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    Summary
    EudraCT Number:2020-001878-29
    Sponsor's Protocol Code Number:35RC18_8852_PROPRADO
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2020-11-23
    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 number2020-001878-29
    A.3Full title of the trial
    The efficacy of traumatic memory modification using a memory reconsolidation procedure under propranolol among adolescents with post-traumatic stress disorder (PROPRADO)
    Impact d’une procédure de reconsolidation de la mémoire sous PROPRanolol sur la mémoire traumatique des ADOlescents atteints du syndrome de stress post-traumatique (PROPRADO)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact of a working method on traumatic memory under PROPRanolol in ADOlescents with post-traumatic stress syndrome (PROPRADO)
    Impact d’une méthode de travail sur la mémoire traumatique sous PROPRanolol chez des ADOlescents atteints du syndrome de stress post-traumatique (PROPRADO)
    A.3.2Name or abbreviated title of the trial where available
    PROPRADO
    PROPRADO
    A.4.1Sponsor's protocol code number35RC18_8852_PROPRADO
    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 SponsorRennes University Hospital
    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 supportHospital clinical research programme
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRennes University Hospital
    B.5.2Functional name of contact pointDRI
    B.5.3 Address:
    B.5.3.1Street Address2 avenue Henri Le Guilloux
    B.5.3.2Town/ cityRennes
    B.5.3.4CountryFrance
    B.5.5Fax number+33299283999
    B.5.6E-mailmarie-laure.gervais@chu-rennes.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 No
    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 namechlorhydrate de propranolol
    D.3.2Product code propranolol
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation Yes
    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.IMP: 2
    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 No
    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 namecellulose microcristalline
    D.3.2Product code placebo
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    post-traumatic stress disorder
    trouble du stress post-traumatique
    E.1.1.1Medical condition in easily understood language
    PTSD
    TPST
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10036316
    E.1.2Term Post-traumatic stress disorder
    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
    To evaluate the efficacy of propranolol in blocking the reconsolidation of traumatic memory in Post-Traumatic Stress Disorder (PTSD)
    Evaluer l’efficacité du propranolol dans le blocage de la reconsolidation de la mémoire traumatique au cours du TSPT.
    E.2.2Secondary objectives of the trial
    1) To establish the detailed symptom profile for the evolution of PTSD during treatment and short and long term after treatment;
    2) To evaluate efficacy on comorbid disorders;
    3) To evaluate tolerance to treatment
    1) Etablir le profil détaillé des symptômes d’évolution du TSPT durant le traitement et à court (1 semaine post-fin de traitement) et à long terme (6 mois et 1 an post-début de traitement).
    2) Evaluer l’efficacité du propranolol associé à la procédure de reconsolidation de la mémoire sur les comorbidités.
    3) Evaluer la tolérance au traitement.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adolescents aged 12 to 18 years;
    - Exposed to a single traumatic event or to events circumscribed in time;
    - Fluent in French ;
    - Positive diagnosis of PTSD (SCID-5)
    - Disorders evolving for at least three months;
    - Heart rate ≥ 55 bpm;
    - Systolic blood pressure ≥ 100 mmHg;
    - Written parental or legal guardian consent;
    - Written agreement by the adolescents;
    - Adolescents affiliated, via their parents, to the French social security body.
    - Adolescents âgés de 12 à 18 ans
    - Exposé à un évènement traumatique unique ou à plusieurs évènements circonscrits dans le temps
    - Parlant couramment le français
    - Diagnostic de TSPT positif au SCID DSM5
    - Symptômes évoluant depuis au moins 3 mois
    - Fréquence cardiaque ≥ 55 bpm
    - Pression artérielle systolique ≥ 100 mmHg;
    - Dont le/les titulaire(s) de l’autorité parentale ou le tuteur légal a/ont donné un consentement écrit et éclairé.
    - Ayant donné son consentement écrit et éclairé;
    - Affiliés, via leur tuteur légal, à un système de sécurité sociale.
    E.4Principal exclusion criteria
    - Medical condition contraindicating administration of propranolol, such as asthma, diabetes, arrhythmia or drugs interfering with the metabolism of propranolol;
    - Schizophrenia;
    - Mental retardation;
    - Autism spectrum disorder;
    - Acute suicidal ideation
    - Traumatic brain injury (loss of consciousness > 10 minutes);
    - Currently treated for substance or alcohol dependence;
    - Currently treated for Attention Deficit Hyperactivity Disorder;
    - Currently treated with a drug that can interfere with propranolol (according to the Summary of Product Characteristics);
    - Currently treated with a bradycardic drug;
    - Concurrent psychotropic medication - with the exception of cyamemazine and hydroxyzine;
    - Concurrent psychotherapy;
    - Pregnancy or breast feeding.
    - Concurrent participation to another interventional study
    - Contre-indications à l’administration de propranolol (asthme, diabète, arythmie ou toute drogue interférant avec le métabolisme du propranolol, selon les RCP)
    - Schizophrénie
    - Déficit mental
    - Trouble autistique
    - Risque suicidaire immédiat élevé
    - Traumatisme crânien avec atteinte cérébrale (dès perte de conscience > 10 minutes)
    - Traitement en cours contre toute dépendance à une drogue ou à l’alcool
    - Traitement en cours contre les troubles de l’attention et l’hyperactivité
    - Traitement bradycardisant en cours
    - Traitement concomitant avec un psychotrope, à l’exception de la cyamemazine et de l’hydroxyzine.
