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    Clinical Trial Results:
    A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Dysport® for the Treatment of Cervical Dystonia

    Summary
    EudraCT number
    		 2005-000709-70
    Trial protocol
    		 DE  
    Global end of trial date
    07 Sep 2006

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Feb 2016
    First version publication date
    06 Feb 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Y-47-52120-051
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ipsen Group
    Sponsor organisation address
    27 Maple Street, Milford, MA, United States, 01757
    Public contact
    Medical Director, Neurology, Ipsen, clinical.trials@ipsen.com
    Scientific contact
    Medical Director, Neurology, Ipsen, 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 Oct 2007
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Sep 2006
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Sep 2006
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy and safety of intramuscular administration of Dysport (500 units) compared to placebo for the treatment of cervical dystonia
    Protection of trial subjects
    The study was conducted in accordance with the applicable Food and Drug Administration (FDA) regulations and/or guidelines, the International Conference on Harmonization (ICH) Guideline for Good Clinical Practice (GCP), and the Declaration of Helsinki. Dysport® for Injection (hereinafter referred to as Dysport) is an injectable form of Botulinum Toxin Type A (BTX-A). Dysport is licensed in many European countries for use in the treatment of a number of focal dystonias, including blepharospasm, spasmodic torticollis (cervical dystonia), and relief of hemifacial spasm. Clinical studies conducted to date have identified 500 units of Dysport as the optimal dose for the treatment of the signs and symptoms of cervical dystonia.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Oct 2005
    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
    Russian Federation: 28
    Country: Number of subjects enrolled
    United States: 88
    Worldwide total number of subjects
    116
    EEA total number of subjects
    0
    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)
    96
    From 65 to 84 years
    20
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Date of first enrollment: 10 October 2005 and Date of last completed: 07 September 2006. The study was conducted at sixteen centers in the USA and four centers in Russia.

    Pre-assignment
    Screening details
    		 A total of 127 subjects were screened across 20 centers. 116 subjects were randomized with 55 and 61 in the Dysport and placebo treatment groups.

    Period 1
    Period 1 title
    Overall Trial (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
    		 Dysport
    Arm description
    		 A single dose of Dysport was administered by intramuscular injection to a maximum of four clinically indicated muscles. The total dose was 500 Dysport units in a single dosing session.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dysport
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A single dose of 500 units of Dysport

    Arm title
    		 Placebo
    Arm description
    		 A single dose of 500 units of placebo by intramuscular injection Principal Investigator (PI)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A single dose of 500 units of placebo by intramuscular injection

    Number of subjects in period 1
    		Dysport Placebo
    Started
    55
    61
    Completed
    45
    38
    Not completed
    10
    23
         Consent withdrawn by subject
    2
    -
         PI & Subject Schedule Conflicts
    1
    -
         Lost to follow-up
    1
    -
         Lack of efficacy
    5
    23
         No Longer Wanted to do Blood Draws
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dysport
    Reporting group description
    		 A single dose of Dysport was administered by intramuscular injection to a maximum of four clinically indicated muscles. The total dose was 500 Dysport units in a single dosing session.

    Reporting group title
    Placebo
    Reporting group description
    		 A single dose of 500 units of placebo by intramuscular injection Principal Investigator (PI)

    Reporting group values
    		 Dysport Placebo Total
    Number of subjects
    		 55 61 116
    Age categorical
    Units: Subjects
        Between 18 and 65 years
    		 46 50 96
        >=65 years
    		 9 11 20
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51.9 ( 13.4 ) 53.9 ( 12.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 37 38 75
        Male
    		 18 23 41
    Race
    Units: Subjects
        Caucasian/White
    		 55 61 116
    Ethnicity
    Units: Subjects
        Hispanic/Latino
    		 3 4 7
        Not Hispanic/Latino
    		 52 57 109
    Height
    Dysport: N= 53 Placebo: N= 60
    Units: cm
        arithmetic mean (standard deviation)
    		 167 ( 10.3 ) 170 ( 8.5 ) -
    Weight
    Dysport: N= 55 Placebo: N= 60
    Units: kg
        arithmetic mean (standard deviation)
    		 73.4 ( 13.8 ) 77.4 ( 15 ) -
    TWSTRS Total Score
    Units: Points on a scale
        arithmetic mean (standard deviation)
    		 43.83 ( 7.97 ) 45.81 ( 8.78 ) -
    Subject’s VAS for Symptom Assessment
    Dysport: N= 55 Placebo: N= 57
    Units: Points on a scale
        arithmetic mean (standard deviation)
    		 67.7 ( 19.7 ) 63.6 ( 18.9 ) -
    Investigator’s VAS for Symptom Assessment
    Dysport: N= 54 Placebo: N= 59
    Units: Points on a scale
        arithmetic mean (standard deviation)
    		 62.3 ( 15.8 ) 65.3 ( 18 ) -
    SF-36 Scores - Mental Health Summary
    Dysport: N= 54 Placebo: N= 59 Short Form 36 Quality of Life questionnaire (SF-36)
    Units: Points on a scale
        arithmetic mean (standard deviation)
    		 44.52 ( 10.41 ) 43.31 ( 11.14 ) -
    SF-36 Scores - Physical Health Summary
    Dysport: N= 54 Placebo: N= 59
    Units: Points on a scale
        arithmetic mean (standard deviation)
    		 39.42 ( 8.84 ) 43.18 ( 7.89 ) -

