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    Summary
    EudraCT Number:2021-000095-10
    Sponsor's Protocol Code Number:69HCL18_0235
    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:2021-06-23
    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 number2021-000095-10
    A.3Full title of the trial
    Evaluation of the long-term efficacy of the injection of botulinum toxin A into the salivary glands versus scopolamine patches in the treatment of drooling in children over 4 years old with cerebral palsy (TOXSIALO-TRIAL)
    Evaluation de l’efficacité à long terme de l’injection de toxine botulique A dans les glandes salivaires versus des patchs de scopolamine, pour le traitement de la sialorrhée chez les enfants paralysés cérébraux de plus de 4 ans
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the efficacy of the injection of botulinum toxin A vs scopolamine patches in the treatment of drooling in children with cerebral palsy
    A.3.2Name or abbreviated title of the trial where available
    TOXSIALO-TRIAL
    A.4.1Sponsor's protocol code number69HCL18_0235
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03616067
    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 SponsorHospices Civils de Lyon
    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 supportDirection Générale de l'Offre de soins
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospices Civils de Lyon
    B.5.2Functional name of contact pointGARANDEAU
    B.5.3 Address:
    B.5.3.1Street Address3 quai des Célestins
    B.5.3.2Town/ cityLYON
    B.5.3.3Post code69002
    B.5.3.4CountryFrance
    B.5.4Telephone number+330472406823
    B.5.5Fax number+330472115190
    B.5.6E-maildrci_promo@chu-lyon.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 Botulinum toxin
    D.2.1.1.2Name of the Marketing Authorisation holderBotox
    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 nameBotox
    D.3.2Product code Botulinum toxin
    D.3.4Pharmaceutical form Powder and solution for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPBuccal use
    Intraglandular use
    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 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.IMP: 2
    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 Scopolamine
    D.2.1.1.2Name of the Marketing Authorisation holderScopoderm
    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 nameScopolamine
    D.3.2Product code Scopoderm
    D.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    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 Yes
    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
    Children with cerebral palsy aged 4 years old and over, presenting a pathological drooling
    Enfants paralysés cérébraux âgés de 4 ans et plus, présentant une sialorrhée pathologique.
    E.1.1.1Medical condition in easily understood language
    Children with cerebral palsy aged 4 years old and over, presenting a pathological drooling
    Enfants paralysés cérébraux âgés de 4 ans et plus, présentant une sialorrhée pathologique.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10008129
    E.1.2Term Cerebral palsy
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic 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 assess the efficacy of Botox® injection in salivary glands compared to Scopoderm® use, on the degree and impact of drooling for children with cerebral palsy, after 15 months of treatment.
    Evaluer l’efficacité de l’injection de Botox® dans les glandes salivaires comparée à l’utilisation de Scopoderm® sur la sévérité des conséquences de la sialorrhée sur la qualité de vie des enfants paralysés cérébraux, après 15 mois de traitement.
    E.2.2Secondary objectives of the trial
    To assess the efficacy of Botox® injection in salivary glands compared to Scopoderm® use, on:
    • Degree and impact of drooling for children, after 1, 3, 6, 9 and 12 months of treatment.
    • Quantification of the drooling (quantity of saliva), after 1, 3, 6, 9, 12 and 15 months of treatment.
    • Clinical complications of the drooling, after 1, 3, 6, 9, 12 and 15 months of treatment.
    To assess the tolerance of both treatments during 15 months of treatment:
    • Description of the adverse events, theirs frequencies and theirs levels of severity
    • Quantification of the adverse events
    • Discontinuation of treatment due to adverse events
    To describe the rehabilitation procedures and treatments used for 15 months
    - Evaluer l’efficacité de l’injection de Botox® dans les glandes salivaires comparée à l’utilisation de Scopoderm® sur :
    • La sévérité des conséquences de la sialorrhée sur la qualité de vie des enfants après 1, 3, 6, 9 et 12 mois de traitement.
    • La quantification de la sialorrhée (quantité de salive) après 1, 3, 6, 9, 12 et 15 mois de traitement.
    • Les complications cliniques de la sialorrhée après 1, 3, 6, 9, 12 et 15 mois de traitement.
    - Evaluer et comparer la tolérance des deux traitements pendant les 15 mois de traitement :
    • Description des effets indésirables (EI) survenus, de leur fréquence et de leurs niveaux d’intensité
    • Quantification des effets indésirables (EI) survenus
    • Survenue d’effets indésirables (EI) ayant conduit à l’arrêt du traitement
    - Décrire les procédures de rééducation et les traitements utilisés pendant 15 mois
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Aged 4 to 17 years old,
    • Cerebral palsy (stable brain injury acquired before the age of 2 years), with disabling drooling,
    • Significant impact of drooling on the children (DIS score ≥40),
    • Affiliated or beneficiary of a social security scheme,
    • At least one of the parents understanding and speaking French,
    • Written consent form signed by both parents
    • Absence of known current pregnancy and breastfeeding
    • Patients des deux sexes âgés de 4 à 17 ans inclus
    • Patients paralysés cérébraux (lésion cérébrale stable (non évolutive/dégénérative) acquise avant l’âge de 2 ans) atteints de sialorrhée pathologique
    • Patients ayant des conséquences significatives de la sialorrhée sur la qualité de vie (DIS score >40)
    • Patients affiliés ou bénéficiaires d’un régime de sécurité sociale.
