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    Clinical Trial Results:
    Study MAG104615, a Proof of Concept Study for GSK249320 versus placebo in Stroke Patients

    Summary
    EudraCT number
    		 2012-004494-23
    Trial protocol
    		 GB   DE  
    Global end of trial date
    28 Jul 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Mar 2016
    First version publication date
    26 Mar 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MAG104615
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01808261
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom,
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline , 1 8664357343, GSKClinicalSupportHD@gsk.com
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom,
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343,
    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
    30 Jan 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jul 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the efficacy of GSK249320 versus placebo on lower limb motor recovery, specifically locomotion, in ischemic stroke patients
    Protection of trial subjects
    n/a
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 May 2013
    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
    United Kingdom: 32
    Country: Number of subjects enrolled
    Germany: 51
    Country: Number of subjects enrolled
    United States: 26
    Country: Number of subjects enrolled
    Canada: 25
    Worldwide total number of subjects
    134
    EEA total number of subjects
    83
    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)
    47
    From 65 to 84 years
    83
    85 years and over
    4

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 This study consisted of a 6 month Core Study Period and an Extended Follow Up Period, if required. The study was terminated early at the time of Interim Analysis for reasons of futility. At the time of early study termination, a total of 134 participants were randomized, of which 133 participants had received at least one dose of study medication.

    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, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants received placebo administered as two intravenous (IV) infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 milliliters (mL) IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo for GSK249320
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    administered as 2 intravenous infusions; the first on study day 1 and the second on study day 6

    Arm title
    		 GSK249320 15 mg/kg
    Arm description
    		 Participants received GSK249320 15 milligrams (mg)/kilogram (kg) administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK249320
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    15mg/kg administered as 2 intravenous infusions; the first on study day 1 and the second on study day 6

    Number of subjects in period 1 [1]
    		Placebo GSK249320 15 mg/kg
    Started
    68
    65
    Completed
    32
    32
    Not completed
    36
    33
         Consent withdrawn by subject
    6
    7
         Physician decision
    -
    2
         Adverse event, non-fatal
    2
    -
         Lost to follow-up
    3
    1
         Study Closed/Terminated
    25
    23
    Notes
    [1] - 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: One participant was randomized but did not receive treatment and so is not included in the baseline characteristic data.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo administered as two intravenous (IV) infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 milliliters (mL) IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).

    Reporting group title
    GSK249320 15 mg/kg
    Reporting group description
    		 Participants received GSK249320 15 milligrams (mg)/kilogram (kg) administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).

    Reporting group values
    		 Placebo GSK249320 15 mg/kg Total
    Number of subjects
    		 68 65 133
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 67.1 ± 11.2 68.2 ± 11.92 -
    Gender categorical
    Units: Subjects
        Female
    		 29 31 60
        Male
    		 39 34 73
    Race, Customized
    Units: Subjects
        African American/African Heritage
    		 4 2 6
        American Indian or Alaska Native
    		 1 0 1
        Asian - South East Asian Heritage
    		 1 1 2
        White - White/Caucasian/European
    		 62 62 124

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo administered as two intravenous (IV) infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 milliliters (mL) IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).

    Reporting group title
    GSK249320 15 mg/kg
    Reporting group description
    		 Participants received GSK249320 15 milligrams (mg)/kilogram (kg) administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).

    Subject analysis set title
    Placebo - PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received placebo administered as two intravenous (IV) infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 milliliters (mL) IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). Placebo - Per Protocol (PP) Population consisted of all participants who were included in the ITT population and did not violate protocol with regards to inclusion/exclusion criteria, unblinding, investigational product administration and gait velocity assessments.

    Subject analysis set title
    GSK249320 15 mg/kg - PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received GSK249320 15 milligrams (mg)/kilogram (kg) administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The GSK249320 15 mg/kg - Per Protocol (PP) Population consisted of all participants who were included in the ITT population and did not violate protocol with regards to inclusion/exclusion criteria, unblinding, investigational product administration and gait velocity assessments.

    Subject analysis set title
    Placebo - Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received placebo administered as two intravenous (IV) infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 milliliters (mL) IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population include all participants who received at least one infusion of investigational product.

    Subject analysis set title
    GSK249320 15 mg/kg - Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received GSK249320 15 milligrams (mg)/kilogram (kg) administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Safety Population included all participants who received at least one infusion of investigational product.

    Subject analysis set title
    GSK249320 15 mg/kg - PK
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received GSK249320 15 milligrams (mg)/kilogram (kg) administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush). The Pharmacokinetic (PK) Population included all participants in the Safety Population who had at least one PK sample with a concentration above the non-quantifiable limit.

    Primary: Change from Baseline (BL) in gait velocity at Month 3/Day 90

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    End point title
    		 Change from Baseline (BL) in gait velocity at Month 3/Day 90
    End point description
    Gait is the way or manner in which a person walks. Gait velocity (walking speed) is an objective, quantitative measure of lower extremity motor recovery in individuals who have had a stroke. Participants were asked to walk at their usual pace over a level, indoor 10 meter(m) distance and were allowed to use their normal assistive devices. The time (seconds[s]) taken by the participants to travel the 10 m distance was recorded. Gait velocity (meters/second [m/s]) as assessed by study personnel was derived as: 10 divided by time to walk 10 meters. Two trials of gait velocity were conducted at each time point. Change from BL was calculated as the mean Month 3/Day 90 value minus the mean BL value. Analysis was done for Intent-To-Treat (ITT) population comprised of participants who received at least 1 infusion of investigational product and had at least 1 post-BL efficacy assessment. The measure type displayed are posterior means.
    End point type
    Primary
    End point timeframe
    Baseline and Month 3/Day 90
    End point values
    		 Placebo GSK249320 15 mg/kg
    Number of subjects analysed
    60 [1]
    60 [2]
    Units: meters per second (m/s)
        arithmetic mean (standard deviation)
    0.5417 ± 0.062
    0.5859 ± 0.0535
    Notes
    [1] - ITT Population
    [2] - ITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Credible intervals are displayed as confidence intervals. Posterior means, standard deviations, and credible intervals are provided in the table.
    Comparison groups
    Placebo v GSK249320 15 mg/kg
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.713 [3]
    Method
    		 Bayesian method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.0443
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.119
         upper limit
    		 0.2
    Notes
    [3] - P-value presented is the posterior probability that the treatment difference (GSK249320 15mg/kg – placebo) is greater than 0 m/s at Month 3/Day 90.