    End points

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    End points reporting groups
    Reporting group title
    Dysport
    Reporting group description
    		 A single dose of Dysport was administered by intramuscular injection to a maximum of four clinically indicated muscles. The total dose was 500 Dysport units in a single dosing session.

    Reporting group title
    Placebo
    Reporting group description
    		 A single dose of 500 units of placebo by intramuscular injection Principal Investigator (PI)

    Primary: Change from Baseline in TWSTRS Total Score at week 4

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    End point title
    		 Change from Baseline in TWSTRS Total Score at week 4
    End point description
    Intention-to Treat (ITT) Population Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) TWSTRS is comprised of three different components which are severity, disability & pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline. The analysis was performed on the intention to treat population which consisted of 55 subjects receiving Dysport and 61 Placebo. There were 4 subjects for Dysport and 3 for placebo who were not assessed on TWSTRS score at Week 4. As there was no imputation of missing TWSTRS score values, these 7 subjects were not taken into account.
    End point type
    Primary
    End point timeframe
    Baseline (week 0) and week 4
    End point values
    		 Dysport Placebo
    Number of subjects analysed
    55
    61
    Units: points on a scale
    arithmetic mean (standard deviation)
        Week 4 (N=51,58)
    -13.99 ( 12.33 )
    -5.23 ( 9.33 )
    Statistical analysis title
    		 Treatment Difference (Dysport & Placebo) - Week 4
    Statistical analysis description
    Baseline TWSTRS total scores are analysed for all subjects of ITT population, while the analysis at Week 4 excludes the scores for the 7 subjects who were not assessed. Mean difference = difference in adjusted least squares mean (Dysport - Placebo).
    Comparison groups
    Dysport v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change from Baseline in TWSTRS Total Score week 8 and 12

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    End point title
    		 Change from Baseline in TWSTRS Total Score week 8 and 12
    End point description
    Week 8: The analysis was performed on the intention to treat population which consisted of 55 subjects receiving Dysport and 61 Placebo. There were 9 subjects for Dysport and 15 for placebo who were not assessed on TWSTRS score at Week 8. As there was no imputation of missing TWSTRS score values, these 24 subjects were not taken into account. Week 12: The analysis was performed on the intention to treat population which consisted of 55 subjects receiving Dysport and 61 Placebo. There were 10 subjects for Dysport and 17 for placebo who were not assessed on TWSTRS score at Week 12. As there was no imputation of missing TWSTRS score values, these 27 subjects were not taken into account.
    End point type
    Secondary
    End point timeframe
    Baseline (week 0), week 8 and week 12
    End point values
    		 Dysport Placebo
    Number of subjects analysed
    55
    61
    Units: points on a scale
    arithmetic mean (standard deviation)
        Week 8 (N=46,46)
    -13.82 ( 11.53 )
    -5.59 ( 11.37 )
        Week 12 (N=45,44)
    -6.98 ( 11.12 )
    -4.53 ( 7.75 )
    Statistical analysis title
    		 Treatment Difference (Dysport & Placebo) - Week 8
    Statistical analysis description
    Baseline TWSTRS total scores are analysed for all subjects of ITT population, while the Week 8 analysis excludes the scores for the 24 subjects who were not assessed. Mean difference = difference in adjusted least squares mean (Dysport - Placebo).
    Comparison groups
    Dysport v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Treatment Difference (Dysport & Placebo) - Week 12
    Statistical analysis description
    Baseline TWSTRS total scores are analysed for all subjects of ITT population, while the Week 12 analysis excludes the scores for the 27 subjects who were not assessed. Mean difference = difference in adjusted least squares mean (Dysport - Placebo).
    Comparison groups
    Dysport v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.019
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change from Baseline in Subject’s VAS for Symptom Assessment

