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    The EU Clinical Trials Register currently displays   39602   clinical trials with a EudraCT protocol, of which   6490   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2010-022881-28
    Sponsor's Protocol Code Number:1014001
    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:2015-06-19
    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 number2010-022881-28
    A.3Full title of the trial
    Etude de l'influence sur la récupération motrice du traitement précoce de la spasticité après AVC : comparaison en double aveugle contre placebo Toxine Botulique A versus baclofène.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Etude de l'influence sur la récupération motrice du traitement précoce de la spasticité après AVC Toxine Botulique A versus baclofène.
    A.3.2Name or abbreviated title of the trial where available
    BacloTox
    A.4.1Sponsor's protocol code number1014001
    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 SponsorCHU Toulouse
    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 supportPHRC National 2010
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU Toulouse
    B.5.2Functional name of contact pointDelphine VERNET
    B.5.3 Address:
    B.5.3.1Street AddressDRMI, 2 rue Viguerie
    B.5.3.2Town/ cityToulouse
    B.5.3.3Post code31052
    B.5.3.4CountryFrance
    B.5.4Telephone number00330561777216
    B.5.5Fax number00330561778411
    B.5.6E-mailvernet.d@chu-toulouse.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 Xéomin
    D.2.1.1.2Name of the Marketing Authorisation holderMerz Pharmaceuticals GMBH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 namexéomin
    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 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 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 Baclofène Zentiva® 10 mg
    D.2.1.1.2Name of the Marketing Authorisation holdersnofi-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 namebacloféne
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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 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 placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Spasticité consécutive à un accident vasculaire cérébral
    E.1.1.1Medical condition in easily understood language
    contractures musculaires involontaires suite à un accident vasculaire cérébral
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparer l'effet sur la récupération motrice après un premier AVC responsable d'une spasticité, de deux traitements pharmacologiques de la spasticité : le baclofène en forme orale et l'injection intramusculaire de toxine botulique A.
    E.2.2Secondary objectives of the trial
    Plusieurs objectifs secondaires sont envisagés :
    - démontrer l'équivalence clinique en terme de récupération motrice au 3e mois entre le groupe toxine et le groupe double placebo
    - évaluer l'évolution du score moteur de Fugl-Meyer entre l'instauration du traitement et le 1e mois
    - comparer l'efficacité sur les symptômes spastiques des deux traitements
    - évaluer l'amélioration fonctionnelle consécutive à l'instauration précoce des deux traitements évaluée à l'inclusion et au 3e mois
    - juger de l'effet sur les douleurs et la qualité de vie de ces deux traitements de la spasticité
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -- homme ou femme entre 18 et 80 ans
    - premier AVC ischémique ou hémorragique responsable d’une hémiplégie.
    - compréhension suffisante pour participer à l’étude : score BDAE > 3.
    - AVC survenu depuis moins de 2 mois
    - une spasticité justifiant un traitement. Le score de Tardieu >1 (≥2) sur un des groupes musculaires suivant : triceps sural, fléchisseur du poignet, fléchisseur des doigts, fléchisseur du coude.
    - obtention du consentement du patient : si la signature du patient est physiquement impossible à recueillir du fait du déficit moteur, la personne de confiance désignée par le patient signera à sa place. Dès que le patient sera en capacité de le faire, il signera à son tour le document de consentement.
    - affilié à un régime de sécurité sociale ou équivalent
    E.4Principal exclusion criteria
    -- insuffisance rénale au moment de l’inclusion : clairance de la créatinine calculée par la formule de Cockroft inférieure à 60 ml/mn
    - prise d’un traitement anti-spastique au moment de l’inclusion dans l’étude : baclofène, dantrolène, tizanidine
    - antécédent d’injection de toxine botulique.
    - antécédent de lésion cérébrale traumatique ou vasculaire
    - grossesse.
    - antécédent de myasthénie, de syndrome de Lambert Eaton
    - antécédent de maladie neuromusculaire
    - chirurgie avec curare depuis moins d’1 mois
    - traitement par aminosides, aminoquinoléines ou cyclosporine
    - pathologie évolutive au moment de l’inclusion
    - antécédent de crise convulsive
    - prise d’un traitement anti-comitial
    - antécédent de psychose ou de traitement par neuroleptique
    - bilan biologique hépatique perturbé selon le jugement de l’investigateur
    - formule numération sanguine perturbée selon le jugement de l’investigateur
    - antécédent d’intolérance ou de réaction allergique au lactose
    - syndrome de malabsorption au glucose ou au galactose, déficit en lactase
    - antécédent de réaction anaphylactique
    - patient ne pouvant pas réaliser une rééducation quotidienne de 2 heures
    - tutelle, curatelle ou sauvegarde de justice
    - prise d’un traitement anticoagulant : héparine à la seringue électrique ou AVK à dose efficace.
    E.5 End points
    E.5.1Primary end point(s)
    Le critère de jugement principal est la progression du score de l'échelle Fugl-Meyer. C'est l'échelle la plus utilisée pour étudier la récupération motrice après AVC. La reproductibilité test-retest évaluée par la méthode des coefficients intra-classes est considérée comme excellente et la reproductibilité inter-observateur est tout aussi performante. Enfin, la consistance interne est aussi de bonne qualité.
    Ces qualités métrologiques ont fait de l'échelle Fugl-Meyer la référence dans le domaine de l'évaluation des déficiences motrices après AVC.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Ce critère est mesuré entre l'inclusion avant le 2e mois et l'évaluation 4 mois plus tard.
    E.5.2Secondary end point(s)
    - l'échelle de spasticité de Tardieu
    - l'échelle d'Ashworth, échelle de spasticité
    - la Rivermead Motor Assessment, échelle de performance motrice validée chez l'hémiplégique vasculaire
    - l'échelle de Barthel, échelle d'activité dans le domaine de l'autonomie dans les actes de la vie quotidienne
    - l'échelle de Rankin, échelle validée pour l'évaluation globale du handicap après AVC
    - recherche d'effets indésirables
    - mesure du temps de réaction
    - l'échelle visuelle analogique pour la satisfaction du traitement
    - le questionnaire RNLI (Reintegration for Normal Life) pour mesure de la qualité de vie
    E.5.2.1Timepoint(s) of evaluation of this end point
    Mesures à l'inclusion, à 1 mois et à 4 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) 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 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 Yes
    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 concerned17
    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
    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 months
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state300
    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 Decision2014-12-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-01
    P. End of Trial
    P.End of Trial StatusCompleted
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