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    Summary
    EudraCT Number:2021-000312-36
    Sponsor's Protocol Code Number:PTSD-FMS
    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:2021-03-24
    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 number2021-000312-36
    A.3Full title of the trial
    Impact of Post-Traumatic Stress Disorder Treatment by Reconsolidation Therapy on Fibromyalgia Syndrome
    Impact de la prise en charge du Trouble de Stress Post-Traumatique par Blocage de la Reconsolidation sur le Syndrome Fibromyalgique
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact of Post-Traumatic Stress Disorder Treatment by Reconsolidation Therapy on Fibromyalgia Syndrome
    Impact de la prise en charge du Trouble de Stress Post-Traumatique par Blocage de la Reconsolidation sur le Syndrome Fibromyalgique
    A.3.2Name or abbreviated title of the trial where available
    PTSD-FMS
    A.4.1Sponsor's protocol code numberPTSD-FMS
    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 SponsorHenri Laborit 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 supportHenri Laborit Hospital
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHenri Laborit Hospital
    B.5.2Functional name of contact pointHenri Laborit Hospital
    B.5.3 Address:
    B.5.3.1Street Address370 avenue Jacques Coeur
    B.5.3.2Town/ cityPoitiers
    B.5.3.4CountryFrance
    B.5.6E-maildirection.generale@ch-poitiers.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 Avlocardyl
    D.2.1.1.2Name of the Marketing Authorisation holderASTRAZENECA
    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 nameAvlocardyl
    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
    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 and fibromyalgia syndrome
    Etat de stress post-traumatique et syndrome fibromyalgique
    E.1.1.1Medical condition in easily understood language
    Post-Traumatic Stress Disorder and fibromyalgia syndrome
    Etat de stress post-traumatique et syndrome fibromyalgique
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10057246
    E.1.2Term Prolonged post-traumatic stress disorder
    E.1.2System Organ Class 100000004873
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10016631
    E.1.2Term Fibromyalgia syndrome
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Significant improvement in quality of life specific to patients with fibromyalgia syndrome in patients with fibromyalgia syndrome with comorbid posttraumatic stress disorder, treated with reconsolidation therapy.
    Amélioration significative de la qualité de vie spécifique aux patients avec syndrome fibromyalgique chez les patients ayant un syndrome fibromyalgique présentant un trouble de stress post-traumatique comorbide, traités par thérapie par blocage de la reconsolidation.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to show after treatment by reconsolidation therapy in patients with fibromyalgia syndrom and comorbid post-traumatic stress disorder a :

    1- Significant decrease of post-traumatic stress disorder symptoms.
    2- Significant decrease in fibromyalgia pain
    3- Decrease in expanse of painful areas
    4- Detection of associated psychiatric comorbidities
    5- Decrease in the severity of depressive symptoms
    6- Improvement of self esteem
    7- Improvement of psychological and somatic quality of live
    8- Improvement of the patient’s overall clinical condition
    Les objectifs secondaires sont de montrer, après traitement par une thérapie par blocage de la reconsolidation chez les patients ayant un syndrome fibromyalgique et présentant un trouble de stress post-traumatique comorbide, une :

    1- Diminution significative des symptômes de trouble de stress post-traumatique chez les patients ayant un syndrome fibromyalgique présentant un trouble de stress post-traumatique comorbide, traités par thérapie par blocage de la reconsolidation.
    2- Diminution significative de la douleur fibromyalgique.
    3- Diminution de l’étendue des zones douloureuses.
    4- Dépistage des comorbidités psychiatriques associées.
    5- Diminution de la sévérité de la symptomatologie dépressive.
    6- Amélioration de l’estime de soi.
    7- Amélioration de la qualité de vie psychologique et somatique.
    8- Amélioration de l’état clinique globale du patient.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult over 18 years old
    - Diagnosis of fibromyalgia syndrome according to ACR 2016 criteria
    - PCL-5 > 44 suggesting the presence of a comorbid post-traumatic stress disorder
    - Meet the DSM-5 criteria for post-traumatic stress disorder secondary to exposure to a traumatic event according to DSM-5 criteria, both unique or repeated and regardless of the date or location of the traumatic event.
    - Pain relief treatment and/or psychotropic treatment stabilized for a period greater than or equal to two months.
    - Signature of a consent form
    - Patient able to understand and read french
    - Adultes âgés de plus de 18 ans.
    - Diagnostic de syndrome fibromyalgique selon les critères ACR 2016.
    - PCL-5 > 44 suggérant la présence d’un TSPT comorbide.
    - Répondre aux critères DSM-5 de Trouble de Stress Post-Traumatique secondaire à l’exposition à un évènement traumatique selon les critères du DSM-5, aussi bien unique que répété et quelle que soit la date ou l’endroit de l’évènement traumatique en question.
    - Traitement antidouleur et/ou psychotrope stabilisé depuis une période supérieure ou égale à deux mois.
    - Signature du formulaire de consentement.
    - Patient sachant comprendre et lire le français.
    E.4Principal exclusion criteria
    - Psychotic disorders
    - Unstable bipolar disorder
    - Patients with a systolic blood pressure < 100 mmHg or heart rate < 55 as established during the initial visit
    - Significant anormal ECG
    - Medical contraindication to taking propranolol
    - Adverse reactions or previous intolerances to a beta blocker
    - Current intake of another beta blocker which can not be stopped during the protocol, regardeless the galenic.
