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    Summary
    EudraCT Number:2010-021691-28
    Sponsor's Protocol Code Number:DAMS-7
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-01-10
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2010-021691-28
    A.3Full title of the trial
    PILOT CLINICAL TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF BOTULINUM NEUROTOXIN TYPE- A IN SALIVARY GLANDS IN THE TREATMENT OF CHRONIC DROOLING IN PATIENTS WITH CEREBRAL PALSY: A CONTROLLED CLINICAL TRIAL
    ENSAYO CLÍNICO PILOTO PARA EVALUAR LA SEGURIDAD Y EFICACIA DE LA TOXINA BOTULÍNICA TIPO-A INFILTRADA EN GLÁNDULAS SALIVALES EN EL TRATAMIENTO DE LA SIALORREA CRÓNICA EN PACIENTES CON PARÁLISIS CEREBRAL:ENSAYO CLINICO CONTROLADO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    APPLICATION OF BOTULINUM TOXIN TYPE -A IN SALIVARY GLANDS AS A TREATMENT OF CHRONIC DROOLING IN PATIENTS WITH CEREBRAL PALSY. CLINICAL TRIAL.
    APLICACIÓN DE LA TOXINA BOTULINICA TIPO-A EN LAS GLÁNDULAS SALIVALES COMO TRATAMIENTO PARA EL BABEO CRÓNICO EN PACIENTES CON PARÁLISIS CEREBRAL
    A.4.1Sponsor's protocol code numberDAMS-7
    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 SponsorHospital Vall d'Hebron
    B.1.3.4CountrySpain
    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 supportInma Bori i Fortuny
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Vall d'Hebron
    B.5.2Functional name of contact pointMaira González
    B.5.3 Address:
    B.5.3.1Street AddressPaseo Vall D Hebron 119-129
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08035
    B.5.3.4CountrySpain
    B.5.4Telephone number93 489 40 00
    B.5.5Fax number93 489 4102
    B.5.6E-maildra_mairagl@me.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 BOTOX
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan Pharmaceuticals Ireland
    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 nameNEUROTOXINA BOTULINICA TIPO-A (Botox)
    D.3.4Pharmaceutical form Solution for injection/infusion
    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.3.8INN - Proposed INNToxina botulínica A
    D.3.9.1CAS number 93384-43-1
    D.3.9.2Current sponsor codeHUVH
    D.3.9.3Other descriptive nameNeurotoxina botulínica A
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hypersalivation (chronic sialorrhea)in patients with cerebral palsy
    Hipersecreción salival (sialorrea crónica). en pacientes con parálisis cerebral.
    E.1.1.1Medical condition in easily understood language
    Chronic drooling in patients with cerebral palsy.
    Babeo crónico en pacientes con parálisis cerebral.
    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 10039424
    E.1.2Term Salivary hypersecretion
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    EVALUATE THE SAFETY AND EFFICAY OF BOTULINUM TOXIN TYPE -A AS A TREATMENT FOR DECREASE DROOLING IN PATIENTS WITH CEREBRAL PASY AND DETERMINATE THE SALIVARY FLOW ML/MIN.
    EVALUAR LA SEGURIDAD Y EFICACIA DE LA TOXINA BOTULÍNICA TIPO-A INFILTRADA EN GLÁNDULAS SALIVALES EN EL TRATAMIENTO DE LA SIALORREA CRÓNICA EN PACIENTES CON PARÁLISIS CEREBRAL. DETERMINAR EL FLUJO SALIVAL ML/MIN
    E.2.2Secondary objectives of the trial
    ASSESS AT WHAT PERIOD OF TIME AFTER INFILTRATION OCCURS THE MAXIMUM RESPONSE OF BOTULINUM NEUROTOXIN TYPE-A IN DECREASED DROOLING.
    EVALUATE THE LONG-TERM EFFECTS OF BOTULINUM NEUROTOXIN TYPE-A IN SALIVARY GLANDS.
    ASSESS WHETER THE BOTULINUM TOXIN TYPE-A MAY REDUCE THE VOLUME OF DROOLING WITHOUT ALTERING THE SWALLOWING FUNCTION.
    EVALUAR EN QUE PERIODO POST-INFILTRACIÓN SE PRODUCE LA MÁXIMA RESPUESTA EN DISMINUIR EL BABEO.
    EVALUAR EL TIEMPO MEDIO DE DURACIÓN APLICADA EN LAS GLÁNDULAS SALIVALES.
    EVALUAR LA DISMINUCIÓN DEL VOLUMEN SALIVAL POST-INFILTRACIÓN SIN ALTERAR LA FUNCIÓN DE LA DEGLUCIÓN.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Chronic sialorrhea,score of > on drooling severity and frecuency scale.
    - Patients aged > 18 years.
    - Confirmed diagnosis of cerebral palsy.
    - Patients with disorders for eating, drinking, chronic irritation of the skin, pneumonia, social exclusion.
    - Informed consent from parents, caregivers or self patient.