    Secondary: Change from Baseline in gait velocity at Month 6/Day 180

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    End point title
    		 Change from Baseline in gait velocity at Month 6/Day 180
    End point description
    Gait is the way or manner in which a person walks. Gait velocity (walking speed) is an objective, quantitative measure of lower extremity motor recovery in individuals who have had a stroke. Participants were asked to walk at their usual pace over a level, indoor 10 meter(m) distance and were allowed to use their normal assistive devices. The time (seconds[s]) taken by the participants to travel the 10 m distance was recorded. Gait velocity (meters/second [m/s]) as assessed by study personnel was derived as: 10 divided by time to walk 10 metrers. Two trials of gait velocity were conducted at each time point. Change from BL was calculated as the mean Month 3/Day 90 value minus the mean BL value. Analysis was done for Intent-To-Treat (ITT) population comprised of participants who received at least 1 infusion of investigational product and had at least 1 post-BL efficacy assessment. The measure type displayed are posterior means.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 6/Day 180
    End point values
    		 Placebo GSK249320 15 mg/kg
    Number of subjects analysed
    60 [4]
    60 [5]
    Units: m/s
        arithmetic mean (standard deviation)
    0.5442 ± 0.0665
    0.6236 ± 0.0556
    Notes
    [4] - ITT Population
    [5] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Credible intervals are displayed as confidence intervals. Posterior means, standard deviations, and credible intervals are provided in the table.
    Comparison groups
    GSK249320 15 mg/kg v Placebo
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.828 [6]
    Method
    		 Bayesian method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.0794
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.093
         upper limit
    		 0.247
    Notes
    [6] - P-value presented is the posterior probability that the treatment difference (GSK249320 15mg/kg – placebo) is greater than 0 m/s at Month 6/Day 180.

    Secondary: Number of participants with indicated transition from one gait velocity category to another category at the indicated timepoints

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    End point title
    		 Number of participants with indicated transition from one gait velocity category to another category at the indicated timepoints
    End point description
    Participants were categorized at each visit into the following gait velocity categories: 0 m/s, >0 to <0.4 m/s, >=0.4 m/s to 0.8 m/s and >0.8m/s. The number of participants transitioning from one gait velocity category to another category was assessed at each post-Baseline visit and was presented in terms of the following transition categories: worsened, no change, improved 1 level, improved 2 levels and improved 3 levels. Analysis was done for Per Protocol(PP) Population that consisted of all participants who were included in the ITT population and did not violate protocol with regards to inclusion/exclusion criteria, unblinding, investigational product administration and gait velocity assessments. Only participants with data available at the specified time points were analyzed(represented by n=X, X in the category titles). By-visit sample sizes vary due to missing data or early termination of the study, missing data was not imputed.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1/Day 30, Month 2/Day 60, Month 3/Day 90 and Month 6/Day 180.
    End point values
    		 Placebo - PP GSK249320 15 mg/kg - PP
    Number of subjects analysed
    52 [7]
    52 [8]
    Units: Participants
    number (not applicable)
        Day 30, Worsened, n=48, 49
    1
    0
        Day 30, No Change, n=48, 49
    19
    18
        Day 30, Improved 1 Level, n=48, 49
    11
    11
        Day 30, Improved 2 Levels, n=48, 49
    9
    9
        Day 30, Improved 3 Levels, n=48, 49
    8
    11
        Day 60, Worsened, n=42, 42
    0
    0
        Day 60, No Change, n=42, 42
    13
    14
        Day 60, Improved 1 Level, n=42, 42
    14
    11
        Day 60, Improved 2 Levels, n=42, 42
    6
    7
        Day 60, Improved 3 Levels, n=42, 42
    9
    10
        Day 90, Worsened, n=42, 41
    1
    0
        Day 90, No Change, n=42, 41
    9
    8
        Day 90, Improved 1 Level, n=42, 41
    12
    14
        Day 90, Improved 2 Levels, n=42, 41
    10
    7
        Day 90, Improved 3 Levels, n=42, 41
    10
    12
        Day 180, Worsened, n=36, 39
    1
    0
        Day 180, No Change, n=36, 39
    7
    6
        Day 180, Improved 1 Level, n=36, 39
    9
    14
        Day 180, Improved 2 Levels, n=36, 39
    11
    5
        Day 180, Improved 3 Levels, n=36, 39
    8
    14
    Notes
    [7] - PP Population
    [8] - PP Population
    No statistical analyses for this end point

    Secondary: Change from Baseline (BL) in dexterity as measured by Box and Blocks test

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    End point title
    		 Change from Baseline (BL) in dexterity as measured by Box and Blocks test
    End point description
    Dexterity is the ability of a person to use the hands skillfully in performing a task. The Box and Blocks test is an objective, gross manual dexterity test in individuals with upper limb impairments. Participants were asked to move small wooden blocks from one side of a partitioned box to other. The score was determined by the number of blocks transferred within a 60 second time period. Both affected and unaffected arms were tested, starting with the unaffected arm. Change from BL was calculated as the individual post-BL value minus the BL value. Change from BL in the number of blocks transferred for the affected arm was analyzed using a Mixed Model Repeated Measures analysis with fixed effects for treatment, visit, treatment by visit interaction, sex, age, BL National Institute of Health stroke scale total score, BL number of blocks transferred by the affected and unaffected arms, country and presence of concomitant medications that potentially impact recovery.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 1/Day 30, Month 2/Day 60, Month 3/Day 90 and Month 6/Day 180
    End point values
    		 Placebo - PP GSK249320 15 mg/kg - PP
    Number of subjects analysed
    52 [9]
    52 [10]
    Units: Number of blocks
    least squares mean (standard error)
        Day 30
    10.13 ± 2.195
    12.538 ± 1.587
        Day 60
    11.469 ± 2.345
    14.484 ± 1.6
        Day 90
    15.196 ± 2.962
    17.631 ± 1.926
        Day 180
    14.869 ± 2.839
    18.813 ± 2.11
    Notes
    [9] - PP Population
    [10] - PP Population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Statistical data for Day 30. The point estimate and confidence interval are for the adjusted mean difference based on least square estimates.
    Comparison groups
    Placebo - PP v GSK249320 15 mg/kg - PP
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.408
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.067
         upper limit
    		 7.883
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Statistical data for Day 60. The point estimate and confidence interval are for the adjusted mean difference based on least square estimates.
    Comparison groups
    Placebo - PP v GSK249320 15 mg/kg - PP
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.015
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.704
         upper limit
    		 8.735
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Statistical data for Day 90. The point estimate and confidence interval are for the adjusted mean difference based on least square estimates.
    Comparison groups
    Placebo - PP v GSK249320 15 mg/kg - PP
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.435
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.668
         upper limit
    		 9.538
    Statistical analysis title
    		 Statistical Analysis 4
    Statistical analysis description
    Statistical data for Day 180. The point estimate and confidence interval are for the adjusted mean difference based on least square estimates.
    Comparison groups
    Placebo - PP v GSK249320 15 mg/kg - PP
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.944
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.15
         upper limit
    		 11.037

