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    Summary
    EudraCT Number:2017-002263-17
    Sponsor's Protocol Code Number:BRN-C-2017-01
    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:2018-01-16
    Trial results View 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 number2017-002263-17
    A.3Full title of the trial
    Efficacy and safety of Passiflora Compose in patients newly diagnosed with adjustment disorder with anxiety, as first-line treatment, compared to alprazolam
    Efficacité et tolérance de Passiflora composé dans l’anxiété réactionnelle récente, en première intention, en comparaison de l’alprazolam.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of the efficacy of a treatment for anxiety with Passiflore Compose (homeopathic treatment) and benzodiazepine, alprazolam (drug therapy).
    Comparaison de l'efficacité sur le traitement de l'anxiété de Passiflora composé (traitement homéopathique) sur une benzodiazépine, l'alprazolam (traitement médicamenteux) .
    A.3.2Name or abbreviated title of the trial where available
    PASSIANCE
    PASSIANCE
    A.4.1Sponsor's protocol code numberBRN-C-2017-01
    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 SponsorBOIRON
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBOIRON
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEURAXI PHARMA
    B.5.2Functional name of contact pointChargée d'Affaires Réglementaires
    B.5.3 Address:
    B.5.3.1Street Address10, rue Gutenberg - BP 80325
    B.5.3.2Town/ cityJOUE-LES-TOURS
    B.5.3.3Post code37303
    B.5.3.4CountryFrance
    B.5.6E-maile.llobetmerkling@euraxipharma.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 Passiflore Compose
    D.2.1.1.2Name of the Marketing Authorisation holderBOIRON
    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 namePassiflore compose
    D.3.4Pharmaceutical form Granules
    D.3.4.1Specific paediatric formulation No
    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 Yes
    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 Yes
    D.2.1.1.1Trade name Alprazolam Mylan 0,25 mg
    D.2.1.1.2Name of the Marketing Authorisation holderMylan
    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 namealprazolam mylan 0,25 mg
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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 placeboGranules
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Adjustment disorder with anxiety
    Anxiété réactionnelle récente
    E.1.1.1Medical condition in easily understood language
    Recent Anxiety
    Anxiété récente
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Psychological processes [F02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10002861
    E.1.2Term Anxiety disorders and symptoms
    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
    The main objective of the study is to demonstrate the non inferiority of PC in comparison to alprazolam in anxiety disorders after 4 weeks of treatment (efficacy objective).
    L’objectif principal de l’étude est de démontrer la non-infériorité de PC en comparaison de l’APZ dans le traitement de l’anxiété réactionnelle après 4 semaines de traitement (objectif d’efficacité).
    E.2.2Secondary objectives of the trial
    The secondary objectives are :
    - Efficacy :
    o To evaluate the rate of responders to the treatment for anxiety or in remission of anxiety ;
    o to evaluate the evolution of anxiety component during treatment ;
    o to evaluate the evolution of the sleep disorders during treatment ;
    - Safety :
    o to evaluate changing in prescription during the follow-up ;
    o to evaluate the concomitant use of medicine ;
    o to evaluate the safety drug ;
    o to evaluate the rebound effect after stopping drug ;
    - Others :
    o to evaluate the evolution of the functional capacity of the patient during treatment ;
    o to evaluate the general impression of the doctor and of the patient for symptoms and the evolution of symptoms ;
    o to evaluate the treatment compliance.