    • Au moins un des parents comprenant et s’exprimant en français
    • Consentement écrit signé par les 2 parents
    • Absence de grossesse et d’allaitement connus
    E.4Principal exclusion criteria
    • Previous history of surgery for drooling,
    • Injection of botulinum toxin (all locations) in the 3 months prior to the inclusion,
    • Treatment by scopolamine patch (Scopoderm®) or other anticholinergic (Artane®, etc.) in the month prior to inclusion,
    • Contraindication to the anesthetic or sedation,
    • Contraindication to one of the treatments studied (glaucoma, myasthenia, uretroprostatic disorders),
    • Injection site infection,
    • Swallowing disorder (to saliva) or absence of spontaneous swallowing reflex not investigated by nasoscopy
    • On-going or programmed orthodontic treatment over the study period.
    • Untreated dental inflammatory condition (dental caries, gingivitis…)
    • Patients ayant déjà eu une chirurgie pour sialorrhée.
    • Patient ayant reçu une injection de toxine (toute localisation) dans les 3 derniers mois précédant l’inclusion
    • Patients traités par patch de Scopoderm® ou autre anticholinergique (Artane…) dans le mois précédant l’inclusion
    • Patients ayant une contre-indication à l’anesthésie ou à la sédation
    • Patients ayant une contre - indication à l’un des traitements étudié (glaucome, myasténie, troubles urétroprostatiques)
    • Infection au site d'injection
    • Patients ayant un trouble de la déglutition ou avec absence de reflexe de déglutition spontané non validée par nasofibroscopie
    • Patients ayant un traitement orthodontique en cours ou programmé pendant l’étude
    • Patients avec des problèmes dentaires inflammatoires (carries dentaires, gingivites)
    E.5 End points
    E.5.1Primary end point(s)
    Score of the degree and impact of the drooling after 15 months of treatment, measured by the Drooling Impact Scale (DIS scale). We will compare the average differences of the DIS score in the 2 groups before and after 15 months of treatment.
    Score de sévérité des conséquences de la sialorrhée sur la qualité de vie après 15 mois de traitement, mesuré par l’échelle DIS « Drooling Impact Scale ». Nous comparerons les différences de moyenne des scores DIS dans les 2 groupes avant et après les 15 mois de traitement.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 15 months of treatment
    Après 15 mois de traitement
    E.5.2Secondary end point(s)
    To evaluate and compare the 2 treatments in terms of efficacy
    • Score of the degree and impact of the drooling, measured by the DIS scale at 1, 3, 6, 9 and 12 months of treatment (compared to the initial measurement at the initiation of treatment at M0).
    • Severity of the drooling (quantity of saliva), measured by the average number of bibs used per day per patient (counted over 7 days) at 1, 3, 6, 9, 12 and 15 months (compared to the initial measurement at treatment initiation at M0).
    • Clinical complications of the drooling, measured by the number of hospitalizations for pulmonary infections and the average number of prescriptions for antibiotic treatment linked to bronchial secondary infection at 1, 3, 6, 9, 12 and 15 months.

    To evaluate and compare the 2 treatments in terms of tolerance during 15 months
    • Description of the nature of the adverse events that have occurred (by symptom), as well as their frequency and their intensity, measured using the AE intensity scale (see § 7.1.5 safety) at each time point.
    • Quantification of the adverse events, measured by the proportion of patients with at least one adverse event and the average number of adverse events per patient at each time point.
    • Level of treatment discontinuation due to adverse effects, measured by the proportion of patients with at least one adverse event having led to a discontinuation of the treatment at each time point.

    To describe rehabilitation procedures and treatments used over 15 months
    • Description of the nature and the frequency of the rehabilitation procedures used at each time point.
    • Description of the therapeutic strategies used (dose modifications /reinjections and their justifications) at each time point.
    • Description of concomitant treatments used at each time point.
    - Evaluer et comparer les 2 traitements en termes d’efficacité :
    • Score de sévérité des conséquences de la sialorrhée sur la qualité de vie mesuré par l’échelle DIS, après 1, 3, 6, 9 et 12 mois de traitement (comparé à la mesure à l’initiation du traitement).
    • Sévérité de la sialorrhée (quantité de salive), mesurée par le nombre moyen de bavoirs utilisés par jour par patient (décompte sur 7 jours) à 1, 3, 6, 9, 12 et 15 mois (comparé à la mesure à l’initiation du traitement).
    • Les complications cliniques de la sialorrhée, mesurée par le nombre moyen d’hospitalisation pour infections pulmonaires et nombre moyen de prescriptions d’antibiothérapie en lien avec une surinfection bronchique à 1, 3, 6, 9, 12 et 15 mois.
    - Evaluer et comparer les 2 traitements en termes de tolérance pendant 15 mois :
    • Description de la nature des EI survenus (par symptôme), de leur fréquence et intensité, mesurées par l’échelle d’intensité à chaque point de mesure (à 1, 3, 6, 9, 12 et 15 mois).
    • Quantification des EI, mesurée par la proportion de patients avec au moins un EI et le nombre moyen d’EI par patient à chaque point de mesure.
    • Taux d’arrêt de traitement dudû à un EI, mesuré par la proportion de patients ayant eu au moins un EI ayant conduit un arrêt du traitement à chaque point de mesure.
    - Décrire les procédures de rééducation et les traitements utilisés pendant 15 mois :
    • Description de la nature et de la fréquence des procédures de rééducation réalisées à chaque point de mesure.
    • Description des stratégies thérapeutiques de la sialorrhée utilisées (modifications de dose/réinjection et leurs justifications) à chaque point de mesure.
    • Description des traitements concomitants utilisés à chaque point de mesure
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 1, 3, 6, 9, 12 and 15 months of treatment
    Après 1, 3, 6, 9, 12 et 15 mois de traitement
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 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 concerned13
    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 Yes
    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 years
    E.8.9.1In the Member State concerned months40
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months40
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 130
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 65
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 65
    F.1.2Adults (18-64 years) No
    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 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 state130
    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)
    Expected treatment following patients' condition.
    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 Decision2021-07-20
    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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