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    Summary
    EudraCT Number:2014-001545-25
    Sponsor's Protocol Code Number:CHDR1409
    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:2014-05-22
    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 number2014-001545-25
    A.3Full title of the trial
    Randomized, double-blind, placebo-controlled, three way crossover, double dummy, single centre study evaluating the effect of haloperidol 2 mg and lorazepam 1 mg on posturography and underlying systems involved in standing balance in 12 healthy elderly subjects.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Studying the effect of haldol and lorazepam on standing balance measured with the BalRoom in healthy elderly.
    A.3.2Name or abbreviated title of the trial where available
    BalRoom study
    A.4.1Sponsor's protocol code numberCHDR1409
    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.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 supportCentre for Human Drug Research
    B.4.2CountryNetherlands
    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.5.3.4CountryNetherlands
    B.5.4Telephone number+31715246 400
    B.5.5Fax number+31715246 499
    B.5.6E-mailclintrials@chdr.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 Haloperidol
    D.2.1.1.2Name of the Marketing Authorisation holderGeneric
    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 INNhaloperidol
    D.3.9.1CAS number 52-86-8
    D.3.9.3Other descriptive nameHALOPERIDOL
    D.3.9.4EV Substance CodeSUB08005MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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.IMP: 2
    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 Lorazepam
    D.2.1.1.2Name of the Marketing Authorisation holderGeneric
    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 INNlorazepam
    D.3.9.3Other descriptive nameLORAZEPAM
    D.3.9.4EV Substance CodeSUB08582MIG
    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.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 placeboTablet
    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
    Healthy volunteers (balance disorders)
    E.1.1.1Medical condition in easily understood language
    Healthy volunteers (balance disorders)
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10049848
    E.1.2Term Balance disorder
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10004070
    E.1.2Term Balance difficulty
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To assess the effect of haloperidol compared to placebo on stability (Body Sway) in relation to stabilizing subsystems (BalRoom) in healthy elderly.
    • To assess the effect of lorazepam compared to placebo on stability (Body Sway) in relation to stabilizing subsystems (BalRoom) in healthy elderly.
    • To assess the effect of lorazepam compared to haloperidol on stability (Body Sway) in relation to stabilizing subsystems (BalRoom) in healthy elderly.
    • To assess the relationship between BalRoom and NeuroCart subtests in healthy elderly.
    • To assess the sensitivity of BalRoom and NeuroCart parameters for drug effects in healthy elderly.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Healthy male and/or female subjects over the age of 70 years (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG, and clinical laboratory tests).

    2. Body Mass Index (BMI) of 17.5 to 35 kg/m2; and a total body weight => 50 kg.

    3. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

    4. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

    5. Mini-Mental Status Examination (MMSE) score > 26 at screening
    E.4Principal exclusion criteria
    1. 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).

    2. Subjects presenting with orthostatic hypotension, in which orthostatic hypotension is defined as a decrease of 20 mmHg for systolic blood pressure or 10 mmHg for diastolic blood pressure 2 minutes after standing from a supine position.

    3. Any condition possibly affecting drug absorption (eg, gastrectomy).

    4. A positive urine drug screen.

    5. 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.

    6. 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.

    7. Use of (non-)prescription medications that are believed to affect subject safety or the overall results of the study following judgment by the investigator.

    8. Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening.

    9. Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol.

    10. Physically unable to perform BalRoom tests, e.g. walking and standing tests.

    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.

    13. Clinical significant abnormalities on ECG and or QTcf > 500ms.
    E.5 End points
    E.5.1Primary end point(s)
    1. Pharmodynamics:
    BalRoom assessment:
    • Sensory weights (weighting factors of proprioceptive, visual and vestibular system).
    • Active dynamics of ankle joint (time delay (s), active stiffness (Nm/rad) and active damping (Nm/rad/s)).
    • Active dynamics of hip joint (time delay (s), active stiffness (Nm/rad) and active damping (Nm/rad/s)).
    • Force feedback (time constant (s) and stiffness (Nm/rad ))
    • Passive dynamics of ankle joint (passive stiffness (Nm/rad) and passive damping (Nm/rad/s)).
    • Passive dynamics of hip joint (passive stiffness (Nm/rad) and passive damping (Nm/rad/s)).

    Neurocart assessment:
    • Saccadic Eye Movements (saccadic reaction time, saccadic peak velocity (deg/sec), and saccadic inaccuracy).
    • Body Sway (antero-posterior sway (mm/2min)).
    • Smooth Pursuit (percentage of time the eyes of the subjects are in smooth pursuit of the target (%)).
    • Bond and Lader VAS (alertness, calmness, mood subscales (mm)).
    • Bowdle VAS (internal & external perception, feeling high )(mm))
    • Adaptive Tracking (%).
    • Pharmaco-EEG ((α, β, δ, γ and θ power)

    Short Phsyical Performance Battery:
    • Ability to maintain standing balance during 10 seconds in the several standing positions
    • 4-meter walking speed (m/s)
    • Sit-to-stand transfer time (s)

    Other:
    • Serum prolactin concentrations
    • Handgrip strength (kg)

    2. Pharmacokinetics of lorazepam and haloperidol
    • Cmax, Tmax, AUClast, AUC24, AUCinf, CL/F, Vz/F, t1/2.

    3. Tolerability / safety
    Adverse events, vital signs measurements, 12-lead ECGs, physical examination findings and clinical safety laboratory measurement.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Various time points
    E.5.2Secondary end point(s)
    2. Pharmacokinetics of lorazepam and haloperidol
    • Cmax, Tmax, AUClast, AUC24, AUCinf, CL/F, Vz/F, t1/2.

    3. Tolerability / safety
    Adverse events, vital signs measurements, 12-lead ECGs, physical examination findings and clinical safety laboratory measurement.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Various time points
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 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 No
    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 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 subject, last visit
    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 months
    E.8.9.1In the Member State concerned days49
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 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)
    Not applicable
    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 Decision2014-05-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-02
    P. End of Trial
    P.End of Trial StatusOngoing
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