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    Clinical Trial Results:
    A double-blind, randomised, placebo controlled, proof-of-concept study in subjects with abdominal or thoracic chronic scar pain to assess the analgesic properties of intradermal doses of Dysport®

    Summary
    EudraCT number
    		 2018-001703-37
    Trial protocol
    		 GB  
    Global end of trial date
    08 Nov 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Nov 2020
    First version publication date
    27 Nov 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D-FR-52120-244
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03663101
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ipsen Innovation SAS
    Sponsor organisation address
    ZI de Courtaboeuf, 5 avenue du Canada, Les Ulis Cedex, France, 91966
    Public contact
    Medical Director, Ipsen Innovation SAS, clinical.trials@ipsen.com
    Scientific contact
    Medical Director, Ipsen Innovation SAS, 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
    08 Nov 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Nov 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective was to describe the pharmacodynamic analgesic profile (time of onset of meaningful analgesic effect, peak effect, time to peak effect, duration of effect) of intradermal doses of Dysport in participants with abdominal or thoracic chronic scar pain.
    Protection of trial subjects
    The study was conducted under the provisions of the Declaration of Helsinki in accordance with the International Council on Harmonisation Consolidated Guideline on Good Clinical Practice. The study also complied with Independent Ethics Committees and informed consent regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Oct 2018
    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
    United Kingdom: 16
    Worldwide total number of subjects
    16
    EEA total number of subjects
    16
    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)
    14
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This Phase II proof-of-concept study was conducted at single investigational site in the United Kingdom. The study consisted of two sequential parts: Part A (Pre-randomisation run-in period) and Part B (Randomised double-blind period). Part A was considered as an extended screening period.

    Pre-assignment
    Screening details
    		 Part A was conducted to identify participants who would potentially benefit from Dysport injection, 'responders'. Part B was a double-blind study of Dysport or placebo injection in responders from Part A. Of the 46 participants who were included in Part A, 17 were responders. Of which, 16 participants were randomised into Part B of the study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants received a single dose of placebo (matching with Dysport) intradermal injection per injection point (maximum of 10 injection points) on Day 1.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    Placebo (matching with Dysport) per injection point (maximum of 10 injection points). Injections were performed under a constant volume of 0.2 milliliter (mL).

    Arm title
    		 Dysport 2.5 U/Injection Site
    Arm description
    		 Participants received a single dose of Dysport 2.5 Units (U) intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 25 U.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dysport
    Investigational medicinal product code
    Other name
    AboBoNT-A, Abobotulinumtoxin-A, Botulinum neurotoxin serotype A
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    Dysport per injection point (maximum of 10 injection points). Injections were performed under a constant volume of 0.2 mL.

    Arm title
    		 Dysport 10 U/Injection Site
    Arm description
    		 Participants received a single dose of Dysport 10 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 100 U.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dysport
    Investigational medicinal product code
    Other name
    AboBoNT-A, Abobotulinumtoxin-A, Botulinum neurotoxin serotype A
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    Dysport per injection point (maximum of 10 injection points). Injections were performed under a constant volume of 0.2 mL.

    Arm title
    		 Dysport 20 U/Injection Site
    Arm description
    		 Participants received a single dose of Dysport 20 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 200 U.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dysport
    Investigational medicinal product code
    Other name
    AboBoNT-A, Abobotulinumtoxin-A, Botulinum neurotoxin serotype A
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    Dysport per injection point (maximum of 10 injection points). Injections were performed under a constant volume of 0.2 mL.

    Number of subjects in period 1
    		Placebo Dysport 2.5 U/Injection Site Dysport 10 U/Injection Site Dysport 20 U/Injection Site
    Started
    4
    3
    5
    4
    Completed
    4
    3
    5
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a single dose of placebo (matching with Dysport) intradermal injection per injection point (maximum of 10 injection points) on Day 1.

    Reporting group title
    Dysport 2.5 U/Injection Site
    Reporting group description
    		 Participants received a single dose of Dysport 2.5 Units (U) intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 25 U.

    Reporting group title
    Dysport 10 U/Injection Site
    Reporting group description
    		 Participants received a single dose of Dysport 10 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 100 U.

    Reporting group title
    Dysport 20 U/Injection Site
    Reporting group description
    		 Participants received a single dose of Dysport 20 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 200 U.

