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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2011-005218-13
    Sponsor's Protocol Code Number:2167SR
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-02-28
    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 number2011-005218-13
    A.3Full title of the trial
    Rationalisation of antipsychotic drug use in older people, using [18F]-Fallypride PET
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Optimisation of amisulpride prescribing in older people
    A.3.2Name or abbreviated title of the trial where available
    Optimisation of amisulpride prescribing in older people
    A.4.1Sponsor's protocol code number2167SR
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01454453
    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 SponsorKings College London
    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 supportNational Institute for Health Research
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKings College London
    B.5.2Functional name of contact pointDr Suzanne Reeves
    B.5.3 Address:
    B.5.3.1Street AddressInstitute of Psychiatry, De Crespigny Park
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE5 8AF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+442078480548
    B.5.5Fax number+442078480632
    B.5.6E-mailsuzanne.j.reeves@kcl.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorSouth London and Maudsley 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 supportNational Institute for Health Research
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing's College London
    B.5.2Functional name of contact pointDr Suzanne Reeves
    B.5.3 Address:
    B.5.3.1Street AddressInstitute of Psychiatry
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE5 8AF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+442078480548
    B.5.5Fax number+442078480632
    B.5.6E-mailsuzanne.j.reeves@kcl.ac.uk
    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.2.5The 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 nameAmisulpride
    D.3.4Pharmaceutical form Tablet
    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.3.8INN - Proposed INNAMISULPRIDE
    D.3.9.1CAS number 71675-85-9
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB05458MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 to 200
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Alzheimer's Disease and schizophrenia like
    illness
    E.1.1.1Medical condition in easily understood language
    Dementia
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Psychological processes [F02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 100000004852
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10032928
    E.1.2Term Other specified types of schizophrenia
    E.1.2System Organ Class 100000004873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    (i)To investigate differences in regional dopamine D2/3 receptor occupancy between Alzheimer's Disease, Schizophrenia Like Psychosis and Healthy Controls after 4 days treatment with amisulpride 50mg daily
    (ii)To investigate differences in the threshold of dopamine D2/3 receptor occupancy required for 25% symptom reduction and emergence of motor side effects in SLP and AD during 4-10 weeks treatment with amisulpride (50-200mg daily)
    (iii) To determine dose-response relationships (dose/plasma level/clinical outcome) in SLP and AD during dose-titration of amisulpride (50-200mg) over 4-10 weeks
    E.2.2Secondary objectives of the trial
    To investigate changes in neuropsychological test performance at the end of dose titration (4-10 weeks) in patients with Alzheimer's Disease and Schizophrenia Like Psychosis


    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Healthy participants will be included if they
    (i)are aged between 60 and 95 years of age
    (ii)are male or female
    (iii)score <6 on the Geriatric depression scale (GDS)
    (iv)score >26/30 on the Mini Mental State Examination

    Patients with SLP will be included if they
    (i)meet diagnostic criteria for SLP (a non-affective, non-organic psychosis)
    (ii)are aged between 60 and 95 years of age
    (iii)are male or female
    (iv)score <6 on the Geriatric Depression Scale (GDS)
    (v)have been deemed eligible to receive amisulpride treatment by the prescribing clinician, but have not yet commenced treatment ƚ

    Patients with AD will be included if they
    (i)meet National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer’s Disease and Related Disorders (NINCDS/ADRDA) criteria for AD
    (ii)score <=4 on the Modified Hachinski Ischaemia Scale (MHIS)
    (iii)score < 8 on a modified version of the Unified Parkinson’s Disease Rating scale (UPDRS) motor component
    (iv)score <6 on the Geriatric Depression Scale
    (v)are aged between 60 and 95 years of age
    (vi)are male or female
    (vii)have been deemed eligible to receive amisulpride for the treatment of behavioural or psychotic symptoms by the prescribing clinician, but have not yet commenced treatment ƚ

    ƚ this does not apply to the control group (group 4), who may be on or off psychotropic medication, provided there has been no change in dose over the previous 2 weeks (6 weeks if depot)


