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    Clinical Trial Results:
    A phase III, multicentre, prospective, double blind, randomised, placebo controlled study, assessing the efficacy and safety of Dysport intramuscular injections used for the treatment of upper limb spasticity in adult subjects with spastic hemiparesis due to stroke or traumatic brain injury.

    Summary
    EudraCT number
    2010-019069-28
    Trial protocol
    BE   CZ   SK   PL   IT   HU  
    Global end of trial date
    04 Sep 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    25 Mar 2016
    First version publication date
    25 Mar 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Y-52-52120-145
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Ipsen Innovation
    Sponsor organisation address
    5 Avenue du Canada, Les Ulis, France, 91940
    Public contact
    Medical Director, Neurology, Ipsen Innovation, clinical.trials@ipsen.com
    Scientific contact
    Medical Director, Neurology., Ipsen Innovation, 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
    17 Apr 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Sep 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Sep 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary study objective is to assess the efficacy of Dysport compared to placebo in reducing upper limb muscle tone in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury. The primary study objective will be assessed by comparing between treatment groups at Week 4 the change from baseline in muscle tone (using the Modified Ashworth Scale (MAS)) in the primary targeted muscle group
    Protection of trial subjects
    This clinical study was designed and implemented and reported in accordance with the International Conference on Harmonization (ICH) Harmonized Tripartite Guidelines for Good Clinical Practice (GCP), with applicable local regulations (including European Directive 2001/20/EC, US Code of Federal Regulations Title 21, and Japanese Ministry of Health, Labor, and Welfare), and with the ethical principles laid down in the Declaration of Helsinki.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    04 Aug 2011
    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
    Slovakia: 11
    Country: Number of subjects enrolled
    United States: 95
    Country: Number of subjects enrolled
    Belgium: 15
    Country: Number of subjects enrolled
    Czech Republic: 22
    Country: Number of subjects enrolled
    France: 34
    Country: Number of subjects enrolled
    Hungary: 8
    Country: Number of subjects enrolled
    Italy: 7
    Country: Number of subjects enrolled
    Poland: 29
    Country: Number of subjects enrolled
    Russian Federation: 22
    Worldwide total number of subjects
    243
    EEA total number of subjects
    126
    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)
    193
    From 65 to 84 years
    50
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This multi-center study was conducted in 34 investigation sites. Subjects screened were 281 and randomized and treated were 243.

    Pre-assignment
    Screening details
    A total of 281 subjects were screened and 243 were randomised and treated into study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Placebo intramuscular injection single treatment cycle 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 intramuscular injection single treatment cycle on day 1

    Arm title
    Dysport 500 U
    Arm description
    Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
    Arm type
    Active comparator

    Investigational medicinal product name
    Dysport 500 U
    Investigational medicinal product code
    Other name
    Botulinum type A toxin
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1

    Arm title
    Dysport 1000 U
    Arm description
    Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
    Arm type
    Active comparator

    Investigational medicinal product name
    Dysport 1000 U
    Investigational medicinal product code
    Other name
    Botulinum type A toxin
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1

    Number of subjects in period 1
    Placebo Dysport 500 U Dysport 1000 U
    Started
    81
    81
    81
    Completed
    74
    78
    77
    Not completed
    7
    3
    4
         Withdrawal by Subject
    1
    -
    2
         Protocol violation
    2
    -
    -
         Adverse event
    3
    1
    1
         lack of subject compliance
    -
    -
    1
         Family reason and moved out of state
    -
    2
    -
         Lost to follow-up
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo intramuscular injection single treatment cycle on day 1

    Reporting group title
    Dysport 500 U
    Reporting group description
    Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1

    Reporting group title
    Dysport 1000 U
    Reporting group description
    Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1