    Reporting group values
    		 Placebo Dysport 2.5 U/Injection Site Dysport 10 U/Injection Site Dysport 20 U/Injection Site Total
    Number of subjects
    		 4 3 5 4 16
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 3 3 5 3 14
        From 65-84 years
    		 1 0 0 1 2
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 56.5 ( 10.7 ) 49.7 ( 6.0 ) 46.0 ( 11.3 ) 48.8 ( 16.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 3 3 3 2 11
        Male
    		 1 0 2 2 5
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0
        Asian
    		 0 0 3 1 4
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        Black or African American
    		 0 0 0 0 0
        White
    		 4 3 2 3 12
        More than one race
    		 0 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a single dose of placebo (matching with Dysport) intradermal injection per injection point (maximum of 10 injection points) on Day 1.

    Reporting group title
    Dysport 2.5 U/Injection Site
    Reporting group description
    		 Participants received a single dose of Dysport 2.5 Units (U) intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 25 U.

    Reporting group title
    Dysport 10 U/Injection Site
    Reporting group description
    		 Participants received a single dose of Dysport 10 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 100 U.

    Reporting group title
    Dysport 20 U/Injection Site
    Reporting group description
    		 Participants received a single dose of Dysport 20 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 200 U.

    Primary: Time to Onset of Effect in the Spontaneous Numerical Rating Scale (NRS) Score

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    End point title
    		 Time to Onset of Effect in the Spontaneous Numerical Rating Scale (NRS) Score [1]
    End point description
    The time to onset of effect was defined as time to a decrease from baseline of two points or greater in the spontaneous NRS score. Pain intensity was scored using an 11-point NRS score ranging from 0 to 10, where 0= no pain and 10= worst possible pain. Participants were provided with an Actiwatch® during an Actiwatch® training visit to record their spontaneous NRS scores at home. The Actiwatch® alerted the participants twice a day to record their average and maximal NRS scores over the preceding 12 hours. The questions were asked of the participants by the Actiwatch®: "Please rate your pain by selecting the one number that best describes your pain on average during the last 12 hours." and "Please rate your pain by selecting the one number that best describes your pain at its worst during the last 12 hours." Randomised population included all participants randomised in the double-blind period (Part B). Here, n= number of participants who reached the time to onset.
    End point type
    Primary
    End point timeframe
    Part B: From baseline (defined as mean of all predose data from Day -7 and including predose on Day 1) up to end of study (Week 16) or early discontinuation.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive statistical analysis was performed for the primary endpoint.
    End point values
    		 Placebo Dysport 2.5 U/Injection Site Dysport 10 U/Injection Site Dysport 20 U/Injection Site
    Number of subjects analysed
    4
    3
    5
    4
    Units: days
    arithmetic mean (standard deviation)
        Worst NRS score (n=2,3,5,2)
    4.41 ( 4.92 )
    15.11 ( 25.17 )
    29.45 ( 39.82 )
    0.65 ( 0.32 )
        Average NRS score (n=3,3,4,2)
    6.75 ( 2.74 )
    31.63 ( 53.78 )
    4.60 ( 6.55 )
    0.90 ( 0.03 )
    No statistical analyses for this end point

    Primary: Peak Effect in the Spontaneous NRS Score

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    End point title
    		 Peak Effect in the Spontaneous NRS Score [2]
    End point description
    The peak effect was defined as the maximal decrease from baseline in the spontaneous NRS score over a 12-hour period. Pain intensity was scored using an 11-point NRS score ranging from 0 to 10, where 0= no pain and 10= worst possible pain. Participants were provided with an Actiwatch® during an Actiwatch® training visit to record their spontaneous NRS scores at home. The Actiwatch® alerted the participants twice a day to record their average and maximal NRS scores over the preceding 12 hours. The questions were asked of the participants by the Actiwatch®: "Please rate your pain by selecting the one number that best describes your pain on average during the last 12 hours." and "Please rate your pain by selecting the one number that best describes your pain at its worst during the last 12 hours." Greater reductions in change from baseline correspond to greater pain relief. Randomised population included all participants randomised in the double-blind period (Part B).
    End point type
    Primary
    End point timeframe
    Part B: From baseline (defined as mean of all predose data from Day -7 and including predose on Day 1) up to end of study (Week 16) or early discontinuation.
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive statistical analysis was performed for the primary endpoint.
    End point values
    		 Placebo Dysport 2.5 U/Injection Site Dysport 10 U/Injection Site Dysport 20 U/Injection Site
    Number of subjects analysed
    4
    3
    5
    4
    Units: score on a scale
    arithmetic mean (standard deviation)
        Worst NRS score
    -2.36 ( 1.58 )
    -4.73 ( 0.55 )
    -3.54 ( 2.15 )
    -2.82 ( 2.91 )
        Average NRS score
    -2.52 ( 0.91 )
    -3.53 ( 0.45 )
    -3.72 ( 1.57 )
    -2.12 ( 2.37 )
    No statistical analyses for this end point

