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    Clinical Trial Results:
    A PHASE III PROSPECTIVE, MULTI-CENTER, RANDOMISED, EVALUATOR-BLINDED STUDY TO COMPARE NEUROMUSCULAR JUNCTION (NMJ) TARGETED TECHNIQUE FOR DYSPORT INJECTIONS IN UPPER LIMB SPASTICITY POST STROKE OR TRAUMATIC BRAIN INJURY TO THE TECHNIQUE USED IN CURRENT CLINICAL PRACTICE

    Summary
    EudraCT number
    		 2011-005375-16
    Trial protocol
    		 SE   FI   DK  
    Global end of trial date
    10 Mar 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Apr 2016
    First version publication date
    03 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    A-99-52120-162
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Institut Produits Synthèse (IPSEN) AB
    Sponsor organisation address
    Kista Science Tower, 15th floor, Färögatan 33, Kista, Sweden, SE-164 51
    Public contact
    Medical Department, Institut Produits Synthèse (IPSEN) AB, clinical.trials@ipsen.com
    Scientific contact
    Medical Department, Institut Produits Synthèse (IPSEN) AB, 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
    03 Mar 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Mar 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Mar 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective is to compare Dysport treatment results after current clinical practice technique and 300U/mL dilution (high-concentration dilution) to the neuromascular junction (NMJ) targeted technique and 100U/mL dilution (low-concentration dilution), in the elbow joint assessed by Modified Ashworth Scale (MAS) 4 weeks post treatment.
    Protection of trial subjects
    This clinical study was designed and implemented and reported in accordance with the International Conference on Harmonisation (ICH) Harmonized Tripartite Guidelines for Good Clinical Practice (GCP), with applicable local regulations (including European Directive 2001/20/EC, and with the ethical principles laid down in the Declaration of Helsinki).
    Background therapy
    		 -
    Evidence for comparator
    		 Previous studies have shown benefit of an NMJ targeted injection and a low-concentration injection separately. This study was designed to show the combined effect of NMJ targeting and a low-concentration. The possibility to reduce the number of injection points would decrease the risk of injection discomfort, pain and injection site bleeding for the patient. A simplified injection technique with one injection per muscle and in a defined location would also benefit physicians.
    Actual start date of recruitment
    24 Sep 2012
    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
    Norway: 7
    Country: Number of subjects enrolled
    Sweden: 41
    Country: Number of subjects enrolled
    Denmark: 41
    Country: Number of subjects enrolled
    Finland: 11
    Worldwide total number of subjects
    100
    EEA total number of subjects
    100
    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)
    62
    From 65 to 84 years
    38
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was performed at a total of 20 sites in four countries: Denmark (5 sites), Finland (2 sites), Norway (2 sites) and Sweden (11 sites).

    Pre-assignment
    Screening details
    		 Approximately 272 subjects were planned to be randomised (136 subjects in each group). In total, 100 subjects were enrolled and 88 were randomised (44 subjects in each group). All randomised subjects were included in the Intention to Treat (ITT) population and Safety population (88 subjects). The Per Protocol (PP) population included 54 subjects

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [1]
    Blinding implementation details
    This was an open study with respect to study drug. However, the treatment group assigned to a randomisation number was to be blinded while it was not allocated.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 NMJ TARGETED
    Arm description
    		 Procedure: NMJ targeted technique and low-concentration dilution
    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
    100 U/mL

    Arm title
    		 CURRENT CLINICAL PRACTICE
    Arm description
    		 Procedure: Current clinical practice technique and high-concentration dilution
    Arm type
    		 Active comparator

    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
    300 U/mL

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: In this study, all efficacy assessments were to be performed by another qualified study personnel, blinded to the injection technique.
    Number of subjects in period 1 [2]
    		NMJ TARGETED CURRENT CLINICAL PRACTICE
    Started
    44
    44
    Completed
    40
    41
    Not completed
    4
    3
         Consent withdrawn by subject
    2
    -
         Lost to follow-up
    1
    2
         Protocol deviation
    1
    1
    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 are reported per total enrolled subjects, and baseline period are reported per randomized subjects.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall period
    Reporting group description
    		 -

    Reporting group values
    		 Overall period Total
    Number of subjects
    		 88 88
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58.7 ± 13 -
    Gender categorical
    Units: Subjects
        Female
    		 30 30
        Male
    		 58 58
    Spasticity pattern
    Units: Subjects
        Type I
    		 9 9
        Type III
    		 50 50
        Type IV
    		 29 29
    Height
    n=82 (missing=6)
    Units: cm
        arithmetic mean (standard deviation)
    		 173.2 ± 8.9 -
    Weight
    n=86 (missing=2)
    Units: kg
        arithmetic mean (standard deviation)
    		 78.1 ± 15.9 -

