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    EudraCT Number:2016-002680-34
    Sponsor's Protocol Code Number:DEXPAR
    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:2016-08-05
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2016-002680-34
    A.3Full title of the trial
    Effects of different concentrations of dexmedetomidine on basal ganglia neuronal activity (local field potentials) in Parkinson's disease.
    Efecto de diferentes concentraciones de dexmedetomidina en la actividad de los ganglios basales (potenciales de campo local) en la enfermedad de Parkinson.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of different concentrations of dexmedetomidine on basal ganglia neuronal activity (local field potentials) in Parkinson's disease.
    Efecto de diferentes concentraciones de dexmedetomidina en la actividad de los ganglios basales (potenciales de campo local) en la enfermedad de Parkinson.
    A.4.1Sponsor's protocol code numberDEXPAR
    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.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 supportClínica Universidad de Navarra
    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 pointUCEC
    B.5.3 Address:
    B.5.3.1Street AddressAvda. Pío XII, 36
    B.5.3.2Town/ cityPamplona
    B.5.3.3Post code31008
    B.5.4Telephone number34948255 4002723
    B.5.5Fax number34948296 667
    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. name Dexdor
    D. 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.3.9.1CAS 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 µg/kg microgram(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.15 to 1
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 19.0
    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
    To study and quantify the possible effect of different doses of dexmedetomidine (0.2-0.6 µg/kg/h) on the local field potentials (deep brain activity) in patients with Parkinson´s disease undergoing deep brain stimulation implantion.
    Conocer la dosis máxima de dexmedetomidina, entre 0,2 – 0,6 µg/kg/h, que se puede administrar en pacientes sometidos a colocación de ECP por EP sin interferir en la actividad cerebral profunda (potenciales de campo local)
    E.2.2Secondary objectives of the trial
    1- To make an observational comparative analysis of possible changes in tremor of the patients between control and different concentrations of dexmedetomidine.
    2- To study the relationship between the effect of dexmedetomidine on the LFPs of the basal ganglia and frontal cortical activity (bispectral index©).
    1- Profundizar en el efecto de la dexmedetomidina en el temblor de los pacientes con EP.
    2- Estudiar la relación del efecto que la dexmedetomidina ejerce en los PCL de los ganglios basales y la actividad cortical frontal (medida median BIS bilateral).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients undergoing placement of DBS for PD in two phases.
    2. The patient must be of legal age (> 17 years old).
    3. The patient or his representative has consented to participate in the study.
    4. The patient should, in the investigator's opinion be able to cooperate during the procedure.
    1. Pacientes sometidos a colocación de ECP por enfermedad de Parkinson (NST o GPi) en dos tiempos.
    2. El paciente deberá ser mayor de edad.
    3. El paciente, o su representante, ha otorgado su consentimiento para participar en el estudio.
    4. El paciente debe, en opinión del investigador, ser capaz de cumplir con todos los requerimientos del ensayo clínico.
    E.4Principal exclusion criteria
    1. Known liver disease.
    2. Pregnant or nursing women.
    3. History of hypersensitivity to dexmedetomidine.
    4. Heart block (2nd or 3rd degree), without pacemaker.
    5. Symptomatic hypotension.
    6. Severe stroke or other neurological deficits that may impair adequate cooperation or observation of the study endpoints
    1. Insuficiencia hepática grave (enfermedad hepática conocida).
    2. Mujeres embarazadas o en período de lactancia. La detección de embarazo se realiza de manera rutinaria previamente al procedimiento de colocación del ECP, por lo que no es necesario volver a realizar la prueba de embarazo.
    3. Antecedentes de hipersensibilidad a dexmedetomidina.
    4. Bloqueo cardíaco en 2º o 3º grado sin marcapasos.
    5. Hipotensión sintomática.
    6. Paciente con enfermedad cerebrovascular grave.
    E.5 End points
    E.5.1Primary end point(s)
    Local field potentials (deep brain activity) recording with the deep brain stimulator under different doses of dexmedetomidine.
    "Registro con dexmedetomidina” de los PCL (actividad cerebral profunda) con diferentes dosis de dexmedetomidina a través del ECP.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Before the second surgery phase (implanting of programmable pulse generator and connection to the deep brain stimulator), in “off” medication and without any residual effect of anesthetic drugs, the patient will be transfer to the post-anesthetic care unit for the administration of dexmedetomidine and recording the local field potentials.
    Antes de empezar el segundo tiempo de la cirugía (colocación del generador de pulsos y conexión al sistema de estimulación cerebral profunda), sin haber recibido su medicación para el tratamiento del Párkinson ni otro tipo de medicación anestésica, el paciente será trasladado a la sala de recuperación anestésica para la administración de la dexmedetomidina y el registro de los potenciales de campo local.
    E.5.2Secondary end point(s)
    • Demographic variables (sex, age, weight, BMI).
    • Patient diagnosis and duration of PD.
    • “Basal tremor” score on the UPDRS-III in state "off" before the surgery.
    • Stimulation target (STN or Gpi).
    • Type of intervention.
    • “Control recording” of LFPs (deep brain activity) through the DBS.
    • “Dexmedetomidine recording” of local field potentials (deep brain activity) at different concentrations of dexmedetomidine through the deep brain stimulation electrode.
    • “Control tremor” and “dexmedetomidine tremor” score at different concentration.
    • Frontal cortical activity (bilateral bispectral index).
    • Adverse events by the administration of dexmedetomidine
    • Variables demográficas (sexo, edad, peso, IMC).
    • Diagnóstico del paciente y tiempo de evolución de la enfermedad.
    • Puntuación basal del temblor en la escala UPDRS-III en “off” previo a la primera intervención (“temblor basal”)
    • Diana de estimulación (NST o GPi).
    • Tipo de intervención (uni o bilateral).
    • “Registro de control” de los PCL (actividad cerebral profunda) a través del ECP.
    • “Registro con dexmedetomidina” de los PCL (actividad cerebral profunda) con diferentes dosis de dexmedetomidina a través del ECP.
    • “Temblor control” y “temblor con dexmedetomidina” a diferentes concentraciones.
    • Actividad del electroencefalograma cortical frontal a través del análisis procesado del BIS bilateral.
    • Posible aparición de acontecimientos adversos por la administración del fármaco en 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 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. 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. trial design description
    En el mismo paciente
    In the same patient
    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. description
    Estado basal
    Basal condition
    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
    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 Decision2016-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-11-28
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