    Primary: Time to Peak Effect in the Spontaneous NRS Score

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    End point title
    		 Time to Peak Effect in the Spontaneous NRS Score [3]
    End point description
    The time to peak effect was defined as the time to reach the peak effect over a 12-hour period. Pain intensity was scored using an 11-point NRS score ranging from 0 to 10, where 0= no pain and 10= worst possible pain. Participants were provided with an Actiwatch® during an Actiwatch® training visit to record their spontaneous NRS scores at home. The Actiwatch® alerted the participants twice a day to record their average and maximal NRS scores over the preceding 12 hours. The questions were asked of the participants by the Actiwatch®: "Please rate your pain by selecting the one number that best describes your pain on average during the last 12 hours." and "Please rate your pain by selecting the one number that best describes your pain at its worst during the last 12 hours." Randomised population included all participants randomised in the double-blind period (Part B).
    End point type
    Primary
    End point timeframe
    Part B: From baseline (defined as mean of all predose data from Day -7 and including predose on Day 1) up to end of study (Week 16) or early discontinuation.
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive statistical analysis was performed for the primary endpoint.
    End point values
    		 Placebo Dysport 2.5 U/Injection Site Dysport 10 U/Injection Site Dysport 20 U/Injection Site
    Number of subjects analysed
    4
    3
    5
    4
    Units: days
    arithmetic mean (standard deviation)
        Worst NRS score
    10.63 ( 10.18 )
    33.46 ( 51.41 )
    41.94 ( 35.72 )
    3.11 ( 1.56 )
        Average NRS score
    12.51 ( 7.26 )
    33.13 ( 52.51 )
    11.04 ( 11.58 )
    26.49 ( 49.89 )
    No statistical analyses for this end point

    Primary: Duration of Effect in the Spontaneous NRS Score

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    End point title
    		 Duration of Effect in the Spontaneous NRS Score [4]
    End point description
    The duration of effect was defined as the duration between time to onset and last timepoint for which decrease from baseline in the spontaneous NRS score was two points or greater. Pain intensity was scored using an 11-point NRS score ranging from 0 to 10, where 0= no pain and 10= worst possible pain. Participants were provided with an Actiwatch® during an Actiwatch® training visit to record their spontaneous NRS scores at home. The Actiwatch® alerted the participants twice a day to record their average and maximal NRS scores over the preceding 12 hours. The questions were asked of the participants by the Actiwatch®: "Please rate your pain by selecting the one number that best describes your pain on average during the last 12 hours." and "Please rate your pain by selecting the one number that best describes your pain at its worst during the last 12 hours." Here, n= number of participants who reached the time to onset.
    End point type
    Primary
    End point timeframe
    Part B: From baseline (defined as mean of all predose data from Day -7 and including predose on Day 1) up to end of study (Week 16) or early discontinuation.
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive statistical analysis was performed for the primary endpoint.
    End point values
    		 Placebo Dysport 2.5 U/Injection Site Dysport 10 U/Injection Site Dysport 20 U/Injection Site
    Number of subjects analysed
    4 [5]
    3 [6]
    5 [7]
    4 [8]
    Units: days
    arithmetic mean (standard deviation)
        Worst NRS score (n=2,3,5,2)
    86.04 ( 25.52 )
    86.68 ( 23.89 )
    66.80 ( 44.28 )
    110.52 ( 0.74 )
        Average NRS score (n=3,3,4,2)
    53.53 ( 51.44 )
    65.17 ( 58.21 )
    102.75 ( 18.36 )
    110.02 ( 1.45 )
    Notes
    [5] - Randomised population.
    [6] - Randomised population.
    [7] - Randomised population.
    [8] - Randomised population.
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Spontaneous NRS Score Throughout the Study

