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    Summary
    EudraCT Number:2021-004919-11
    Sponsor's Protocol Code Number:FLAIR-i
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-01-19
    Trial 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-004919-11
    A.3Full title of the trial
    The effect of colchicine on Food-reLAted effort-based decision making in brain and behavIouR in overweight and obesity: the FLAIR-i study.
    Het effect van colchicine op voedselgerelateerd inspannings-gerelateerd keuzegedrag in het brain en gedrag in mensen met overgewicht en obesitas: de FLAIR-i studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of the anti-inflammatory drug colchicine on brain and behaviour in overweight and obesity: the FLAIR-i study.
    Het effect van de ontstekingsremmer colchicine op het brein en gedrag in mensen met overgewicht en obesitas: de FLAIR-i studie.
    A.3.2Name or abbreviated title of the trial where available
    FLAIR-i
    FLAIR-i
    A.4.1Sponsor's protocol code numberFLAIR-i
    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 SponsorDonders Institute for Brain, Cognition and Behaviour, Radboud University
    B.1.3.4CountryNetherlands
    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 supportEuropean Research Council
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDonders Institute for Brain, Cognition and Behaviour
    B.5.2Functional name of contact pointStudy team
    B.5.3 Address:
    B.5.3.1Street AddressKapittelweg 29
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525 EN
    B.5.3.4CountryNetherlands
    B.5.6E-mailflairstudie@donders.ru.nl
    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 Colchicine CF 0,5mg
    D.2.1.1.2Name of the Marketing Authorisation holderCentrafarm B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameColchicine CF 0,5 mg
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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 placeboTablet
    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
    Low-grade inflammation in obesity
    Laaggradige inflammatie in obesitas
    E.1.1.1Medical condition in easily understood language
    Chronic inflammation in obesity
    Chronische onsteking in obesitas
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10029883
    E.1.2Term Obesity
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 24.1
    E.1.2Level PT
    E.1.2Classification code 10033307
    E.1.2Term Overweight
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To study the causal role of inflammation in affecting food-related effort-based decision making in brain and behaviour in obese participants by employing a placebo-controlled intervention design with the anti-inflammatory agent colchicine.
    Het onderzoeken van de causale effect van inflammatie op het voeding-gerelateerd keuzegedrag in het brein en gedrag in mensen met obesitas, door het uitvoeren van een placebo-gecontroleerd ontstekingsremmende interventie met de ontstekingsremmer colchicine.
    E.2.2Secondary objectives of the trial
    To study whether the primary objective translate to more ecologically valid measures/settings.
    Het onderzoeken hoe de primaire doelstelling zich vertaalt in meer ecologisch valide methoden/settings.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General inclusion criteria:
    • BMI ≥ 30 kg/m2
    • Female sex
    • Age: 18-59 years
    • Right-handed
    • Low-grade inflammation, as defined by C-reactive protein (hsCRP) between 3.0 and 10.0 mg/L for BMI between 30-31 kg/m2, and hsCRP between 3.0 and 22.1 mg/L for BMI > 31 kg/m2.
    In case of a hsCRP level above these thresholds, the measurement is repeated after at least 4 weeks (as part of the FLAIR-o study, NL77503.091.21). For this second measurement the thresholds for inclusion are: hsCRP 3.0-19.7 for BMI between 30-31 kg/m2 and hsCRP 3.0-27.8 for BMI > 31 kg/m2.
    Algemene inclusiecriteria:
    • BMI ≥ 30 kg/m2
    • Geslacht: vrouw
    • Leeftijd: 18-59 jaar
    • Rechtshandig
    • Laaggradige inflammatie, aangetoond door C-reactive protein (hsCRP) tussen de 3.0 en 10.0 mg/L bij BMI tussen de 30-31 kg/m2, en hsCRP tussen de 3.0 en 22.1 mg/L bij BMI > 31 kg/m2
    In het geval van een hsCRP waarde boven deze waarden wordt de meting na minimaal 4 weken herhaald (als onderdeel van de FLAIR-o studie, as part of the FLAIR-o study, NL77503.091.21). Bij een tweede meting gelden dan de volgende afkapwaarden als inclusie: hsCRP 3.0-19.7 mg/L voor een BMI tussen de 30-31 kg/m2 en hsCRP 3.0-27.8 mg/L voor een BMI > 31 kg/m2.
