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    Clinical Trial Results:
    BOTOX® Treatment in Adult Patients with Upper Limb Spasticity

    Summary
    EudraCT number
    		 2013-002346-37
    Trial protocol
    		 GB   HU  
    Global end of trial date
    14 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Feb 2017
    First version publication date
    10 Feb 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    191622-127
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02145676
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Allergan Limited
    Sponsor organisation address
    Allergan Limited Marlow International The Parkway, Marlow, United Kingdom, SL7 1YL
    Public contact
    Allergan Limited EU Regulatory Dept, Allergan Limited, 44 1628 494444, ml-eu_reg_affairs@allergan.com
    Scientific contact
    Allergan Limited EU Regulatory Dept, Allergan Limited, 44 1628 494444, ml-eu_reg_affairs@allergan.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
    14 Dec 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Dec 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This is a safety and efficacy study of onabotulinumtoxinA in poststroke patients with upper limb spasticity.
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 May 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    United States: 52
    Worldwide total number of subjects
    53
    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)
    41
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Each patient was screened for a period of up to 4 weeks prior to randomization.

    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, Monitor, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 onabotulinumtoxinA 500U
    Arm description
    		 OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    onabotulinumtoxinA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.

    Arm title
    		 onabotulinumtoxinA 300U
    Arm description
    		 OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    onabotulinumtoxinA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.

    Arm title
    		 placebo (normal saline)
    Arm description
    		 Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.

    Number of subjects in period 1
    		onabotulinumtoxinA 500U onabotulinumtoxinA 300U placebo (normal saline)
    Started
    17
    18
    18
    Completed
    17
    18
    18

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    onabotulinumtoxinA 500U
    Reporting group description
    		 OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.

    Reporting group title
    onabotulinumtoxinA 300U
    Reporting group description
    		 OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.

    Reporting group title
    placebo (normal saline)
    Reporting group description
    		 Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.

    Reporting group values
    		 onabotulinumtoxinA 500U onabotulinumtoxinA 300U placebo (normal saline) Total
    Number of subjects
    		 17 18 18 53
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 12 14 15 41
        From 65-84 years
    		 5 4 3 12
    Age Continuous |
    Units: Years
        arithmetic mean (standard deviation)
    		 58.8 ( 11.46 ) 59.7 ( 10.36 ) 56.2 ( 8.3 ) -
    Gender, Male/Female
    Units: Participants
        Female
    		 4 8 10 22
        Male
    		 13 10 8 31

    End points

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    End points reporting groups
    Reporting group title
    onabotulinumtoxinA 500U
    Reporting group description
    		 OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.

    Reporting group title
    onabotulinumtoxinA 300U
    Reporting group description
    		 OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.

    Reporting group title
    placebo (normal saline)
    Reporting group description
    		 Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.

    Primary: Change from Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Elbow Flexors Using a 6-Point Scale

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    End point title
    		 Change from Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Elbow Flexors Using a 6-Point Scale [1]
    End point description
    The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the elbow flexors by passively moving the elbow flexor muscles through their range of motion. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
    End point type
    Primary
    End point timeframe
    Baseline, Week 6
    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: No statistical analysis is reported for this outcome measure.
    End point values
    		 onabotulinumtoxinA 500U onabotulinumtoxinA 300U placebo (normal saline)
    Number of subjects analysed
    17
    18
    18
    Units: Scores on a Scale
    least squares mean (standard deviation)
        Baseline
    4.12 ( 0.332 )
    4.06 ( 0.236 )
    4.17 ( 0.383 )
        Change from Baseline at Week 6 (N=16, 18, 17)
    -1.62 ( 1.455 )
    -1.47 ( 1.247 )
    -0.74 ( 0.97 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in the MAS-B Score of Shoulder Adductors Using a 6-Point Scale

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    End point title
    		 Change from Baseline in the MAS-B Score of Shoulder Adductors Using a 6-Point Scale
    End point description
    The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the shoulder adductors by passively moving the shoulder adductor muscles through their range of motion. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 6
    End point values
    		 onabotulinumtoxinA 500U onabotulinumtoxinA 300U placebo (normal saline)
    Number of subjects analysed
    17
    18
    18
    Units: Scores on a Scale
    least squares mean (standard deviation)
        Baseline
    4 ( 0 )
    4.06 ( 0.236 )
    4 ( 0 )
        Change from Baseline at Week 6 (N=16, 18, 17)
    -1.59 ( 1.263 )
    -1.39 ( 1.042 )
    -1.44 ( 1.004 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Pain on an 11-Point Scale

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    End point title
    		 Change from Baseline in Pain on an 11-Point Scale
    End point description
    The patient is asked to select a number that best describes his/her pain in the treated areas of the study limb on an 11-point scale from 0 = “no pain” to 10 = “pain as bad as can be imagined”. Patients are instructed to recall their average pain in the study limb during the 48-hour period prior to the visit. Patients with a baseline pain score >0 are included in the analyses. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 6
    End point values
    		 onabotulinumtoxinA 500U onabotulinumtoxinA 300U placebo (normal saline)
    Number of subjects analysed
    11
    10
    13
    Units: Scores on a Scale
    least squares mean (standard deviation)
        Baseline
    4.89 ( 2.714 )
    6.05 ( 3.197 )
    5.13 ( 3.586 )
        Change from Baseline at Week 6 (N=11, 10, 11)
    -2.08 ( 3.585 )
    -2.51 ( 4.606 )
    -2.64 ( 3.857 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Dressing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)

