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    Summary
    EudraCT Number:2020-005742-42
    Sponsor's Protocol Code Number:SCALA
    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:2021-06-10
    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 number2020-005742-42
    A.3Full title of the trial
    Effect of botulinum toxin on hamstring contracture and the occurrence of cyclops syndrome after anterior cruciate ligament reconstruction
    Effet de la toxine botulique sur la contracture des ischio-jambiers et la survenue d’un syndrome du cyclope post reconstruction du ligament croisé antérieur
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Cyclops syndrome after anterior cruciate ligament reconstruction
    Syndrome du Cyclope après reconstruction du ligament croisé antérieur
    A.4.1Sponsor's protocol code numberSCALA
    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 SponsorGroupement de Coopération Sanitaire Ramsay Générale de Santé pour l’Enseignement et la Recherche
    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 supportGroupement de Coopération Sanitaire Ramsay Générale de Santé pour l'Enseignement et la Recherche
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVIVACTIS M2RESEARCH
    B.5.2Functional name of contact pointSAHBANE
    B.5.3 Address:
    B.5.3.1Street Address114 AVENUE Charles de Gaulle
    B.5.3.2Town/ cityNeuilly sur Seine
    B.5.3.3Post code92200
    B.5.3.4CountryFrance
    B.5.4Telephone number330170922454
    B.5.5Fax number330146678410
    B.5.6E-mails.sahbane@vivactis-m2research.com
    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.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A
    D.3.9.3Other descriptive nameCLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD), FREE OF COMPLEXING PROTEINS
    D.3.9.4EV Substance CodeSUB26174
    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 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 injection
    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
    Cyclops syndrome
    Syndrome du Cyclope
    E.1.1.1Medical condition in easily understood language
    Loss of extension after reconstruction of the anterior cruciate ligament (ACL) of the knee
    Perte de l'extension après reconstruction du ligament croisé antérieur (LCA) du genou
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10058029
    E.1.2Term Arthrofibrosis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue 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 benefit of an injection of botulinum toxin into the muscle body of the semitendinosus on the reduction of contracture of the hamstrings after ACL ligamentoplasty
    Evaluer le bénéfice d’une injection de toxine botulique dans le corps musculaire du demi-tendineux sur la réduction de la contracture des ischio jambiers post ligamentoplastie du LCA.
    E.2.2Secondary objectives of the trial
    To assess the benefit of botulinum toxin injection on the incidence of post ligamentoplasty cyclops syndrome.
    To assess the impact of the treatment on muscle recovery of the hamstring.
    To evaluate the tolerance of the treatment.
    Evaluer le bénéfice de l’injection de toxine botulique sur l’incidence du syndrome du cyclope post ligamentoplastie.
    Evaluer l’impact du traitement sur la récupération musculaire des ischio jambiers.
    Evaluer la tolérance du traitement.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient over 18 years of age
    - Patient who has read and signed the informed consent form for participation in the study
    - Patient operated on for primary ACL ligamentoplasty with or without meniscal repair
    - Patient with reducible flatus >10° at 1 month post ligamentoplasty
    • Patient âgé de plus de 18 ans
    • Patient ayant lu et signé le formulaire de consentement éclairé pour sa participation à l’étude
    • Patient opéré d'une ligamentoplastie du LCA primaire avec ou sans réparation méniscale
    • Patient présentant un flessum réductible >10° à 1 mois post ligamentoplastie
    E.4Principal exclusion criteria
    - Revision of ligamentoplasty
    - Multi-ligament knee
    - Patient under court protection, guardianship or trusteeship
    - Patient not affiliated to the French social security system
    - Patient participating in another therapeutic protocol
    - Pregnant woman or woman of childbearing age without effective contraception
    - Patient unable to understand the informed information and/or to give written informed consent: dementia, psychosis, disturbed consciousness, non-French speaking patient
    - Patient with known hypersensitivity to botulinum toxin
    - Patient with peripheral neuromuscular dysfunction or pronounced atrophy of the semitendinosus muscle
    - Patient treated with anticoagulants, chloroquine (or hydroxychloroquine)
    - Patient treated in the previous seven days with antibiotics or muscle relaxants (such as tubocurarine)
    • Reprise de ligamentoplastie
    • Genou multi ligamentaire
    • Patient sous sauvegarde de justice, sous tutelle ou sous curatelle
    • Patient non affilié au régime français de la sécurité sociale
    • Patient participant à un autre protocole thérapeutique
    • Femme enceinte ou femme en âge de procréer sans moyen de contraception efficace
    • Patient dans l’incapacité de comprendre les informations éclairées et/ou de donner son consentement éclairé écrit : démence, psychose, troubles de la conscience, patient non francophone
    • Patient présentant une hypersensibilité connue à la toxine botulique
    • Patient présentant un dysfonctionnement neuromusculaire périphérique ou une atrophie prononcée du muscle demi tendineux
    • Patient traité par anticoagulants, par chloroquine (ou hydroxychloroquine)
    • Patient traité au cours des sept jours précédents par antibiothérapie, ou par relaxants musculaires (de type tubocurarine)
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation of the effectiveness of the treatment is based on the assessment of knee mobility at Month 2 post-botulinum toxin injection (i.e. 3 months after the ligamentoplasty).
    Therapeutic success is defined by the absence of extension defects at this assessment.
    L’évaluation de l’efficacité du traitement est basée sur l’évaluation de la mobilité du genou à M2 post injection de toxine botulique (soit 3 mois après la ligamentoplastie).
    Le succès thérapeutique est défini par l’absence de défaut d’extension lors de cette évaluation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Total number of evaluations: 3
    Inclusion D0; month 2; month 5
    Nombre total d'évaluations: 3
    Inclusion J0; mois 2; mois 5
    E.5.2Secondary end point(s)
    Cyclops syndrome should be systematically investigated in patients with a six-month extension defect. Its diagnosis is based on MRI data (nodular lesion, anterior to the graft, hypointense or intermediate signal on T1 and T2 weighted sequences).

