Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

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

    Summary
    EudraCT number
    		 2009-015868-34
    Trial protocol
    		 BE   CZ   SK   IT   PT   HU  
    Global end of trial date
    13 May 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    17 Aug 2017
    First version publication date
    01 Aug 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Following the system outage last year; this completed record had been indicated as "Removed from public view". No applicable reason provided in options above therefore 'correction of full data set' chosen.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    Y-55-52120-140
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01249404
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ipsen Pharma SAS
    Sponsor organisation address
    65 quai Georges Gorse, Boulogne-Billancourt, France, 92100
    Public contact
    Medical Director, Ipsen Pharma SAS, clinical.trials@ipsen.com
    Scientific contact
    Medical Director, Ipsen Pharma SAS, clinical.trials@ipsen.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    10 Apr 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 May 2014
    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 at Week 4 on the change from baseline in the gastrocnemius-soleus complex (GSC) muscle tone (knee extended) in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury.
    Protection of trial subjects
    This clinical study was designed and implemented and reported in accordance with the International Conference on Harmonisation (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
    		 Placebo
    Actual start date of recruitment
    29 Mar 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 86
    Country: Number of subjects enrolled
    Portugal: 12
    Country: Number of subjects enrolled
    Slovakia: 16
    Country: Number of subjects enrolled
    Belgium: 19
    Country: Number of subjects enrolled
    Czech Republic: 18
    Country: Number of subjects enrolled
    France: 54
    Country: Number of subjects enrolled
    Hungary: 15
    Country: Number of subjects enrolled
    Italy: 24
    Country: Number of subjects enrolled
    Australia: 43
    Country: Number of subjects enrolled
    Russian Federation: 30
    Country: Number of subjects enrolled
    United States: 68
    Worldwide total number of subjects
    385
    EEA total number of subjects
    244
    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)
    319
    From 65 to 84 years
    66
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 This was a multicenter study conducted in 62 investigational sites. Subjects were screened at 53 centers and in 52 centers subjects were randomized to receive study treatment.

    Pre-assignment
    Screening details
    		 Subjects randomized were 388 and 385 subjects who received treatment were included in the safety population. Only 381 subjects were included in the intent-to-treat (ITT) population. Subjects excluded from ITT population were 7 (including 4 subjects due to no MAS score at the baseline and/or at Week 4).

    Pre-assignment period milestones
    Number of subjects started
    		 456 [1]
    Number of subjects completed
    		 388

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Screening Failures: 68
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Either resolve this issue or provide a justification.
    Period 1
    Period 1 title
    Randomised Population
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dysport 1000 U
    Arm description
    		 Dysport 1000 U intramuscular injection single treatment cycle on day 1
    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
    Dysport 1000 U intramuscular injection single treatment cycle on day 1

    Arm title
    		 Dysport 1500 U
    Arm description
    		 Dysport 1500 U intramuscular injection single treatment cycle on day 1
    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
    Dysport 1500 U intramuscular injection single treatment cycle on day 1

    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

    Number of subjects in period 1
    		Dysport 1000 U Dysport 1500 U Placebo
    Started
    127
    129
    132
    Completed
    125
    128
    128
    Not completed
    2
    1
    4
         Did not meet entry criteria
    -
    -
    2
         No functional need for Dysport
    -
    1
    -
         No MAS score at baseline and/or Week 4
    2
    -
    2
    Period 2
    Period 2 title
    Treatment phase - ITT
    Is this the baseline period?
    		 Yes [2]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dysport 1000 U
    Arm description
    		 Dysport 1000 U intramuscular injection single treatment cycle on day 1
    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
    Dysport 1000 U intramuscular injection single treatment cycle on day 1

    Arm title
    		 Dysport 1500 U
    Arm description
    		 Dysport 1500 U intramuscular injection single treatment cycle on day 1
    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
    Dysport 1500 U intramuscular injection single treatment cycle on day 1

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

    Investigational medicinal product name
    Placebo Comparator
    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

