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    Summary
    EudraCT Number:2013-004755-21
    Sponsor's Protocol Code Number:CHUBX2012/17
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-03-15
    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 ConcernedFrance - ANSM
    A.2EudraCT number2013-004755-21
    A.3Full title of the trial
    Multicenter double-blind randomized clinical trial assessing efficacy and safety of exenatide in the treatment of hypothalamic obesity after craniopharyngioma therapy.
    Essai multicentrique randomisé en double insu évaluant l’efficacité et la tolérance du traitement par exénatide dans l’obésité hypothalamique de l’adulte secondaire au traitement du craniopharyngiome
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assessing efficacy and safety of exenatide in the treatment of hypothalamic obesity
    Evaluer l’efficacité et la tolérance du traitement par exénatide dans l’obésité hypothalamique.
    A.3.2Name or abbreviated title of the trial where available
    CRANIOEXE
    CRANIOEXE
    A.4.1Sponsor's protocol code numberCHUBX2012/17
    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 SponsorCHU de Bordeaux
    B.1.3.4CountryFrance
    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 supportMinistry of Health
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Bordeaux
    B.5.2Functional name of contact pointClinical trials manager
    B.5.3 Address:
    B.5.3.1Street Address12 rue Dubernat
    B.5.3.2Town/ cityTalence
    B.5.3.3Post code33404
    B.5.3.4CountryFrance
    B.5.4Telephone number33557820329
    B.5.5Fax number33556794629
    B.5.6E-mailceline.bairras-martin@chu-bordeaux.fr
    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 BYETTA
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca
    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.3.4Pharmaceutical form Solution for injection in pre-filled pen
    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 placeboSuspension for injection in pre-filled pen
    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
    Hypothalamic obesity after craniopharyngioma therapy.
    Obésité hypothalamique de l’adulte secondaire au traitement du craniopharyngiome.
    E.1.1.1Medical condition in easily understood language
    Hypothalamic obesity.
    Obésité hypothalamique
    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
    Compare the change of body weight at month 6 after a lifestyle intervention + exenatide compare to the one after the same lifestyle intervention+ placebo in adults patients suffering from a hypothalamic obesity due to treatment of craniopharyngioma.
    Comparer l’évolution de poids à 6 mois obtenue par l’application d’une prise en charge associant mesures hygiéno-diététiques et exénatide par rapport à celle obtenue par une prise en charge associant mesures hygiéno-diététiques et placebo d’exénatide, chez des patients adultes ayant une obésité hypothalamique secondaire au traitement du craniopharyngiome.
    E.2.2Secondary objectives of the trial
    - Compare treatment tolerance in booth groups
    - Assess exenatid efficacy compare to placebo on:
    * metabolic and cardiovascular risks factors
    * glycemia control
    * eating behaviour
    * quality of life
    * energy expenditure
    - Comparer la tolérance
    - Comparer efficacité de l’exénatide par rapport à celle du placebo sur :
    *les facteurs de risque cardio-métabolique
    *contrôle glycémique
    *comportement alimentaire
    *qualité de vie
    *dépense énergétique
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
     They are between 18 and 75 yrs.
     They had been diagnosed with a craniopharyngioma treated by surgery and/or irradiation without sign of recurrence.
     They have a BMI > 30kg/m² with intractable weight gain following therapy for craniopharyngioma.
     They demonstrate at least one other endocrinopathy, as a marker of hypothalamic damage.
     All pituitary deficiencies are correctly treated.
     They gave their written, informed consent before the beginning of the study.
     Age compris entre 18 et 65 ans.
     Antécédents de craniopharyngiome traité par chirurgie associée ou non à une radiothérapie, sans signe de récidive évolutive depuis 12 mois.
     IMC > 30kg/m² avec prise de poids vérifiée depuis le traitement du craniopharyngiome.
     Présence d’au moins un déficit antéhypophysaire attestant de l’atteinte hypothalamo-hypophysaire.