    End points

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    End points reporting groups
    Reporting group title
    NMJ TARGETED
    Reporting group description
    		 Procedure: NMJ targeted technique and low-concentration dilution

    Reporting group title
    CURRENT CLINICAL PRACTICE
    Reporting group description
    		 Procedure: Current clinical practice technique and high-concentration dilution

    Subject analysis set title
    Evaluation-Total
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Investigator Preference of Injection Technique

    Primary: Change from baseline to week 4 (Visit 2) for elbow flexors muscle as measured on the Modified Ashworth Scale (MAS) based on number of responders

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    End point title
    		 Change from baseline to week 4 (Visit 2) for elbow flexors muscle as measured on the Modified Ashworth Scale (MAS) based on number of responders
    End point description
    ITT Population Responder: A change from baseline of at least one score in MAS was considered clinically relevant and the subject was classified as a responder
    End point type
    Primary
    End point timeframe
    Baseline (Visit 1) and 4 weeks (Visit 4)
    End point values
    		 NMJ TARGETED CURRENT CLINICAL PRACTICE
    Number of subjects analysed
    44
    44
    Units: Number of responders
        Number of Responders
    25
    32
    Statistical analysis title
    		 Treatment
    Statistical analysis description
    ITT Population
    Comparison groups
    NMJ TARGETED v CURRENT CLINICAL PRACTICE
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.0986
    Method
    		 Generalised linear model
    Confidence interval
    Statistical analysis title
    		 specificity pattern
    Statistical analysis description
    ITT Population
    Comparison groups
    NMJ TARGETED v CURRENT CLINICAL PRACTICE
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.5682
    Method
    		 Generalised linear model
    Confidence interval
    Statistical analysis title
    		 Country
    Statistical analysis description
    ITT Population
    Comparison groups
    NMJ TARGETED v CURRENT CLINICAL PRACTICE
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.8543
    Method
    		 Generalised linear model
    Confidence interval
    Statistical analysis title
    		 MAS baseline
    Statistical analysis description
    ITT Population
    Comparison groups
    NMJ TARGETED v CURRENT CLINICAL PRACTICE
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.9167
    Method
    		 Generalised linear model
    Confidence interval

    Secondary: Change from baseline to week 12 (visit 3) for elbow flexors muscle tone as measured by the MAS based on number of responders

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    End point title
    		 Change from baseline to week 12 (visit 3) for elbow flexors muscle tone as measured by the MAS based on number of responders
    End point description
    ITT Population Responder: A change from baseline of at least one score in MAS was considered clinically relevant and the subject was classified as a responder. Change from baseline to week 12 for elbow flexors muscle tone as measured by the MAS equal to or greater than 1.
    End point type
    Secondary
    End point timeframe
    Baseline (Visit 1) and Week 12 (Visit 3)
    End point values
    		 NMJ TARGETED CURRENT CLINICAL PRACTICE
    Number of subjects analysed
    44
    44
    Units: Number of responders
        Number of responders
    13
    19
    Statistical analysis title
    		 Treatment
    Statistical analysis description
    ITT Population
    Comparison groups
    NMJ TARGETED v CURRENT CLINICAL PRACTICE
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.242
    Method
    		 Generalised linear model
    Confidence interval
    Statistical analysis title
    		 Spasticity pattern
    Statistical analysis description
    ITT Population
    Comparison groups
    NMJ TARGETED v CURRENT CLINICAL PRACTICE
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.38
    Method
    		 Generalised linear model
    Confidence interval
    Statistical analysis title
    		 Country
    Statistical analysis description
    ITT Population
    Comparison groups
    NMJ TARGETED v CURRENT CLINICAL PRACTICE
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.1037
    Method
    		 Generalised linear model
    Confidence interval
    Statistical analysis title
    		 MAS baseline
    Statistical analysis description
    ITT Population
    Comparison groups
    NMJ TARGETED v CURRENT CLINICAL PRACTICE
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.2348
    Method
    		 Generalised linear model
    Confidence interval

    Secondary: Mean change from baseline of spasticity related pain measured by Visual Analogue Scale (VAS)