    -Sialorrea Crónica, con un marcaje >3 en la valoración de la severidad y frecuencia de babeo.
    -Edad de los sujetos >18 años y < de 65.
    -Diagnóstico confirmado de parálisis cerebral.
    _Pacientes que presenten dificultades para comer, beber,irritación crónica de la piel,neumonías de repetición, baja autoestima que les impida la exclusión social.
    -consentimiento informado sobre participación de estudio.
    E.4Principal exclusion criteria
    Patients < 18 years.
    Swallowing disorders,dysphagia.
    -Diagnoses of Eaton-Lambert Syndrome. Amyothropic lateral Sclerosis or diseases that interfere with the function neuroglandular.
    -Presence of significant lung problems.
    - Pregnant or lactating period
    -Enrolment in another medical study or participation 30 days before.
    -Use of drugs that interfere with salival secretion.
    -Menores de 18 años
    -Presencia de disfagia por oclusión traumática,evaluación y determinación de alimentación oral.
    -Diagnóstico de miastenia gravis, síndrome de Eaton Lambert, esclerosis lateral aminotrófica o cualquier otra enfermedad que interfiera con la función neuromuscular o neuroglandular.
    -Pacientes embarazadas o lactantes.
    -Pacientes con profunda atrofía o excesiva debilidad de los músculos en el área donde se aplicará la inyección.
    - Participación recurrente en otro estudio clínico con medicación o participación 30 dias previos al comenzar el estudio clínico.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy Evaluate:
    Decrease of salivary flow expressed in ml/min before and after infiltration,will be considered the proportion of patients showing a decrease of 25% of salivary secretion.
    Safety Evaluate: The proportion of patients with a good response according to the criteria defined response during treatment or follow-up.
    Good response: If the patients register a proportion of adeverse events not more than usual due to underlying pathology.
    - Low/ non response.
    Register a high proportion of adverse events more than usual.
    Evaluación de la Eficacia: Es el descenso del flujo salival, expresado ml/min, antes y después de la infiltración se considerará la proporción de pacientes que manifiesten un descenso del 25% de secreción salival.
    Evaluación de la Seguridad.
    Buena respuesta:
    si se registra una proporción de aconecimientos adversos no superior a lo habitual debido a su patología de base.
    -Baja/ Nula respuesta:
    Aparición de acontecimientos adversos en un porcentaje superior a lo habitual debido a su patología de base
    E.5.1.1Timepoint(s) of evaluation of this end point
    Average time of evaluation every 4 weeks after first infiltration, allowed a washout period. The second infiltration evaluation every 4 weeks untill complete one year of follow-up.
    Tiempo medio de evaluación de cada variable cada 4 semanas después de la primera infiltración, ddejando un período de lavado. En la segunda infiltración la evaluación es cada cuatro semanas hasta completar un año de seguimiento.
    E.5.2Secondary end point(s)
    Salivary flow expressed in ml/min evaluated in different subtypes of cerebral palsy compared with healthy volunteers salivary flow.
    To assess wheter patients with cerebral palsy have hypersalivation or oral motor dysfunction.
    Assess wheter the Botulinum Toxin Type A reduce the volume of drooling without altering the swallowing function
    - Evaluar el flujo salival expresado en ml/min en los diferentes subtipos pacientes con parálisis cerebral, comparandolo con le flujo salival de los voluntarios sanos.
    - Evaluar si los pacientes con parálisis cerebral presentan hipersalivación o es debido a la disfunción motora oral.
    - Evaluar si la utilización de la toxina botulínica tipo-A reduce el volumen del babeo sin alterar la función de deglución.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Average time of evaluation every 4 weeks after first infiltration, allowed a washout period. The second infiltration evaluation every 4 weeks untill complete one year of follow-up.
    Tiempo medio de evaluación de cada variable cada 4 semanas después de la primera infiltración, ddejando un período de lavado. En la segunda infiltración la evaluación es cada cuatro semanas hasta completar un año de seguimiento.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 Yes
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    1 grupo control sin tratamiento
    one control group without treatment
    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
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    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 Yes
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Given that the trial be held in cerebral palsy patients the protocol provides the option of informed consent by the legal representative
    Teniendo en cuenta que el ensayo clínico se realizará en pacientes con parálisis cerebral el protocolo contempla la opción del consentimiento informado a través del representante legal
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    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)
    MONITORIZACIÓN DE LOS SUJETOS E INCLUSIÓN A TERAPIAS ALTERNATIVAS COMO ESTIMULACIÓN MOTORA ORAL POR MEDIO DE EJERCICIOS PARA ESTIMULACIÓN DE MUSCULATURA ORAL.
    MONITORIZACIÓN DE LOS SUJETOS E INCLUSIÓN A TERAPIAS ALTERNATIVAS COMO ESTIMULACIÓN MOTORA ORAL POR MEDIO DE EJERCICIOS PARA ESTIMULACIÓN DE MUSCULATURA ORAL.
    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 Decision2011-11-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-25
    P. End of Trial
    P.End of Trial StatusOngoing
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