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    Summary
    EudraCT Number:2017-001709-33
    Sponsor's Protocol Code Number:P160926J
    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:2017-09-05
    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 number2017-001709-33
    A.3Full title of the trial
    Randomized, Double-blind, Placebo-controlled Trial on the Efficacy of the Botulinum Toxin for the Treatment of Lateral Epicondylitis
    Essai randomisé en double aveugle pour évaluer l’efficacité de la toxine botulique dans le traitement de l'épicondylite
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NA
    NA
    A.3.2Name or abbreviated title of the trial where available
    EPITOX
    A.4.1Sponsor's protocol code numberP160926J
    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-mailmireille.toy-miou@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 Yes
    D.2.1.1.1Trade name Xeomin
    D.2.1.1.2Name of the Marketing Authorisation holderMERZ PHARMACEUTICALS GMBH
    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 injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeurotoxine de Clostridium botulinum de type A, sans protéines complexantes
    D.3.9.3Other descriptive nameNeurotoxine de Clostridium botulinum de type A, sans protéines complexantes
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    D.2.1.1.1Trade name Hydrocortancyl
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-AVENTIS FRANCE
    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 nameHydrocortancyl
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAcétate de prednisolone
    D.3.9.3Other descriptive nameAcétate de prednisolone
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2,5
    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 placeboPowder for solution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients suffering from unilateral lateral epicondylitis, persistent for more than 3 months or recurrent and not having responded to at least one reference treatment
    Patients ayant une épicondylite latérale unilatérale, persistante depuis plus de 3 mois ou récidivante et n'ayant pas répondu à au moins un traitement de référence
    E.1.1.1Medical condition in easily understood language
    NA
    NA
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10014971
    E.1.2Term Epicondylitis
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that the intramuscular injection of botulinum toxin at paralytic doses coupled with a local injection of corticosteroids is more effective (i) than the injection of corticosteroids alone and (ii) than the injection of botulinum toxin alone, to reduce pain at 6 months, in patients with lateral epicondylitis.
    Démontrer que l'injection intramusculaire de toxine botulique à des doses paralysantes couplée à une injection locale de corticoïde est plus efficace (i) que l'injection de corticoïde seule et (ii) que l'injection de toxine seule pour réduire la douleur à 6 mois chez les patients atteints d'une épicondylite latérale.
    E.2.2Secondary objectives of the trial
    - To show an improvement in the quality of life for the patients and an early resumption of sporting or professional activity.
    - To evaluate the tolerance of the treatment by measuring the gripping force and collecting the adverse effects that may be encountered.
    - Montrer l'amélioration de la qualité de vie des patients et un effet positif sur le retour à l'activité professionnelle ou sportive ;
    - Évaluer la tolérance du traitement en mesurant la force de préhension et en recueillant les effets indésirables éventuellement rencontrés.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Males or females aged from 18 to 60 years;
    2) Whether or not having a professional activity;
    3) Whether or not having a motor disability;
    4) Unilateral lateral epicondylitis, persistent for more than 3 months, or recurrent and not having responded to at least one reference treatment: local injection of corticosteroids, physical therapy, rest, or NSAIDs;
    5) Signing of an informed consent form;
    6) Affiliation to a health insurance organism.
    1) Hommes et femmes âgés de 18 à 60 ans inclus ;
    2) En cours d'activité professionnelle ou non ;
    3) Présentant ou non un handicap moteur ;
    4) Épicondylite latérale unilatérale, persistante depuis plus de 3 mois ou récidivante et n'ayant pas répondu à au moins un traitement de référence : injection locale de corticoïde, physiothérapie, repos, ou prise per os d'AINS ;
    5) Signature d'un formulaire de consentement éclairé ;
    6) Affiliation à un régime d'Assurance-Maladie ou ayant-droit.
    E.4Principal exclusion criteria
    1) Central nervous system disorder, which is responsible for spasticity in the limb suffering from epicondylitis;
    2) History of severe psychiatric disorder;
    3) History of myasthenia gravis;
    4) Pregnant or nursing women;
    5) Inability to understand or to answer questions;
    6) Contra-indication to botulinum toxin or corticosteroids;
    7) Injection of botulinum toxin within 3 months prior to inclusion;
    8) Taking any anticoagulant drugs;
    9) Predictable difficulties of follow-up;
    10) Patient under guardianship or curatorship.
    1) Affection neurologique centrale responsable de spasticité sur le membre présentant l'épicondylite ;
    2) Antécédents psychiatriques graves ;
    3) Antécédents de myasthénie ;
    4) Femme enceinte ou allaitante ;
    5) Incapacité de comprendre ou de répondre aux questions posées ;
    6) Contre-indications à la toxine botulique ou aux corticoïdes ;
    7) Injection de toxine botulique dans les 3 mois précédant l'inclusion ;
    8) Prise d'anticoagulants ;
    9) Suivi anticipé comme difficile ;
    10) Patient privé de liberté ou sous protection juridique (tutelle ou curatelle).
    E.5 End points
    E.5.1Primary end point(s)
    Variation between the injection and 6 months after the injection, of the intensity of pain during the contraction of the extensor muscles of the wrist, measured by a VAS (Visual Analogue Scale).
    Variation entre l'injection et 6 mois après l'injection, de l'intensité de la douleur ressentie lors de la contraction contrariée des muscles extenseurs du poignet, mesurée par une EVA (échelle visuelle analogique).
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 mois
    E.5.2Secondary end point(s)
    - Intensity of pain (measured by VAS), before injection, at 3 months and at 6 months after injection:
    - spontaneous at rest;
    - during flexion of the wrist;
    - during palpation of the proximal insertion of the muscles responsible for epicondylitis.
    - Number of days off work within the 6 months after the injection, and the date of resumption of the professional or sporting activity;
    - Proportion of patients who resumed their professional or sporting activity at 6 months after the injection;
    - Gripping force, measured with a Jamar Hand Hydraulic Dynamometer, evaluated at inclusion and then at 3 months and 6 months after injection;
    - Functional repercussion of the epicondylitis: "Patient Rated Tennis Elbow Assessment Evaluation" questionnaire before injection, then at 3 months and 6 months after injection;
    - Hospital Anxiety and Depression scale;
    - Frequency and severity of the adverse effects.
    - Intensité de la douleur (mesurée par l'EVA), avant l'injection, à 3 mois et à 6 mois après l'injection :
    - spontanée au repos ;
    - lors de la flexion du poignet ;
    - lors de la palpation de l'insertion proximale des muscles responsables de l'épicondylite.
    - Nombre de jours d'arrêt de travail dans les 6 mois après l'injection et la date de reprise de l'activité professionnelle ou sportive ;
    - Proportion de patients ayant repris leur activité professionnelle ou sportive à 6 mois après l'injection ;
    - Force de préhension, mesurée à l'aide d'un dynamomètre hydraulique de main Jamar, évaluée à l'inclusion, puis à 3 mois et 6 mois après l'injection ;
    - Retentissement fonctionnel de l'épicondylite : Questionnaire Patient Rated Tennis Elbow Evaluation avant l'injection, puis à 3 mois et 6 mois après l'injection ;
    - Échelle anxiété-dépression : Hospital Anxiety and Depression scale ;
    - Fréquence et gravité des effets indésirables.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 months and 6 months
    3 mois et 6 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) 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 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 trial3
    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 concerned4
    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 years2
    E.8.9.1In the Member State concerned months6
    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: 150
    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 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 state150
    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
    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 Decision2017-10-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-27
    P. End of Trial
    P.End of Trial StatusCompleted
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