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    Clinical Trial Results:
    Aggression Following TBI: Effectiveness of Risperidone (AFTER)-a feasibility RCT.

    Summary
    EudraCT number
    		 2015-000641-23
    Trial protocol
    		 GB  
    Global end of trial date
    08 Jun 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 May 2019
    First version publication date
    24 May 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CNWL/MC/AFT/01
    Additional study identifiers
    ISRCTN number
    		 ISRCTN30191436
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Central and North West London NHS Foundation Trust
    Sponsor organisation address
    1st Floor, Bloomsbury Building St Pancras Hospital, London, United Kingdom, NW1 0PE
    Public contact
    Angela Williams, Central and North West London NHS Foundation Trust, 44 20 3317 3765, after.noclor@nhs.net
    Scientific contact
    Angela Williams, Central and North West London NHS Foundation Trust, 44 20 3317 3765, after.noclor@nhs.net
    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
    24 Oct 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Jun 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jun 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Using the Modified Overt Aggression Scale (MOAS) to assess aggression at 12 weeks in order to estimate sample size for future full RCT, and gauge the potential recruitment and drop-out rates.
    Protection of trial subjects
    Thorough monitoring of adverse events and participant wellbeing occurred as part of the assessment process. During assessment and testing breaks were provided to minimise possible fatigue or stress, and if indicated, the assessment were spread over more than one visit.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2015
    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: 14
    Worldwide total number of subjects
    14
    EEA total number of subjects
    14
    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)
    14
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Exclusions included post-traumatic amnesia, severe mental illness, contraindications to risperidone, pregnancy/breastfeeding, cardiovascular disease, low white blood cell count, drug-induced leukopenia/neutropenia, history of seizures. For those already prescribed an antipsychotic, a wash-out period of two weeks was required prior to randomisation.

    Period 1
    Period 1 title
    Overall Trial (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
    		 Risperidone
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    risperidone
    Investigational medicinal product code
    N05AX08
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Dosing started with 1 mg once daily and was titrated in 1mg increments, not more than once every 7 days, to a maximum of 4mg a day.

    Arm title
    		 Placebo
    Arm description
    		 -
    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
    Administration was matched to the active (risperidone) arm.

    Number of subjects in period 1
    		Risperidone Placebo
    Started
    6
    8
    Completed
    5
    7
    Not completed
    1
    1
         Physician decision
    1
    -
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Risperidone
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Risperidone Placebo Total
    Number of subjects
    		 6 8 14
    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)
    		 39.3 ( 8.7 ) 43.1 ( 11.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 1 3 4
        Male
    		 5 5 10
    Modified Overt Aggression Scale
    The MOAS is a simple but widely used 4-item scale that measures verbal aggression along with physical aggression towards other people, property and self.
    Units: Score
        arithmetic mean (standard deviation)
    		 5.5 ( 2.9 ) 13.9 ( 11.0 ) -

    End points

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    End points reporting groups
    Reporting group title
    Risperidone
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: MOAS at 12-week assessment

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    End point title
    		 MOAS at 12-week assessment [1]
    End point description
    End point type
    Primary
    End point timeframe
    Modified Overt Aggression Scale score at 12 week follow-up
    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: As this was a feasibility study the primary aim was to work out the standard deviation of the MOAS score at 12 week follow up to inform a sample size calculation for a future full scale RCT.
    End point values
    		 Risperidone Placebo
    Number of subjects analysed
    5
    7
    Units: score
        arithmetic mean (standard deviation)
    2.2 ( 3.9 )
    2.0 ( 2.4 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Timeframe for reporting adverse events was 17th January 2017 to 6th June 2018
    Adverse event reporting additional description
    Participants were assessed for the known side effects of antipsychotic medication using a published scale- the UKU scale (Lingjaerde et al, 1987) at study visits. Ad hoc spontaneous adverse event reporting was also used.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    Risperidone
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Risperidone Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 8 (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: 5%
    Non-serious adverse events
    		 Risperidone Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 6 (83.33%)
    4 / 8 (50.00%)
    Injury, poisoning and procedural complications
    Injury
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
    Additional description: dizziness resulting in a fall
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    0
    2
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    2 / 6 (33.33%)
    1 / 8 (12.50%)
         occurrences all number
    5
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Anger
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    Anxiety
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Nov 2015
    A change to the protocol to clarify existing eligibility criteria, and a change of sites.
    17 Jul 2017
    A change to the inclusion criterion “a history of seizures” changed to only exclude patients that have experienced a neurogenic seizure in the past three months

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    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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