    - Current intake of a drug with potential contraindication with the propranolol, according to the summary of product characteristics of the propranolol.
    - Patient under legal protection, under guardianship or under curatorship
    - Patient having suffered a head trauma for less than a year or with clinical symptoms and neurological sequelae
    - Known severe suicide risk (MINI-S and medical exam)
    - Current opioid addiction or alcohol dependence
    - Patients treated for less than 2 months with antidepressants or painkillers
    - Patients unafiliated to a social health care
    - Woman who is pregnant or breast-feeding or whithout efficient contraception
    - Troubles psychotique.
    - Troubles bipolaire non stabilisés.
    - Patients présentant une tension artérielle systolique <100 mm Hg ou une fréquence cardiaque < 55 tel qu’établi lors de la visite initiale.
    - ECG significativement anormal
    - Contre-indication médicale à la prise de propranolol :
    - Effets indésirables ou intolérances antérieures à un bêtabloquant :
    - Prise actuelle d’un autre bêtabloquant ne pouvant être arrêté le temps du protocole, quelle que soit la galénique.
    - Prise actuelle d’un médicament présentant une interaction médicamenteuse potentielle avec le propranolol, en se référant au RCP du Propranolol en vigueur
    - Patient sous sauvegarde de justice, sous tutelle ou sous curatelle.
    - Patient ayant subi un traumatisme crânien depuis moins d’un an ou avec symptômes cliniques et porteur de séquelles neurologiques
    - Risque suicidaire sévère avéré (MINI-S et examen médical).
    - Toxicomanie aux opiacés ou dépendance alcoolique actuelles.
    - Patients traités depuis moins de 2 mois par antidépresseurs ou antidouleurs.
    - Patients non affiliés à un régime de sécurité sociale
    - Femme enceinte ou allaitante ou sans contraception efficace.
    E.5 End points
    E.5.1Primary end point(s)
    Modification in quality of life in patients with fibromyalgia syndrome measured by the Fibromyalgia Impact Measurement Questionnaire (FIQ).
    Modification de la qualité de vie chez les patients présentant un FMS mesurée par le Questionnaire de mesure d’Impact de la Fibromyalgie (FIQ).
    E.5.1.1Timepoint(s) of evaluation of this end point
    At day 0 (pre-treatment) and at 3 months (post-treatment).
    En pré-traitement (Jour 0) et en post-traitement (à 3 mois).
    E.5.2Secondary end point(s)
    1- Use of the french version of the Posttraumatic Stress Disorder Checklist–5 (PCL-5) for quantification of the PTSD severity. Difference between score at J0 and at M3 will be calculated and a decrease of 30% will be considered significant.
    2- Evolution of the average of pain score over the last 7 days on a visual analog scale.
    3- Evolution of the extent of pain mapping on a body diagram.
    4- Detection of associated psychiatric comorbidities by the l’International Neuropsychiatric Interview (MINI).
    5- Evolution of the severity of associated depressive symptomatology evaluated by the Montgomery and Asberg Depression Rating Scale (MADRS) and by the Beck Depression Inventory (BDI) questionnaire.
    6- Evolution of self esteem measured by the Rosenberg scale.
    7- Evolution of psychology and somatic quality of life evaluated by the SF-36 scale.
    8- Modification of the patient’s global clinical condition severity appreciated by the Clinical Global Impression (CGI) scale.
    1- Utilisation de la version française de la Posttraumatic Stress Disorder Checklist–5 (PCL-5) pour la quantification du score de sévérité du TSPT. Ce score sera mesuré en pré traitement (J0) et en post traitement (M3). La différence de score sera calculée et une diminution d’au moins 30% sera considérée comme significative.
    2- Evolution du score moyen de la douleur sur les 7 derniers jours sur une échelle visuelle analogique (EVA).
    3- Evolution de l’étendue de la cartographie des douleurs sur un schéma corporel.
    4- Dépistage des comorbidités psychiatriques associées par l’International Neuropsychiatric Interview (MINI).
    5- Evolution de la sévérité de la symptomatologie dépressives associée évaluée par l’hétéroquestionnaire Montgomery and Asberg Depression Rating Scale (MADRS) et l’auto-questionnaire Beck Depression Inventory (BDI).
    6- Evolution de l’estime de soi mesurée par l’Echelle d’estime de soi de Rosenberg.
    7- Evolution de la qualité de vie psychologie et somatique évaluée par l’échelle SF-36.
    8- Modification de la gravité de l’état clinique global du patient appréciée par la Clinical Global Impression (CGI).
    E.5.2.1Timepoint(s) of evaluation of this end point
    At day 0 (pre-treatment) and at 3 months (post-treatment).
    En pré-traitement (Jour 0) et en post-traitement (à 3 mois).
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 No
    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 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 concerned2
    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
    The end of the study is defined as the last visit of the last subject undergoing the trial.
    La fin de l'étude est définie par la dernière visite du dernier patient suivi dans l'étude.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state25
    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 Decision2021-05-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-11
    P. End of Trial
    P.End of Trial StatusCompleted
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