    Les objectifs secondaires sont de trois types :
    - Efficacité :
    o Évaluer le taux de patients répondeurs au traitement pour l’anxiété ou en rémission de l’anxiété ;
    o Évaluer l’évolution des composantes de l’anxiété au cours du traitement ;
    o Évaluer l’évolution des troubles du sommeil au cours du traitement ;
    - Sécurité :
    o Évaluer les changements de prescription au cours du suivi ;
    o Évaluer la consommation concomitante de médicaments ;
    o Évaluer la tolérance des traitements ;
    o Évaluer l’effet rebond à l’arrêt du traitement ;
    - Autres :
    o Évaluer l’évolution de la capacité fonctionnelle du patient au cours du traitement ;
    o Évaluer l’impression générale du médecin et du patient sur les symptômes et leur évolution ;
    o Évaluer l’observance au traitement.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥ 18 and ≤ 70 years ;
    - Patient having adjustment disorder with anxiety or trait anxiety ;
    - Hamilton score scale-anxiety (HAM-A) ≥ 18 at inclusion ;
    - Recent anxiety (inferior or equals to 3 months), with no pharmacological or psychological treatment ;
    - Disorders needing prescription of anxiolytic treatment with homeopathic medicine or benzodiazepine according to the doctor ;
    - Patient unable to understand informations about study , to read information sheet and accepting to sign the informed consent.
    - Âge ≥ 18 et ≤ 70 ans ;
    - Patient présentant un trouble de l’adaptation avec anxiété, ou anxiété réactionnelle ;
    - Score de Hamilton-anxiété (HAM-A) ≥ 18 à l’inclusion ;
    - Anxiété récente (inférieure ou égale à 3 mois), non prise en charge par un traitement pharmacologique ou psychologique ;
    - Trouble relevant selon le médecin de la prescription d’un traitement anxiolytique par traitement homéopathique ou par benzodiazépine ;
    - Patient capable de comprendre les informations liées à l’étude, de lire la notice d’information et acceptant de signer le formulaire de consentement.
    E.4Principal exclusion criteria
    - Patient with anxiety disorder other than adjustment disorder with anxiety, major depressive disorder or all other mental pathology ;
    - Anxiety related to bereavement ;
    - Anxiety felt more than 3 months ;
    - Patient treated for anxiety with psychtropic substances or with psychotherapy in the last 3 months ;
    - History of alcohol abuse or drug abuse ;
    - Pregnancy or lactation, woman of childbearing potential not using a medically acceptable, highly effective
    method of birth control ;
    - Known hypersensitivity to one of the components of the study or contra-indication to one of the treatments ;
    - Participation in another clinical study or at exclusion period for another clinical trial ;
    - Patient présentant un trouble anxieux d’autre nature, un syndrome dépressif majeur ou toute autre pathologie mentale ;
    - Anxiété liée à un deuil ;
    - Anxiété ressentie depuis plus de 3 mois ;
    - Patient traité par des psychotropes ou une psychothérapie pour son anxiété dans les 3 derniers mois ;
    - Dépendance à l’alcool ou aux drogues ;
    - Femme enceinte ou allaitante, femme en état de procréer non couverte par une méthode de contraception active ;
    - Intolérance ou allergie à l’un des composants des traitements à l’étude ou contre-indication à l’un des traitements ;
    - Patient participant à un autre essai clinique, ou en période d’exclusion d’un autre essai clinique
    E.5 End points
    E.5.1Primary end point(s)
    The main objective is to evaluate the non inferiority of PC compared to APZ with the HAM-A score at V2.
    L’objectif principal est de tester la non infériorité de PC versus APZ sur le score HAM-A à V2.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 4 weeks
    A 4 semaines
    E.5.2Secondary end point(s)
    The secondary efficacy analysis are :
    o the rates of responders to the teatment and the rates of remission in anxiety
    o the evolutions of the total anxiety score and of the components during treatment
    o the evolution of the quality of sleep between V0 and V2
    Les analyses secondaires d’efficacité sont les suivantes :
    o Les taux de répondeurs au traitement et de rémission pour l’anxiété
    o Les évolutions du score total de l’anxiété et de ses composantes au cours du traitement
    o L’évolution de la qualité du sommeil entre V0 et V2

    E.5.2.1Timepoint(s) of evaluation of this end point
    At 4 weeks
    A 4 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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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) Yes
    E.8.2.2Placebo No
    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
    LVLP
    Dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    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: 270
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state282
    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 Decision2017-11-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-06-27
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