    Reporting group values
    Placebo Dysport 500 U Dysport 1000 U Total
    Number of subjects
    81 81 81 243
    Age categorical
    Units: Subjects
        <65 years
    66 66 61 193
        >=65 years
    15 15 20 50
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    52.9 ± 13.8 52.8 ± 12.8 53.2 ± 13.8 -
    Gender categorical
    Units: Subjects
        Female
    31 28 28 87
        Male
    50 53 53 156
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    1 3 2 6
        Black/African American
    9 7 11 27
        Caucasian/White
    71 70 67 208
        Multiple
    0 1 1 2
    Ethnicity
    Units: Subjects
        Hispanic/Latino
    5 3 10 18
        Not Hispanic/Latino
    76 78 71 225
    BMI
    Aggregate analysis for BMI is 27.33(5.17) for participants Placebo: N=78, Dysport 500 U: N=80, and Dysport 1000 U: N=80.
    Units: kg/m2
        arithmetic mean (standard deviation)
    26.78 ± 5.38 27.63 ± 4.61 27.58 ± 5.51 -
    Modified Ashworth Scale Score
    Aggregate analysis for MAS at baseline is 3.9(0.4) for participants Placebo:N=79, Dysport500U:N=80 & Dysport1000U:N=79. MAS scale is used to assess MT using a 6-point scale where:0=No increase in MT, 1=Slight increase in MT,1±=Slight increase in MT manifested by a catch followed by minimal resistance throughout remainder of ROM,2=Marked increase in MT through most of ROM but affected part easily moved,3=Considerable increase in MT passive movement difficult or 4=Affected part(s) rigid in flexion or extension. The MAS has been derived for analyses as follows:0=0 ; 1=1; 1+=2; 2=3; 3=4; 4=5.
    Units: units on a scale
        arithmetic mean (standard deviation)
    3.9 ± 0.4 3.9 ± 0.5 3.9 ± 0.4 -
    Disability Assessment Scale Score
    Aggregate analysis for DAS at baseline is 2.6(0.5) for participants Placebo:N=79 Dysport500U:N=80 Dysport1000U:N=78 DAS is a 4-point scale used to determine the extent of functional impairment in 4 functional domains(dressing, hygiene, limb position and pain). DAS scale rating: 0=No disability,1=Mild disability (noticeable but does not interfere significantly with normal activities),2=Moderate disability (normal activities require increased effort and/or assistance),3=Severe disability (normal activities limited). If the subject chose Hygiene as PTT the score collected will be between 0 & 3
    Units: units on a scale
        arithmetic mean (standard deviation)
    2.6 ± 0.5 2.6 ± 0.5 2.5 ± 0.5 -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo intramuscular injection single treatment cycle on day 1

    Reporting group title
    Dysport 500 U
    Reporting group description
    Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1

    Reporting group title
    Dysport 1000 U
    Reporting group description
    Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1

    Primary: Change From Baseline in MAS Score in the Primary Targeted Muscle Group (PTMG)

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    End point title
    Change From Baseline in MAS Score in the Primary Targeted Muscle Group (PTMG) [1]
    End point description
    MAS scale is used to assess muscle tone (MT) using a 6-point scale where: 0=No increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the part is flexed or extended, 1±Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the ROM, 2=Marked increase in muscle tone through most of the ROM but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part(s) rigid in flexion or extension. The MAS has been derived for analyses as follows: 0=0 ; 1=1; 1+=2; 2=3; 3=4 and 4=5. Intention to treat (ITT) population included all randomized subjects who received at least one injection of study drug and had a MAS score at baseline (pretreatment) and at week 4. Total 5 subjects were excluded from ITT population as they did not have MAS score at baseline or/and at week 4.
    End point type
    Primary
    End point timeframe
    From Baseline (Day 1) to Week 4.
    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 analyses for this endpoint.
    End point values
    Placebo Dysport 500 U Dysport 1000 U
    Number of subjects analysed
    79
    80
    79
    Units: units on a scale
    arithmetic mean (standard deviation)
        Change From Baseline in MAS Score in the PTMG
    -0.3 ± 0.6
    -1.2 ± 1
    -1.4 ± 1.1
    No statistical analyses for this end point

    Secondary: Physician's Global Assessment (PGA) of Treatment Response

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    End point title
    Physician's Global Assessment (PGA) of Treatment Response
    End point description
    PGA is a 9-point scale used to assess global overall treatment response by the investigator (-4: markedly worse, -3: much worse, -2: worse, -1: slightly worse, 0: no change, +1: slightly improved, +2: improved, +3: much improved and +4: markedly improved). ITT population. Two subjects each from Placebo and Dysport 1000 U had missed PGA assessment at week 4
    End point type
    Secondary
    End point timeframe
    At week 4
    End point values
    Placebo Dysport 500 U Dysport 1000 U
    Number of subjects analysed
    78
    80
    78
    Units: units on a scale
    arithmetic mean (standard deviation)
        PGA of Treatment Response
    0.6 ± 1
    1.4 ± 1.1
    1.8 ± 1.1
    No statistical analyses for this end point

