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    Summary
    EudraCT Number:2017-004984-11
    Sponsor's Protocol Code Number:P150962J
    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:2018-02-05
    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 number2017-004984-11
    A.3Full title of the trial
    "Study of maintenance of the efficacy and adverse effects of pharmacological treatments in sex offenders with paraphilia" ESPARA
    " Etude de maintien de l'efficacité et des effets indésirables des traitements pharmacologiques chez les délinquants sexuels atteints de paraphilie " ESPARA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    "Study of maintenance of the efficacy and adverse effects of pharmacological treatments in sex offenders with paraphilia"
    " Etude de maintien de l'efficacité et des effets indésirables des traitements pharmacologiques chez les délinquants sexuels atteints de paraphilie "
    A.3.2Name or abbreviated title of the trial where available
    ESPARA
    A.4.1Sponsor's protocol code numberP150962J
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    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 supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointDRCI Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address 1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.6E-mailchristophe.aucan@aphp.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 Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMP
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Information not present in EudraCT
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMP
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Information not present in EudraCT
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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
    Sexual offenders with paraphilia
    Délinquants sexuels atteints de paraphilie
    E.1.1.1Medical condition in easily understood language
    Sex offenders with paraphilie
    Délinquants sexuelles paraphiliques
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10033888
    E.1.2Term Paraphilia
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    SSRI Group: Determining factors associated with maintaining effectiveness.
    Anti-androgen group: estimation of the incidence of adverse events and the determination of factors associated with the occurrence of these events, which could be different from those usually observed in the treatment of prostate cancer.
    Groupe ISRS : détermination des facteurs associés au maintien de l'efficacité.
    Groupe anti-androgènes : estimation de l'incidence d'événements indésirables et la détermination de facteurs associés à la survenue de ces événements, qui pourraient être différents de ceux habituellement observés dans le traitement du cancer de la prostate.
    E.2.2Secondary objectives of the trial
    SSRI group: incidence of adverse events and determination of associated factors
    Anti-androgen group: determination of factors associated with maintaining the efficacy of treatment

    Other Secondary Objectives: (see details in the protocol)
    Estimation of the relapse rate (deviant sexual behavior)
    Role of psychiatric comorbidity, personality disorders
    Treatment compliance
    Changes in the clinical and cognitive characteristics of sex offenders over time
    Role of life trajectories
    Research of genetic factors
    Groupe ISRS : incidence d'événements indésirables et la détermination de facteurs associés
    Groupe anti-androgène : détermination de facteurs associés au maintien de l'efficacité du traitement

    Autres Objectifs secondaires: (voir les détails dans le protocole)
    Estimation du taux de rechute (comportement sexuel déviant)
    Rôle de la comorbidité psychiatrique, des troubles de la personnalité
    Observance du traitement
    Modifications des caractéristiques cliniques et cognitives des délinquants sexuels au cours du temps
    Rôle des trajectoires de vie
    Recherche de facteurs génétiques
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.) Sexual offenders (sexual offense or assault including exhibitionism, rape, sexual touching, incest, possession of video material of a child pornography nature) (severity level 2 to 6 as recommended by the WFSBP)

    2.) Men with paraphilic disorders (DSM-5 criteria described in Chapter 4)

    3.) Receiving pharmacological treatments, either SSRI or antiandrogenic treatments. Levels 2-6 of severity of paraphilic disorders (DSM-5 criteria) will be included (see Chapter 2 for definition of 6 levels, WFSBP recommendations for pharmacological treatment of paraphilias). According to current recommendations, patients with level 2 and 3 severity should receive SSRIs and they above level 3 severity should receive antiandrogens, but the treatment decision is made by the psychiatrist in charge of the patient before the inclusion in this study (design of the naturalistic study).

    4.) Aged 18 to 65 years

    5.) Patients 100% covered by their medical cover for the treatment of their paraphilia
    1.) Délinquants sexuels (délit ou agression à caractère sexuel(le) incluant exhibitionnisme, viol, attouchement sexuel, inceste, détention de matériel vidéo à caractère pédopornographique) (niveau de gravité 2 à 6 selon les recommandations de la WFSBP)

    2.) Hommes souffrant de troubles paraphiles (critères DSM-5 décrits au chapitre 4)

    3.) Recevant des traitements pharmacologiques, soit ISRS soit traitements antiandrogènes. Les niveaux 2 à 6 de gravité des troubles paraphiles (DSM-5 critères) seront inclus (voir le chapitre 2 pour la définition des 6 niveaux, recommandations WFSBP de traitement pharmacologique des paraphilies). Selon les recommandations actuelles, les patients atteints de niveau 2 et 3 de gravité devraient recevoir les ISRS et eux au-dessus du niveau 3 de gravité devraient recevoir des antiandrogènes, mais la décision de traitement est prise par le psychiatre en charge du patient avant l'inclusion dans cette étude (conception de l'étude naturalistique).