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    End point title
    		 Change from Baseline in Subject’s VAS for Symptom Assessment
    End point description
    Visual Analog Scale (VAS): The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms). Week 4:Analysis was performed on ITT population which consisted of 55 subjects on Dysport and 61 Placebo.There were 5 subjects on Dysport and 8 on placebo who were not assessed on the change in subject VAS score for CD symptoms at Week 4.There was no imputation of missing VAS scores, so these 13 subjects were not taken into account. Week 8:Analysis was performed on ITT population which consisted of 55 subjects receiving Dysport and 61 Placebo.There were 3 subjects for Dysport and 5 for placebo who were not assessed on the change in investigator VAS score at Week 4. As there was no imputation of missing VAS scores, these 8 subjects were not taken into account. Week 12:Analysis was performed on ITT population which consisted of 55 subjects on Dysport and 61 on Placebo.Missing assessments at Week 8 were imputed using LOCF Methodolgy.
    End point type
    Secondary
    End point timeframe
    Baseline (week 0), weeks 4, 8 and 12
    End point values
    		 Dysport Placebo
    Number of subjects analysed
    55
    61
    Units: points on a scale
    arithmetic mean (standard deviation)
        Week 4 (N=50,53)
    -24.2 ( 29.5 )
    -6.7 ( 20.8 )
        Week 8 (N=55,57)
    -24.6 ( 30 )
    -5.4 ( 25.4 )
        Week 12 (N=55,57)
    -14.4 ( 25.2 )
    -4.6 ( 23.3 )
    Statistical analysis title
    		 Treatment Difference (Dysport & Placebo) - Week 4
    Statistical analysis description
    Analysis at baseline (and on change at Week 4) excludes 4 subjects (and 13 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)
    Comparison groups
    Dysport v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Treatment Difference (Dysport & Placebo) - Week 8
    Statistical analysis description
    Analysis at baseline (and on change at Week 8) excludes 4 subjects (and 4 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)
    Comparison groups
    Dysport v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Treatment Difference (Dysport & Placebo) - Week 12
    Statistical analysis description
    Analysis at baseline (and on change at Week 12) excludes 4 subjects (and 4 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)
    Comparison groups
    Dysport v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change from Baseline in Investigator’s VAS for Symptom Assessment

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    End point title
    		 Change from Baseline in Investigator’s VAS for Symptom Assessment
    End point description
    Week 4: Analysis was performed on intention to treat population which consisted of 55 subjects receiving Dysport and 61 Placebo. There were 3 subjects for Dysport and 5 for placebo who were not assessed on the change in investigator VAS score at Week 4. As there was no imputation of missing VAS scores, these 8 subjects were not taken into account. Week 8: Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. Missing assessments at Week 8 were imputed using Last Observation Carried Forward (LOCF) methodology. There was no imputation for 3 patients with missing baseline and Week 4 values. Week 12: Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. Missing assessments at Week 12 were imputed using Last Observation Carried Forward (LOCF) methodology. There was no imputation for 3 patients with missing baseline, Week 4 and Week 8 values.
    End point type
    Secondary
    End point timeframe
    Baseline (week 0), weeks 4, 8 and 12,
    End point values
    		 Dysport Placebo
    Number of subjects analysed
    55
    61
    Units: points on a scale
    arithmetic mean (standard deviation)
        Week 4 (N=52,56)
    -23.1 ( 22.1 )
    -9.1 ( 20.2 )
        Week 8 (N=54,59)
    -20.5 ( 22.7 )
    -5 ( 21.3 )
        Week 12 (N=54,59)
    -8.5 ( 18.9 )
    -5.8 ( 15.8 )
    Statistical analysis title
    		 Treatment Difference (Dysport & Placebo) - Week 4
    Statistical analysis description
    Analysis at baseline (and on change at Week 4) excludes 3 subjects (and 8 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)
    Comparison groups
    Dysport v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Treatment Difference (Dysport & Placebo) - Week 8
    Statistical analysis description
    Analysis at baseline (and on change at Week 8) excludes 3 subjects (and 3 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)
    Comparison groups
    Dysport v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Treatment Difference (Dysport & Placebo) - Week 12
    Statistical analysis description
    Analysis at baseline (and on change at Week 12) excludes 3 subjects (and 3 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)
    Comparison groups
    Dysport v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.028
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change from Baseline in SF-36 Scores