    Secondary: Number of participants who experienced at least one fall

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    End point title
    		 Number of participants who experienced at least one fall
    End point description
    The number of participants who experienced at least one fall between Baseline to Day 90 and Baseline to Day 180 is summarized.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 180
    End point values
    		 Placebo - Safety GSK249320 15 mg/kg - Safety
    Number of subjects analysed
    68 [11]
    65 [12]
    Units: Participants
    number (not applicable)
        Baseline to Day 90
    15
    12
        Baseline to Day 180
    18
    16
    Notes
    [11] - Safety Population
    [12] - Safety Population
    No statistical analyses for this end point

    Secondary: Number of participants who experienced indicated number of falls

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    End point title
    		 Number of participants who experienced indicated number of falls
    End point description
    The number of participants who experienced 1, 2, 3 or >=4 falls between Baseline to Day 90 and Baseline to Day 180 is summarized. Only those participants who experienced at least one fall at the specified time points were analyzed (represented by n=X, X in the category titles). By-visit sample sizes vary due to missing data or early termination of the study.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 180
    End point values
    		 Placebo - Safety GSK249320 15 mg/kg - Safety
    Number of subjects analysed
    68 [13]
    65 [14]
    Units: Participants
    number (not applicable)
        Baseline to Day 90, 1 Fall, n=15, 12
    8
    6
        Baseline to Day 90, 2 Falls, n=15, 12
    3
    3
        Baseline to Day 90, 3 Falls, n=15, 12
    0
    2
        Baseline to Day 90, >=4 Falls, n=15, 12
    4
    1
        Baseline to Day 180, 1 Fall, n=18, 16
    7
    9
        Baseline to Day 180, 2 Falls, n=18, 16
    6
    2
        Baseline to Day 180, 3 Falls, n=18, 16
    1
    2
        Baseline to Day 180, >=4 Falls, n=18, 16
    4
    3
    Notes
    [13] - Safety Population
    [14] - Safety Population
    No statistical analyses for this end point

    Secondary: Number of participants with any adverse event (AE) and any serious adverse event (SAE)

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    End point title
    		 Number of participants with any adverse event (AE) and any serious adverse event (SAE)
    End point description
    An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect or all events of possible drug-induced liver injury with hyperbilirubinaemia. Medical or scientific judgement is exercised in other situations.
    End point type
    Secondary
    End point timeframe
    From Day 1 until early withdrawal, death, Month 6/Day 180, or Extended Follow-Up visit
    End point values
    		 Placebo - Safety GSK249320 15 mg/kg - Safety
    Number of subjects analysed
    68 [15]
    65 [16]
    Units: Participants
    number (not applicable)
        Any AE
    57
    49
        Any SAE
    16
    9
    Notes
    [15] - Safety Population: all participants who received at least one infusion of investigational product
    [16] - Safety Population: all participants who received at least one infusion of investigational product
    No statistical analyses for this end point

    Secondary: Number of participants with events common to stroke

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    End point title
    		 Number of participants with events common to stroke
    End point description
    Events common to stroke were those AEs that commonly occur after a stroke and are generally associated with the underlying stroke or the progression of stroke. These include Joint or soft tissue pain, Bladder Incontinence, Depression/Mood Disorder, Urinary tract infection, Dysphagia, Bowel Incontinence, Dysarthia, Confusion, Spasticity, Limb Edema, Aspiration Pneumonia, Hemorrhagic Transformation (symptomatic or asymptomatic), Pressure Ulcers, Progression of Stroke, Malnutrition, Deep vein thrombosis, Brain Herniation, Pulmonary embolism, Seizures, and Falls.
    End point type
    Secondary
    End point timeframe
    From Day 1 until early withdrawal, death, Month 6/Day 180
    End point values
    		 Placebo - Safety GSK249320 15 mg/kg - Safety
    Number of subjects analysed
    68
    65
    Units: Participants
    number (not applicable)
        Joint or soft tissue pain
    19
    22
        Bladder Incontinence
    11
    23
        Depression/Mood Disorder
    17
    16
        Urinary tract infection
    17
    13
        Dysphagia
    12
    12
        Bowel Incontinence
    11
    12
        Dysarthia
    11
    11
        Confusion
    8
    13
        Spasticity
    9
    9
        Limb Edema
    5
    12
        Aspiration Pneumonia
    5
    3
        Hemorrhagic Transformation
    4
    4
        Pressure Ulcers
    3
    2
        Progression of Stroke
    2
    2
        Malnutrition
    1
    2
        Deep vein thrombosis
    2
    0
        Brain Herniation
    0
    1
        Pulmonary embolism
    1
    0
        Seizures
    0
    1
        Falls
    18
    16
    No statistical analyses for this end point

    Secondary: Change from Baseline in diastolic blood pressure (DBP) and systolic blood pressure (SBP) at Day 1 Post-dose, Day 6, Day 180 and Early Withdrawal (EW) visit

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    End point title
    		 Change from Baseline in diastolic blood pressure (DBP) and systolic blood pressure (SBP) at Day 1 Post-dose, Day 6, Day 180 and Early Withdrawal (EW) visit
    End point description
    Safety was measured by monitoring vital signs including blood pressure. The Baseline for DBP and SBP was the value of pre-dose assessment on Day 1. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles). By-visit sample sizes vary due to missing data or early termination of the study.
    End point type
    Secondary
    End point timeframe
    Day 1 (Baseline), Day 6, Day 180 and EW visit
    End point values
    		 Placebo - Safety GSK249320 15 mg/kg - Safety
    Number of subjects analysed
    68 [17]
    65 [18]
    Units: Millimeters of mercury
    arithmetic mean (standard deviation)
        DBP, Day 1 Post-dose, n=68, 65
    1.7 ± 10.58
    0.5 ± 10.14
        DBP, Day 6 Pre-dose, n=60, 59
    0.2 ± 16.52
    -1.1 ± 11.98
        DBP, Day 6 Post-dose, n=58, 57
    2.4 ± 15.06
    1.9 ± 16.36
        DBP, Day 180, n=27, 28
    8.1 ± 13.97
    5 ± 14.6
        DBP, EW visit, n=24, 22
    -5 ± 15.55
    1.8 ± 15.05
        SBP, Day 1 Post-dose, n=68, 65
    3.1 ± 16.15
    0.7 ± 11.81
        SBP, Day 6 Pre-dose, n=60, 59
    -3.5 ± 26.46
    -6 ± 20.13
        SBP, Day 6 Post-dose, n=58, 57
    -0.9 ± 24.59
    -2 ± 20.14
        SBP, Day 180, n=27, 28
    -6.4 ± 22.96
    -6.4 ± 27.79
        SBP, EW visit, n=24, 22
    -15.2 ± 29.08
    0 ± 25.42
    Notes
    [17] - Safety Population
    [18] - Safety Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in heart rate at Day 1 Post-dose, Day 6, Day 180 and EW visit

