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    The EU Clinical Trials Register currently displays   37236   clinical trials with a EudraCT protocol, of which   6125   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2017-003365-99
    Sponsor's Protocol Code Number:NL62809.068.17
    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:2017-08-29
    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 number2017-003365-99
    A.3Full title of the trial
    The effects of ceasing opioid, benzodiazepine, or Z-hypnotic drug use on measures of driving performance and postural balance.
    De effecten van het stoppen van opiaten, benzodiazepinen, of Z-hypnotica gebruik op maten van rijvaardigheid en lichaamsevenwicht.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of tappering off medications on driving performance and balance.
    Het effect van medicatie afbouw op rijvaardigheid en evenwicht.
    A.3.2Name or abbreviated title of the trial where available
    The effects of ceasing sedative medications on driving and balance.
    De effecten van het stoppen van sederende medicatie of rijden en evenwicht.
    A.4.1Sponsor's protocol code numberNL62809.068.17
    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 SponsorMaastricht University
    B.1.3.4CountryNetherlands
    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 supportMaastricht University
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMaastricht University
    B.5.2Functional name of contact pointJan Ramaekers
    B.5.3 Address:
    B.5.3.1Street AddressUniversiteitssingel 40
    B.5.3.2Town/ cityMaastricht
    B.5.3.3Post code6200 MD
    B.5.3.4CountryNetherlands
    B.5.6E-mailj.ramaekers@maastrichtuniversity.nl
    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 all available benzodiazepines, z-hypnotics, opioids
    D.2.1.1.2Name of the Marketing Authorisation holdernot applicable
    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 nameBenzodiazepines, z-hypnotics, opioids
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPGastroenteral 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) 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
    Insomnia, Anxiety, chronic pain
    Insomnia, angst, chronische pijn
    E.1.1.1Medical condition in easily understood language
    Slaap- en angststoornissen, chronische pijn
    Slaap -en angststoornissen, chronische pijn
    E.1.1.2Therapeutic area Not possible to specify
    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
    The aim of this study is primarily to investigate the effects of a withdrawal intervention on measures of driving performance in a clinical population that uses benzodiazepines, Z-hypnotics, or opioid analgesics chronically.
    Het doel van het onderzoek is om de effecten van een ontwenningsinterventie op maten van rijvaardigheid vast te stellen binnen een klinische populatie van chronische gebruikers van benzodiazepinen, z-hypnotica en opiaten.
    E.2.2Secondary objectives of the trial
    As a secondary objective, this study also aims to replicate previous findings that demonstrate that fall risk decreases after cessation of psychoactive medications by observing the effects of cessation on measures of postural balance.
    Als een tweede doel beoogt deze studie het eerder gevonden effect dat valrisico verlaagt na het stoppen va psychoactieve medicaties repliceren door het observeren van de effecten van het stoppen op lichaamsevenwicht.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Possession of a valid driver's license for at least 3 years.
    A driving frequency of at least once a week.
    A weekly driving distance of at least 50km.
    Being able to operate a manual transmission
    The chronic (at least 90 days per year) use of a relevant medication (for patients only).
    In het bezit zijn van een geldig rijbewijs voor ten minste 3 jaar.
    Een rij frequentie van minstens 1 maal per week.
    Een wekelijkse rijafstand van ten minste 50 kilometer.
    Een manuele versnellingsbak kunnen bedienen.
    Het chronisch (minstens 90 dagen per jaar) gebruiken van een relevante medicatie (Patiënten).
    E.4Principal exclusion criteria
    Mini Mental State Examination score of less than 24.
    Deemed medically unfit to drive based on a medical screening.
    Recurrent illicit or recreational drug use.
    Excessive alcohol use (>21 beverages per week)
    Not willing to consider discontinuation of the use of a medication of interest in case this is advised by a clinician (patients only).
    The use of any psychoactive substance (control participants only)
    Mini Mental State examination score van minder dan 24.
    Geacht medisch ongeschikt te zijn om te rijden op basis van een medische screening.]
    Herhaaldelijk illegaal en/of recreatief middelengebruik.
    Overmatig alcohol gebruik (>21 consumpties per week)
    Niet bereid zijn om te stoppen met het gebruik van een medicatie wanneer dit wordt aanbevolen door een arts (voor deelnemeres uit de patiënten groepen).
    Het gebruik van een psychoactieve stof (controle deelnemers).
    E.5 End points
    E.5.1Primary end point(s)
    The main outcome parameter of the study will be the standard deviation of the lateral position (SDLP) of the test vehicle during a standardized on-the-road driving test.
    De hoofd uitkomstmaat van de studie is de standaard afwijking van de laterale positie (SDLP) van het testvoertuig tijdens de gestandaardiseerde rijtest op de weg.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Once before and once after cessation of the relevant medication
    Een keer voor en een keer na het stoppen met de relevante medicatie
    E.5.2Secondary end point(s)
    Furthermore, a neurocognitive test battery consisting of neuropsychological tests and laboratory computer tasks will be used. Also, a driving simulator test will be included. For our secondary objective, a postural balance task is included which measures body sway.
    Buiten de hoofdmaat wordt een neurocognitieve testbatterij bestaande uit neuropsychologische en lab computertaken gebruikt. Ook wordt er een rijsimulator taak gebruikt. Voor het secundaire doel wordt er een evenwicht taak gebruikt die het zwieren van het lichaam meet.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Once before and once after cessation of the relevant medication
    Een keer voor en een keer na het stoppen met de relevante medicatie
    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 Yes
    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 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 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 Yes
    E.8.2.3.1Comparator description
    Controle deelnemers die geen enkele psychoactieve medicatie gebruiken. Geen behandeling
    Control participants, not using any psychoactive medications. No treatment
    E.8.2.4Number of treatment arms in the trial3
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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
    LVLS
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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: 108
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 108
    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 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 state108
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 108
    F.4.2.2In the whole clinical trial 108
    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)
    None. Care as usual.
    Geen. Zorg als gebruikelijk
    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 Decision2017-08-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-08
    P. End of Trial
    P.End of Trial StatusOngoing
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