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    Summary
    EudraCT Number:2021-003315-25
    Sponsor's Protocol Code Number:APHP210416
    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:2022-01-18
    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 number2021-003315-25
    A.3Full title of the trial
    Botulinum toxin and degenerative rotator cuff tendinopathies: a randomized trial »DEROTOX (DEgenerative ROtator cuff disease and botulinum TOXin)
    Toxine botulique et tendinopathies dégénératives de la coiffe des rotateurs : un essai randomisé » DEROTOX (DEgenerative ROtator cuff disease and botulinum TOXin)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Botulinum toxin and degenerative rotator cuff tendinopathies: a randomized trial »DEROTOX (DEgenerative ROtator cuff disease and botulinum TOXin)
    Toxine botulique et tendinopathies dégénératives de la coiffe des rotateurs : un essai randomisé » DEROTOX (DEgenerative ROtator cuff disease and botulinum TOXin)
    A.3.2Name or abbreviated title of the trial where available
    DEROTOX
    DEROTOX
    A.4.1Sponsor's protocol code numberAPHP210416
    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 Sponsor
    B.1.3.4Country
    B.3.1 and B.3.2Status of the sponsor
    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
    B.Sponsor: 2
    B.1.1Name of SponsorASSISTANCE PUBLIQUE – HÔPITAUX DE PARIS - Direction de la Recherche Clinique et de l’Innovation
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsor
    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 XEOMIN 100 units powder for solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderMERZ Labroatory
    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 nameXEOMIN
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular 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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Degenerative tendinopathies of the rotator cuff
    Tendinopathies dégénératives de la coiffe des rotateurs
    E.1.1.1Medical condition in easily understood language
    Diseases of the tendons of the patella of the shoulder
    Maladies des tendons de la rotule de l'épaule
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10080130
    E.1.2Term Tendinopathy
    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
    The main objective of the study is to evaluate the efficacy of botulinum toxin in the treatment of degenerative tendinopathies of the rotator cuff of the shoulder, at 1 month, on the basis of the Shoulder Pain And Disability Index score ( SPADI) total.
    L’objectif principal de l’étude est d’évaluer l’efficacité de la toxine botulique dans le traitement des tendinopathies dégénératives de la coiffe des rotateurs de l’épaule, à 1 mois, sur la base du score Shoulder Pain And Disability Index (SPADI) total.
    E.2.2Secondary objectives of the trial
    The secondary objective of the study is to evaluate the efficacy of botulinum toxin in the treatment of degenerative tendinopathies of the rotator cuff of the shoulder, on the basis of the total SPADI score at 3 months, sub-scores SPADI pain and function at 3 months, overall improvement perceived at 1 month and 3 months, drug consumption over 3 months of follow-up, and acceptability of treatment at 1 month and 3 months.
    L’objectif secondaire de l’étude est d’évaluer l’efficacité de la toxine botulique dans le traitement des tendinopathies dégénératives de la coiffe des rotateurs de l’épaule, sur la base du score du SPADI total à 3 mois, des sous scores SPADI douleur et fonction à 3 mois, de l’amélioration globale perçue à 1 mois et 3 mois, de la consommation médicamenteuse sur les 3 mois de suivi, et de l’acceptabilité du traitement à 1 mois et 3 mois.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age> 40 years old
    • Duration of pain> 1 month
    • Pain intensity ≥ 40/100 on the visual analogue scale
    • SPADI score ≥ 30/100
    • Pain medication (s) unchanged within 30 days of enrollment
    • Pain with or without weakness during Jobe's maneuver (29)
    • Ultrasound within 30 days, showing tendinopathy of the supra-spinatus, with or without rupture
    • Affiliation to a social security scheme
    • Ability to give consent, complete the weekly notebook (collection of drug treatments taken against pain)
    • Availability for the visits provided for by the protocol
    • Age > 40 ans
    • Durée de la douleur > 1 mois
    • Intensité de la douleur ≥ 40/100 sur l'échelle visuelle analogique
    • Score de SPADI ≥ 30/100
    • Médicament(s) contre la douleur inchangé(s) dans les 30 jours avant l'enrôlement
    • Douleur avec ou sans faiblesse lors de la manœuvre de Jobe (29)
    • Echographie dans les 30 jours, montrant une tendinopathie du supra-spinatus, avec ou sans rupture
    • Affiliation à un régime de sécurité sociale
    • Capacité à donner son consentement, remplir le cahier hebdomadaire (recueil des traitements médicamenteux pris contre la douleur)
    • Disponibilité pour les visites prévues par le protocole
    E.4Principal exclusion criteria
    • Reduced passive range of motion
    • Glenohumeral instability
    • Tendon calcification
    • Ultrasound showing a concomitant rupture of the infra-spinatus or the subscapularis
    • Corticosteroid infiltration in the 30 days preceding the inclusion visit
    • Shoulder surgery
    • Humeral fracture, inflammatory rheumatism and neoplastic disease
    • Contraindication to XEOMIN® (hypersensitivity to XEOMIN® or to one of the excipients or to any other botulinum toxin product, generalized disorder of muscle activity, in the event of infection or inflammation at the injection site concerning)
    • Concomitant use of aminosides, ciclosporin, aminoquinolines
    • Skin infection at the intended injection site
    • Participation in another interventional research involving the human person (RIPH) during the 3 months of follow-up of the DEROTOX Research. Participation in another RIPH will be possible beyond these 3 months.