    Notes
    [2] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Period 1 is not the baseline period. It is expected that period 1 will be the baseline period. Either resolve this issue or provide a justification
    Number of subjects in period 2 [3]
    		Dysport 1000 U Dysport 1500 U Placebo
    Started
    125
    128
    128
    Completed
    120
    121
    125
    Not completed
    5
    7
    3
         Consent withdrawn by subject
    2
    2
    -
         Adverse event, non-fatal
    2
    2
    2
         Unspecified
    1
    3
    1
    Notes
    [3] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Either resolve this issue or provide a justification.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Dysport 1000 U
    Reporting group description
    		 Dysport 1000 U intramuscular injection single treatment cycle on day 1

    Reporting group title
    Dysport 1500 U
    Reporting group description
    		 Dysport 1500 U intramuscular injection single treatment cycle on day 1

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo intramuscular injection single treatment cycle on day 1

    Reporting group values
    		 Dysport 1000 U Dysport 1500 U Placebo Total
    Number of subjects
    		 125 128 128 381
    Age categorical
    Units: Subjects
        Adults (18-80 years)
    		 125 128 128 381
    Age continuous
    ITT Population
    Units: years
        arithmetic mean (standard deviation)
    		 53.2 ( 13.2 ) 53.3 ( 12 ) 51.4 ( 12.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 38 49 38 125
        Male
    		 87 79 90 256
    Race
    ITT Population
    Units: Subjects
        Asian
    		 3 4 3 10
        African American
    		 5 13 5 23
        Caucasian/White
    		 116 109 119 344
        Hawaiian/Pacific
    		 0 1 0 1
        Multiple
    		 1 1 1 3
    Ethnicity
    ITT Population
    Units: Subjects
        Hispanic
    		 14 11 11 36
        Not Hispanic
    		 111 117 117 345
    Weight
    ITT Population
    Units: kg
        arithmetic mean (standard deviation)
    		 79.6 ( 16.5 ) 80.1 ( 14.8 ) 79.7 ( 17.9 ) -
    BMI
    ITT Population
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 27.3 ( 5 ) 27.3 ( 4.1 ) 27.4 ( 5.2 ) -
    MAS score at Baseline
    Units: Units on a scale
        arithmetic mean (standard deviation)
    		 3.8 ( 0.5 ) 3.7 ( 0.5 ) 3.9 ( 0.5 ) -
    Barefoot Comfortable Walking Speed at Baseline
    Units: m/s
        arithmetic mean (standard deviation)
    		 0.44 ( 0.23 ) 0.47 ( 0.22 ) 0.45 ( 0.2 ) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Dysport 1000 U
    Reporting group description
    		 Dysport 1000 U intramuscular injection single treatment cycle on day 1

    Reporting group title
    Dysport 1500 U
    Reporting group description
    		 Dysport 1500 U intramuscular injection single treatment cycle on day 1

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo intramuscular injection single treatment cycle on day 1
    Reporting group title
    Dysport 1000 U
    Reporting group description
    		 Dysport 1000 U intramuscular injection single treatment cycle on day 1

    Reporting group title
    Dysport 1500 U
    Reporting group description
    		 Dysport 1500 U intramuscular injection single treatment cycle on day 1

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo intramuscular injection single treatment cycle on day 1

    Primary: Change from baseline in Modified Ashworth Scale (MAS) score in the Gastrocnemius Soleus Complex (Knee Extended)

    		 Close Top of page
    End point title
    		 Change from baseline in Modified Ashworth Scale (MAS) score in the Gastrocnemius Soleus Complex (Knee Extended) [1]
    End point description
    Intention to treat (ITT) population MAS is a 6-point scale which measures the amount of muscle tone by measuring the resistance of the muscle to passive lengthening or stretching. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented
    End point type
    Primary
    End point timeframe
    At 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 have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Either resolve this issue or provide a justification.
    End point values
    		 Dysport 1000 U Dysport 1500 U Placebo
    Number of subjects analysed
    125
    128
    128
    Units: Units on a scale
    least squares mean (confidence interval 95%)
        MAS score change from Baseline to Week 4
    -0.6 (-0.8 to -0.5)
    -0.8 (-0.9 to -0.7)
    -0.5 (-0.7 to -0.4)
    No statistical analyses for this end point