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    End point title
    		 Change from Baseline in heart rate at Day 1 Post-dose, Day 6, Day 180 and EW visit
    End point description
    Safety was measured by monitoring vital signs including heart rate. The Baseline for heart rate was the value of pre-dose assessment on Day 1. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles). By-visit sample sizes vary due to missing data or early termination of the study.
    End point type
    Secondary
    End point timeframe
    Day 1, Day 6, Day 180 and EW visit
    End point values
    		 Placebo - Safety GSK249320 15 mg/kg - Safety
    Number of subjects analysed
    68 [19]
    65 [20]
    Units: Beats per minute
    arithmetic mean (standard deviation)
        Day 1 Post-dose, n=67, 65
    0.9 ± 8.68
    0.7 ± 7.98
        Day 6 Pre-dose, n=60, 59
    -1.8 ± 13.03
    -0.4 ± 17.47
        Day 6 Post-dose, n=58, 57
    -3.9 ± 12.09
    -3.1 ± 15.3
        Day 180, n=27, 28
    -0.3 ± 17.5
    -3 ± 15.48
        EW visit, n=24, 22
    3.3 ± 15.47
    -2.1 ± 15.4
    Notes
    [19] - Safety Population
    [20] - Safety Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in the indicated electrocardiogram (ECG) parameters at Day 6, Day 30 and EW visit

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    End point title
    		 Change from Baseline in the indicated electrocardiogram (ECG) parameters at Day 6, Day 30 and EW visit
    End point description
    A single 12-lead ECG was obtained at each time point and the following ECG intervals were determined: PR, QRS, QT, RR and corrected QT (QTc), QT interval corrected by Bazett's formula (QTcB), QT interval corrected by Fridericia's formula (QTcF). Baseline for ECG parameters was the value of Day 1. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles). By-visit sample sizes vary due to missing data or early termination of the study.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 6, Day 30 and EW visit
    End point values
    		 Placebo - Safety GSK249320 15 mg/kg - Safety
    Number of subjects analysed
    68 [21]
    65 [22]
    Units: Milliseconds
    arithmetic mean (standard deviation)
        PR, Day 6, n=50, 46
    -1 ± 30.47
    -0.8 ± 20.02
        PR, Day 30, n=38, 40
    -5.9 ± 36.05
    -3.5 ± 42.08
        PR, EW Visit, n=10, 14
    -0.4 ± 21.01
    3.1 ± 33.96
        QRS, Day 6, n=60, 57
    4.9 ± 15.75
    -4 ± 44.11
        QRS, Day 30, n=46, 50
    3.4 ± 10.97
    1.1 ± 17.74
        QRS, EW Visit, n=16, 16
    2.6 ± 27.47
    -23.7 ± 81.24
        RR, Day 6, n=53, 53
    61.1 ± 246.84
    12.9 ± 154.09
        RR, Day 30, n=40, 45
    80.5 ± 245.31
    -21.8 ± 181.99
        RR, EW Visit, n=13, 16
    -21.6 ± 164.19
    85.6 ± 349.82
        QT, Day 6, n=60, 57
    10.4 ± 40.86
    9.4 ± 36.46
        QT, Day 30, n=46, 49
    4.1 ± 43.59
    -12.1 ± 42.06
        QT, EW Visit, n=16, 15
    20.8 ± 37.16
    43.7 ± 93.85
        QTc, Day 6, n=58, 58
    2.9 ± 30.7
    6.8 ± 43.87
        QTc, Day 30, n=45, 50
    -1.3 ± 32.92
    -2.2 ± 39.49
        QTc, EW Visit, n=16, 16
    7.1 ± 27.75
    8.9 ± 69.58
        QTcB, Day 6, n=53, 51
    2.2 ± 124.73
    4.5 ± 46.49
        QTcB, Day 30, n=40, 44
    -31.9 ± 120.26
    -13.9 ± 79.33
        QTcB, EW Visit, n=13, 14
    28.2 ± 37.06
    6.9 ± 52.02
        QTcF, Day 6, n=53, 51
    4.3 ± 74.12
    5.7 ± 33.25
        QTcF, Day 30, n=40, 44
    -16.9 ± 75.41
    -12 ± 58.16
        QTcF, EW Visit, n=13, 14
    26 ± 31.85
    18.3 ± 62.78
    Notes
    [21] - Safety Population
    [22] - Safety Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in heart rate measured by ECG at Day 6, Day 30 and EW visit

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    End point title
    		 Change from Baseline in heart rate measured by ECG at Day 6, Day 30 and EW visit
    End point description
    A single 12-lead ECG was obtained at each time point that measured heart rate. Baseline was the value obtained on Day 1. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles). By-visit sample sizes vary due to missing data or early termination of the study.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 6, Day 30 and EW visit
    End point values
    		 Placebo - Safety GSK249320 15 mg/kg - Safety
    Number of subjects analysed
    68 [23]
    65 [24]
    Units: Beats per minute
    arithmetic mean (standard deviation)
        Day 6, n=60, 58
    -3.4 ± 17.57
    -4.9 ± 15.37
        Day 30, n=46, 50
    -3.4 ± 19.81
    0.9 ± 16
        EW Visit, n=16, 16
    -5.4 ± 16.82
    -10.3 ± 29.58
    Notes
    [23] - Safety Population
    [24] - Safety Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in albumin (ALB) and total protein (TP)

