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    The EU Clinical Trials Register currently displays   37220   clinical trials with a EudraCT protocol, of which   6123   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2012-001777-86
    Sponsor's Protocol Code Number:91710346.1.2
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-07-10
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-001777-86
    A.3Full title of the trial
    Pilot study for classification of attempted movement from the electroencephalogram in healthy participants with a temporary paralysis of one arm induced by local administration of rocuronium
    Pilot: Classificatie van pogingen tot bewegen in het electroencephalogram van gezonde proefpersonen tijdens een tijdelijke verlamming van de arm veroorzaakt door toediening van rocuronium.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Attempted movement in EEG
    Detecteren van pogingen tot bewegen in het EEG
    A.3.2Name or abbreviated title of the trial where available
    Attempted movement in EEG
    Detecteren van pogingen tot bewegen in het EEG
    A.4.1Sponsor's protocol code number91710346.1.2
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    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 Rocuroniumbromide Fresenius Kabi 10 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Nederland BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameRocuroniumbromide
    D.3.4Pharmaceutical form Injection
    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 INNRocuroniumbromide Fresenius Kabi 10 mg/ml
    D.3.9.1CAS number 119302-91-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Intraoperative awareness during general anesthesia
    Bewustzijn tijdens algehele narcose
    E.1.1.1Medical condition in easily understood language
    Awareness during surgery
    Bewustzijn tijdens operatie
    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
    We hypothesize that attempted but pharmacologically blocked movement can be detected from EEG (i.e., with a classification rate higher than chance), possibly as well as imagined movement or even isometric movement.

    By recording the EEG from participants instructed to attempt hand movement even though motor output is blocked, it can be tested whether our system is able to reliably detect these attempted movements.
    E.2.2Secondary objectives of the trial
    The brain responses between different conditions (actual movement, imagined movement, isometric movement and attempted (blocked) movement) can be compared, possibly leading to new insights regarding the nature and underlying processes of movement-related EEG-changes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -18-65 years old
    -right-handed
    -normal or corrected to normal vision
    -normal or corrected to normal hearing
    -18-65 jaar oud
    -rechtshandig
    -normaal of gecorrigeerd zicht
    -normaal of gecorrigeerd gehoor
    E.4Principal exclusion criteria
    -neurological impairment
    -motor disabilities
    -known allergies to Rocuronium and/or Sugammadex
    -regular drug intake
    -hypertension
    -neurologische afwijking(en)
    -problemen met bewegingen/spieren
    -allergie voor rocuronium en/of suggamadex
    -regelmatig drugsgebruik
    -hypertensie
    E.5 End points
    E.5.1Primary end point(s)
    The main study parameter is the classification rate of our algorithm, i.e. the percentage of movement trials that are correctly classified as movement trials and the percentage of non-movement trials that are correctly classified as non-movement trials.
    Although the algorithm is programmed in such a way that it can take into account any feature from the EEG that distinguishes between the two classes, we expect the main useful feature to be the combined Event-Related Desynchronization (ERD), a power decrease in the α- and β-frequency bands known to occur during (planning) of movement and Event-Related Synchronization (ERS), a power increase in approximately the same frequencies, known to occur after movement has stopped. These features have been well established in the literature and these findings have been replicated in our own lab.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After data collection and analysis for all subjects
    E.5.2Secondary end point(s)
    As also EMG and the level of neuromuscular blockade (train-of four monitoring) will be measured throughout the experiment, insight might be gained into the influence of Rocuronium on EMG and the level of neuromuscular blockade (train-of four monitoring) and the interplay between them.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After data collection and analysis for all subjects
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Paradigm evaluation
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 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 No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    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 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: 10
    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 No
    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 state10
    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)
    N/A
    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 Decision2012-07-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-23
    P. End of Trial
    P.End of Trial StatusOngoing
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