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    The EU Clinical Trials Register currently displays   38177   clinical trials with a EudraCT protocol, of which   6271   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2014-003956-30
    Sponsor's Protocol Code Number:CHDR1429
    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:2014-10-07
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-003956-30
    A.3Full title of the trial
    A single-centre randomized double-blind, double-dummy, placebo-controlled, four-way crossover study in healthy subjects to investigate the effect of ethanol 0.5 and 1.0 g/L and alprazolam 1 mg on a driving simulator and to compare the results with the NeuroCart CNS test battery.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Validate a driving simulator by determining the sensitivity of a driving simulator test battery to the effects of ethanol 0.5 and 1.0 g/L and alprazolam 1 mg, and compare results with CNS test battery scores and to explore the relationships with historical results from actual driving performance.
    A.4.1Sponsor's protocol code numberCHDR1429
    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 SponsorCentre for Human Drug Research
    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 supportCentre for Human Drug Research
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre for Human Drug Research
    B.5.2Functional name of contact pointJ.M.A. van Gerven
    B.5.3 Address:
    B.5.3.1Street AddressZernikedreef 8
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CL
    B.5.4Telephone number+31715246400
    B.5.5Fax number+31715246499
    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 Alprazolam 1 PCH (The Netherlands)
    D. of the Marketing Authorisation holderPharmachemie B.V.
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAlprazolam
    D.3.9.1CAS number 28981-97-7
    D.3.9.3Other descriptive nameALPRAZOLAM
    D.3.9.4EV Substance CodeSUB05370MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    A total of 24 healthy subjects, both male and female, will be enrolled into the study following satisfactory completion of a screening visit where eligibility for the study will be checked.
    Subjects will be recruited via media advertisement or from the subjects’ database of the Centre for Human Drug Research, Leiden, the Netherlands.
    E.1.1.1Medical condition in easily understood language
    Healthy subjects aged 18 to 55, inclusive.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
    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
    Primary objectives:
    • To assess the effect of ethanol compared to placebo on a driving simulator performance tests;
    • To assess the effect of alprazolam compared to placebo on a driving simulator performance tests;
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    • To assess the effect of alprazolam compared to ethanol on driving simulator performance tests;
    • To establish the relationship between driving simulator and NeuroCart performances;
    • To study the suitability of additional complex parameters of driving simulation on the assessment of drug effects.
    • To explore the relationships between driving simulator and historical results from actual driving performance.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Eligible subjects must meet all of the following inclusion criteria:
    1. Healthy subjects, aged 18 to 55 years, inclusive; healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including 12-lead ECG, and clinical laboratory tests.
    2. Subjects are in possession of a valid driver’s license and are active and experienced drivers; this is to be determined by the investigators;
    3. Evidence of a personally signed and dated informed consent form indicating that the study subject has been informed of all pertinent aspects of the study.
    4. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures.
    5. Female subjects of childbearing potential must have a negative (β-hCG) test (at screening and before the start of each occasion) and be willing and able to use one of the following double-barrier methods of birth control: hormonal intrauterine device with condom, or oral contraceptives with condom from the screening visit to the end of study.
    E.4Principal exclusion criteria
    Eligible subjects must meet none of the following exclusion criteria:
    1. Confirmed or suspected myasthenia gravis, severe respiratory insufficiency, sleep apnoea syndrome, severe hepatic insufficiency or hypersensitivity to benzodiazepines;
    2. Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
    3. Any condition possibly affecting drug absorption (e.g., gastrectomy).
    4. A positive urine drug screen for cocaine, amphetamine, morphine, benzodiazepine and THC.
    5. Subject is not able to perform the drive simulator tests.
    6. History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of hard liquor) within 6 months of Screening.
    7. Treatment with an investigational drug within 3 months prior to screening or having participated in more than 4 investigational drug studies within 1 year prior to screening.
    8. Use of (non-)prescription medications that are believed to affect subject safety or the overall results of the study following judgment by the investigator.
    9. Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening.
    10. Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol.
    11. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    12. Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or subjects directly involved in the conduct of the study.
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacodynamic driving simulator endpoints:
    1. Primary driving simulator outcome: SDLP

    Pharmacodynamic CNS test battery primary endpoints:
    1. Adaptive tracking (average performance %);
    2. Saccadic eye movements (saccadic reaction time (sec), saccadic peak velocity (deg/sec), and saccadic inaccuracy (%));
    3. Smooth pursuit eye movements (percentage of the time that subject’s eyes are in smooth pursuit of the target (%));
    4. Body sway (antero-posterior sway (mm/2min));
    5. Visual verbal learning test (VVLT);
    6. Visual Analogue Scales according to Bond and Lader (alertness, mood, and calmness subscales (mm)).
    E.5.1.1Timepoint(s) of evaluation of this end point
    This is a single-centre, randomized, double-blind, double-dummy, placebo-controlled, crossover study with ethanol and alprazolam in healthy subjects while performing neurocognitive and psychomotor tests on the NeuroCart and a driving simulator. The tests will be conducted on four separate study days with a wash out period of at least three days. On each study day subjects arrive at the clinic in the morning (8AM) and perform baseline assessments. After the administration of the study drug, driving tests and CNS tests will be performed at intervals (+2, +4, +5 and +6 hours post-dosing).
    E.5.2Secondary end point(s)
    Secondary driving simulator endpoints:
    a. Automative behaviour (tracking, steering, vigilance, sustained attention);
    b. Control behaviour (maintaining distance, passing, motor performance, maneuvers, divided attention, perception);
    c. Executive planning behaviour (risk taking, impulsivity, information processing, attention, cognition, judgement).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Tests will be conducted on four (4) separate study days with a wash out period of at least three days. On each study day subjects arrive at the clinic in the morning (8AM) and perform baseline assessments. After the administration of the study drug, driving tests and CNS tests will be performed at intervals (+2, +4, +5 and +6 hours post-dosing).
    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
    This is a validation study. The purpose of the study is to determine the sensitivity of a driving simulator test battery to the effects of ethanol 0.5 and 1.0 g/L and alprazolam 1 mg, and to explore the relationships with historical results from actual driving performance. In addition, the results will also be compared with those of the NeuroCart, a validated test battery that quantifies a large range of drug-sensitive CNS-functions.
    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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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 Yes
    E. description
    Ethanol 0.5 and 1.0 g/L
    E.8.2.4Number of treatment arms in the trial4
    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 years0
    E.8.9.1In the Member State concerned months6
    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: 24
    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 state24
    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)
    Telephonic follow-up
    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 Decision2014-10-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-13
    P. End of Trial
    P.End of Trial StatusOngoing
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