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    End point title
    		 Change from Baseline in albumin (ALB) and total protein (TP)
    End point description
    ALB and TP were measured at Baseline, Day 6, Day 30, Day 90 and Day 180. Baseline was the value obtained on Day 1. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles). By-visit sample sizes vary due to missing data or early termination of the study.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 6, Day 30, Day 90 and Day 180
    End point values
    		 Placebo - Safety GSK249320 15 mg/kg - Safety
    Number of subjects analysed
    68 [25]
    65 [26]
    Units: Grams per liter
    arithmetic mean (standard deviation)
        ALB, Day 6, n=56, 57
    0 ± 3.02
    -0.2 ± 3.67
        ALB, Day 30, n=44, 47
    1 ± 3.44
    3 ± 5.5
        ALB, Day 90, n=32,38
    2.3 ± 3.23
    4.4 ± 5.14
        ALB, Day 180, n=23, 24
    2.3 ± 3.8
    5.3 ± 3.86
        TP, Day 6, n=56, 57
    1 ± 4.64
    0.9 ± 5.9
        TP, Day 30, n=44, 47
    2.7 ± 5.13
    5.6 ± 8.11
        TP, Day 90, n=32,38
    3.1 ± 4.92
    6.5 ± 7.34
        TP, Day 180, n=23, 24
    4.4 ± 5.07
    7.6 ± 5.89
    Notes
    [25] - Safety Population
    [26] - Safety Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in alkaline phosphatase (ALP), alanine aminotransferase (ALT) and aspartate aminotransferase (AST)

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    End point title
    		 Change from Baseline in alkaline phosphatase (ALP), alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
    End point description
    ALP, ALT and AST were measured at Baseline, Day 6, Day 30, Day 90 and Day 180. Baseline was the value obtained on Day 1. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles). By-visit sample sizes vary due to missing data or early termination of the study.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 6, Day 30, Day 90 and Day 180
    End point values
    		 Placebo - Safety GSK249320 15 mg/kg - Safety
    Number of subjects analysed
    68 [27]
    65 [28]
    Units: International units per liter
    arithmetic mean (standard deviation)
        ALP, Day 6, n=56, 57
    7.7 ± 20.05
    6.2 ± 16.4
        ALP, Day 30, n=44, 47
    11.7 ± 21.47
    19.5 ± 35.87
        ALP, Day 90, n=32,38
    8.6 ± 27.18
    6.7 ± 18.01
        ALP, Day 180, n=23, 24
    8.9 ± 12.73
    4 ± 17.63
        ALT, Day 6, n=56, 57
    11.4 ± 25.92
    10.7 ± 16.22
        ALT, Day 30, n=44, 47
    7.9 ± 19.02
    10.6 ± 27.84
        ALT, Day 90, n=32,38
    -0.8 ± 16.14
    3.2 ± 11.21
        ALT, Day 180, n=23, 24
    -2 ± 12.83
    1.4 ± 10.66
        AST, Day 6, n=56, 54
    7.9 ± 26.39
    2.5 ± 15.52
        AST, Day 30, n=44, 46
    0.2 ± 14.24
    -0.9 ± 13.18
        AST, Day 90, n=32,37
    -6.1 ± 11.78
    -5.2 ± 13.33
        AST, Day 180, n=23, 23
    -3.2 ± 7.13
    -5 ± 9.7
    Notes
    [27] - Safety Population
    [28] - Safety Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in direct bilirubin, total bilirubin, and creatinine

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    End point title
    		 Change from Baseline in direct bilirubin, total bilirubin, and creatinine
    End point description
    Direct bilirubin, total bilirubin and creatinine were measured at Baseline, Day 6, Day 30, Day 90 and Day 180. Baseline was the value obtained on Day 1. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles). By-visit sample sizes vary due to missing data or early termination of the study.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 6, Day 30, Day 90 and Day 180
    End point values
    		 Placebo - Safety GSK249320 15 mg/kg - Safety
    Number of subjects analysed
    68 [29]
    65 [30]
    Units: Micromoles per liter
    arithmetic mean (standard deviation)
        direct bilirubin, Day 6, n=56, 57
    0.3 ± 3.81
    0 ± 1.58
        direct bilirubin, Day 30, n=44, 47
    -1 ± 1.93
    -0.4 ± 1.48
        direct bilirubin, Day 90, n=32,38
    -1.5 ± 1.92
    -0.5 ± 1.62
        direct bilirubin, Day 180, n=23, 24
    -1.2 ± 1.59
    -0.1 ± 1.38
        total bilirubin, Day 6, n=56, 57
    -1.5 ± 3.76
    -1.8 ± 5.9
        total bilirubin, Day 30, n=44, 47
    -4.6 ± 4.9
    -3 ± 4.85
        total bilirubin, Day 90, n=32,38
    -4.9 ± 4.75
    -3.5 ± 5.59
        total bilirubin, Day 180, n=23, 24
    -4.6 ± 4.83
    -3.8 ± 5.28
        creatinine, Day 6, n=56, 57
    2.35 ± 20.52
    3.48 ± 16.778
        creatinine, Day 30, n=44, 47
    4.94 ± 31.767
    9.79 ± 28.329
        creatinine, Day 90, n=32,38
    6.69 ± 18.98
    3.09 ± 15.387
        creatinine, Day 180, n=23, 24
    5.07 ± 12.925
    0.24 ± 13.857
    Notes
    [29] - Safety Population
    [30] - Safety Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in calcium (Ca), chloride (Cl), glucose (Gluc), potassium (K), sodium (Na) and urea/blood urea nitrogen (BUN)

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    End point title
    		 Change from Baseline in calcium (Ca), chloride (Cl), glucose (Gluc), potassium (K), sodium (Na) and urea/blood urea nitrogen (BUN)
    End point description
    Ca, Cl, Gluc, K, Na and urea/BUN were measured at Baseline, Day 6, Day 30, Day 90 and Day 180. Baseline was the value obtained on Day 1. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles). By-visit sample sizes vary due to missing data or early termination of the study.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 6, Day 30, Day 90 and Day 180
    End point values
    		 Placebo - Safety GSK249320 15 mg/kg - Safety
    Number of subjects analysed
    68 [31]
    65 [32]
    Units: Millimoles per liter
    arithmetic mean (standard deviation)
        Ca, Day 6, n=56, 54
    0.042 ± 0.1163
    0.059 ± 0.1564
        Ca, Day 30, n=44, 46
    0.091 ± 0.1254
    0.158 ± 0.1985
        Ca, Day 90, n=32,37
    0.093 ± 0.1092
    0.186 ± 0.196
        Ca, Day 180, n=23, 23
    0.087 ± 0.1053
    0.182 ± 0.1315
        Cl, Day 6, n=56, 57
    -0.9 ± 3.13
    -1.4 ± 4.08
        Cl, Day 30, n=44, 47
    -1.6 ± 3.72
    -3.1 ± 5.01
        Cl, Day 90, n=32,38
    -1.3 ± 3.02
    -2.7 ± 4.67
        Cl, Day 180, n=23, 24
    -1.4 ± 2.48
    -3.4 ± 3.93
        Gluc, Day 6, n=56, 57
    0.21 ± 3.123
    -0.35 ± 2.619
        Gluc, Day 30, n=44, 47
    -0.93 ± 2.611
    -0.45 ± 2.476
        Gluc, Day 90, n=32,38
    -1.12 ± 2.075
    -0.38 ± 2.17
        Gluc, Day 180, n=23, 24
    -1.09 ± 3.045
    -1.02 ± 2.136
        K, Day 6, n=55, 54
    0.17 ± 0.384
    0.21 ± 0.452
        K, Day 30, n=43, 46
    0.37 ± 0.487
    0.3 ± 0.429
        K, Day 90, n=31,37
    0.36 ± 0.477
    0.39 ± 0.404
        K, Day 180, n=22, 23
    0.33 ± 0.517
    0.54 ± 0.472
        Na, Day 6, n=56, 57
    0.1 ± 2.82
    0 ± 2.83
        Na, Day 30, n=44, 47
    -0.3 ± 2.64
    -0.8 ± 3.21
        Na, Day 90, n=32,38
    0.4 ± 1.87
    -0.7 ± 2.91
        Na, Day 180, n=23, 24
    0.5 ± 2.04
    -1.2 ± 2.9
        Urea/BUN, Day 6, n=56, 57
    1.57 ± 2.392
    1.61 ± 2.541
        Urea/BUN, Day 30, n=44, 47
    1.09 ± 2.673
    2.19 ± 5.436
        Urea/BUN, Day 90, n=32,38
    1.02 ± 2.31
    1.04 ± 2.655
        Urea/BUN, Day 180, n=23, 24
    0.51 ± 2.364
    1.04 ± 3.502
    Notes
    [31] - Safety Population
    [32] - Safety Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in hemoglobin