    Iso-kinetics is a technique that allows an objective, reliable and reproducible assessment of muscle strength.
    The speed of movement of the joint is constant throughout the movement and the resistance exerted by the machine is self-adapted to the force that the patient is capable of developing in order to avoid muscle injuries.
    Using this data, the machine calculates the peak torque, i.e. the maximum power of the muscle group tested according to the relationship Power = Force*Speed; and the total work corresponding to all the force put into play over the entire iso kinetic session.

    The tolerance of the test treatment will be assessed by collecting the adverse events that occurred during the study.
    Un syndrome du cyclope sera systématiquement recherché chez les patients présentant à six mois un défaut d’extension. Son diagnostic repose sur les données d’IRM (lésion nodulaire, antérieure à la greffe hypo intense ou de signal intermédiaire sur les séquences pondérées en T1 et T2).

    L’iso-cinétisme est une technique qui permet de réaliser une évaluation objective, fiable et reproductible de la force musculaire.
    La vitesse de déplacement de l’articulation s’effectue à vitesse constante pendant tout le mouvement et la résistance exercée par la machine est auto-adaptée à la force que le patient est capable de développer afin d’éviter les blessures musculaires.
    Grâce à ces données, la machine calcule le pic de couple, soit la puissance maximale du groupe musculaire testé selon la relation Puissance = Force*Vitesse; et le travail total correspondant à l’ensemble de la force mis en jeu sur toute la séance iso-cinétique.

    La tolérance du traitement à l’essai sera évaluée par le recueil des événements indésirables survenus pendant la durée de l’étude.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Total number of evaluations: 3
    Inclusion D0; month 2; month 5
    Nombre total d'évaluations: 3
    Inclusion J0; mois 2; mois 5
    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) 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) 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
    LVLS
    Dernière visite du dernier patient
    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 months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    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: 118
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 118
    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 state118
    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 Decision2023-04-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-20
    P. End of Trial
    P.End of Trial StatusOngoing
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