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    End point title
    		 Change from Baseline in SF-36 Scores
    End point description
    Mental and Physical Health Summaries (ITT Population) SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Mental Health Summary Score is derived from four individual domains (vitality, social functioning, role limitations due to emotional problems and mental health). SF-36 Physical Health Summary Score is derived from four individual domains (physical functioning, role physical, bodily pain and general health). MHS and PHS: Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. There were 13 subjects on Dysport and 24 on placebo who were not assessed on the change in mental and physical health summary at Week 8. There was no imputation of missing scores, so these 37 subjects were not taken into account.
    End point type
    Secondary
    End point timeframe
    Baseline (week 0) and at week 8
    End point values
    		 Dysport Placebo
    Number of subjects analysed
    55
    61
    Units: points on a scale
    arithmetic mean (standard deviation)
        Week 8: Mental Health Summary (N=42,37)
    4.11 ( 9.18 )
    2.48 ( 8.12 )
        Week 8: Physical Health Summary (N=42,37)
    4.37 ( 5.46 )
    -0.64 ( 6.41 )
    Statistical analysis title
    		 Treatment Difference (Dysport & Placebo) - Week 8
    Statistical analysis description
    Mental Health Summary (MHS) Analysis at baseline (and on change at Week 8) excludes 3 subjects (and 37 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)
    Comparison groups
    Dysport v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.061
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Treatment Difference (Dysport & Placebo) - Week 8
    Statistical analysis description
    Physical Health Summary (PHS) Analysis at baseline (and on change at Week 8) excludes 3 subjects (and 37 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)
    Comparison groups
    Dysport v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Number of Subjects Considered by the Investigator to be Overall Treatment Successes

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    End point title
    		 Number of Subjects Considered by the Investigator to be Overall Treatment Successes
    End point description
    Overall treatment success was defined by a global efficacy assessment of “better” or “much better” and a global safety assessment of no worse than “moderate”.
    End point type
    Secondary
    End point timeframe
    At week 12
    End point values
    		 Dysport Placebo
    Number of subjects analysed
    55
    61
    Units: participants
    32
    10
    Statistical analysis title
    		 Dysport - Placebo
    Comparison groups
    Dysport v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [1]
    Method
    		 Odds Ratio
    Confidence interval
    Notes
    [1] - The odds ratio represents the odds of success on Dysport versus Placebo stratified for strata and country

    Other pre-specified: Number of Subjects with Adverse Event

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    End point title
    		 Number of Subjects with Adverse Event
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Up to 12 Months
    End point values
    		 Dysport Placebo
    Number of subjects analysed
    55
    61
    Units: Number of subjects
    number (not applicable)
        Any adverse event
    26
    27
        Any treatment related adverse event
    12
    9
        Any severe adverse event
    4
    4
        Any severe treatment related adverse event
    4
    2
        Any serious adverse event
    0
    1
        Any adverse events leading to withdrawal
    0
    0
        Adverse event leading to death
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 12 Months
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.0
    Reporting groups
    Reporting group title
    Dysport
    Reporting group description
    		 A single dose of Dysport was administered by intramuscular injection to a maximum of four clinically indicated muscles. The total dose was 500 Dysport units in a single dosing session

    Reporting group title
    Placebo
    Reporting group description
    		 A single dose of 500 units of placebo by intramuscular injection

    Serious adverse events
    		 Dysport Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 61 (1.64%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Psychiatric disorders
    Suicide attempt
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 61 (1.64%)
         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: 5%
    Non-serious adverse events
    		 Dysport Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 55 (20.00%)
    5 / 61 (8.20%)
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    3 / 55 (5.45%)
    2 / 61 (3.28%)
         occurrences all number
    3
    2
    Gastrointestinal disorders
    Dysphagia
         subjects affected / exposed
    5 / 55 (9.09%)
    0 / 61 (0.00%)
         occurrences all number
    5
    0
    Musculoskeletal and connective tissue disorders
    Neck pain
         subjects affected / exposed
    3 / 55 (5.45%)
    3 / 61 (4.92%)
         occurrences all number
    4
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 May 2006
    Changes were mostly administrative, but also included an update to the Subject Informed Consent form, providing further information on the potential for Adverse Event (AEs) due to study treatment.

    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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