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    Summary
    EudraCT Number:2014-004393-41
    Sponsor's Protocol Code Number:2004
    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:2015-04-21
    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 number2014-004393-41
    A.3Full title of the trial
    A double-blind, placebo-controlled study of the impact of prophylactic treatment with Galantamine 8mg of cognitive impairment during an electroconvulsive therapy (ECT) in patients with major depressive disorder (MDD).
    Essais contrôlé-randomisé en double aveugle évaluant l'impact d'un traitement prophylactique par Galantamine 8mg sur les altérations cognitives pendant une cure d'électroconvulsivothérapie (ECT) chez des patients présentant un épisode dépressif majeur (EDM).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A double-blind, placebo-controlled study of the impact of prophylactic treatment with Galantamine 8mg of cognitive impairment during an electroconvulsive therapy (ECT) in patients with major depressive desorder (MDD).
    Essais contrôlé-randomisé en double aveugle évaluant l'impact d'un traitement prophylactique par Galantamine 8mg sur les altérations cognitives pendant une cure d'électroconvulsivothérapie (ECT) chez des patients présentant un épisode dépressif majeur (EDM).
    A.4.1Sponsor's protocol code number2004
    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 SponsorCUB Hospital Erasme
    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 supportCUB Hospital Erasme
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCUB Hospital Erasme/ Department of Psychiatry
    B.5.2Functional name of contact pointLoas Gwenole
    B.5.3 Address:
    B.5.3.1Street Address808, route de Lennik
    B.5.3.2Town/ city Brussels
    B.5.3.3Post code1070
    B.5.3.4CountryBelgium
    B.5.4Telephone number0032255555256
    B.5.6E-mailGwenole.Loas@erasme.ulb.ac.be
    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 Reminyl
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag NV Antwerpseweg 15-17 B-2340 Beerse
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPBuccal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGALANTAMINE
    D.3.9.1CAS number 357-70-0
    D.3.9.4EV Substance CodeSUB07870MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 placeboBuccal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The subjects enrolled in the study will be major patients with major depressive disorder diagnosed according to DSM-IV, receiving electroconvulsive therapy.
    Les sujets admis dans l’étude seront des patients majeurs présentant un épisode dépressif majeur diagnostiqué selon les critères du DSM-IV, recevant une cure d'électroconvulsivotherapie.
    E.1.1.1Medical condition in easily understood language
    The subjects enrolled in the study will be major patients with major depressive disorder diagnosed according to DSM-IV, receiving ECT treatment.
    Les sujets admis dans l’étude seront des patients majeurs présentant un épisode dépressif majeur diagnostiqué selon les critères du DSM-IV, recevant une cure d’ECT.
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    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
    The objective of the study is to determine the effectiveness of the prophylactic use of Galantamine 8mg in non-demented patients during an electroconvulsive treatment (ECT) to prevent the onset of cognitive impairment secondary to such treatment.
    L’objectif de l’étude est de vérifier si l'utilisation prophylactique d'un traitement par Galantamine 8mg chez des patients non déments pendant une cure d’électroconvulsivotherapie (ECT) permet de prévenir efficacement l’apparition de troubles cognitifs secondaires à ce type de traitement.
    E.2.2Secondary objectives of the trial
    Not applicable
    Non applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The subjects enrolled in the study will be major patients (>or= 18year) with major depressive disorder diagnosed according to DSM-IV, receiving electroconvulsive therapy.
    Les sujets admis dans l’étude seront des patients majeurs (>ou= 18ans) présentant un épisode dépressif majeur diagnostiqué selon les critères du DSM-IV, recevant une cure d’ECT.
    E.4Principal exclusion criteria
    Exclusion criteria are refusing to participate, lack of knowledge of French or an inability to respond to a type evaluation ACE-r (illiteracy, etc.), patients Patient who are forbiden to use the treatment because of disease such as heartburn, insufficient liver or kidney, COPD or active asthma, symptomatic urinary retention, bradycardia defined as heart rate less than 60 / min or block or QTc prolongation in ECG.
    The patient with schizoaffective disorder, defined according to DSM-IV-TR will also be excluded.
    Pregnant patients or patients without contraception during the therapy will not be included in the trial.
    We will exclude patients with deterioration of memory before the treatment. That is to say, all the patients with MMSE less than 25. If this score is between 25 and 30, we will select patients over 82 in the ACE-r with a maximum score of obligation question Q5 and Q23 of the CEA to ensure the encoding capacity and a good recovery information before ECT.
    Les critères d’exclusion seront le refus de participer, la maitrise insuffisante du français ou une incapacité à répondre à une évaluation de type ACE-r (analphabétisme, etc), les patients présentant des contre-indications relatives telles que du pyrosis, une insuffisance hépatique ou rénale connue ou une altération métabolique en rapport dans la prise de sang, une BPCO ou un asthme actif, une rétention urinaire symptômatique, une bradycardie définie par un rythme cardiaque inférieur à 60/min ou un bloc ou un allongement du QTc à l’ECG.
    Les patient souffrant d’un trouble schizo-affectifs, défini selon les critères DSM-IV-TR seront également exclus.
    Les patientes enceintes ou susceptibles de l'être pendant la cure ne pourront pas être admises dans l'étude.
    Nous exclurons les patients présentant une dégradation du fonctionnement mnésique avant la cure. C’est-à-dire tous les patients dont le MMSE est inférieur à 25. Si ce score se situe entre 25 et 30, nous sélectionnerons les patients ayant plus de 82 à l’ACE-r avec une obligation de score maximal aux questions Q5(7/7) afin d’assurer les capacités d’encodage et maximale à la Q 23 (5/5) de l’ACE comme signe d’une bonne capacité de récupération de l’information avant les ECT.
    E.5 End points
    E.5.1Primary end point(s)
    The cognitive status of patients will be evaluated weekly during the electroconvulsive therapy and one week, two and six months after the therapy with cognition scales: MMSE, ACE-r.
    L'état cognitif des patients sera évalué une fois par semaine pendant la cure et une semaine et deux et six mois après la cure lors de la passation des échelles de cognition: MMSE, ACE-r.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weekly during the electroconvulsive therapy and one week, two and six months after the therapy
    Une fois par semaine pendant la cure et une semaine, deux et six mois après la cure
    E.5.2Secondary end point(s)
    Drug tolerance and mood assessment scale (Hamilton 24 criteria) will be evaluated.
    La tolérance des patients au médicament et les échelles d'évaluation thymique (Hamilton 24 items) seront également étudiées.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Drug tolerance: weekly during the therapy
    Mood assessment scale: weekly during the therapy and one week, two and six months after the therapy.
    Évaluation de la tolérance médicamenteuse: hebdomadaire durant la cure
    Echelle d'évaluation thymique: hebdomadaire durant la cure et une semaine, deux et six mois après la cure.
    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 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 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 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
    La fin de l'essais correspond à la dernière visite du dernier sujet soumis à l'essai.
    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 months22
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state34
    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 (LPLV)
    aucun (dernier patient, dernière visite).
    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 Decision2015-05-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-05
    P. End of Trial
    P.End of Trial StatusOngoing
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