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    End point title
    		 Change From Baseline in the Spontaneous NRS Score Throughout the Study
    End point description
    Pain intensity was scored using an 11-point NRS score ranging from 0 to 10, where 0= no pain and 10= worst possible pain. Participants were provided with an Actiwatch® during an Actiwatch® training visit to record their spontaneous NRS scores at home. The Actiwatch® alerted the participants twice a day to record their average and maximal NRS scores over the preceding 12 hours. The questions were asked of the participants by the Actiwatch®: "Please rate your pain by selecting the one number that best describes your pain on average during the last 12 hours." and "Please rate your pain by selecting the one number that best describes your pain at its worst during the last 12 hours." Greater reductions in change from baseline correspond to greater pain relief. Randomised population included all participants randomised in the double-blind period (Part B). Here, n= number of participants analysed at specific time point.
    End point type
    Secondary
    End point timeframe
    Part B: From baseline (defined as mean of all predose data from Day -7 and including predose on Day 1) up to end of study (Week 16) or early discontinuation.
    End point values
    		 Placebo Dysport 2.5 U/Injection Site Dysport 10 U/Injection Site Dysport 20 U/Injection Site
    Number of subjects analysed
    4
    3
    5
    4
    Units: score on a scale
    arithmetic mean (standard deviation)
        Daily worst NRS score: Baseline (n=4,3,5,4)
    5.1 ( 1.0 )
    5.1 ( 1.0 )
    5.3 ( 1.6 )
    5.8 ( 0.9 )
        Daily worst NRS score: Week 2 (n=4,3,4,4)
    -0.6 ( 0.9 )
    -2.1 ( 2.1 )
    -1.4 ( 3.5 )
    -1.1 ( 2.7 )
        Daily worst NRS score: Week 4 (n=4,3,4,4)
    -1.6 ( 1.8 )
    -2.1 ( 1.8 )
    -1.4 ( 4.2 )
    -1.6 ( 2.7 )
        Daily worst NRS score: Week 6 (n=4,3,4,4)
    -1.1 ( 0.7 )
    -0.1 ( 1.0 )
    -1.7 ( 2.9 )
    -1.6 ( 2.6 )
        Daily worst NRS score: Week 12 (n=3,3,5,4)
    -0.5 ( 1.4 )
    -1.4 ( 0.6 )
    -0.7 ( 1.1 )
    -0.8 ( 3.3 )
        Daily worst NRS score: Week 16 (n=3,3,5,4)
    -0.0 ( 2.0 )
    -1.4 ( 1.1 )
    -1.3 ( 3.1 )
    -0.3 ( 1.7 )
        Daily average NRS score: Baseline (n=4,3,5,4)
    4.5 ( 1.1 )
    3.9 ( 1.0 )
    4.7 ( 1.2 )
    4.9 ( 1.2 )
        Daily average NRS score: Week 2 (n=4,3,4,4)
    -0.9 ( 1.0 )
    -2.0 ( 1.8 )
    -2.1 ( 2.8 )
    -1.7 ( 2.5 )
        Daily average NRS score: Week 4 (n=4,3,4,4)
    -1.6 ( 1.9 )
    -1.9 ( 1.3 )
    -2.1 ( 3.2 )
    -1.4 ( 2.0 )
        Daily average NRS score: Week 6 (n=4,3,4,4)
    -1.0 ( 0.9 )
    -0.4 ( 2.0 )
    -2.0 ( 2.6 )
    -1.4 ( 2.0 )
        Daily average NRS score: Week 12 (n=3,3,5,4)
    -0.5 ( 1.6 )
    -1.5 ( 0.6 )
    -1.2 ( 1.9 )
    -0.6 ( 2.5 )
        Daily average NRS score: Week 16 (n=3,3,5,4)
    -0.6 ( 1.5 )
    -0.9 ( 0.8 )
    -1.6 ( 2.3 )
    -0.4 ( 1.5 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in the Stimulus-Evoked NRS Score on the Painful Area at Weeks 6 and 12

