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    Summary
    EudraCT Number:2010-023161-21
    Sponsor's Protocol Code Number:2010.607/11
    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:2011-09-06
    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 number2010-023161-21
    A.3Full title of the trial
    Evaluation de la toxine botulinique dans le traitement du trouble salivaire chez le patient atteint de sclérose latérale amyotrophique
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Sclérose Latérale Amyotrophique (SLA) – toxine botulinique A (Botox®)
    A.3.2Name or abbreviated title of the trial where available
    SLA-TOX
    A.4.1Sponsor's protocol code number2010.607/11
    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 supportAssociation Française contre les Myopathies
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportAssociation pour le Développement de la Neurogénétique
    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 pointPLATTNER valérie
    B.5.3 Address:
    B.5.3.1Street Address3 quai des Célestins
    B.5.3.2Town/ cityLyon cedex 02
    B.5.3.3Post code69229
    B.5.3.4CountryFrance
    B.5.4Telephone number472 115 213+33
    B.5.5Fax number472 115 190+33
    B.5.6E-mailvalerie.plattner@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 BOTOX 100 UNITES ALLERGAN (PR1)
    D.2.1.1.2Name of the Marketing Authorisation holderALLERGAN 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.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOther use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 93384-43-1
    D.3.9.3Other descriptive nameBOTULINUM TOXIN TYPE A
    D.3.9.4EV Substance CodeSUB13117MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U 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 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 placeboOther use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Sclérose Latérale Amyotrophique (SLA)
    E.1.1.1Medical condition in easily understood language
    Sclérose Latérale Amyotrophique (SLA)
    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 14.0
    E.1.2Level PT
    E.1.2Classification code 10002026
    E.1.2Term Amyotrophic lateral sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Démontrer une amélioration de la gêne fonctionnelle induite par le trouble salivaire évalué par une EVA gêne présentée au patient, 1 mois après l’injection de Botox
    E.2.2Secondary objectives of the trial
    - Démontrer une diminution de la quantité de salive et une amélioration de la gêne pour l’aidant principal 1 mois après l’injection de Botox.
    - Démontrer une amélioration du score du critère hypersalivation dans l’échelle ALSFRS-R, une diminution du score de sévérité et de fréquence du trouble salivaire (score DRS), une diminution du poids des rouleaux dentaires imbibées de salive, une modification de l’évaluation orthophonique, une diminution du nombre de mouchoirs en papier utilisés par jour et une amélioration de la qualité de vie du patient mesurée par l’échelle ALSAQ-40 (Cf 4.1 critères dévaluation).
    - Comparer le poids des rouleaux dentaires imbibés de salive et la gêne fonctionnelle mesurée par EVA pour évaluer sa place dans le suivi du trouble salivaire chez les patients avec une SLA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age > 18 ans
    - Obtention d’un consentement éclairé écrit après information
    - Diagnostic de SLA “ probable ” ou “ certaine ” selon les critères El Escorial de la “ World Fédération and Neurology Committee on Neuromuscular Diseases ”
    - Patient faisant l’objet d’un suivi dans un centre SLA
    - Trouble salivaire gênant avec une EVA gêne fonctionnelle > ou égale à 50/100 mm.
    - Patient bénéficiaire d’un régime de sécurité sociale.
    E.4Principal exclusion criteria
    - Maladie évolutive associée avec survie prévisible < 1 mois
    - Patient ayant auparavant reçu une injection de toxine botulinique au niveau des glandes salivaires
    - Mise en place récente (moins de 7 jours) d’un autre traitement médicamenteux pour le trouble salivaire (scopolamine, trihexyphénidyle, atropine, ipratropium, amitriptyline, clomipramine, oxybutinine, diphenhydramine, bêta-bloquants)
    - Patient ayant bénéficié d’une radiothérapie ou d’une chirurgie au niveau des glandes salivaires accessoires
    - Troubles du comportement, démence ou atteinte psychiatrique majeure
    - Myasthénie
    - Grossesse connue ou absence de contraception reconnue comme efficace, allaitement
    - Patients majeurs protégés par la loi.
    E.5 End points
    E.5.1Primary end point(s)
    Gêne fonctionnelle due au trouble salivaire mesurée sur l’Echelle Visuo-Analogique horizontale (EVA) (mesure de 0 à 100 mm).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 mois après l'injection de Botox
    E.5.2Secondary end point(s)
    - Mesure des échelles :
    ○ EVA horizontale « Quantité de salive »
    ○ EVA horizontale « Gêne » aidant principal
    - Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) : permet d’observer la variation du score de l’item hypersalivation
    - Drooling rating scale (DRS) : évaluation de la sévérité et de la fréquence du trouble salivaire
    - Pesée des rouleaux dentaires
    - Evaluation orthophonique
    - Nombre de mouchoirs en papier utilisés / jour
    - Echelle de qualité de vie
    - Tolérance
    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) 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 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
    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 months6
    E.8.9.1In the Member State concerned days
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 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 state90
    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 Decision2011-09-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-23
    P. End of Trial
    P.End of Trial StatusOngoing
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