    E.4Principal exclusion criteria
    • Diagnosed with Diabetes Mellitus type I or II
    • Having been vaccinated in the 4 weeks preceding the first test session
    • Gained or lost >5 kg of body weight over the last 6 months
    • Followed an energy restricting diet during the last 2 months
    • Habitual smoking, i.e. one or more cigarettes per day
    • Current or history of alcohol and/or drugs abuse (i.e. >14 units per week)
    • Pregnant, lactating or wishing to become pregnant in the period between the screening and until 3 months after the last study visit (self-reported)
    • (History of) clinically significant psychiatric or neurological disorder
    • (History of) clinically significant metabolic, cardiovascular, renal, endocrinological, autoimmune or chronic inflammatory disease
    • General medical conditions, such as sensorimotor handicaps, deafness, blindness or colorblindness, as judged by the investigator
    • Regular use of anti-inflammatory, anti-diabetic, anti-histamine and psychoactive medication
    • Regular use of CYP3A4 inhibitors, P-glycoprotein inhibitors, statins, fibrates, ciclosporin, and digoxin, as a contraindication for colchicine
    • Renal impairment as evidenced by serum creatinine >150 µmol/l or eGFR <50mL/min/1.73m2
    • Have moderate to severe hepatic disease
    • Contraindications for fMRI
    • Gediagnosticeerd met Diabetes Mellitus type I of II
    • Gevaccineerd zijn in de 4 weken voor de eerste test sessie
    • >5 kg aangekomen of afgevallen in de afgelopen 6 maanden
    • Een energiebeperkend dieet hebben gevolgd in de afgelopen 2 maanden
    • Roken (1 of meer sigaretten per dag)
    • Huidig of vroeger alcohol- of drugsmisbruik (meer dan 14 eenheden per week)
    • Zwanger, borstvoeding geven of de wens hebben om zwanger te worden in periode tussen de screening en tot 3maanden na de laatste studie-afspraak (zelf gerapporteerd)
    • (Vroegere) klinisch significante psychiatrische stoornis of neurologische aandoening
    • (Vroegere) klinisch significante metabole, cardiovasculaire, endocrinologische, autoimmuun, nier- of chronische ontstekingsziekte/aandoening
    • Algemene medische conditie, zoals sensorimotorische handicaps, doofheid, blindheid, kleurenblindheid, zoalsbeoordeeld door de onderzoeker
    • Regelmatig gebruik van ontstekingsremmende, anti-diabetes, anti-histamine en psychoactieve medicatie
    • Regelmatig gebruik van CYP3A4 remmers, P-glycoprotein remmers, statines, fibraten, ciclosporine, and digoxine
    • Nierfalen, aangetoond door serum creatinine >150 µmol/l of eGFR <50mL/min/1.73m2
    • Matig tot ernstige leverziekte
    • Contra-indicaties voor MRI
    E.5 End points
    E.5.1Primary end point(s)
    The main outcomes are brain activity and behavioural weightings of effort and reward valuation, measured by functional MRI and by a behavioural effort-based decision-making task.
    De belangrijkste uitkomstmaten zijn hersenactiviteit en gedragsmatige wegingen van inspanning en beloning, gemeten door functionele MRI en door een taak waarin inspanningsgerelateerd keuzegedrag wordt gemeten.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At baseline (as part of a larger observatory study, the FLAIR-o) and after the trial period.
    Op baseline (deel van een grotere observationele studie, de FLAIR-o) en na de trial periode.
    E.5.2Secondary end point(s)
    Secondary outcomes are effort- and reward-related food intake in the lab, anhedonia, reward anticipation, and active behaviour in daily life, measured by Experience Sampling Method and qualitative interviews.
    Secondaire uitkomstmaten zijn inspanning- en beloning-gerelateerde voedselinname in het lab, anhedonia, anticipatie van beloning, en actief gedrag in het dagelijks leven, gemeten door de Experience Sampling Method en kwalitatieve interviews.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At baseline (as part of a larger observational study, the FLAIR-o study, NL77503.091.21) and after the intervention period.
    Op baseline (deel van een grotere observationele studie, de FLAIR-o studie, NL77503.091.21) en na de interventieperiode.
    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 Yes
    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 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
    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 months0
    E.8.9.1In the Member State concerned days0
    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: 60
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state60
    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
    Geen
    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 Decision2022-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-03
    P. End of Trial
    P.End of Trial StatusOngoing
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