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    End point title
    		 Mean change from baseline of spasticity related pain measured by Visual Analogue Scale (VAS)
    End point description
    ITT Population Mean change from baseline to week 4 and 12 of spasticity related pain. The VAS ruler used in this study will be a straight 10 cm (100 mm) horizontal line with anchor points of No pain (score 0) and Worst pain imaginable (score 10 [100 mm]).
    End point type
    Secondary
    End point timeframe
    Baseline (visit 1), Week 4 and 12
    End point values
    		 NMJ TARGETED CURRENT CLINICAL PRACTICE
    Number of subjects analysed
    44
    44
    Units: mm
    arithmetic mean (standard deviation)
        Baseline
    21.66 ± 28.97
    14.32 ± 22.64
        Mean Change from Baseline to Visit 2 (week 4)
    -5.8 ± 23.07
    -4.35 ± 12.29
        Mean Change from Baseline to Visit 3 (week 12)
    -0.03 ± 26.02
    0.03 ± 20.67
    Statistical analysis title
    		 Week 4
    Statistical analysis description
    ITT Population
    Comparison groups
    NMJ TARGETED v CURRENT CLINICAL PRACTICE
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.9448
    Method
    		 Generalised linear model
    Confidence interval
    Statistical analysis title
    		 Week 12
    Statistical analysis description
    ITT Population
    Comparison groups
    NMJ TARGETED v CURRENT CLINICAL PRACTICE
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.5458
    Method
    		 Generalised linear model
    Confidence interval

    Secondary: Injection pain measured at baseline by Visual Analogue Scale (VAS)

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    End point title
    		 Injection pain measured at baseline by Visual Analogue Scale (VAS)
    End point description
    ITT Population Subject perceived injection site pain at day 1. The VAS ruler used in this study will be a straight 10 cm (100 mm) horizontal line with anchor points of No pain (score 0) and Worst pain imaginable (score 10 [100 mm]).
    End point type
    Secondary
    End point timeframe
    Baseline (Visit 1)
    End point values
    		 NMJ TARGETED CURRENT CLINICAL PRACTICE
    Number of subjects analysed
    44
    44
    Units: mm
        arithmetic mean (standard deviation)
    25.67 ± 25.37
    30.68 ± 27.33
    Statistical analysis title
    		 Injection Related Pain using VAS
    Statistical analysis description
    ITT Population
    Comparison groups
    NMJ TARGETED v CURRENT CLINICAL PRACTICE
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.4006
    Method
    		 Generalised linear model
    Confidence interval

    Secondary: Achievement of the primary goal measured by Goal Attainment Scale (GAS) based on number of subjects for overall category

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    End point title
    		 Achievement of the primary goal measured by Goal Attainment Scale (GAS) based on number of subjects for overall category
    End point description
    At baseline, the investigator will interview the subject to identify the main problem area and establish an agreed primary goal related to elbow flexion to be followed up at week 4 or 12 depending on the time point defined at the baseline visit.
    End point type
    Secondary
    End point timeframe
    Up to Week 12
    End point values
    		 NMJ TARGETED CURRENT CLINICAL PRACTICE
    Number of subjects analysed
    44
    44
    Units: Participants
        -2
    3
    1
        -1
    9
    15
        Zero
    11
    18
        +1
    9
    6
        +2
    1
    1
        Missing
    11
    3
    Statistical analysis title
    		 Goal Attainment Scale (GAS)
    Statistical analysis description
    ITT population
    Comparison groups
    CURRENT CLINICAL PRACTICE v NMJ TARGETED
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.5747
    Method
    		 Mann-Whitney U-test
    Confidence interval

    Secondary: Subject global evaluation of treatment effect based on number of subjects

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    End point title
    		 Subject global evaluation of treatment effect based on number of subjects
    End point description
    ITT Population Comparison of treatment effect between previous (pre study) and study treatment cycles assessed by the subject at the end of study (visit 3 or 4) Categorised as follows: much worse/worse/same (no change from baseline)/better/much better.
    End point type
    Secondary
    End point timeframe
    Up to Week 24
    End point values
    		 NMJ TARGETED CURRENT CLINICAL PRACTICE
    Number of subjects analysed
    44
    44
    Units: Participants
        Much Better
    3
    2
        Better
    11
    16
        No Change From Baseline
    18
    20
        Worse
    7
    2
        Much Worse
    1
    0
        Missing
    4
    4
    Statistical analysis title
    		 Subject Global Evaluation of Treatment Effect
    Statistical analysis description
    ITT population
    Comparison groups
    NMJ TARGETED v CURRENT CLINICAL PRACTICE
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.1802
    Method
    		 Mann-Whitney U-test
    Confidence interval

    Secondary: Investigator Preference of Injection Technique

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    End point title
    		 Investigator Preference of Injection Technique
    End point description
    The Investigator preference of injection technique is summarized. Only three of the 20 Investigators answered the question on preferred injection technique.
    End point type
    Secondary
    End point timeframe
    Up to week 24
    End point values
    		 Evaluation-Total
    Number of subjects analysed
    20
    Units: Participants
        Current Clinical Practice Technique
    2
        NMJ Targeted Technique
    1
        Missing
    17
    No statistical analyses for this end point