    E.4Principal exclusion criteria
    Healthy participants will be excluded for the following reasons:
    (i)current or past psychiatric illness (such as schizophrenia), addiction (drug or alcohol), traumatic brain injury or epilepsy
    (ii)prescribed psychotropic or other oral medication that might interfere with brain dopamine function in the past 2 weeks (6 weeks for depot medication).
    (iii)medical conditions that might affect a person’s ability to tolerate a brain scan, such as significant respiratory or cardiac disease or severe kyphosis, or needle phobia (the latter because the scan required intravenous cannulation).
    (iv)unable to give informed consent

    Patients with SLP will be excluded for the following reasons
    (i)past history of addiction (drug or alcohol), traumatic brain injury or epilepsy
    (ii)prescribed an antipsychotic or other oral drug that interferes with brain dopamine function within the past 2 weeks (6 weeks for depot medication)*
    (iii)medical conditions that might affect a person’s ability to tolerate a brain scan, such as significant respiratory or cardiac disease or severe kyphosis, or needle phobia (the latter because the scan required intravenous cannulation).
    (iv)unable to give informed consent

    Patients with AD will be excluded for the following reasons
    (i)past history of schizophrenia (before the age of 60 years), addiction (drug or alcohol), traumatic brain injury or epilepsy
    (ii)prescribed an antipsychotic or other oral drug that interferes with brain dopamine function within the past 2 weeks (6 weeks for depot medication)*
    (iii)overt parkinsonian (facial masking, action tremor, resting tremor rigidity, bradykinesia) features (scores >7 on the modified UPDRS) (Ballard 1997) or other features suggestive of a Lewy Body Dementia including fluctuating conscious level, frequent falls, or visual hallucinations as a predominant feature.
    (iv)medical conditions that might affect a person’s ability to tolerate a brain scan, such as significant respiratory or cardiac disease or severe kyphosis, or needle phobia (the latter because the scan required intravenous cannulation).
    ƚ patients with AD who are unable to give informed consent because of illness severity will not be excluded, but will require the carer to provide assent as personal legal representative.

    Although MRI is required to optimise analysis of PET data in groups 1-3, alternative methods are being explored (for example creating a template from existing participants to map PET data on to), hence participants in whom an MRI scan is contraindicated will not necessarily be excluded.

    *For group 4, participants will only be excluded if there has been a change in psychotropic prescribing (2 weeks for oral medication, 6 weeks for depot)



    E.5 End points
    E.5.1Primary end point(s)
    (i)D2/3 receptor occupancy following steady state (4 days) treatment with amisulpride 50mg daily (groups 1,2) (data from group 5 used to ensure that there is sufficient pre-treatment data)
    (ii)D2/3 receptor occupancy, symptom reduction, motor side effect score at the end of dose-titration (4-10 weeks of 50-200mg amisulpride) (group 3) (data from group 5 used to ensure that there is sufficient pre-treatment data)
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 days for groups 1 and 2
    4-10 weeks for group 3
    E.5.2Secondary end point(s)
    (i)Change in neuropsychological test performance measures at the end of dose titration (4-10 weeks treatment with 50-200mg amisulpride) (groups 2 and 3)
    (ii)Change in test performance measures over a 4 week period in the absence of treatment (group 4)

    E.5.2.1Timepoint(s) of evaluation of this end point
    4-10 weeks
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    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 concerned3
    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
    Last Visit Last Subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days28
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 140
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    A proportion of participants with Alzheimer's Disease may be unable to give informed consent because of the nature and severity of their dementia. Where this is the case, a carer will be asked to act as a personalised legal representative.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state140
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 140
    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)
    This is an observational study of amisulpride treatment. Apart from healthy participants taking part in the effects of a single dose of drug (4 days only, administered by the research team), amisulpride will be prescribed by a responsible clinician in either a community or inpatient setting. Treatment will continue to be monitored by the relevant team during the patient's invovlement in the study and subsequent to this.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-02-04
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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
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