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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    The EU Clinical Trials Register currently displays   44363   clinical trials with a EudraCT protocol, of which   7387   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    Summary
    EudraCT Number:2006-006749-15
    Sponsor's Protocol Code Number:P-T-06
    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:2010-03-03
    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 number2006-006749-15
    A.3Full title of the trial
    NEUROIMAGEN MOLECULAR EN EL TEMBLOR ESENCIAL: ESTUDIO PET MULTITRAZADOR.
    A.3.2Name or abbreviated title of the trial where available
    PET-TEMBLOR ESENCIAL
    A.4.1Sponsor's protocol code numberP-T-06
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorInstitut de Recerca Hospital de Sant Pau
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    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 name[C11]-DASB
    D.3.2Product code [C11]-DASB
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravascular use (Noncurrent)
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product Yes
    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 Information not present in EudraCT
    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 No
    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 nameflumazenilo (N-metil[11C])
    D.3.2Product code flumazenilo (N-metil[11C])
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous 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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product Yes
    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 Information not present in EudraCT
    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
    Flumazenilo (N-metil[11C]): evaluacion de la densidad de receptores benzodiacepinicos del complejo GABA en el cerebro humano en condiciones normales y diversas patologias mediante imagenes de tomografia por emision de positrones (PET)
    (11C)-DASB: evaluacion de la densidad del transportador de serotonina en areas cerebrales corticales y subcorticales en condiciones normales y diversas patologias mediante imagenes de tomografia por emision de positrones (PET)
    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
    Determinar, mediante tomografia por emission de positrones con los trazadores 9C11)-DASB y flumazenilo (N-metil[11C]) la funcion cerebral de los sistemas serotoninergico y GABA en el temblor esencial.
    E.2.2Secondary objectives of the trial
    1. Desarrollar y poner a punto de las condiciones experimentales para la producción (síntesis, purificación, formulación, acondicionado y control de calidad) de dos radiotrazadores que incorporan Carbono-11, un radionúclido emisor de positrones:

    a) 3-amino-4-[[2-[([C11]-dimetilamino)metil]fenil]tio]benzonitrilo ([C11]-DASB), ligando de los transportadores de serotonina.
    b) Flumazenilo (N-metil[11C]), ligando de los receptores GABA-a.

    2. Estudio de la zona cerebral implicada en la génesis de temblor esencial.

    3. Estudiar la existencia de marcadores para el diagnóstico diferencial de pacientes con temblor postural: en concreto entre temblor esencial y temblor fisiológico exagerado y entre temblor orgánico y psicógeno.

    4. Analizar la correlación entre la intensidad del temblor y la neuroimagen molecular.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a) Pacientes
    1-Edad comprendida entre 21 y 65 años.
    2-Temblor postural crónico, monosintomático con afectación de las manos; con o sin
    historia familiar; con sintomatología continua como mínimo durante 1 año.
    3-No haber recibido ninguna medicación previa para el tratamiento del temblor esencial
    o haber suspendido la misma al menos durante 72 horas antes del estudio .
    4-En el caso de estar en tratamiento con fármacos gabaérgicos: ácido valproico, gabapentina,
    amogtrigina, tiagabina, o serotoninérgicos: IRSS: suspender el tratamiento al menos
    7 días antes de las exploraciones PET.
    5-Haber recibido información adecuada sobre las ventajas e inconvenientes del estudio
    con aceptación libre de participar en el estudio, y con consentimiento informado por
    escrito del voluntario y firmado .

    b) Grupo control
    1-Edad comprendida entre 21 y 65 años, ambos inclusive. Apareamiento por edad con el grupo de pacientes.
    2-Exploración neurológica normal. Específicamente, ausencia de temblor.
    3-Historia familiar de temblor esencial negativa.
    4-Haber recibido información adecuada sobre las ventajas e inconvenientes del estudio
    con aceptación libre de participar en el estudio, y con consentimiento informado por
    escrito del voluntario y firmado .
    E.4Principal exclusion criteria
    a) Pacientes y controles
    1-Consumo de alcohol superior a 80 gr/día.
    2-Hábito tabáquico.
    3-Encontrarse bajo tratamiento con psicofármacos o fármacos con posible efecto tremorígeno: ac.valproico, alfa o beta adrenérgicos, litio, cinaricina, flunaricina, etc.
    4-Claustrofobia
    5-Portador de marcapasos.
    6-Protesis metálicas.
    7-Válvulas cardíacas metálicas
    8-Clips vasculares
    9-Embarazo
    10-Mujeres en periodo de lactancia.
    11-Antecedentes o presencia de cualquier tipo de patología física o psiquiátrica que comprometa el estado general del paciente actualmente.
    12-Alteración de la función renal o hepática.
    13-Antecedentes patológicos de depresión mayor.
    14-Escala de Hamilton de depresión con puntuación > 18.
    15-Antecedentes familiares de primer grado de depresión mayor.
    16-Antecedentes de daño cerebral (traumatismo, neurocirugía, ictus, neoplasia).
    17-En mujeres premenopáusicas, el estudio PET se realizará en los primeros 10 días de la fase folicular del ciclo menstrual.
    18-No estar recibiendo tratamiento farmacológico que pueda interferir con los radiofármacos durante un mínimo de cinco semividas biológicas antes de la realización de la PET con (N-metil[11C])-flumazenilo y PET(11C)-DASB. En concreto psicofármacos con actividad gabaérgica (por ejemplo: gabapentina, pregabalina, tiagabina, benzodiazepinas...) o con actividad serotoninérgica (por ejemplo: inhidores selectivos de recaptación de la serotonina).
    19-Contraindicaciones de uso tanto de (N-metil[11C])-flumazenilo y de (11C)-DASB.
    20-Exposición a una dosis de radiación ionizante (incluyendo las dosis recibidas en este ensayo clínico) que exceda 10 mSv en los 365 días previos a cada uno de los estudios PET a que son sometidos los participantes.
    E.5 End points
    E.5.1Primary end point(s)
    El objetivo principal del estudio consiste en determinar la existencia de diferencias entre la distribucion de la retencion cerebral de los nuevos radiotrazadores entre controles sanos y pacientes diagnosticados de temblor esencial.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Information not present in EudraCT
    E.6.5Efficacy Information not present in EudraCT
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    healthy volunteers
    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 Information not present in EudraCT
    E.8.5The trial involves multiple Member States Information not present in EudraCT
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Information not present in EudraCT
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    Ulima visita del ultimo paciente incluido
    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
    E.8.9.2In all countries concerned by the trial years2
    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.1.3Elderly (>=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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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)
    Se continuara con el tratamiento y seguimiento estandarizado para cada una de las situaciones clinicas
    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 Decision2009-03-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-28
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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