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    End point title
    		 Change From Baseline in the Stimulus-Evoked NRS Score on the Painful Area at Weeks 6 and 12
    End point description
    For stimulus-evoked NRS score during Quantitative Sensory Testing (QST), participants were submitted to stimuli of various nature (light touch, pressure and temperature) applied to the painful area. Pain intensity was scored using an 11-point NRS score ranging from 0 to 10, where 0= no pain and 10= worst possible pain. Randomised population included all participants randomised in the double-blind period (Part B).
    End point type
    Secondary
    End point timeframe
    Part B: Baseline (defined as mean of all predose data from Day -7 and including predose on Day 1) and Weeks 6 and 12
    End point values
    		 Placebo Dysport 2.5 U/Injection Site Dysport 10 U/Injection Site Dysport 20 U/Injection Site
    Number of subjects analysed
    4
    3
    5
    4
    Units: score on a scale
    arithmetic mean (standard deviation)
        Static mechanical allodynia: Baseline
    1.3 ( 1.5 )
    3.0 ( 3.6 )
    4.2 ( 1.1 )
    4.5 ( 3.1 )
        Static mechanical allodynia: Week 6
    1.0 ( 1.2 )
    -1.7 ( 4.0 )
    -2.6 ( 1.8 )
    -1.0 ( 5.5 )
        Static mechanical allodynia: Week 12
    0.8 ( 1.0 )
    -0.3 ( 5.7 )
    -2.0 ( 1.4 )
    -0.8 ( 5.1 )
        Dynamic mechanical allodynia: Baseline
    1.3 ( 1.0 )
    2.3 ( 3.2 )
    2.4 ( 1.7 )
    5.3 ( 1.0 )
        Dynamic mechanical allodynia: Week 6
    -0.5 ( 1.0 )
    -1.7 ( 2.1 )
    -2.0 ( 1.9 )
    -2.5 ( 2.6 )
        Dynamic mechanical allodynia: Week 12
    -0.3 ( 2.1 )
    -1.3 ( 1.5 )
    -0.2 ( 1.5 )
    -2.0 ( 2.7 )
        Temporal summation: Baseline
    1.5 ( 1.3 )
    0.3 ( 1.5 )
    3.6 ( 3.0 )
    1.8 ( 2.1 )
        Temporal summation: Week 6
    1.8 ( 2.1 )
    0.3 ( 0.6 )
    1.8 ( 1.1 )
    2.8 ( 1.7 )
        Temporal summation: Week 12
    2.0 ( 0.8 )
    0.3 ( 3.1 )
    1.4 ( 1.1 )
    2.8 ( 1.7 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) in Part B up to end of study visit or early discontinuation, approximately 16 weeks.
    Adverse event reporting additional description
    Safety population included all participants who received at least one dose of the study drug during the randomised double-blind period (Part B).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a single dose of placebo (matching with Dysport) intradermal injection per injection point (maximum of 10 injection points) on Day 1.

    Reporting group title
    Dysport 2.5 U/Injection Site
    Reporting group description
    		 Participants received a single dose of Dysport 2.5 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 25 U.

    Reporting group title
    Dysport 10 U/Injection Site
    Reporting group description
    		 Participants received a single dose of Dysport 10 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 100 U.

    Reporting group title
    Dysport 20 U/Injection Site
    Reporting group description
    		 Participants received a single dose of Dysport 20 U intradermal injection per injection point (maximum of 10 injection points) on Day 1. The maximal total dose was 200 U.

    Serious adverse events
    		 Placebo Dysport 2.5 U/Injection Site Dysport 10 U/Injection Site Dysport 20 U/Injection Site
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Pancreatogenous diabetes
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 4 (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
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo Dysport 2.5 U/Injection Site Dysport 10 U/Injection Site Dysport 20 U/Injection Site
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 4 (75.00%)
    3 / 3 (100.00%)
    4 / 5 (80.00%)
    4 / 4 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Melanocytic naevus
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    General disorders and administration site conditions
    Injection site bruising
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Injection site rash
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    1
    Cough
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nasal congestion
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Psychiatric disorders
    Depressed mood
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Product issues
    Device physical property issue
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Investigations
    Blood triglycerides increased
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Congenital, familial and genetic disorders
    Hereditary non-polyposis colorectal cancer syndrome
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    2 / 5 (40.00%)
    3 / 4 (75.00%)
         occurrences all number
    0
    0
    2
    3
    Dizziness
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    1
    1
    Hyporeflexia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Paraesthesia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Sensory loss
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Eye disorders
    Vision blurred
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    0
    1
    Abdominal pain
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastric mucosa erythema
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hiatus hernia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nausea
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Pancreatic failure
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pancreatitis acute
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 3 (0.00%)
    2 / 5 (40.00%)
    0 / 4 (0.00%)
         occurrences all number
    3
    0
    2
    0
    Rash pustular
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    2
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Aug 2018
    Updated Section “Early Discontinuation or End of Study Visit” and “Study Schedule of Assessments” to ensure participant beneficence and to clarify how participants were monitored through each stage of the study. Updated inclusion and exclusion criteria. Updated the list of medications that should not start during the study.
    04 Dec 2018
    Maximum age of the participant for inclusion to the study was increased to 75 years old. The time from surgery which caused the painful scar for inclusion to the study was extended to 10 years. Updated Section “Pre-randomisation Run-in Period (Part A)” to permit the scar area to return to baseline after examination, test dosing or QST procedures. Two parts of the QST test, punctate hyperalgesia and vibration disappearance were not performed. Section “Stimulus-evoked NRS Score during Quantitative Sensory Testing” was modified.

    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.
    Recruitment was closed prematurely by 30 June 2019 due to slow enrolment, which meant Sponsor did not believe it was feasible to continue study in an acceptable timeframe. The decision was not related to any safety/tolerability concern with Dysport.
    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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