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    Clinical Trial Results:
    A multicentre, randomized, double-blind, parallel and controlled with placebo pilot study to evaluate the efficacy and safety of a single dose of botulinum toxin Type A (Dysport®) associated with rehabilitation treatment, in patients with primary myofascial syndrome of cervical and dorsal localization.

    Summary
    EudraCT number
    		 2004-001443-29
    Trial protocol
    		 ES  
    Global end of trial date
    02 Feb 2006

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

    Trial information

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    Trial identification
    Sponsor protocol code
    A-92-52120-089
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ipsen Pharma
    Sponsor organisation address
    S.A. Avda. Laura Miro 395, Barcelona, France, 08980
    Public contact
    Medical director, anestesiologia , Ipsen Pharma, clinical.trials@ipsen.com
    Scientific contact
    Medical director, anestesiologia , Ipsen Pharma, clinical.trials@ipsen.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    19 Feb 2007
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Feb 2006
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Feb 2006
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluate the efficacy and safety of a single dose of botulinum toxin associated with rehabilitation treatment, on pain control in patients with primary myofascial syndrome of cervical and dorsal localization.
    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
    10 Jan 2005
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 3 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    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)
    22
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited at 4 investigational centres in spain.

    Pre-assignment
    Screening details
    		 A total of 24 participants were screened of which all 24 subjects were randomised to either dysport or Placebo.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 0 U, One vial containing sterile solution of sodium chloride ready for intramuscular injection.
    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 U

    Arm title
    		 Dysport
    Arm description
    		 500 U, One vial containing lyophilized powder, previous dissolution in sodium chloride (0.9%) ready for intramuscular injection.
    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
    500 U

    Number of subjects in period 1
    		Placebo Dysport
    Started
    12
    12
    Completed
    12
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 0 U, One vial containing sterile solution of sodium chloride ready for intramuscular injection.

    Reporting group title
    Dysport
    Reporting group description
    		 500 U, One vial containing lyophilized powder, previous dissolution in sodium chloride (0.9%) ready for intramuscular injection.

    Reporting group values
    		 Placebo Dysport Total
    Number of subjects
    		 12 12 24
    Age categorical
    Units: Subjects
    Age continuous
    Total mean = 42.9 SD = ± 13.2
    Units: years
        arithmetic mean (standard deviation)
    		 44.8 ± 12.5 41 ± 14.2 -
    Gender categorical
    Units: Subjects
        Female
    		 10 12 22
        Male
    		 2 0 2
    Race
    Units: Subjects
        Caucasian
    		 12 12 24
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 68 ± 12.2 64.1 ± 6 -
    Systolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 131.8 ± 19.4 126 ± 19 -
    Diastolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 73.8 ± 10.3 73.3 ± 6.8 -
    Heart rate
    Units: bpm
        arithmetic mean (standard deviation)
    		 73 ± 6 74.2 ± 6.8 -
    Baseline pain VAS
    Units: mm
        arithmetic mean (standard deviation)
    		 61.2 ± 11.1 60.3 ± 16 -
    Baseline PPT associated with the most sensitive TP
    Units: kg/cm2
        arithmetic mean (standard deviation)
    		 1.9 ± 1.1 1.7 ± 0.9 -
    Baseline PPT associated with all the TP
    Units: kg/cm2
        arithmetic mean (standard deviation)
    		 2.1 ± 1 1.9 ± 0.9 -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 0 U, One vial containing sterile solution of sodium chloride ready for intramuscular injection.

    Reporting group title
    Dysport
    Reporting group description
    		 500 U, One vial containing lyophilized powder, previous dissolution in sodium chloride (0.9%) ready for intramuscular injection.

    Primary: Evolution of the pain visual analogue scale (VAS) score

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    End point title
    		 Evolution of the pain visual analogue scale (VAS) score
    End point description
    The values reported are for the change from baseline in pain visual analogue scale (VAS) score The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. In the VAS the best result is 0 and the worst is 100.
    End point type
    Primary
    End point timeframe
    Baseline (Day 0), Week 2, Week 4, Week 8 and Week 12
    End point values
    		 Placebo Dysport
    Number of subjects analysed
    12
    12
    Units: mm
    arithmetic mean (standard deviation)
        Week 2
    -17.75 ± 20.53
    -9.83 ± 23.22
        Week 4
    -22.08 ± 21
    -22 ± 18.2
        Week 8
    -19.92 ± 26.03
    -23.42 ± 17.86
        Week 12
    -15.92 ± 21.38
    -26.92 ± 19.45
    Statistical analysis title
    		 Main analysis(repeated measures)- Treatment effect
    Comparison groups
    Placebo v Dysport
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.832
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Main analysis(repeated measures)- visit effect
    Comparison groups
    Placebo v Dysport
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.048
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Main analysis(repeated measures)- Baseline VAS
    Comparison groups
    Placebo v Dysport
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.778
    Method
    		 ANCOVA
    Confidence interval

    Primary: Evolution of pressure pain threshold (PPT) associated with the most sensitive trigger point (TP)