    Secondary: Physician’s Global Assessment of Treatment Response

    		 Close Top of page
    End point title
    		 Physician’s Global Assessment of Treatment Response
    End point description
    ITT Population Physician’s Global Assessment (PGA) is a 9 points 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).
    End point type
    Secondary
    End point timeframe
    At week 4
    End point values
    		 Dysport 1000 U Dysport 1500 U Placebo
    Number of subjects analysed
    125
    128
    128
    Units: Units on a scale
        least squares mean (confidence interval 95%)
    0.9 (0.7 to 1.1)
    0.9 (0.7 to 1.1)
    0.7 (0.5 to 0.9)
    No statistical analyses for this end point

    Secondary: Change from baseline in Comfortable Barefoot Walking Speed (Without Walking Aids)

    		 Close Top of page
    End point title
    		 Change from baseline in Comfortable Barefoot Walking Speed (Without Walking Aids)
    End point description
    ITT Population Barefoot Comfortable Walking (BCW)
    End point type
    Secondary
    End point timeframe
    At week 4
    End point values
    		 Dysport 1000 U Dysport 1500 U Placebo
    Number of subjects analysed
    124
    127
    126
    Units: m/s
    least squares mean (confidence interval 95%)
        BCW Speed from Baseline to Week 4
    0.05 (0.03 to 0.07)
    0.04 (0.03 to 0.06)
    0.05 (0.03 to 0.07)
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Up to 24 ±2 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Dysport 1000 U
    Reporting group description
    		 Safety Population

    Reporting group title
    Dysport 1500 U
    Reporting group description
    		 Safety Population

    Reporting group title
    Placebo
    Reporting group description
    		 Safety Population

