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    Summary
    EudraCT Number:2013-004705-59
    Sponsor's Protocol Code Number:406201215432
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-11-21
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2013-004705-59
    A.3Full title of the trial
    Monocentric phase III clinical trial using citalopram (antidepressive compound fequently used in clinic) added to the standard of care (radio- combined with temozolomide chemotherapy and followed by temozolomide) for newly diagnosed glioblastoma patients compared to the standard of care published in the literature
    Essai clinique monocentrique de phase III utilisant le citalopram (médicament antidépresseur souvent utilisé en clinique) ajouté au traitement standard (radio- et chimiothérapie de type temozolomide) pour les patients atteints d'un glioblastome nouvellement diagnostiqué comparativement au traitement standard publié dans la littérature
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Monocentric phase III clinical trial using citalopram (antidepressive compound fequently used in clinic) added to the standard of care (radio- combined with temozolomide chemotherapy and followed by temozolomide) for newly diagnosed glioblastoma patients (the most frequent malignant brain cancer) compared to the standard of care published in the literature
    Essai clinique monocentrique de phase III utilisant le citalopram (médicament antidépresseur souvent utilisé en clinique) ajouté au traitement standard (radio- et chimiothérapie de type temozolomide) pour les patients atteints d'un glioblastome (cancer du cerveau le plus fréquent) nouvellement diagnostiqué comparativement au traitement standard publié dans la littérature
    A.3.2Name or abbreviated title of the trial where available
    Phase III clinical trial using citalopram for glioblastoma patients
    Essai clinique de phase III utilisant le citalopram pour les patients atteints d'un glioblastome
    A.4.1Sponsor's protocol code number406201215432
    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 SponsorHôpital Erasme, ULB
    B.1.3.4CountryBelgium
    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 supportTeva
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHôpital Erasme ULB
    B.5.2Functional name of contact pointPr Florence Lefranc
    B.5.3 Address:
    B.5.3.1Street AddressRoute de Lennik 808
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1070
    B.5.3.4CountryBelgium
    B.5.6E-mailflorence.lefranc@erasme.ulb.ac.be
    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 citalopram
    D.2.1.1.2Name of the Marketing Authorisation holderTeva
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 namecitalopram
    D.3.2Product code N06AB04
    D.3.4Pharmaceutical form Pillules
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Newly diagnosed glioblastoma (primary highly malignant brain cancer) patients Under treatment
    Patients en traitement pour un glioblastome (cancer hautement malin du cerveau) nouvellement diagnostiqué
    E.1.1.1Medical condition in easily understood language
    Newly diagnosed brain cancer patients
    Patients atteints d'un cancer du cerveau nouvellement diagnostiqué
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    Phase III study comparing the standard of care radio- and temozolomide therapy for newly diagnosed glioblastoma patients (published in the literature) as compared to the same treatment adding citalopram each day 20 mg a day from the diagnosis to survival
    Survival analysis
    Essai clinique de phase III comparant le standard de soin avec le même traitement accompagné d'un traitement anti-dépresseur
    Evaluation de la survie
    E.2.2Secondary objectives of the trial
    Quality of live comparison knowing that the treatment of depression during cancer therapy could increase quality of live and even survival
    We will be helped by a psychiatrist practician
    Analyse de la qualité de vie
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Newly diagnosed glioblastoma
    Signed informed consent
    Age > = 18 years
    Patients ayant un glioblastome nouvellement diagnostiqué
    Patients ayant signé le formulaire d'information et de consentement
    Age > = 18 ans
    E.4Principal exclusion criteria
    Recurrent glioblastoma
    Citalopram related exclusion criteria
    Participation in another study
    Glioblastomes en récidive
    Exclusion liée au citalopram
    Participation dans un autre essai clinique
    E.5 End points
    E.5.1Primary end point(s)
    could citalopram added to the standard of care increase quality of live and survival of glioblastoma patients
    Le citalopram ajouté au traitement standard des patients atteints d'un glioblastome peut-il améliorer leur survie ou leur qualité de vie?
    E.5.1.1Timepoint(s) of evaluation of this end point
    survival
    survie
    E.5.2Secondary end point(s)
    quality of live
    qualité de vie
    E.5.2.1Timepoint(s) of evaluation of this end point
    quality of live questionnaire (EORTC) and with a psychiatric evaluation
    questionnaire de qualité de vie utilisé par l'EORTC ainsi qu'un questionnaire spécifique mis au point par un psychiatre de notre institution
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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.8.2.4Number of treatment arms in the trial1
    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 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
    End of the trial after the inclusion of 50 patients (from diagnosis to the death)
    inclusion du 50ème patient (du diagnostic de glioblastome au décès du patient)
    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 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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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)
    The patient will be treated and followed for all the care till its death
    Le patient sera suivi et traité jusqu'à sa mort même s'il sort de l'étude
    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 Decision2013-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-17
    P. End of Trial
    P.End of Trial StatusOngoing
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