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    End point title
    		 Change from Baseline in the Dressing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)
    End point description
    The SIA-UL asks the patient to assess the impact of upper limb spasticity in his/her daily life on a 19-item scale. The scale covers impacts on activities of dressing, showering/bathing, and self-care. The SIA score ranged from 0 (not at all difficult) to 4 (extremely difficult) for each question. The dressing domain was calculated based on the average of 2 questions.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 6
    End point values
    		 onabotulinumtoxinA 500U onabotulinumtoxinA 300U placebo (normal saline)
    Number of subjects analysed
    17
    18
    18
    Units: Scores on a Scale
    least squares mean (standard deviation)
        Baseline
    2.61 ( 1.346 )
    2.91 ( 1.123 )
    2.82 ( 1.092 )
        Change from Baseline at Week 6 (N=16, 18, 17)
    -0.36 ( 0.854 )
    -0.27 ( 0.932 )
    -0.55 ( 1.082 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Showering/Bathing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)

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    End point title
    		 Change from Baseline in the Showering/Bathing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)
    End point description
    The SIA-UL asks the patient to assess the impact of upper limb spasticity his/her daily life on a 19-item scale. The scale covers impacts on activities of dressing, showering/bathing, and self-care. The SIA score ranged from 0 (not at all difficult) to 4 (extremely difficult) for each question. The showering/bathing domain was based on a single question.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 6
    End point values
    		 onabotulinumtoxinA 500U onabotulinumtoxinA 300U placebo (normal saline)
    Number of subjects analysed
    17
    18
    18
    Units: Scores on a Scale
    least squares mean (standard deviation)
        Baseline
    2.71 ( 1.231 )
    2.69 ( 1.263 )
    2.58 ( 1.188 )
        Change from Baseline at Week 6 (N=16, 18, 17)
    -0.62 ( 1.147 )
    -0.36 ( 1.247 )
    -0.51 ( 1.064 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Self-Care Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)

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    End point title
    		 Change from Baseline in the Self-Care Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)
    End point description
    The SIA-UL asks the patient to assess the impact of upper limb spasticity in his/her daily life on a 19-item scale. The scale covers impacts on activities of dressing, showering/bathing, and self-care. The SIA score ranged from 0 (not at all difficult) to 4 (extremely difficult) for each question. The self-care domain was calculated based on the average of 4 questions.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 6
    End point values
    		 onabotulinumtoxinA 500U onabotulinumtoxinA 300U placebo (normal saline)
    Number of subjects analysed
    17
    18
    18
    Units: Scores on a Scale
    least squares mean (standard deviation)
        Baseline
    2.58 ( 1.234 )
    2.61 ( 1.189 )
    2.61 ( 1.086 )
        Change from Baseline at Week 6 (N=16, 18, 17)
    -0.26 ( 0.779 )
    -0.21 ( 0.667 )
    -0.48 ( 1.094 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were recorded from signing the informed consent to the end of study (Week 16).
    Adverse event reporting additional description
    The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    onabotulinumtoxinA 500U
    Reporting group description
    		 OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.

    Reporting group title
    placebo (normal saline)
    Reporting group description
    		 Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.

    Reporting group title
    onabotulinumtoxinA 300U
    Reporting group description
    		 OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.

    Serious adverse events
    		 onabotulinumtoxinA 500U placebo (normal saline) onabotulinumtoxinA 300U
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 17 (11.76%)
    3 / 18 (16.67%)
    0 / 18 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Seizure
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 18 (11.11%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscular weakness
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 onabotulinumtoxinA 500U placebo (normal saline) onabotulinumtoxinA 300U
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 17 (23.53%)
    7 / 18 (38.89%)
    5 / 18 (27.78%)
    Investigations
    Electromyogram abnormal
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Pulmonary function test decreased
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Fall
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Wrist fracture
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Head injury
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Seizure
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Headache
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 18 (11.11%)
    0 / 18 (0.00%)
         occurrences all number
    0
    2
    0
    Immune system disorders
    Seasonal allergy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Diarrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Nausea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Vomiting
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Large intestine polyp
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Rash
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Muscular weakness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Arthritis
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Osteoarthritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Arthralgia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    Myalgia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    0
    1
    Sialoadenitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 18 (11.11%)
    1 / 18 (5.56%)
         occurrences all number
    0
    2
    1
    Tooth abscess
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Upper respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 18 (11.11%)
    0 / 18 (0.00%)
         occurrences all number
    0
    2
    0
    Metabolism and nutrition disorders
    Hyperlipidaemia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Apr 2014
    The pectoralis minor muscle was removed from the injection paradigm, and its associated dose and volume were reallocated to the pectoralis major muscle.
    01 Jul 2014
    Retreatment was removed as an option and the planned EU study sites were eliminated from the study.

    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
    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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