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    Summary
    EudraCT Number:2017-003705-17
    Sponsor's Protocol Code Number:LUMC-NECH-201801-ACA
    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:2019-01-07
    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 number2017-003705-17
    A.3Full title of the trial
    Prevention of neuropsychiatric adverse effects caused by dexamethasone: translational insights from a placebo-controlled trial with hydrocortisone.
    De preventie van nadelige neuropsychiatrische effecten veroorzaakt door dexamethason: inzichten van een placebo gecontroleerde studie met hydrocortison.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Hydrocortisone as co-treatment to prevent neuropsychiatric adverse effects of dexamethasone.
    Hydrocortison als co-medicatie om nadelige neuropsychiatrische effecten van dexamethason tegen te gaan.
    A.3.2Name or abbreviated title of the trial where available
    DEXA-CORT
    DEXA-CORT
    A.4.1Sponsor's protocol code numberLUMC-NECH-201801-ACA
    A.5.4Other Identifiers
    Name:The Netherlands National Trial RegisterNumber:NTR6937
    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 SponsorLUMC
    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 supportZonMw
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLUMC
    B.5.2Functional name of contact pointDepartment of Endocrinology
    B.5.3 Address:
    B.5.3.1Street AddressAlbinusdreef 2
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 ZA
    B.5.3.4CountryNetherlands
    B.5.6E-mailendo.secretariaat@lumc.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 Hydrocortison Tiofarma 20 mg, tabletten
    D.2.1.1.2Name of the Marketing Authorisation holderTiofarma
    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.3.11 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
    Neuropsychiatric adverse effects which can be caused by dexamethasone. For example delirium, anxiety, depression, mania and psychosis. But also cognitive impairment and sleep disturbance.
    Psychiatrische klachten die kunnen ontstaan bij dexamethason gebruik, zoals delier, angst, depressie, manie en psychoses. Ook cognitieve klachten en slaap klachten.
    E.1.1.1Medical condition in easily understood language
    Neuropsychiatric adverse effects which can be caused by dexamethasone. For example delirium, anxiety, depression, mania and psychosis. But also cognitive impairment and sleep disturbance.
    Psychiatrische klachten die kunnen ontstaan bij dexamethason gebruik, zoals delier, angst, depressie, manie en psychoses. Ook cognitieve klachten en slaap klachten.
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    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
    Investigate whether a low-dose of hydrocortisone (cortisol) reduces neuropsychiatric symptoms in glioma, meningioma and brain metastasis patients who are perioperatively treated with a high dose of the synthetic glucocorticoid dexamethasone, compared to patients treated with high dose dexamethasone alone.
    Ons doel is onderzoeken of hydrocortison de neuropsychiatrische bijwerkingen van dexamethason kan verminderen.
    E.2.2Secondary objectives of the trial
    Investigate whether additional hydrocortisone improves sleep quality of neurosurgical patients treated with high dose dexamethasone.
    Investigate whether additional hydrocortisone improves quality of life of neurosurgical patients treated with high dose dexamethasone.
    Investigate whether additional hydrocortisone improves cognitive functioning of neurosurgical patients treated with high dose dexamethasone.
    Investigate whether a history of psychiatric problems predisposes for psychiatric problems during the use of dexamethasone.
    Investigate the short-term and long-term effects of hydrocortisone addition to dexamethasone.
    Verify MR targeting and study the molecular effects of hydrocortisone co-treatment in resected tumour specimens.
    Onderzoeken of hydrocortison de slaapkwaliteit, cognitief functioneren en kwaliteit van leven kan verbeteren. Ook of geschiedenis van psychische klachten voorspellend is voor het ontwikkelen van psychische klachten bij dexamethason gebruik. Onderzoeken van het korte en lange termijn effect van hydrocortison. En moleculaire effecten van hydrocortison onderzoeken in specimen uit het tumor weefsel.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Cranial glioma, meningioma or brain metastasis scheduled to undergo surgery (resection)
    Minimal dose of peri-operative cumulative dexamethasone exposure of 24mg or more in 6 days
    ≥18 years
    Good clinical condition; KPS ≥ 70 (see attachments 1)
    Life expectancy ≥ 6 months
    Craniale glioma, meningioma of hersenmetastase patiënten die een operatie ondergaan (resectie)
    Minimale dosis dexamethason rondom de operatie van 24mg of meer in 6 dagen
    ≥18 jaar
    Goede klinische conditie; KPS≥70
    Levensverwachting ≥6 maanden
    E.4Principal exclusion criteria
    Non-native speakers of Dutch or insufficient command of the Dutch language
    Patients that are unable to overview consequences of trial participation
    Patients with aphasia
    Patients that are not able to fill in the questionnaires because of cognitive impairments at the discretion of the physician
    Patients with psychiatric diseases or neurological deficits that interfere with the study to the judgement of treating physician
    Moedertaal niet Nederlands of onvoldoende beheersing van de Nederlandse taal
    Patiënten die de gevolgen van deelname aan de studie niet kunnen overzien
    Patiënten met afasie
    Patiënten die niet in staat zijn vragenlijsten in te vullen door cognitieve problemen, naar oordeel van de behandelend arts
    Patiënten met psychiatrische ziekten of neurologische gebreken die interfereren met de studie, naar oordeel van de behandelend arts
    E.5 End points
    E.5.1Primary end point(s)
    Neuropsychiatric adverse effects will be measured with the Brief Psychiatric Rating Scale (BPRS) version 4.0. The BPRS is a validated questionnaire, which provides a description of major symptom characteristics in psychiatric patients. It is developed as a rapid evaluation technique to assess treatment change, and available in Dutch. The BPRS covers the presence and seriousness of 24 symptoms scored on a 7 point scale (1=not present, 7=extremely severe). The total score is used and compared from one evaluation to the next to measure the response to treatment.