    4.) Agés de 18 à 65 ans

    5.) Patients pris en charge à 100% par la sécurité sociale et leur mutuelle pour le traitement de leur paraphilie
    E.4Principal exclusion criteria
    1.) Subjects under the age of 18 or over 65
    2.) Subject in prison (whatever the reason)
    3.) Female subjects
    4.) Subjects under guardianship
    5.) Subjects who have committed a sexual offense and who do not meet the criteria for a paraphilic disorder (eg rape of a spouse or friend under the influence of alcohol)
    6.) No registration with the social security system
    7.) Refusal of consent
    8.) Subjects concomitantly receiving SSRIs and antiandrogens at baseline
    9.) Contraindications or allergies to the treatments used
    1.) Sujets âgés de moins de 18 ans ou de plus de 65 ans
    2.) Sujet en prison (quel qu'en soit le motif)
    3.) Sujets de sexe féminin
    4.) Sujets sous tutelle
    5.) Les sujets ayant commis une infraction sexuelle et qui ne répondent pas aux critères d'un trouble paraphilique (par exemple le viol sur un conjoint ou d'un amie sous l'emprise de l'alcool)
    6.) Aucune inscription au régime de la sécurité sociale
    7.) Refus de consentement
    8.) Les sujets recevant de façon concomitante des ISRS et des anti-androgènes à l'inclusion
    9.) Contre-indications ou allergies aux traitements utilisés
    E.5 End points
    E.5.1Primary end point(s)
    Main evaluation criterion
    SSRI group: maintenance of treatment effectiveness: intensity of sexual desire and scale of measurement of symptoms of deviant sexual behavior (self-assessment) measured every 3 months;
    Anti-androgen group: incidence of adverse events: report of adverse events (CTC), biological parameters and other measures such as depression and suicidal intentionality as well as bone mineralization

    Secondary evaluation criteria
    SSRI Group: Incidence of Adverse Events: Report of Any Adverse Events (CTCs)
    Anti-androgen group: maintenance of treatment effectiveness: intensity of sexual desire and scale of measurement of symptoms of deviant sexual behavior (self-evaluation) measured every 3 months

    Other evaluation criteria: See protocol
    Critère d'évaluation principal
    Groupe ISRS : maintien de l'efficacité du traitement: intensité du désir sexuel et échelle de mesure des symptômes de comportement sexuel déviant (auto-évaluation) mesurés tous les 3 mois ;
    Groupe anti-androgènes : incidence d'événements indésirables : rapport de tout événement indésirable (CTC), des paramètres biologiques et d'autres mesures telles que la dépression et l'intentionnalité suicidaire ainsi que la minéralisation osseuse

    Critères d'évaluation secondaires
    Groupe ISRS : incidence d'événements indésirable : rapport de tout événement indésirable (CTC)
    Groupe anti-androgène : maintien de l'efficacité du traitement : intensité du désir sexuel et échelle de mesure des symptômes de comportement sexuel déviant (auto-évaluation) mesurés tous les 3 mois

    Autres critères d'évaluation: Voir protocole
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 years
    3 ans
    E.5.2Secondary end point(s)
    Secondary evaluation criteria
    SSRI Group: Incidence of Adverse Events: Report of Any Adverse Events (CTCs)
    Anti-androgen group: maintenance of treatment effectiveness: intensity of sexual desire and scale of measurement of symptoms of deviant sexual behavior (self-evaluation) measured every 3 months
    Critères d'évaluation secondaires
    Groupe ISRS : incidence d'événements indésirable : rapport de tout événement indésirable (CTC)
    Groupe anti-androgène : maintien de l'efficacité du traitement : intensité du désir sexuel et échelle de mesure des symptômes de comportement sexuel déviant (auto-évaluation) mesurés tous les 3 mois
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 years
    3 ans
    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 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 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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 Yes
    E.8.1.7.1Other trial design description
    cohorte
    cohort
    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.8.3 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
    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 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: 200
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    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 state200
    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)
    Usual management of patients (not modified by research).
    Prise en charge habituelle des patients (non modifiées par la recherche).
    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 Decision2018-03-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-06
    P. End of Trial
    P.End of Trial StatusOngoing
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