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    The EU Clinical Trials Register currently displays   41189   clinical trials with a EudraCT protocol, of which   6742   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2013-000823-15
    Sponsor's Protocol Code Number:NEUPRODEX
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-11-19
    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 ConcernedGermany - BfArM
    A.2EudraCT number2013-000823-15
    A.3Full title of the trial
    Neuroprotection with Dexmedetomidine in patients undergoing elective cardiac or abdominal surgery
    Neuroprotektion durch Dexmedetomidin bei Patienten mit kardio- oder abdominalchirurgischen Eingriffen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Neuroprotection with Dexmedetomidine in patients undergoing elective cardiac or abdominal surgery
    Schutz der geistigen Leistungsfähigkeit durch Dexmedetomidin bei Patienten mit Eingriffen am Herzen oder an der Bauchhöhle
    A.3.2Name or abbreviated title of the trial where available
    NEUPRODEX
    A.4.1Sponsor's protocol code numberNEUPRODEX
    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 SponsorCharité – Universitätsmedizin Berlin
    B.1.3.4CountryGermany
    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 supportCharité – Universitaetsmedizin Berlin
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK)
    B.5.2Functional name of contact pointUniv.-Prof. Dr. C. Spies
    B.5.3 Address:
    B.5.3.1Street AddressAugustenburger Platz 1
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13353
    B.5.3.4CountryGermany
    B.5.4Telephone number+4930450 551001
    B.5.5Fax number+4930450 551909
    B.5.6E-mailclaudia.spies@charite.de
    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 100 Microgramm
    D.2.1.1.2Name of the Marketing Authorisation holderOrion Corporation
    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.3.4Pharmaceutical 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.3.9.4EV Substance CodeSUB07037MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The drug Dexmedetomidine will be investigated in patients (men and women) undergoing elective cardiac or abdominal surgery. The study medication will be administered perioperatively by intravenous infusion continously (at the longest 48 h) to prevent/reduce the rate of Delirium and the incidence of POCD.
    E.1.1.1Medical condition in easily understood language
    The drug Dexmedetomidine will be investigated in patients (men and women) undergoing elective cardiac or abdominal surgery to prevent/reduce postoperative confusion and cognitive impairment.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    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
    Incidence of postoperative delirium measured with the Confusion Assessment Method for the ICU (CAM-ICU)“or the „Confusion Assessment Method (CAM) and/or Chart Review and/or DSM V/ICD-10 “
    E.2.2Secondary objectives of the trial
    1.Incidence of Subsyndromal Delirium (SSD) 2.Severity of Delirium 3. Incidence of POCD incl. subjective Memory - feeling 4.Severity of anxiety (Faces Anxiety Scale)5.Management of sedation (RASS –Score)6.Management of Vigilance Glasgow Coma Scale 7.Management of analgesia and pain levels: (NRS-V or FPS-R or BPS or BPS-NI) 8.Relevant medication 9.Severity of illness (SAPS II, APACHE II, SOFA) 10.Mechanical ventilation/weaning failure 11. Cerebral oximetry 12. Processive EEG/EMG-Data(SedLine®) 13.Complete blood count, AChE-analysis 14.Cortisol-analysis 15.Organ dysfunctions 16.Infections 17.LOS-ICU 18.LOS-hospital 19.Quality of life (EuroQuol 5D (EQ-5D-Instrument)) 20.Incidence of postop. ve cognitive dysfunction (POCD) (CANTAB®, MMS) 21.Mortality 22. Sleep quality 23. Changes of hemodynamic parameters in the intraoperative transesophageal echocardiography 24. Photomotor Reflex
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patients aged ≥ 60 years
    2.Male and female patients undergoing elective cardiac (elective CABG-surgery without valve surgery with left ventricular ejection fraction ≥ 30%) or pancreatic or hepatic or intestinal or gastric surgery of both Campus Charité Mitte and Campus Virchow - Klinikum, Charité – University Medicine Berlin
    3.Offered patient information and written consent by the patient (according to AMG § 40 (1) 3b)
    4.Premedication only with benzodiazepines
    5.Paintherapy during the operation with regional procedures and/or Sufentanil/Fentanyl
    6.Anesthesia in cardioasurgery according to Heart-Lung-Apparatus
    7.Anesthesia with hypnoticum Propofol
    8.Paintherapy after operation according to S3-Guideline
    9.Postoperative medication for anxiolysis only with benzodiazepines
    E.4Principal exclusion criteria
    1.Known drug intolerance/allergy: dexmedetomidine or to other ingredients
    2.Lacking willingness to save and hand out pseudonymised data within the clinical trial