    De primaire uitkomstmaat is neuropsychiatrische bijwerkingen gemeten met de Brief Psychiatric Rating Scale (BPRS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The BPRS will be assessed three times: on an outpatient clinic appointment before surgery, at the day of discharge, and 5 - 8 weeks after surgery.
    De BPRS wordt drie keer afgenomen: tijdens een poli-afspraak voor de operatie, op de dag van ontslag, en 5 - 8 weken na de operatie.
    E.5.2Secondary end point(s)
    Secondary parameters are neuropsychiatric adverse effects measured with different questionnaires (Hospital Anxiety and Depression Scale (HADS), Altman Self-Rating Mania scale (ASRM), Positive Affect Negative Affect Scale (PANAS), Delirium Observation Scale (DOS)); neurophysiological functioning assessed with different cognitive tests, sleep quality measured with the Leeds Sleep Evaluation Questionnaire (LSEQ) and quality of life with QLQ-C30+BN20.
    Secundaire uitkomstmaten zijn: neuropsychiatrische bijwerkingen gemeten met vragenlijsten (Hospital Anxiety and Depression Scale (HADS), Altman Self-Rating Mania scale (ASRM), Positive Affect Negative Affect Scale (PANAS), Delirium Observation Scale (DOS)); slaap kwaliteit gemeten met vragenlijst (Leeds Sleep Evaluation Questionnaire (LSEQ)); cognitie gemeten met cognitieve testen en kwaliteit van leven met QLQ-C30 + BN20 vragenlijst.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Between day -14 and -2 before surgery: HADS, QoL, PANAS, LSEQ, ASRM (these questionnaires can be filled in at home). In addition: BPRS, cognitive tests, miniscreen on psychiatric background, NPI-Q and aphasia screening (when needed).
    During hospitalisation after surgery: nurses will fill in the DOS (in case of clinical psychiatric symptoms).
    Day of discharge: BPRS, LSEQ, MoCA, PANAS, NPI-Q and aphasia screening (when needed), and DOS by nurses (in case of clinical psychiatric symptoms).
    2 weeks after surgery: HADS, PANAS, LSEQ, ASRM (filled in at home).
    5 - 8 weeks after surgery: BPRS, cognitive tests, LSEQ, PANAS, NPI-Q.
    3 months after surgery: HADS, QoL, PANAS, LSEQ, ASRM (filled in at home).
    Tussen dag -14 en -2 voor operatie op de dag van een poli-afspraak: HADS, QoL, PANAS, LSEQ, ASRM (vragenlijsten kunnen thuis ingevuld worden). Ook: BPRS, cognitieve testen, miniscreen voor psychiatrische achtergrond, NPI-Q en afasie screening (wanneer nodig).
    Gedurende opname in ziekenhuis na operatie: de verpleegkundigen zullen de DOS bijhouden (in geval van klinische psychiatrische symptomen).
    Dag van ontslag: BPRS, LSEQ, MoCA, PANAS, NPI-Q en afasie screening (wanneer nodig), en DOS door verpleegkundigen (in geval van klinische psychiatrische symptomen).
    2 weken na operatie: HADS, PANAS, LSEQ, ASRM (thuis ingevuld).
    5 - 8 weken na operatie: BPRS, cognitieve testen, LSEQ, PANAS, NPI-Q.
    3 maanden na operatie: HADS, QoL, PANAS, LSEQ, ASRM (thuis ingevuld).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    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 Yes
    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
    The end of the study is defined as the last patient hands in the last questionnaires. This is estimated at 29 January 2025.
    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 days
    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: 130
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Brain tumor patients that undergo surgery
    F.4 Planned number of subjects to be included
    F.4.1In the member state180
    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.
    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 Decision2019-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-22
    P. End of Trial
    P.End of Trial StatusOngoing
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