    • Pregnancy, breastfeeding
    • Injection of botulinum toxin in the last 6 months
    • Vulnerable people (under legal protection, guardianship or curatorship).
    • Amplitude de mouvement passive réduite
    • Instabilité gléno-humérale
    • Calcification tendineuse
    • Echographie montrant une rupture concomitante de l'infra-spinatus ou du sous-scapulaire
    • Infiltration de corticostéroïdes dans les 30 jours précédents la visite d’inclusion
    • Chirurgie de l’épaule
    • Fracture humérale, rhumatisme inflammatoire et affection néoplasique
    • Contre-indication à XEOMIN® (hypersensibilité à XEOMIN® ou à l’un des excipients ou à tout autre produit de toxine botulique, trouble généralisé de l’activité musculaire , en cas d’infection ou d’inflammation au site d’injection concerné)
    • L’usage concomitant d’aminosides, ciclosporine, aminoquinoléines
    • Infection cutanée au site d'injection prévu
    • Participation à une autre recherche interventionnelle impliquant la personne humaine (RIPH) pendant les 3 mois de suivi de la Recherche DEROTOX. La participation à une autre RIPH sera possible au-delà de ces 3 mois.
    • Grossesse, allaitement
    • Injection de la toxine botulique dans le 6 derniers mois
    • Personnes vulnérables (sous protection juridique, tutelle ou curatelle).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the total SPADI score at one month.
    The SPADI is a questionnaire made up of 13 items. The total SPADI includes a pain sub-score and a function sub-score making it possible to rate pain (question 1-5) and functional limitation (question 1-8) (17.4.1) from 0 to 100, where 100 corresponds to the impact on the most important.
    Le critère d’évaluation principal est le score du SPADI total, à un mois.
    Le SPADI est un questionnaire composé de 13 items. Le SPADI total comprend un sous score douleur et un sous score fonction permettant de coter la douleur (question 1-5) et la limitation fonctionnelle (question 1-8) (17.4.1) de 0 à 100, où 100 correspond au retentissement le plus important.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 months
    1 mois
    E.5.2Secondary end point(s)
    • The total SPADI score at 3 months,
    • The SPADI sub-scores (pain and functional limitation) at 3 months,
    • The overall improvement perceived by EVA (17.4.2) from 0 to 100 at 1 and at 3 months
    • Analgesic medication from a weekly logbook over the 3-month follow-up
    • The acceptability of VAS treatment from 0 to 100 at 1 and 3 months.
    • Le score du SPADI total à 3 mois,
    • Les sous scores SPADI (douleur et limitation fonctionnelle) à 3 mois,
    • L’amélioration globale perçue par EVA (17.4.2) de 0 à 100 à 1 et à 3 mois
    • La médication antalgique à partir d’un cahier de recueil hebdomadaire sur les 3 mois de suivi
    • L’acceptabilité du traitement par EVA de 0 à 100 à 1 et 3 mois.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 and 3 months
    1 et 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 No
    E.6.4Safety No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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) 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 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
    Last visit of the last patient after 3 months of follow-up.
    Dernière visite du dernier patient après 3 mois de suivi.
    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 months24
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 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 state60
    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)
    Patients will be referred to the treating rheumatologist for further treatment.
    Les patients seront orientés vers le rhumatologue traitant pour la suite de la prise en charge.
    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 Decision2021-10-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusOngoing
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