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    Summary
    EudraCT Number:2015-000641-23
    Sponsor's Protocol Code Number:CNWL/MC/AFT/01
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-02-06
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2015-000641-23
    A.3Full title of the trial
    Aggression Following TBI: Effectiveness of Risperidone (AFTER)-a feasibility RCT.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Trial of Risperidone for Irritability and Aggression after a Head Injury
    A.3.2Name or abbreviated title of the trial where available
    AFTER
    A.4.1Sponsor's protocol code numberCNWL/MC/AFT/01
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCentral and North West London NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentral and North West London NHS Foundation Trust
    B.5.2Functional name of contact pointAngela Williams
    B.5.3 Address:
    B.5.3.1Street Address1st Floor, Bloomsbury Building St Pancras Hospital 4, St Pancras Way
    B.5.3.2Town/ city London
    B.5.3.3Post codeNW1 0PE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number020 3317 3765
    B.5.6E-mailafter.noclor@nhs.net
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name risperidone- generic product
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namegeneric risperidone
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.4EV Substance CodeAS1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    aggression and agitation following on from a traumatic brain injury
    E.1.1.1Medical condition in easily understood language
    aggression and agitation following on from a traumatic brain injury
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behaviours [F01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.
    E.2.2Secondary objectives of the trial
    Irritability score on the Irritability Questionnaire (IRQ) and global social function on the Glasgow Outcome Scale-Extended (GOS-E) will be used to establish standard deviations that will inform the power calculation for the full scale RCT.

    Data from health-related Quality of life (QoL) measures, EQ-5D-5L and SF-12 will be compared in order to assess their suitability for data collection in this sample. This will allow us to calculate quality adjusted life years (QALYs) in the proposed full scale RCT in future which is necessary to undertake an economic evaluation using the methods preferred by the National Institute of Health and Care Excellence.

    To assess the feasibility and suitability of data collection on the adverse events profile using Udvalg for Kliniske Undersøgelser (UKU) scale, and physical health measures.

    To assess change in carer wellbeing on the 'Wellbeing' section of the 'Carer Wellbeing and Support Questionnaire (CWS) to establish the sensitivity of the measur
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age 18 to 65 years.
    - A confirmed clinical diagnosis of TBI which happened at least six months prior to recruitment.
    - Referred to the clinician for the management of aggression and for whom the clinician is considering a pharmacological intervention for this problem after investigating and addressing physical, psychological and social triggers.
    - Is able to give written, informed consent, as judged by a medically qualified doctor.
    - The patient or their carer is able to understand how to manage prescribed medication, as determined by discussion at the screening assessment.
    E.4Principal exclusion criteria
    - Suffering from Post-Traumatic Amnesia (PTA), which constitutes a sub-acute confusional state.
    - Co-morbid serious mental illness such as schizophrenia and other psychoses, bipolar disorder, major depressive disorder, personality disorder, and dementia.
    - Already prescribed an antipsychotic drug or any other drug that may interact with risperidone at the time of randomisation.
    - Any other contraindication for using risperidone including a previous history of severe adverse events.
    - Has no fixed abode or any other reason for which compliance with trial medication and monitoring could pose a major problem.
    -Is pregnant or trying to conceive, as determined by self-report.
    -Lactose intolerance
    E.5 End points
    E.5.1Primary end point(s)
    The standard deviation of the Modified Overt Aggression Scale (MOAS) score at 12 weeks' follow-up and as changes from baseline will be calculated. These data will inform a sample size calculation for our proposed full scale RCT in future, along with any other relevant published information.
    The range and mean score change in MOAS from baseline to 12 weeks for those who have scored 'improved' and 'very much improved' according to Clinical Global Impression-Improvement (CGI-I) scale. This information will determine what effect size on MOAS corresponds to a clinically important improvement for an individual patient. This will inform the sample size calculation for the full RCT.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Feasibility
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days31
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Twelve weeks after a participant is randomised into the study, regardless of whether the participant withdraws from the study early or completes the participation period in full, a letter will be sent to the referring psychiatrist.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-11-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-06-08
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