     Substitution correcte des déficits antéhypophysaires.
     Consentement libre, éclairé et écrit signé par le patient après avoir été informé sur l’étude et l’investigateur (au plus tard le jour de la pré-inclusion et avant tout examen nécessité par l’essai).
     Sujet affilié ou bénéficiaire d’un régime de sécurité sociale.
    E.4Principal exclusion criteria
     They have type 1 diabetes.
     They have type 2 diabetes treated with insulin.
     Acidocetosis.
     Bariatric surgery
     Previous personal history of thyroid or pancreatic cancer.
     Hypercalcitoninemia.
     They have been previously treated by GLP1 analogs.
     Hypertriglyceridemia > 5g/l
     They had previously demonstrated voluntary weight loss during the three previous months.
     They are under the age of 18 years or over the age of 65 yrs.
     They are maintained on medical treatment against obesity.
     They are receiving supraphysiologic hydrocortisone therapy (> 30 mg/jour).
     Their GH status change during the course of the study.
     Exenatide is contraindicated.
     Psychological and/or medical problems that would create difficulties for the patient to comply with the study protocol are present.
     Diabète de type 1.
     Patients diabétiques de type 2 insulinotraités
     Traitement préalable par analogue du GLP1.
     Antécédent de chirurgie bariatrique
     Antécédent d’acidocétose.
     Pathologie gastro-intestinale sévère, gastroparésie.
     Antécédent personnel de cancer thyroïdien ou pancréatique.
     Elévation de la calcitonine plasmatique.
     Hypertriglycéridémie > 7 g/l
     Perte de poids volontaire vérifiée au cours des 3 derniers mois.
     Mineur ou majeur sous tutelle.
     Femme sans insuffisance gonadotrope et sans contraception efficace (dispositif intra-utérin ou pilule œstroprogestatif).
     Femmes enceintes ou allaitant.
     Présence d’une contre-indication à l’exénatide.
     Traitements médicaux contre l’obésité en cours ou interrompus depuis moins de 3 mois.
     Traitement par hydrocortisone à une dose supra physiologique (> 30 mg/jour).
     Introduction d’une substitution somatotrope pendant la durée de l’étude.
     Insuffisance hépatique sévère.
     Insuffisance rénale sévère.
     Hyperlipasémie > 100 UI/l
     Hypersensibilité au principe actif ou à l’un des excipients.
     Intolérance au galactose, déficit en lactase ou malabsorption du glucose ou du galactose.
     Situation qui, selon l'investigateur, pourrait interférer avec sa participation optimale à l'étude ou constituer un risque particulier pour le sujet.
     Refus de signer la déclaration de consentement éclairé.
    E.5 End points
    E.5.1Primary end point(s)
    Weight variation.
    Variation de poids.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 6 months after inclusion.
    6 mois après l'inclusion.
    E.5.2Secondary end point(s)
    - Tolerance assessment,
    - Evolution of :
    *metabolic and cardiovascular risks factors
    * glycemia control
    * eating behaviour
    * quality of life
    * energy expenditure
    - Evaluation de la tolérance des 2 stratégies.
    - L’évolution des facteurs de risque cardio-métaboliques
    - L’évolution du contrôle glycémique entre le début et la fin de l’étude
    - L’évolution du comportement alimentaire entre le début et la fin de l’étude
    - L’évolution de la qualité de vie entre le début et la fin de l’étude,
    - L’évolution de la dépense énergétique entre le début et la fin de l’étude.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - after each visit and at the end of the trial,
    - at the inclusion visit and at the last visit
    - Lors de chaque visite, et à la fin de l’étude dans sa globalité.
    - A la visite d'inclusion et à la dernière visite de l’étude.
    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 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 Yes
    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 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 concerned10
    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
    DVDP
    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 months1
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 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 state50
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 50
    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 Decision2016-03-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-27
    P. End of Trial
    P.End of Trial StatusCompleted
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