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    Summary
    EudraCT Number:2009-016443-19
    Sponsor's Protocol Code Number:PPG-TOC2009
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2009-11-12
    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 number2009-016443-19
    A.3Full title of the trial
    Etude prospective du rôle prédictif du polymorphisme fonctionnel 5-HTTLPR sur la réponse au traitement par l’escitalopram des patients souffrant d’un trouble obsessionnel compulsif
    A.4.1Sponsor's protocol code numberPPG-TOC2009
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCHU de Poitiers
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 SEROPLEX 10mg et 20mg
    D.2.1.1.2Name of the Marketing Authorisation holderLUNDBECK SAS
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameSEROPLEX
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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.IMP: 2
    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 DEROXAT 20mg
    D.2.1.1.2Name of the Marketing Authorisation holderGLAXOSMITHKLINE
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameDEROXAT
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    obsessive compulsive disorder
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10029898
    E.1.2Term Obsessive-compulsive disorder
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the predictive character of the 5-HTTLPR functional polymorphism in the answer to the treatment with escitalopram in patients suffering from OCD
    E.2.2Secondary objectives of the trial
    - To determine prevalency of LL, SS, LS genotypes of 5-HTTLPR, CYP2C19*2 and CYP2C19*17.
    - To evaluate the answer to escitalopram after 12 weeks of treatment according to CYP2C19 polymorphisms (CYP2C19*2 and CYP2C19*17 in particular).
    - To evaluate the clinical answer after 24 weeks of escitalopram treatment in subjects responding to this drug after 12 weeks, according to the 5-HTTLPR polymorphism.
    - To evaluate after 24 weeks, the answer to the treatment of second intention with paroxetine, prescribed at the patients not answering to escitalopram after 12 weeks, according to the 5-HTTLPR polymorphism.
    - To evaluate the tolerance of escitalopram and/or paroxetine, on the whole population and according to the 5-HTTLPR polymorphism.
    - To determine the clinical factors associated with a nonresponse after 12 and 24 weeks of treatment.
    - To estimate the association between the consciousness of the disorders (insight of the OCD) and the treatment answer after 12 and 24 weeks
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient suffering from an OCD with Y BOCS > 16 without other untreated axis I disorders (MINI) or to whom the current treatment is ineffective or badly tolerated.
    - Age ≥ 18 years.
    - Caucasian Origin.
    - Free subject, without guardianship or subordination.
    - Cover of the subjects by a national insurance scheme or by benefiting through a third person in agreement with the French law on the biomedical research (Huriet Law n°88.1138 and its modifications).
    E.4Principal exclusion criteria
    - OCD patients suffering from other axis I disorders (MINI).
    - Patients being already treated with escitalopram or paroxetine in this indication.
    - Patients suffering from neurological disorder (epilepsy, encephalopathy) or cognitive disorder (memory deficit with MMSE < 26 and reminder upper to 1).
    - Mental delay.
    - Unstable clinical State, schizophrenia.
    - Patients hospitalized in automatic Hospitalization or Hospitalization at the request of a third.
    - Addictive comorbidity including alcoholism or abuse of substances
    - Treatment with other psychotropic drugs (antidepressant, neuroleptic)
    Patients having a contraindication of the use of escitalopram: hypersensitivity to escitalopram or excipients, association with monoamine oxydase inhibitor (IMAO, respect the delay of 14 days after the stop of an irreversible IMAO). Cautions are recommended in case of diabetes, associations with serotoninergic molecules including L-tryptophane, triptans, tramadol, linezolide, SRIs, lithium and St.-John's wort, with oral anticoagulants, with cytochromes inhibitors of the CYP2C19 isoenzyme (for example omeprazole, esomeprazole, fluvoxamine, lansoprazole, ticlodipine, cimetidine), with drugs mainly metabolized by the CYP2D6 isoenzyme (for example, flecaïnide, propafenone, metoprolol, antidepressants such as desipramine, clomipramine and nortriptyline or antipsychotics such as risperidone, thioridazine and haloperidol).
    - Patients having a contraindication of the use of paroxetine: hypersensitivity to paroxetine or excipients, association with monoamine oxydase inhibitor (IMAO, respect the delay of at least 24 hours after the stop of reversible IMAO (moclobémide, linézolide) and 2 weeks after the stop of irreversible IMAO), association with thioridazine, pimozide. Cautions are recommended in case of diabetes, narrow-angle glaucoma, associations with serotoninergic molecules including L-tryptophane, triptans, tramadol, linezolide, SRIs, lithium and St.-John's wort, with oral anticoagulants, with NSAID/ acetylsalicylic acid, with drugs affecting the gastric pH (antiacids, proton pump inhibitors or histamine H2 receptor antagonists).
    - Age < 18 years.
    - Not Caucasian Origin.
    - Under guardianship patient or guardianship without social coverage.
    - Subject without social coverage.
    - Woman in genital activity period without contraception.
    - Persons benefiting from a strengthened protection including minors, pregnant women, breast-feeding women, people private of freedom by a court or administrative order, persons staying in a sanitary or social establishment, adults under legal protection, and finally patients in emergency situation.
    E.5 End points
    E.5.1Primary end point(s)
    The criteria is the answer to escitalopram after 12 weeks of treatment.
    A patient is considered as "responder" in case of improvement of OCD estimated by a reduction of the initial score of Y BOCS ≥ 25 %.
    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 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 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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned3
    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 Information not present in EudraCT
    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
    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 months30
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 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 Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    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 Decision2009-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-01-26
    P. End of Trial
    P.End of Trial StatusOngoing
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