    Secondary: Change From Baseline in DAS Score for the Principal Target of Treatment (PTT)

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    End point title
    Change From Baseline in DAS Score for the Principal Target of Treatment (PTT)
    End point description
    DAS is a 4-point scale used to determine the extent of functional impairment in 4 functional domains (dressing, hygiene, limb position and pain). DAS scale rating: 0=No disability, 1=Mild disability (noticeable but does not interfere significantly with normal activities), 2=Moderate disability (normal activities require increased effort and/or assistance) and 3=Severe disability (normal activities limited). If subject chose 'Hygiene' as PTT the score collected will be between 0 and 3. ITT population. Two subjects from Placebo and one subject from Dysport 1000 U had missed DAS assessment at baseline and week 4.
    End point type
    Secondary
    End point timeframe
    From Baseline (Day 1) to Week 4
    End point values
    Placebo Dysport 500 U Dysport 1000 U
    Number of subjects analysed
    79
    80
    78
    Units: units on a scale
        arithmetic mean (standard deviation)
    -0.5 ± 0.7
    -0.7 ± 0.8
    -0.7 ± 0.7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 24±2 weeks
    Adverse event reporting additional description
    Non-serious adverse event affecting >2% of total subjects are reported.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo intramuscular injection single treatment cycle on day 1

    Reporting group title
    Dysport 500 U
    Reporting group description
    Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1

    Reporting group title
    Dysport 1000 U
    Reporting group description
    Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1

