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    The EU Clinical Trials Register currently displays   42732   clinical trials with a EudraCT protocol, of which   7035   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-000868-17
    Sponsor's Protocol Code Number:DEXPROPAR
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-03-17
    Trial results View 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 number2014-000868-17
    A.3Full title of the trial
    Effect of dexmedetomidine vs propofol on basal ganglia activity (local field potentials) recorded through implanted stimulators
    Efecto de dexmedetomidina vs propofol en el registro de la actividad cerebral profunda (potenciales de campo) medida a través de estimulador implantado
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of dexmedetomidine vs propofol on basal ganglia activity (local field potentials) recorded through implanted stimulators
    Efecto de dexmedetomidina vs propofol en el registro de la actividad cerebral profunda (potenciales de campo) medida a través de estimulador implantado
    A.4.1Sponsor's protocol code numberDEXPROPAR
    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 SponsorClínica Universidad de Navarra/Universidad de Navarra
    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 supportOrion Corporation
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinica Universidad de Navarra
    B.5.2Functional name of contact pointUCICEC
    B.5.3 Address:
    B.5.3.1Street AddressAvda. Pío XII, 36
    B.5.3.2Town/ cityPamplona
    B.5.3.3Post code31008
    B.5.3.4CountrySpain
    B.5.4Telephone number34948255 4001144
    B.5.5Fax number34948296 667
    B.5.6E-mailucicec@unav.es
    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 Dexdor
    D.2.1.1.2Name of the Marketing Authorisation holderOrion Corporation
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameDexdor
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDEXMEDETOMIDINE
    D.3.9.1CAS number 113775-47-6
    D.3.9.3Other descriptive nameDEXMEDETOMIDINA
    D.3.9.4EV Substance CodeSUB07037MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg/h milligram(s)/kilogram/hour
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.0002 to 0.0014
    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.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 Propofol-Lipuro
    D.2.1.1.2Name of the Marketing Authorisation holderB. Braun Melsungen AG
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 namePropofol-Lipuro
    D.3.4Pharmaceutical form Emulsion for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPROPOFOL
    D.3.9.3Other descriptive namePROPOFOL
    D.3.9.4EV Substance CodeSUB10116MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg/h milligram(s)/kilogram/hour
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.5 to 4
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Parkinson's disease
    Enfermedad de Parkinson
    E.1.1.1Medical condition in easily understood language
    Parkinson's disease
    Enfermedad de Parkinson
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10013113
    E.1.2Term Disease Parkinson's
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Study whether there are changes (and their characteristics) in local field potentials recordings in deep subcortical structures, obtained through the stimulators implanted to treat Parkinson's disease, with the administration of dexmedetomidine and propofol.
    Establecer si se producen cambios (y caracterizarlos en caso de que ocurran) en el registro de los potenciales de campo en estructuras profundas subcorticales, obtenido a través de estimulador implantado para tratar la enfermedad de Parkinson, con la administración de dexmedetomidina y propofol.
    E.2.2Secondary objectives of the trial
    Make a comparative analysis of possible changes in the patient´ score of the UPDRS-III scale at ?off? situation, with dexmedetomidine and different estimated plasma levels of propofol.
    Realizar un análisis comparativo de los posibles cambios en la puntuación de la escala UPDRS-III del paciente en situación ?off?, con dexmedetomidina y con diferentes concentraciones plasmáticas estimadas de propofol.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All patients must meet all the following inclusion criteria:
    1. Ability to provide informed consent and express their desire to satisfy all requirements of the protocol during the study period.
    2. The patient should, in the investigator's opinion, be able to meet all the requirements of the clinical trial.
    3. The patient must be an adult (more than 18 years old).
    4. The patient will undergo placement of a deep brain stimulator for Parkinson's disease in subthalamic nucleus or globus pallidus under sedation, by indication of the responsible physician.
    Todos los pacientes deben cumplir todos los siguientes criterios de inclusión:
    1. Capacidad para otorgar consentimiento informado y expresar su deseo de cumplir todos los requisitos del protocolo durante el periodo de estudio.
    2. El/la paciente debe, en opinión del investigador, ser capaz de cumplir con todos los requerimientos del ensayo clínico.
    3. El paciente deberá ser mayor de edad.
    4. El paciente va a someterse a la colocación de un estimulador cerebral profundo por enfermedad de Parkinson en núcleo subtalámico o globo pálido bajo sedación, por indicación de su médico responsable.
    E.4Principal exclusion criteria
    Patients with any of the following exclusion criteria will not be included in the clinical trial:
    1. Hypersensitivity to dexmedetomidine or propofol.
    2. Heart block type 2nd or 3rd degree without pacemaker.
    3. Symptomatic hypotension.
    4. Patient with severe stroke.
    5. Pregnant or lactating patient.
    Los pacientes que presenten alguno de los siguientes criterios de exclusión no podrán ser incluidos en el ensayo clínico:
    1. Antecedentes de hipersensibilidad a dexmedetomidina o propofol.
    2. Bloqueo cardíaco en 2º o 3º grado sin marcapasos.
    3. Hipotensión sintomática.
    4. Paciente con enfermedad cerebrovascular grave.
    5. Paciente embarazada o en período de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    Registration signal potency of deep brain activity at different frequencies through the stimulator (microvolts?m-2).
    Potencia de la señal del registro de la actividad cerebral profunda en distintas frecuencias a través del estimulador (microvoltios?m-2).
    E.5.1.1Timepoint(s) of evaluation of this end point
    In "baseline" situation without anesthetic medication (day 4), with dexmedetomidine (day 1) and after different concentrations of propofol (day 6).
    En situación ?basal? sin medicación anestésica (día 4), con dexmedetomidina (día 1) y tras diferentes concentraciones de propofol (día 6).
    E.5.2Secondary end point(s)
    ? Demographic data (gender, age, weight).
    ? Parkinson disease type, duration and regular medication.
    ? Score of the UPDRS-III scale at "off" and "on" situation.
    ? Stimulation target nucleus. Subthalamic nucleus or globus pallidus.
    ? Changes in the score UPDRS-III scale with the administration of dexmedetomidine and propofol.
    ? Adverse events observed during the study.
    ? Variables demográficas (sexo, edad, peso).
    ? Tipo de enfermedad de Parkinson, tiempo de evolución y medicación habitual.
    ? Puntuación en la escala UPDRS-III en situación ?off? y ?on?.
    ? Núcleo diana de la estimulación. Núcleo subtalámico o globo pálido.
    ? Tipo de intervención realizada. Unilateral o bilateral.
    ? Cambios en la puntuación de la escala UPDRS-III con la administración de dexmedetomidina y propofol.
    ? Acontecimientos adversos observados a lo largo del estudio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At different moments during the study
    A lo largo del estudio
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    En el mismo paciente
    En el mismo paciente
    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 trial1
    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
    LVLS
    UVUS
    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 months18
    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: 4
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state12
    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)
    Will continue with the usual treatment for the pathology
    Se continuará con el tratamiento habitual para la patología
    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 Decision2014-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-02
    P. End of Trial
    P.End of Trial StatusCompleted
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