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    End point title
    		 Change from Baseline in hemoglobin
    End point description
    Hemoglobin was measured at Baseline, Day 6, Day 30, Day 90 and Day 180. Baseline was the value obtained on Day 1. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles). By-visit sample sizes vary due to missing data or early termination of the study.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 6, Day 30, Day 90 and Day 180
    End point values
    		 Placebo - Safety GSK249320 15 mg/kg - Safety
    Number of subjects analysed
    68 [33]
    65 [34]
    Units: Grams per liter
    arithmetic mean (standard deviation)
        Day 6, n=48, 51
    -0.1 ± 9.55
    2.4 ± 10.21
        Day 30, n=38, 44
    -1 ± 13.19
    3.8 ± 14.84
        Day 90, n=28, 35
    -4.1 ± 16.61
    4.7 ± 15.91
        Day 180, n=20, 22
    -6.2 ± 17.7
    7.6 ± 13.45
    Notes
    [33] - Safety Population
    [34] - Safety Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in hematocrit

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    End point title
    		 Change from Baseline in hematocrit
    End point description
    Hematocrit was measured at Baseline, Day 6, Day 30, Day 90 and Day 180. Baseline was the value obtained on Day 1. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles). By-visit sample sizes vary due to missing data or early termination of the study.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 6, Day 30, Day 90 and Day 180
    End point values
    		 Placebo - Safety GSK249320 15 mg/kg - Safety
    Number of subjects analysed
    68 [35]
    65 [36]
    Units: percentage
    arithmetic mean (standard deviation)
        Day 6, n=48, 51
    0.00096 ± 0.032094
    0.00896 ± 0.032858
        Day 30, n=38, 44
    -0.0035 ± 0.040669
    0.01116 ± 0.046146
        Day 90, n=28, 35
    -0.01446 ± 0.053418
    0.01329 ± 0.049054
        Day 180, n=20, 22
    -0.02455 ± 0.056181
    0.01909 ± 0.043139
    Notes
    [35] - Safety Population
    [36] - Safety Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in eosinophils (EOS), lymphocytes (LYM), total absolute neutrophil count (ANC), platelet (PLT) count, white blood cell (WBC) count

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    End point title
    		 Change from Baseline in eosinophils (EOS), lymphocytes (LYM), total absolute neutrophil count (ANC), platelet (PLT) count, white blood cell (WBC) count
    End point description
    EOS, LYM, Total ANC, PLT count and WBC count were measured at Baseline, Day 6, Day 30, Day 90 and Day 180. Baseline was the value obtained on Day 1. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles). By-visit sample sizes vary due to missing data or early termination of the study.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 6, Day 30, Day 90 and Day 180
    End point values
    		 Placebo - Safety GSK249320 15 mg/kg - Safety
    Number of subjects analysed
    68 [37]
    65 [38]
    Units: Giga (10^9 cells) per liter
    arithmetic mean (standard deviation)
        EOS, Day 6, n=48, 51
    0.049 ± 0.1153
    0.082 ± 0.1692
        EOS, Day 30, n=38, 44
    0.058 ± 0.2207
    0.086 ± 0.1318
        EOS, Day 90, n=28 ,35
    0.058 ± 0.1175
    0.058 ± 0.1149
        EOS, Day 180, n=20, 22
    0.045 ± 0.1314
    0.048 ± 0.1206
        LYM, Day 6, n=48, 51
    -0.046 ± 0.3904
    -0.03 ± 0.675
        LYM, Day 30, n=38, 44
    0.026 ± 0.4666
    -0.002 ± 0.5728
        LYM, Day 90, n=28, 35
    0.066 ± 0.411
    0.236 ± 0.5854
        LYM, Day 180, n=20, 22
    0.017 ± 0.5005
    0.075 ± 0.5919
        Total ANC, Day 6, n=48, 51
    -0.375 ± 2.2795
    -0.756 ± 2.5842
        Total ANC, Day 30, n=38, 44
    -1.486 ± 2.4578
    -0.581 ± 4.7282
        Total ANC, Day 90, n=28, 35
    -1.469 ± 2.1498
    -1.455 ± 2.3515
        Total ANC, Day 180, n=20, 22
    -2.202 ± 2.7396
    -0.579 ± 1.6956
        PLT Count, Day 6, n=47, 48
    17.4 ± 37.57
    32.4 ± 41.01
        PLT Count, Day 30, n=37, 42
    40.5 ± 62.89
    47.6 ± 44.23
        PLT Count, Day 90, n=28, 34
    33.2 ± 53.36
    60.4 ± 56.3
        PLT Count, Day 180, n=20, 22
    19.9 ± 35.91
    35.9 ± 39.15
        WBC Count,Day 6, n=48, 51
    -0.4 ± 2.294
    -0.78 ± 2.288
        WBC Count, Day 30, n=38, 44
    -1.46 ± 2.524
    -0.54 ± 4.819
        WBC Count, Day 90, n=28, 35
    -1.45 ± 2.017
    -1.28 ± 2.119
        WBC Count, Day 180, n=20, 22
    -2.15 ± 2.496
    -0.55 ± 1.943
    Notes
    [37] - Safety Population
    [38] - Safety Population
    No statistical analyses for this end point

    Secondary: National Institute of Health Stroke Scale (NIHSS) total score at the indicated timepoints

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    End point title
    		 National Institute of Health Stroke Scale (NIHSS) total score at the indicated timepoints
    End point description
    The NIHSS is a 15 item, standardized, disease-specific, deficit scale which measures neurological impairment and is used to quantify participant status by measuring the severity of the stroke as assessed by NIHSS certified study personnel. The total NIHSS score is calculated as the sum of responses to the 15 items. The total NIHSS score ranges from 0-42, with a higher score indicative of a more severe impairment. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles). By-visit sample sizes vary due to missing data or early termination of the study.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Day 30, Day 90 and Day 180
    End point values
    		 Placebo - Safety GSK249320 15 mg/kg - Safety
    Number of subjects analysed
    68 [39]
    65 [40]
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        Day 1, n=68, 65
    10 ± 4.4
    9.8 ± 3.79
        Day 30, n=52, 55
    6.4 ± 4.4
    5.7 ± 4.66
        Day 90, n=40, 45
    5 ± 3.83
    4.8 ± 4.89
        Day 180, n=27, 30
    3.9 ± 3.22
    4.2 ± 3.87
    Notes
    [39] - Safety Population
    [40] - Safety Population
    No statistical analyses for this end point

    Secondary: Number of participants with suicidal ideation or behavior during treatment based on the Columbia Suicide Severity Rating Scale (C-SSRS)

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    End point title
    		 Number of participants with suicidal ideation or behavior during treatment based on the Columbia Suicide Severity Rating Scale (C-SSRS)
    End point description
    Prospective assessment of treatment-emergent suicidality was performed by the investigator via the C-SSRS. The C-SSRS is a questionnaire designed to assess severity of suicidality. C-SSRS has 10 questions (5 suicidal ideation questions and 5 suicidal behavior questions) and each question has a binary response (Yes/No). Suicidality during treatment was assessed by integrating both behavior and ideation categories of C-SSRS. Only participants with at least one on-treatment C-SSRS assessment were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Day 1, Day 6, Day 30, Day 60, Day 90 and Day 180
    End point values
    		 Placebo - Safety GSK249320 15 mg/kg - Safety
    Number of subjects analysed
    63 [41]
    63 [42]
    Units: Participants
        number (not applicable)
    10
    3
    Notes
    [41] - Safety Population
    [42] - Safety Population
    No statistical analyses for this end point

    Secondary: Area under the concentration-time curve from 0 to 5 days [AUC(0-5d)] and area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time [AUC(0-inf)] for GSK249320

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    End point title
    		 Area under the concentration-time curve from 0 to 5 days [AUC(0-5d)] and area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time [AUC(0-inf)] for GSK249320
    End point description
    Blood samples were collected for determination of plasma concentrations of GSK249320. AUC (0-5d) and AUC (0-inf) were derived from the plasma concentration-time data. Analysis was performed for Pharmacokinetic (PK) Population that comprised of all participants in the Safety Population who had at least one PK sample with a concentration above the non-quantifiable limit. Only participants in the GSK249320 15 mg/kg group were analyzed.
    End point type
    Secondary
    End point timeframe
    Day 6, Day 30 and Day 180
    End point values
    		 GSK249320 15 mg/kg - PK
    Number of subjects analysed
    62 [43]
    Units: Milligrams/milliliter*hour
    geometric mean (geometric coefficient of variation)
        AUC(0-5d)
    28.2273 ± 10.9
        AUC(0-inf)
    120.6895 ± 20.4
    Notes
    [43] - PK Population
    No statistical analyses for this end point

    Secondary: Maximum observed plasma concentration (Cmax) for GSK249320

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    End point title
    		 Maximum observed plasma concentration (Cmax) for GSK249320
    End point description
    Cmax is the maximum observed concentration of GSK249320 obtained at the end of infusion post dose on day 6. Only those participants who provided a PK sample at the indicated time point were included in the analysis (as indicated by n=X in the category title).
    End point type
    Secondary
    End point timeframe
    Day 6, Day 30 and Day 180
    End point values
    		 GSK249320 15 mg/kg - PK
    Number of subjects analysed
    62 [44]
    Units: Nanograms/milliliter
    arithmetic mean (standard deviation)
        Day 6, n=52
    494523.4 ± 172671
        Day 30, n=50
    111067 ± 42801.2
        Day 180, n=24
    2180.47 ± 2245.78
    Notes
    [44] - PK Population
    No statistical analyses for this end point

    Secondary: Time to Cmax (tmax) for GSK249320

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    End point title
    		 Time to Cmax (tmax) for GSK249320
    End point description
    Cmax is defined as the maximum observed concentration of GSK249320 obtained at the end of infusion post dose on day 6. Tmax is the time of the occurrence of Cmax. Tmax was not calculated therefore there is no data to present for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Day 6, Day 30 and Day 180
    End point values
    		 GSK249320 15 mg/kg - PK
    Number of subjects analysed
    0 [45]
    Units: Hours
        arithmetic mean (standard deviation)
    ±
    Notes
    [45] - PK Population. Tmax was not calculated therefore there is no data to present here.
    No statistical analyses for this end point

    Secondary: Terminal phase half-life for GSK249320

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    End point title
    		 Terminal phase half-life for GSK249320
    End point description
    Blood samples were collected for determination of plasma concentrations of GSK249320. Terminal phase half-life was derived from the plasma concentration-time data. Analysis was performed for PK Population that comprised of all participants in the Safety Population who had at least one PK sample with a concentration above the non-quantifiable limit. Only participants in the GSK249320 15 mg/kg group were analyzed.
    End point type
    Secondary
    End point timeframe
    Day 6, Day 30 and Day 180
    End point values
    		 GSK249320 15 mg/kg - PK
    Number of subjects analysed
    62 [46]
    Units: Days
        median (full range (min-max))
    23.09 (13.5 to 42.9)
    Notes
    [46] - PK Population
    No statistical analyses for this end point

    Secondary: Clearance (CL) for GSK249320

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    End point title
    		 Clearance (CL) for GSK249320
    End point description
    Blood samples were collected for determination of plasma concentrations of GSK249320. CL was derived from the plasma concentration-time data. Analysis was performed for PK Population that comprised of all participants in the Safety Population who had at least one PK sample with a concentration above the non-quantifiable limit. Only participants in the GSK249320 15 mg/kg group were analyzed.
    End point type
    Secondary
    End point timeframe
    Day 6, Day 30 and Day 180
    End point values
    		 GSK249320 15 mg/kg - PK
    Number of subjects analysed
    62 [47]
    Units: Milligrams/kilograms/hour
        geometric mean (geometric coefficient of variation)
    0.1243 ± 20.4
    Notes
    [47] - PK Population
    No statistical analyses for this end point

    Secondary: Volume of distribution (V1 and V2) and Volume at steady state (Vss) for GSK249320

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    End point title
    		 Volume of distribution (V1 and V2) and Volume at steady state (Vss) for GSK249320
    End point description
    Blood samples were collected for determination of plasma concentrations of GSK249320. V1, V2 and Vss were derived from the plasma concentration-time data. Analysis was performed for PK Population that comprised of all participants in the Safety Population who had at least one PK sample with a concentration above the non-quantifiable limit. Only participants in the GSK249320 15 mg/kg group were analyzed.
    End point type
    Secondary
    End point timeframe
    Day 6, Day 30 and Day 180
    End point values
    		 GSK249320 15 mg/kg - PK
    Number of subjects analysed
    62 [48]
    Units: milliliters/kilogram
    geometric mean (geometric coefficient of variation)
        V1
    43.6992 ± 6.7
        V2
    41.4193 ± 17.8
        Vss
    85.2892 ± 11.5
    Notes
    [48] - PK Population
    No statistical analyses for this end point

    Secondary: Number of participants with positive or negative results for antibodies against GSK249320

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    End point title
    		 Number of participants with positive or negative results for antibodies against GSK249320
    End point description
    Blood samples were collected and the presence of antibodies against GSK249320 was assessed using immunoelectrochemiluminescent assays for antibodies against GSK249320. Positive result indicated presence of antibodies and negative result indicated absence of antibodies. Confirmed samples with presence of antibodies were further characterized for neutralizing activity as binding antibody (BAb) and neutralising antibody (NAb) by a neutralization assay. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles). By-visit sample sizes vary due to missing data or early termination of the study.
    End point type
    Secondary
    End point timeframe
    Day 1, Day 30, Day 180, EW visit and Follow-up visit
    End point values
    		 Placebo - Safety GSK249320 15 mg/kg - Safety
    Number of subjects analysed
    68 [49]
    65 [50]
    Units: Participants
    number (not applicable)
        Day 1, BAb Positive, n=68, 65
    7
    5
        Day 1, BAb Negative, n=68, 65
    60
    59
        Day 1, NAb Positive, n=7, 5
    0
    0
        Day 1, NAb Negative, n=7, 5
    0
    2
        Day 30, BAb Positive, n=59, 60
    4
    4
        Day 30, BAb Negative, n=59, 60
    44
    46
        Day 30, NAb Positive, n=4, 4
    0
    0
        Day 30, NAb Negative, n=4, 4
    1
    1
        Day 180, BAb Positive, n=42, 41
    0
    5
        Day 180, BAb Negative, n=42, 41
    24
    19
        Day 180, NAb Positive, n=0, 5
    0
    0
        Day 180, NAb Negative, n=0, 5
    0
    0
        EW visit, BAb Positive, n=23, 23
    1
    4
        EW visit, BAb Negative, n=23, 23
    22
    18
        EW visit, NAb Positive, n=1, 4
    0
    0
        EW visit, NAb Negative, n=1, 4
    1
    4
        FU visit, BAb Positive, n=0, 1
    0
    1
        FU visit, BAb Negative, n=0, 1
    0
    0
        FU visit, NAb Positive, n=0, 1
    0
    0
        FU visit, NAb Negative, n=0, 1
    0
    1
    Notes
    [49] - Safety Population
    [50] - Safety Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study at constent to treatement until the end of study or follow up visit (6 months).
    Adverse event reporting additional description
    SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants who were randomized and took at least one dose of study medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo administered as two intravenous (IV) infusions, the first on Study Day 1 which is 24-72 hours post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 milliliters (mL) IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).

    Reporting group title
    GSK249320 15 mg/kg
    Reporting group description
    		 Participants received GSK249320 15 milligrams (mg)/kilogram (kg) administered as two IV infusions, the first on Study Day 1 which is 24-72 post-stroke onset, and the second on Study Day 6 (+/- 2 days). Each 100 mL IV infusion was delivered over a period of 75 minutes (a 60 minute infusion followed by a 10 to 15 minute flush).

    Serious adverse events
    		 Placebo GSK249320 15 mg/kg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    16 / 68 (23.53%)
    9 / 65 (13.85%)
         number of deaths (all causes)
    5
    2
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Femoral neck fracture
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Joint injury
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Neck injury
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Vascular disorders
    Hypertensive emergency
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Atrial fibrillation
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Atrial flutter
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Atrioventricular block complete
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Bradyarrhythmia
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Cardiac arrest
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Cardiac failure congestive
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Sick sinus syndrome
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Nervous system disorders
    Brain oedema
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Cerebrovascular accident
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Haemorrhagic transformation stroke
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Ischaemic cerebral infarction
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Stroke in evolution
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Gastrointestinal disorders
    Anal ulcer
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Diarrhoea
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Rectal haemorrhage
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Respiratory, thoracic and mediastinal disorders
    Pneumonia aspiration
         subjects affected / exposed
    2 / 68 (2.94%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Respiratory failure
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    1 / 68 (1.47%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 65 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Sepsis
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo GSK249320 15 mg/kg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 68 (36.76%)
    32 / 65 (49.23%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    4 / 68 (5.88%)
    3 / 65 (4.62%)
         occurrences all number
    4
    3
    Hypotension
         subjects affected / exposed
    4 / 68 (5.88%)
    2 / 65 (3.08%)
         occurrences all number
    4
    2
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 68 (0.00%)
    4 / 65 (6.15%)
         occurrences all number
    0
    5
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 68 (10.29%)
    12 / 65 (18.46%)
         occurrences all number
    7
    14
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    6 / 68 (8.82%)
    13 / 65 (20.00%)
         occurrences all number
    7
    13
    Nausea
         subjects affected / exposed
    3 / 68 (4.41%)
    5 / 65 (7.69%)
         occurrences all number
    3
    5
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    3 / 68 (4.41%)
    4 / 65 (6.15%)
         occurrences all number
    3
    4
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    4 / 68 (5.88%)
    5 / 65 (7.69%)
         occurrences all number
    4
    5
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    4 / 68 (5.88%)
    0 / 65 (0.00%)
         occurrences all number
    5
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Jun 2013
    Addition of actigraphy endpoint, change to membership and remit of the iSRC, change to the medical monitor, further clarification around certain study aspects and correction of typographical errors.

    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
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