    3.Accommodation in an institution due to an official or judicial order
    (according to AMG §40 (1) 4)
    4. Employee of the Charité - University - Medicine Berlin CVK/CCM
    5. Illiteracy
    6. Inability to speak and/or read German
    7. Minimal mental status examination (MMSE) < 24
    8. Severe hearing loss or visual impairment
    9. Acute brain injury
    10. Intracranial haemorrhage within one year before participation in the study
    11. Manifest psychiatric disease
    12. Known illicit substance abuse
    13. Acute intoxication
    14. For women: Pregnancy or positive pregnancy test within the preoperative screening
    15. Homeless or other circumstances, where the patient would not be reachable by telephone or postal services for the 3-months follow up
    16. Participation in another interventional clinical trial according to the German Drug Law at time of inclusion and during the trial
    17. Acute circulatory failure at time of randomisation (severe hypotension with mean arterial pressure < 55 mmHg despite vasopressors or optimal preload)
    18. AV-conduction-block II or III (unless pacemaker installed)
    19. Severe bradycardia (heart-rate < 50 bpm, preoperative, permanent)
    20. Spinal cord injury with known autonomic dysregulation
    21. Preoperative acute cerebrovascular event with neurologic residues
    22. Liver insufficiency (Child C cirrhosis, MELD Score > 17)
    23. Aplication of Remifentanil during the operation
    24. Postoperatively planned deep sedation (RASS, -4 to -5)
    25. Administration of Clonidin during administration of the study drug
    26. Additional administration of Dexmedetomidine within 3 months after study inclusion
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of postoperative delirium measured with the Confusion Assessment Method for the ICU (CAM-ICU)“or the „Confusion Assessment Method (CAM) and/or Chart Review and/or DSM V/ICD-10 “
    E.5.1.1Timepoint(s) of evaluation of this end point
    Measured until the 5th postoperative day
    E.5.2Secondary end point(s)
    1.Incidence of Subsyndromal Delirium (SSD) 2.Severity of Delirium 3. Incidence of POCD (Cambridge Neuropsychological Automated Test Battery CANTAB®, Minimal Mental Status Examination MMSE) including subjective Memory - feeling (Item 10 of the Geriatric Depression Scale, including limitation in usual activities (EQ-5D)) 4.Severity of anxiety (Faces Anxiety Scale FAS)5.Management of sedation (RASS –Score)6.Management of Vigilance Glasgow Coma Scale (GCS) 7.Management of analgesia and pain levels: (NRS-V or FPS-R or BPS or BPS-NI) 8.Relevant medication 9.Severity of illness (SAPS II, APACHE II, SOFA) 10.Mechanical ventilation/weaning failure 11. Cerebral Oximetry 12. Processive EEG/EMG-Data(SedLine®) 13.Complete blood count (Sysmex Parameter), AChE-analysis 14.Cortisol-analysis 15.Organ dysfunctions 16.Infections (CDC), (SSI)) 17.LOS-ICU 18.LOS-hospital (time that discharge criteria were met: PADSS) 19.Quality of life (EuroQuol 5D (EQ-5D-Instrument)) 20.Incidence of postoperative cognitive dysfunction (POCD) (CANTAB®, MMS) 21.Mortality (3-month-mortality) 22. Sleep quality 23. Changes of hemodynamic parameters in the intraoperative transesophageal echocardiography (size and function of left and right ventricle; diastolic function; cardiac responsiveness to volume; heart valves and their function] 24. Photomotor Reflex
    E.5.2.1Timepoint(s) of evaluation of this end point
    Measured:
    1-2and 5-6 and 8-10 until the 5th postoperative day
    11-12 intraoperatively until first postoperative day
    13 preoperatively and until the 3rd postoperative day
    14 preoperatively and until the 3rd postoperative day, at discharge and after 3 months
    17-18 until the end of hospital stay
    3,4 and 7 and 15-16 and 19-22 until 3 months
    23 intraoperatively; 24 preoperatively at the day of operation and at discharge
    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 No
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 patient last visit (of last follow up)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    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: 7
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state77
    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)
    After hospital stay one follow up investigation will be carried out 3 months after the operation.
    The examination could be conducted by an investigator of the study centre. A patient questionnaire on quality of life (EuroQuol 5D (EQ-5D-Instrument)) and severity (Faces Anxiety Scale FAS), sleep quality and pain will be carried out and POCD-mesurement ((CANTAB®, MMSE) conducted.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Charité - Universitaetsmedizin Berlin - Campus Virchow-Klinikum - Central Pharmacy
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-09-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-07-31
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