    Serious adverse events
    		 Dysport 1000 U Dysport 1500 U Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 127 (3.94%)
    5 / 128 (3.91%)
    7 / 130 (5.38%)
         number of deaths (all causes)
    0
    0
    2
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Pancreatic carcinoma
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
    0 / 130 (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
    Femur fracture
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 128 (0.78%)
    0 / 130 (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
    Humerus fracture
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
    0 / 130 (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
    Femoral neck fracture
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 128 (0.00%)
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Atrial septal defect
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 128 (0.00%)
    1 / 130 (0.77%)
         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
    Sinus tachycardia
         subjects affected / exposed
    1 / 127 (0.79%)
    0 / 128 (0.00%)
    0 / 130 (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
    Additional description: Safety Population
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 128 (0.78%)
    0 / 130 (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
    Convulsion
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 128 (0.00%)
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 128 (0.00%)
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 128 (0.00%)
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 128 (0.78%)
    0 / 130 (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
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 128 (0.00%)
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 128 (0.78%)
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Musculoskeletal and connective tissue disorders
    Muscular weakness
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 128 (0.78%)
    0 / 130 (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
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 127 (0.00%)
    1 / 128 (0.78%)
    0 / 130 (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
    Post procedural infection
         subjects affected / exposed
    0 / 127 (0.00%)
    0 / 128 (0.00%)
    1 / 130 (0.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         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
    		 Dysport 1000 U Dysport 1500 U Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    55 / 127 (43.31%)
    52 / 128 (40.63%)
    41 / 130 (31.54%)
    Injury, poisoning and procedural complications
    Fall
    Additional description: Safety Population
         subjects affected / exposed
    12 / 127 (9.45%)
    8 / 128 (6.25%)
    4 / 130 (3.08%)
         occurrences all number
    14
    9
    8
    Nervous system disorders
    Headache
    Additional description: Safety Population
         subjects affected / exposed
    0 / 127 (0.00%)
    4 / 128 (3.13%)
    1 / 130 (0.77%)
         occurrences all number
    0
    5
    1
    Convulsion
    Additional description: Safety Population
         subjects affected / exposed
    4 / 127 (3.15%)
    0 / 128 (0.00%)
    1 / 130 (0.77%)
         occurrences all number
    4
    0
    1
    Paraesthesia
    Additional description: Safety Population
         subjects affected / exposed
    2 / 127 (1.57%)
    0 / 128 (0.00%)
    3 / 130 (2.31%)
         occurrences all number
    2
    0
    3
    General disorders and administration site conditions
    Fatigue
    Additional description: Safety Population
         subjects affected / exposed
    1 / 127 (0.79%)
    5 / 128 (3.91%)
    0 / 130 (0.00%)
         occurrences all number
    2
    5
    0
    Asthenia
    Additional description: Safety Population
         subjects affected / exposed
    3 / 127 (2.36%)
    1 / 128 (0.78%)
    1 / 130 (0.77%)
         occurrences all number
    3
    1
    2
    Influenza like illness
    Additional description: Safety Population
         subjects affected / exposed
    3 / 127 (2.36%)
    0 / 128 (0.00%)
    0 / 130 (0.00%)
         occurrences all number
    3
    0
    0
    Psychiatric disorders
    Depression
    Additional description: Safety Population
         subjects affected / exposed
    2 / 127 (1.57%)
    4 / 128 (3.13%)
    0 / 130 (0.00%)
         occurrences all number
    2
    4
    0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
    Additional description: Safety Population
         subjects affected / exposed
    7 / 127 (5.51%)
    8 / 128 (6.25%)
    3 / 130 (2.31%)
         occurrences all number
    7
    9
    3
    Muscular weakness
    Additional description: Safety Population
         subjects affected / exposed
    3 / 127 (2.36%)
    8 / 128 (6.25%)
    4 / 130 (3.08%)
         occurrences all number
    3
    9
    4
    Arthralgia
    Additional description: Safety Population
         subjects affected / exposed
    5 / 127 (3.94%)
    3 / 128 (2.34%)
    1 / 130 (0.77%)
         occurrences all number
    5
    4
    1
    Myalgia
    Additional description: Safety Population
         subjects affected / exposed
    3 / 127 (2.36%)
    2 / 128 (1.56%)
    2 / 130 (1.54%)
         occurrences all number
    3
    2
    2
    Back pain
         subjects affected / exposed
    4 / 127 (3.15%)
    0 / 128 (0.00%)
    2 / 130 (1.54%)
         occurrences all number
    4
    0
    2
    Infections and infestations
    Nasopharyngitis
    Additional description: Safety Population
         subjects affected / exposed
    0 / 127 (0.00%)
    3 / 128 (2.34%)
    2 / 130 (1.54%)
         occurrences all number
    0
    3
    2

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Apr 2011
    Amendment 2: The procedure for blinding and breaking the blind was clarified. The statistical methodology for the primary and first secondary efficacy endpoints was modified to account for separate registration in US and non-US countries.
    09 Feb 2012
    Amendment 3: The definition of naïve and non naïve subjects was clarified following questions raised by the investigators. A naïve subject was one who had never received any BTX in the affected lower limb. Criterion 6, regarding exclusion due to surgery was clarified and made more specific to refer only to surgery for spasticity on the affected lower limb. Exclusion criterion 19 was added to exclude the use of intrathecal baclofen during the course of the study or during the 4 weeks before entering the study. The study duration was amended to reflect new timelines and a delay in subject recruitment.
    12 Jul 2012
    Amendment 4: Inclusion criterion 3 was altered to allow entry into the study of subjects with a nonevolutive lesion diagnosed before the stroke and in the same cerebral hemisphere. Inclusion criterion 7 was altered to include subjects with a spasticity angle greater than or equal to 5 degrees (instead of greater than 5 degrees) in the GSC of the affected leg as assessed by the TS. 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. The pharmacovigilance/emergency contact details for the USA were updated.

    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.

    European Medicines Agency © 1995-Wed May 07 23:05:03 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA