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    Clinical Trial Results:
    A trial of Guanfacine, an alpha 2 adrenergic agonist, for Spatial Neglect and Impaired Vigilance following Stroke and Focal Brain Damage

    Summary
    EudraCT number
    		 2008-001160-36
    Trial protocol
    		 GB  
    Global end of trial date
    28 Mar 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Dec 2019
    First version publication date
    29 Dec 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2008-1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00955253
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Imperial College London
    Sponsor organisation address
    South Kensington Campus, London, United Kingdom, SW7 2AZ
    Public contact
    Paresh A Malhotra, Imperial College London, +44 2088467286, p.malhotra@imperial.ac.uk
    Scientific contact
    Paresh A Malhotra, Imperial College London, +44 2088467286, p.malhotra@imperial.ac.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    03 Aug 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Mar 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Mar 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To establich whether spatial neglect and impaired sustained attention (secondary to hemispheric stroke or brain injury) are improved by a single dose of oral guanfacine
    Protection of trial subjects
    None
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Apr 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 13
    Worldwide total number of subjects
    13
    EEA total number of subjects
    13
    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)
    8
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Stroke patients with evidence of neglect on bedside testing were recruited from Imperial College Healthcare NHS Trust, the National Hospital for Neurology and Neurosurgery and Northwick Park Hospital. Patients were recruited during their inpatient rehabilitation or via the outpatient clinic.

    Pre-assignment
    Screening details
    		 Patients with robust visual neglect when tested twice with cancellation tests (specifically an overall score on one or both tests <75% total and/or five or more omissions on the left than on the right) were considered for inclusion.

    Period 1
    Period 1 title
    First treatment (day 2)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Guanfacine
    Arm description
    		 Participants received Guanfacine
    Arm type
    		 Experimental

    Investigational medicinal product name
    Guanfacine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    On day 2, individuals received 2mg of active drug

    Arm title
    		 Placebo
    Arm description
    		 Participants received placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    On day 2, individuals received 2mg of placebo

    Number of subjects in period 1
    		Guanfacine Placebo
    Started
    7
    6
    Completed
    7
    6
    Period 2
    Period 2 title
    Second intervention (day 4)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Guanfacine
    Arm description
    		 Participants received Guanfacine
    Arm type
    		 Experimental

    Investigational medicinal product name
    Guanfacine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    On day 2, individuals received 2mg of active drug

    Arm title
    		 Placebo
    Arm description
    		 Participants received placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    On day 2, individuals received 2mg of placebo

    Number of subjects in period 2
    		Guanfacine Placebo
    Started
    6
    7
    Completed
    6
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    First treatment (day 2)
    Reporting group description
    		 -

    Reporting group values
    		 First treatment (day 2) Total
    Number of subjects
    		 13 13
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 8 8
        From 65-84 years
    		 5 5
    Age continuous
    Units: years
        geometric mean (standard deviation)
    		 63.2 ( 10.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 12 12
    Behavioural Inattention Test Star Cancellation Score
    This is a standard scale for measuring the severity of spatial neglect. Patients are asked to find and mark targets (which are embedded amongst distractors) on a piece of paper. The maximum number of targets that can be found is 54 (Therefore minimum score =0, maximum =54), which represents normal performance.
    Units: Number of targets found
        geometric mean (standard deviation)
    		 35.4 ( 15.9 ) -
    Touchscreen Cancellation
    This is a computerized scale for measuring the severity of spatial neglect as described in previous publications (Malhotra et al, Annals of Neurology 2006; Parton et al, Neuroreport 2006). Patients are asked to find and touch targets (which are embedded amongst distractors) on a touchscreen. In the variant of the task employed here, the targets are not marked when touched ("Invisible Cancellation").The maximum number of targets that can be found is 64 (Therefore minimum score = 0, maximum = 64), which represents normal performance.
    Units: Number of targets found
        geometric mean (standard deviation)
    		 28.4 ( 13.9 ) -
    Subject analysis sets

    Subject analysis set title
    Guanfacine
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All participants who received Guanfacine

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All participants who received placebo

    Subject analysis sets values
    		 Guanfacine Placebo
    Number of subjects
    13
    13
    Age categorical
    Units: Subjects
        Adults (18-64 years)
        From 65-84 years
    Age continuous
    Units: years
        geometric mean (standard deviation)
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
        Male
    Behavioural Inattention Test Star Cancellation Score
    This is a standard scale for measuring the severity of spatial neglect. Patients are asked to find and mark targets (which are embedded amongst distractors) on a piece of paper. The maximum number of targets that can be found is 54 (Therefore minimum score =0, maximum =54), which represents normal performance.
    Units: Number of targets found
        geometric mean (standard deviation)
    35.4 ( 15.9 )
    35.4 ( 15.9 )
    Touchscreen Cancellation
    This is a computerized scale for measuring the severity of spatial neglect as described in previous publications (Malhotra et al, Annals of Neurology 2006; Parton et al, Neuroreport 2006). Patients are asked to find and touch targets (which are embedded amongst distractors) on a touchscreen. In the variant of the task employed here, the targets are not marked when touched ("Invisible Cancellation").The maximum number of targets that can be found is 64 (Therefore minimum score = 0, maximum = 64), which represents normal performance.
    Units: Number of targets found
        geometric mean (standard deviation)
    28.4 ( 13.9 )
    28.4 ( 13.9 )

    End points

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    End points reporting groups
    Reporting group title
    Guanfacine
    Reporting group description
    		 Participants received Guanfacine

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo
    Reporting group title
    Guanfacine
    Reporting group description
    		 Participants received Guanfacine

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo

    Subject analysis set title
    Guanfacine
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All participants who received Guanfacine

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All participants who received placebo

    Primary: Performance on Tests of Hemispatial Neglect and Sustained Attention

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    End point title
    		 Performance on Tests of Hemispatial Neglect and Sustained Attention
    End point description
    Touchscreen Cancellation: This is a computerized scale for measuring the severity of spatial neglect as described in previous publications (Malhotra et al, Annals of Neurology 2006; Parton et al, Neuroreport 2006). Patients are asked to find and touch targets (which are embedded amongst distractors) on a touchscreen. In the variant of the task employed here, the targets are not marked when touched ("Invisible Cancellation"). The maximum number of targets that can be found is 64 (Therefore minimum score =0, maximum = 64), which represents normal performance.
    End point type
    Primary
    End point timeframe
    5 days
    End point values
    		 Guanfacine Placebo
    Number of subjects analysed
    13
    13
    Units: Number of targets found
        geometric mean (standard deviation)
    31.15 ( 15.1 )
    26.15 ( 41.29 )
    Statistical analysis title
    		 Hemispatial Neglect and Sustained Attention
    Comparison groups
    Guanfacine v Placebo
    Number of subjects included in analysis
    26
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.013
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Sustained attention

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    End point title
    		 Sustained attention
    End point description
    The computed response time variability, which is commonly used as an index of sustained attention, with higher variability indicating poorer deployment of attention on the task. The main effect of the drug on response bias.
    End point type
    Secondary
    End point timeframe
    5 days
    End point values
    		 Guanfacine Placebo
    Number of subjects analysed
    13
    13
    Units: signal detection
        median (standard deviation)
    0.72 ( 0.42 )
    0.51 ( 0.45 )
    Statistical analysis title
    		 Sustained attention
    Comparison groups
    Placebo v Guanfacine
    Number of subjects included in analysis
    26
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.004
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    5 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Guanfacine
    Reporting group description
    		 Participants received Guanfacine

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo

    Serious adverse events
    		 Guanfacine Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Guanfacine Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 13 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No adverse event reported

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/29436486
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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