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    End point title
    		 Evolution of pressure pain threshold (PPT) associated with the most sensitive trigger point (TP)
    End point description
    The values reported are for the change from baseline in pressure pain threshold (PPT)
    End point type
    Primary
    End point timeframe
    Baseline (Day 0), Week 2, Week 4, Week 8 and Week 12
    End point values
    		 Placebo Dysport
    Number of subjects analysed
    12
    12
    Units: kg/cm2
    arithmetic mean (standard deviation)
        Week 2
    0.75 ± 1.2
    0.33 ± 0.62
        Week 4
    0.78 ± 1.35
    0.68 ± 0.77
        Week 8
    1 ± 1.33
    0.76 ± 0.99
        Week 12
    0.68 ± 1.36
    0.99 ± 1.07
    Statistical analysis title
    		 Main analysis(repeated measures)- Treatment effect
    Comparison groups
    Placebo v Dysport
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.748
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Main analysis(repeated measures)- Visit effect
    Comparison groups
    Dysport v Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.115
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Main analysis(repeated measures)- Baseline VAS
    Comparison groups
    Placebo v Dysport
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.187
    Method
    		 ANCOVA
    Confidence interval

    Primary: Evolution of pressure pain threshold (PPT) associated with all trigger points (TP)

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    End point title
    		 Evolution of pressure pain threshold (PPT) associated with all trigger points (TP)
    End point description
    The values reported are for the change from baseline in pressure pain threshold (PPT)
    End point type
    Primary
    End point timeframe
    Baseline (Day 0), Week 2, Week 4, Week 8 and Week 12
    End point values
    		 Placebo Dysport
    Number of subjects analysed
    12
    12
    Units: kg/cm2
    arithmetic mean (standard deviation)
        Week 2
    0.74 ± 1.23
    0.29 ± 0.73
        Week 4
    0.82 ± 1.37
    0.72 ± 0.75
        Week 8
    1.01 ± 1.42
    0.68 ± 0.99
        Week 12
    0.66 ± 1.35
    0.92 ± 1.03
    Statistical analysis title
    		 Main analysis(repeated measures)- Treatment effect
    Comparison groups
    Placebo v Dysport
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.679
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Main analysis(repeated measures)- Visit effect
    Comparison groups
    Placebo v Dysport
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.053
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Main analysis(repeated measures)- Baseline VAS
    Comparison groups
    Placebo v Dysport
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.147
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Evolution of global assessment of improvement by the investigator

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    End point title
    		 Evolution of global assessment of improvement by the investigator
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0), Week 2, Week 4, Week 8 and Week 12
    End point values
    		 Placebo Dysport
    Number of subjects analysed
    12
    12
    Units: Participants
        Week 2 Worsening
    2
    2
        Week 2 No change
    3
    4
        Week 2 Improvement
    7
    6
        Week 4 Worsening
    1
    2
        Week 4 No change
    3
    1
        Week 4 Improvement
    8
    9
        Week 8 Worsening
    0
    2
        Week 8 No change
    5
    0
        Week 8 Improvement
    7
    10
        Week 12 Worsening
    0
    1
        Week 12 No change
    5
    0
        Week 12 Improvement
    7
    11
    Statistical analysis title
    		 Treatment effect
    Comparison groups
    Dysport v Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.985
    Method
    		 Regression, Logistic
    Confidence interval
    Statistical analysis title
    		 Visit effect
    Comparison groups
    Dysport v Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.049
    Method
    		 Regression, Logistic
    Confidence interval

    Secondary: Evolution of global assessment of improvement by the patient

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    End point title
    		 Evolution of global assessment of improvement by the patient
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0), Week 2, Week 4, Week 8 and Week 12
    End point values
    		 Placebo Dysport
    Number of subjects analysed
    12
    12
    Units: Participants
        Week 2 Worsening
    2
    2
        Week 2 No change
    2
    5
        Week 2 Improvement
    8
    5
        Week 4 Worsening
    1
    3
        Week 4 No change
    3
    1
        Week 4 Improvement
    8
    8
        Week 8 Worsening
    2
    2
        Week 8 No change
    1
    2
        Week 8 Improvement
    9
    8
        Week 12 Worsening
    1
    1
        Week 12 No change
    4
    1
        Week 12 Improvement
    7
    10
    Statistical analysis title
    		 Treatment effect
    Comparison groups
    Placebo v Dysport
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.574
    Method
    		 Regression, Logistic
    Confidence interval
    Notes
    [1] - Method: Logistic regression for longitudinal data.
    Statistical analysis title
    		 Visit effect
    Comparison groups
    Placebo v Dysport
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.103 [2]
    Method
    		 Regression, Logistic
    Confidence interval
    Notes
    [2] - Method: Logistic regression for longitudinal data.

    Secondary: Modification in usual analgesic intake

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    End point title
    		 Modification in usual analgesic intake
    End point description
    End point type
    Secondary
    End point timeframe
    Week 2 to 12
    End point values
    		 Placebo Dysport
    Number of subjects analysed
    12
    12
    Units: Participants
        Patients with at least one new drug along study
    4
    5
        Patients with at least one drug stopped
    5
    9
        Patients with atleast 1 dose increase during study
    1
    5
        Patients with at least 1 dose decrease during the
    1
    5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 12
    Adverse event reporting additional description
    Non-Serious Treatment Emergent Adverse Events are reported under non-serious adverse events
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 0 U, One vial containing sterile solution of sodium chloride ready for intramuscular injection.

    Reporting group title
    Dysport
    Reporting group description
    		 500 U, One vial containing lyophilized powder, previous dissolution in sodium chloride (0.9%) ready for intramuscular injection.

    Serious adverse events
    		 Placebo Dysport
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo Dysport
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 12 (41.67%)
    5 / 12 (41.67%)
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Adverse event
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Malaise
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Pain
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    2
    Pyrexia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Hepatobiliary disorders
    Hepatic steatosis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Hepatomegaly
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Muscle contracture
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Muscle weakness
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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