    Other pre-specified: Number of subjects with summary adverse events

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    End point title
    		 Number of subjects with summary adverse events
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Up to week 24
    End point values
    		 NMJ TARGETED CURRENT CLINICAL PRACTICE
    Number of subjects analysed
    44
    44
    Units: Number of subjects
        Any Adverse Events
    15
    11
        Any Treatment Emergent Adverse Events (TEAEs)
    15
    11
        Intensity of TEAEs - Severe
    3
    0
        Intensity of TEAEs - Moderate
    7
    2
        Intensity of TEAEs - Mild
    8
    10
        Causality of TEAEs - Related
    1
    2
        Causality of TEAEs - Not related
    14
    10
        TEAEs Leading to Withdrawal
    0
    0
        TEAEs Leading to Death
    0
    0
        Serious Adverse Events (SAEs)
    2
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline (day 1) to week 24
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    NMJ TARGETED
    Reporting group description
    		 Procedure: NMJ targeted technique and low-concentration dilution

    Reporting group title
    CURRENT CLINICAL PRACTICE
    Reporting group description
    		 Procedure: Current clinical practice technique and high-concentration dilution

    Serious adverse events
    		 NMJ TARGETED CURRENT CLINICAL PRACTICE
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 44 (4.55%)
    2 / 44 (4.55%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Femoral neck fracture
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cystitis
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 NMJ TARGETED CURRENT CLINICAL PRACTICE
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 44 (29.55%)
    9 / 44 (20.45%)
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 44 (0.00%)
         occurrences all number
    2
    0
    Fall
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 44 (0.00%)
         occurrences all number
    2
    0
    Muscle strain
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 44 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 44 (6.82%)
    0 / 44 (0.00%)
         occurrences all number
    3
    0
    Epilepsy
         subjects affected / exposed
    1 / 44 (2.27%)
    1 / 44 (2.27%)
         occurrences all number
    1
    1
    Migraine
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 44 (0.00%)
         occurrences all number
    1
    0
    Neuralgia
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 44 (0.00%)
         occurrences all number
    1
    0
    Syncope
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 44 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 44 (2.27%)
    1 / 44 (2.27%)
         occurrences all number
    1
    1
    Influenza like illness
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    0
    1
    Injection site hypersensitivity
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Epididymitis
         subjects affected / exposed
    1 / 44 (2.27%)
    1 / 44 (2.27%)
         occurrences all number
    1
    1
    Acquired hydrocele
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 44 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    0
    1
    Dysphagia
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    0
    1
    Gastritis
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Pain of skin
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 44 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    2 / 44 (4.55%)
    0 / 44 (0.00%)
         occurrences all number
    2
    0
    Back pain
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 44 (0.00%)
         occurrences all number
    1
    0
    Bursitis
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 44 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Eye infection
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 44 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 44 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 44 (0.00%)
    3 / 44 (6.82%)
         occurrences all number
    0
    3
    Nasopharyngitis
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    0
    1

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 May 2012
    Amendment 1: • Subjects will not be included in the study if they meet any or the following criteria: Any elbow flexor contracture prohibiting MAS evaluation and/or elbow flexion improvement of at least 1 step on the MAS. • Efficacy assessments should be made by another qualified study personnel, blinded to the injection technique • EMG/electrical stimulation use and Dysport doses given per muscle will be recorded in the CRF.
    03 Mar 2014
    Amendment 2: • Secondary objectives - To compare Dysport treatment results between the two treatment groups with respect to: Elbow joint, assessed by MAS, 12 weeks post treatment • The following treatments for spasticity must remain unchanged during the course of the study: BoNT-A treatment of spastic muscles involved in the elbow function (same dose and concentration as pre study treatment) • Subjects in group 1 will receive the same dose of Dysport injected in the elbow flexion related muscles as during the last pre study treatment. Subjects in group 2 will receive the same dose of Dysport injected in the elbow flexion related muscles as during the last pre study treatment but with a lower concentration (higher volume) and with a different injection technique where injections are targeted at the NMJs. • Inclusion criteria: Need of the same treatment modality in m. brachialis, m. biceps brachii, m. brachioradialis, m. flex. carpi ulnaris, m. flex. carpi radialis as the previous treatment cycle. • 272 subjects suffering from upper limb spasticity post stroke or traumatic brain injury, with an elbow flexor muscle spasticity position pattern type 1, 3 or 4, will be included in the study. •Secondary Efficacy Endpoints and Evaluations: MAS of elbow flexors at 12 weeks. Change from baseline to week 12 for elbow flexors muscle tone as measured by the MAS. • The sample size calculation was made assuming alpha level 0.025, one sided test. With an estimated drop out rate of 10%, the number of subjects will be 136 in each treatment group, 272 subjects are required to be randomised in the study • Visit 1/Visit 2/Visit 3 MAS of elbow flexors • Clarification of which muscles that are evaluated for elbow flexion.

    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 slow recruitment rate it was clear that the study would not be completed in a reasonable time frame, therefore the study was stopped early.
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