    Serious adverse events
    Placebo Dysport 500 U Dysport 1000 U
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 81 (3.70%)
    3 / 81 (3.70%)
    3 / 81 (3.70%)
         number of deaths (all causes)
    1
    1
    0
         number of deaths resulting from adverse events
    1
    1
    0
    Vascular disorders
    Behcet's syndrome
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 81 (1.23%)
    0 / 81 (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
    Deep vein thrombosis
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 81 (0.00%)
    0 / 81 (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
    Injury, poisoning and procedural complications
    Craniocerebral injury
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 81 (0.00%)
    0 / 81 (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
    Ligament sprain
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 81 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiovascular disorder
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 81 (1.23%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary oedema
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 81 (0.00%)
    0 / 81 (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
    Cerebrovascular accident
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 81 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Partial seizures
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 81 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 81 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 81 (0.00%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 81 (1.23%)
    0 / 81 (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
    Muscular weakness
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 81 (0.00%)
    0 / 81 (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
    Infections and infestations
    Sepsis
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 81 (1.23%)
    0 / 81 (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
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    Placebo Dysport 500 U Dysport 1000 U
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 81 (12.35%)
    25 / 81 (30.86%)
    18 / 81 (22.22%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 81 (1.23%)
    2 / 81 (2.47%)
         occurrences all number
    0
    1
    2
    Investigations
    Blood glucose increased
         subjects affected / exposed
    0 / 81 (0.00%)
    2 / 81 (2.47%)
    0 / 81 (0.00%)
         occurrences all number
    0
    2
    0
    Blood pressure increased
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 81 (1.23%)
    2 / 81 (2.47%)
         occurrences all number
    0
    1
    2
    Blood triglycerides increased
         subjects affected / exposed
    0 / 81 (0.00%)
    3 / 81 (3.70%)
    1 / 81 (1.23%)
         occurrences all number
    0
    3
    1
    Gamma glutamyl transferase increased
         subjects affected / exposed
    0 / 81 (0.00%)
    2 / 81 (2.47%)
    2 / 81 (2.47%)
         occurrences all number
    0
    2
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 81 (0.00%)
    2 / 81 (2.47%)
    1 / 81 (1.23%)
         occurrences all number
    0
    3
    1
    Epistaxis
         subjects affected / exposed
    0 / 81 (0.00%)
    2 / 81 (2.47%)
    0 / 81 (0.00%)
         occurrences all number
    0
    3
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 81 (1.23%)
    2 / 81 (2.47%)
         occurrences all number
    0
    1
    2
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 81 (1.23%)
    2 / 81 (2.47%)
    0 / 81 (0.00%)
         occurrences all number
    1
    2
    0
    Injection site bruising
         subjects affected / exposed
    2 / 81 (2.47%)
    1 / 81 (1.23%)
    1 / 81 (1.23%)
         occurrences all number
    2
    1
    1
    Injection site erythema
         subjects affected / exposed
    0 / 81 (0.00%)
    0 / 81 (0.00%)
    2 / 81 (2.47%)
         occurrences all number
    0
    0
    2
    Injection site pain
         subjects affected / exposed
    3 / 81 (3.70%)
    1 / 81 (1.23%)
    0 / 81 (0.00%)
         occurrences all number
    3
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 81 (0.00%)
    2 / 81 (2.47%)
    1 / 81 (1.23%)
         occurrences all number
    0
    2
    1
    Nausea
         subjects affected / exposed
    0 / 81 (0.00%)
    3 / 81 (3.70%)
    0 / 81 (0.00%)
         occurrences all number
    0
    3
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 81 (1.23%)
    2 / 81 (2.47%)
    1 / 81 (1.23%)
         occurrences all number
    1
    4
    1
    Back pain
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 81 (0.00%)
    2 / 81 (2.47%)
         occurrences all number
    1
    0
    2
    Muscular Weakness
         subjects affected / exposed
    1 / 81 (1.23%)
    2 / 81 (2.47%)
    4 / 81 (4.94%)
         occurrences all number
    1
    2
    4
    Musculoskeletal pain
         subjects affected / exposed
    1 / 81 (1.23%)
    2 / 81 (2.47%)
    1 / 81 (1.23%)
         occurrences all number
    1
    2
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 81 (1.23%)
    7 / 81 (8.64%)
    1 / 81 (1.23%)
         occurrences all number
    1
    7
    1
    Sinusitis
         subjects affected / exposed
    0 / 81 (0.00%)
    2 / 81 (2.47%)
    1 / 81 (1.23%)
         occurrences all number
    0
    2
    1
    Urinary tract infections
         subjects affected / exposed
    0 / 81 (0.00%)
    2 / 81 (2.47%)
    1 / 81 (1.23%)
         occurrences all number
    0
    2
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Apr 2011
    Protocol amendment 1: Made the following changes: • The primary efficacy analysis was changed from a Hochberg procedure to a hierarchical testing procedure following feedback from the Food and Drug Administration. • The procedure for breaking the blind was clarified. • The definition of treatment naïve was harmonised to that used in similar protocols. • Minor formatting and typographical issues were corrected.
    17 Feb 2012
    Protocol amendment 2: Made the following changes: •In inclusion criterion 2, it was clarified that subjects had to have a diagnosis of hemiparesis. • In inclusion criterion 5, the definition of naïve/non-naïve subjects was clarified. Naive subjects were defined as those who had never previously received BTX in the injected upper limb. • In exclusion criterion 6, the text for exclusion due to surgery was clarified and made more specific. • Exclusion criterion 20 was added to exclude the use of intrathecal baclofen during or for the 4 weeks prior to the study. • For the PTMG for elbow flexors, a clarification was added regarding the choice of ‘brachialis’ or ‘brachialis and brachioradialis’. • For the assessments of upper limb muscle groups, assessments for elbow pronators were removed owing to the number of evaluations to be performed. • Minor formatting and typographical issues were corrected. • The time for which subjects were required to be supine before ECG was recorded was corrected. • Text was added to item 9 in the Modified Frenchay Scale to clarify that the affected hand holds the fork during the assessment. In light of the amendment, the CRF, database and RAP required updating.
    12 Jul 2012
    Protocol amendment 3, dated 12 July 2012, made the following changes: • The pharmacovigilance/emergency contact details for the USA were updated. • Inclusion criterion 3 was altered to allow entry into the study of subjects with a non-evolutive lesion diagnosed before the stroke and in the same cerebral hemisphere. • Inclusion criterion 7 was altered to include subjects with a spasticity angle of 10°. • The wording of Section 9.5 was amended to clarify the meaning and take into account all possibilities regarding used and unused treatments and empty boxes for destruction. • References to Sponsor’s CDDS Department were amended to Statistics Department. • Instructions for disposal of used vials were clarified.

    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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