    - Psychothérapie concomitante
    - Enceinte ou allaitante.
    - Participation simultanée à une autre étude interventionnelle
    E.5 End points
    E.5.1Primary end point(s)
    Score on the PTSD Checklist for DSM-5 (PCL-5) one week after the end of treatment.
    Le critère de jugement principal est le score obtenu pour le PCL-5 une semaine après la fin du traitement par rapport à celui obtenu à l’inclusion.
    E.5.1.1Timepoint(s) of evaluation of this end point
    7 weeks
    7 semaines
    E.5.2Secondary end point(s)
    1) Symptomatic evolution of PTSD
    - PCL5 at inclusion visit, before each dispensation of treatment (once per week for 6 weeks), one week after the end of treatment, and 3, 6, 12 months after the beginning of treatment.
    - Functional impairment score (CPC- DSM5, Scheerringa) at the inclusion visit, before each dispensation of treatment (once per week for 6 weeks), one week after the end of treatment and 3, 6, 12 months after the beginning of treatment
    - Categorical diagnosis of PTSD (SCID 5 ) at inclusion visit, one week after the end of treatment, 6 months and 12 months after the beginning of treatment
    2) Evaluation of efficacy on comorbid disorders
    - CDI score at the inclusion visit, one week after the end of treatment, 6 months and 12 months after the beginning of treatment;
    - DES-A score at inclusion visit, one week after the end of treatment, 6 months and 12 months after the beginning of treatment;
    - Scores for Behavioral and Somatic Disorders and for School/social functioning (CBCL/YSR, parents/children) (Achenbach, 2001) at inclusion visit, one week after the end of treatment, 6 months and 12 months after the beginning of treatment;
    - Mini-Kid DSM4 part C score for suicidal risk at inclusion, 1 week after the end of treatment, 6 months and 12 months after the beginning of treatment
    - Spatial working memory test (Corsi Block) at inclusion visit, one week after the end of treatment, 6 months and 12 months after the beginning of treatment
    3) Evaluation of the tolerance to treatment at each dispensation of treatment (once per week for 6 weeks): Clinical evaluation (cardiac rate, blood pressure, general tolerance)
    1) Evolution des symptômes du TSPT via évaluation :
    - du score PCL-5 à la visite d’inclusion, avant chaque dispensation du traitement, à 1 semaine après la fin du traitement, à 3, 6 et 12 mois après le début du traitement.
    - du score CPC-DSM5 (Scheerringa) à la visite d’inclusion, avant chaque dispensation du traitement, à 1 semaine après la fin du traitement, à 3, 6 et 12 mois après le début du traitement.
    - de la catégorisation clinique du TSPT via l’utilisation du SCID-5, DSM5 à la visite d’inclusion, avant chaque dispensation du traitement, à 1 semaine après la fin du traitement, à 6 et 12 mois après le début du traitement

    2) Evaluation de l’efficacité sur les comorbidités via évaluation :
    - du score CDI à la visite d’inclusion, à 1 semaine après la fin du traitement, à 6 et 12 mois après le début du traitement
    - du score DES-A à la visite d’inclusion, à 1 semaine après la fin du traitement, à 6 et 12 mois après le début du traitement
    - du score MINI-KID DSMIV partie C à la visite d’inclusion, à 1 semaine après la fin du traitement, à 6 et 12 mois après le début du traitement
    - des scores CBCL/YSR à la visite d’inclusion, à 1 semaine après la fin du traitement, à 6 et 12 mois après le début du traitement
    - du score suite à l’épreuve de Corsi à la visite d’inclusion, à 1 semaine après la fin du traitement, à 6 et 12 mois après le début du traitement
    -du MINI Kid, évaluant de nombreux troubles psychiatriques à 1 semaine après la fin du traitement, à 6 et 12 mois après le début du traitement

    3) Évaluation de la tolérance au traitement à chaque dispensation du traitement.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) 12 months
    2) 12 months
    3) 7 weeks
    1) 12 mois
    2) 12 mois
    3) 7 semaines
    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 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 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 concerned11
    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 Yes
    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
    An independent Data and Safety Monitoring Board will be constituted at the beginning of the study with 5 members who are not involved in the study, including a cardiologist, a paediatrician, a psychiatrist, a pharmacologist, and a methodologist/statistician.
    No interim analysis is provided for in this protocol, but Data and Safety Monitoring Board will meet every six months and on request
    The IDSMB will evaluate the safety data and the risk-benefit ratio of the therapeutic strategy evaluated.
    Le Comité Indépendant de Surveillance a pour mission de suivre la sécurité des procédures à l’étude. Il se réunira au démarrage de l’étude puis tous les 6 mois et/ou sur demande. Il sera chargé d’éclairer le Conseil Scientifique dans ses décisions d’amendement ou d’interruption de l’essai. Il est constitué à l’initiation de l’étude et comprend 5 membres non impliqués directement dans l’essai, incluant un cardiologue, un pédiatre, un pharmacologiste et un méthodologiste/statisticien.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 74
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 74
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    minors
    mineurs
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state74
    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
    aucun
    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 Decision2021-05-21
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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