/mL and <10 ng/mL must have prostate cancer excluded • To: Previous or current diagnosis of bladder and urethral disease or surgery, or prostate cancer (PSA of >10 ng/mL). Subjects with serum PSA concentrations >4 ng/mL and <10 ng/mL must have prostate cancer excluded. In light of this amendment, the CRF, local consent form, database and RAP required updating.
    15 Jan 2013
    Protocol version 6.0 The protocol was amended to increase the number of participating centres (from approximately 8 to 10 to 22 centres) and to reduce the sample size following difficulties in recruitment. The sections on Sample Size Determination were changed • From: This is a preliminary, pilot study with a limited number of subjects where the sample size of 56 subjects was based on the clinical judgement/practical constraints and not on statistical considerations. A total of 56 subjects will be randomised in this study, out of which: - 20 will receive Dysport 750 U, 0.5 mL in 15 sites - 8 will receive placebo, 0.5 mL in 15 sites - 20 will receive Dysport 750 U, 0.5 mL in 30 sites - 8 will receive placebo, 0.5 mL in 30 sites. • To: This is a preliminary, pilot study with a limited number of subjects where the sample size of at least 42 subjects was based on the clinical judgement/practical constraints and not on statistical considerations. A total of at least 42 subjects will be randomised in this study, out of which: - At least 15 will receive Dysport 750 U, 0.5 mL in 15 sites - At least 6 will receive placebo, 0.5 mL in 15 sites - At least 15 will receive Dysport 750 U, 0.5 mL in 30 sites - At least 6 will receive placebo, 0.5 mL in 30 sites. The protocol was also amended to allow the replacement of subjects who were randomised but who were not assessed on the primary efficacy variable at Baseline. In light of this amendment, the local consent form and RAP required updating.

    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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