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    Summary
    EudraCT Number:2012-005404-17
    Sponsor's Protocol Code Number:TAO-EX-2012
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-01-02
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2012-005404-17
    A.3Full title of the trial
    Treatment of antipsychotic associated obesity with a GLP-1 Analogue: the TAO study
    Behandling af antipsykotika-associeret fedme med en GLP-1 analog: TAO studiet
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of antipsychotic associated obesity with an antidiabetic agent: the TAO study
    Behandling af antipsykotika-associeret fedme med middel mod sukkersyge: TAO studiet
    A.3.2Name or abbreviated title of the trial where available
    Treatment of antipsychotic associated obesity
    Behandling af antipsykotika-associeret fedme
    A.4.1Sponsor's protocol code numberTAO-EX-2012
    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 SponsorCenter for Neuropsychiatric Schizophrenia Research
    B.1.3.4CountryDenmark
    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 supportRegion Hovedstadens Psykiatri
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportUniversity of Copenhagen
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCenter for Neuropsychiatric Schizophrenia Research
    B.5.2Functional name of contact pointPsychiatric Center Glostrup
    B.5.3 Address:
    B.5.3.1Street AddressNordre Ringvej 29-67
    B.5.3.2Town/ cityGlostrup
    B.5.3.3Post code2600
    B.5.3.4CountryDenmark
    B.5.4Telephone number00452613 3832
    B.5.6E-mailbebdrup@cnsr.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Bydureon
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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 placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Obesity
    Fedme
    E.1.1.1Medical condition in easily understood language
    Obesity
    Fedme
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    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
    To investigate if 3 months treatment with a GLP-1-analogue can reduce antipsychotic associated obesity in non-diabetic patients with a diagnosis within the schizophrenic spectrum
    E.2.2Secondary objectives of the trial
    Moreover we will investigate the associations between GLP-1-analogue treatment and peripheral metabolic parameters as well as associations with central psychological parameters such as magnetic resonance imaging (MRI) scans of the brain and cognitive tests.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age: 18 - 65 years
    Diagnosis in the schizophrenic spectrum (ICD-10: F20.x, F25.x)
    Treatment with a least one antipsyhcotic agent (FGS/SGA) for a least 3 months
    BMI ≥ 30 kg/m2
    HbA1c < 6,5 %
    Alder: 18 - 65 år
    Diagnose i det skizofrene spektrum (ICD-10: F20.x, F25.x)
    Behandling med mindst ét antipsykotikum (FGA og/eller SGA) gennem mindst 3 måneder
    BMI ≥ 30 kg/m2
    HbA1c < 6,5 %
    E.4Principal exclusion criteria
    Active abuse of psychoactive drugs (ICD-10: F1x.2 (not nicotine))
    Contradictions to MRI (metalimplant, pacemaker, claustrofobia, ≥150 kg (max. weight in the MR scanner))
    Former headtrauma with loss of conciousness more than 5 minutes
    Pregnancy
    Severe medical condition/illness
    Allergi towards exenatide (Bydureon®)
    Suicidality
    Forensic psychiatry patient
    Conditions, who according to Sponsor or Invesigator are not fit for joining the investigation
    Aktivt afhængighedssyndrom af psykoaktive stoffer (ICD-10: F1x.2 (fraset nikotinafhængighed F17.2))
    Kontraindikationer mod MR-scanning (metalimplantater, pacemaker, svær klaustrofobi, ≥150 kg (max. lejevægt i MR scanner))
    Tidligere hovedtraume med bevidsthedstab i mere end 5 minutter
    Graviditet (screenet ved urin humant chorion gonadotropin (urin-hCG), amning eller ingen accept af
    Manglende brug af sikker prævention i interventionsperioden
    Alvorlig somatisk sygdom, herunder anæmi, nedsat nyrefunktion og inflammatorisk tarmsygdom
    Allergi overfor exenatid (Bydureon®)
    Suicidalitet
    Tvangsforanstaltninger iht. Psykiatriloven
    Tilstande, der ifølge sponsor eller investigator ikke er forenelige med deltagelse
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is weightloss after 3 moths treatment with the GLP-1-analogue, exenatide.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 week
    1 month
    3 moths
    E.5.2Secondary end point(s)
    The effect of GLP-1-analogue treatment on a wide range of secondary endpoints will be examined. By means of MRI, potential neuroprotective effects and changes in cerebral blood flow will be explored. Changes in cerebral blood flow following GLP-1 analogue treatment, with particular focus on the blood flow in hypothalamus and prefrontal cortex, will be correlated to measures of global cognitive ability. Moreover, associations between GLP-1 analogue treatment, weight loss and improvement in secondary metabolic parameters will be associated with improvements in the patients' subjective quality of life. Finally, we will examine if possible GLP-1 analogue-induced volumetric changes in the striatum are correlated with reductions in the extrapyramidal side effects of antipsychotic medication.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 months
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 Yes
    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 years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 80
    F.1.3Elderly (>=65 years) No
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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)
    None
    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 Decision2013-01-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-06-23
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