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    The EU Clinical Trials Register currently displays   35419   clinical trials with a EudraCT protocol, of which   5814   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2015-001563-39
    Sponsor's Protocol Code Number:DENISH2015
    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:2016-02-15
    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 number2015-001563-39
    A.3Full title of the trial
    Dexamethasone (DXM) therapy in symptomatic patients with chronic subdural hematoma (DECSA– Trial). Effect of initial corticosteroid therapy versus primary surgery on clinical outcome.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of dexamethasone (DXM) therapy in patients with a brain bleed: A comparision of a non-operative treatment versus surgery on patient recovery.
    A.3.2Name or abbreviated title of the trial where available
    DECSA-trial
    A.4.1Sponsor's protocol code numberDENISH2015
    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 SponsorMedical Centre Haaglanden (MCH)
    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 supportMedical Centre Haaglanden (MCH)
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical Centre Haaglanden (MCH)
    B.5.2Functional name of contact pointDepartment of Neurosurgery
    B.5.3 Address:
    B.5.3.1Street AddressLijnbaan 32
    B.5.3.2Town/ cityDen Haag
    B.5.3.3Post code2512VA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031703302000
    B.5.6E-mailw.peul@mchaaglanden.nl
    B.Sponsor: 2
    B.1.1Name of SponsorMedical Centre Haaglanden (MCH)
    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 supportMedical Centre Haaglanden
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical Centre Haaglanden
    B.5.2Functional name of contact pointDepartment of Neurology
    B.5.3 Address:
    B.5.3.1Street AddressLijnbaan 32
    B.5.3.2Town/ cityDen Haag
    B.5.3.3Post code2512VA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031703302000
    B.5.6E-mailk.jellema@mchaaglanden.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 Dexamethasone (generic: i.e. Apotex, Centrafarm, Teva)
    D.2.1.1.2Name of the Marketing Authorisation holderVarious (i.e. Apotex, Centrafarm, Teva)
    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 IMPIntravenous use
    Oral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDEXAMETHASONE
    D.3.9.1CAS number 50-02-2
    D.3.9.4EV Substance CodeSUB07017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0,5 to 4
    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
    Chronic subdural hematoma.
    E.1.1.1Medical condition in easily understood language
    Bleeding within the skull.
    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 18.1
    E.1.2Level LLT
    E.1.2Classification code 10049163
    E.1.2Term Chronic subdural hematoma
    E.1.2System Organ Class 100000004863
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the effect of initial dexamethasone therapy compared to primary surgery on functional outcome (as expressed by the modified Rankin Score, mRS) in patients with a chronic subdural hematoma after 3 months.
    E.2.2Secondary objectives of the trial
    To compare other variables in both subject groups (dexamethasone versus surgery), such as:
    - Clinical outcome at discharge, 2 weeks and 6 months (expressed by mRS and Markwalder Grading Score, MGS).
    - Number of surgical intervention prevented in intervention (DXM) group.
    - Quality of life (as expressed by Short Form (36) Health Survey, at 6 months).
    - Haematoma thickness (after 2 weeks).
    - Haematoma recurrence: Recurrence of symptoms and neurological sign after initial improvement with persistence, recurrence or increase of CSDH on CT-scan (within the first 6 months).
    - Complications (during hospital stay and DXM therapy).
    - Mortality (within the first 3 months).
    - Drug related adverse events.
    - Duration of hospital stay.
    - Costs.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a subject must meet all of the following criteria:
    - Presence of a chronic subdural hematoma: An isodens or hypodens hematoma on cranial CT-scan. Hyperdens components may be present but must compromise less than 1/3 of the hematoma.
    - Clinical symptoms must correlate to the cerebral lesion.
    - Severity of symptoms must be Marwalder Grading Score 1-3.
    - Subject must be 18 years or older.
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this study:
    - An acute subdural haematoma.
    - Pregnancy.
    - Known hypersensitivity to DXM.
    - Known ulceration in the gastro-intestinal tract.
    - Uncontrolled diabetes mellitus (DM).
    - Clinical suspicion of an acute systemic infection (fever, leucocytosis, elevated C-reactive protein (CRP)).
    - History of gastro-intestinal bleeding.
    - Glaucoma.
    - Previous history of severe affective disorders on steroids (i.e. psychosis).
    E.5 End points
    E.5.1Primary end point(s)
    The functional outcome (as expressed by the modified Rankin Scale, mRS) in patients with a chronic subdural hematoma.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 3 months.
    E.5.2Secondary end point(s)
    Secondary Objectives:
    - Clinical outcome at discharge, 2 weeks and 6 months (expressed by mRS and Markwalder Grading Score, MGS).
    - Number of surgical intervention prevented in intervention (DXM) group.
    - Quality of life (as expressed by Short Form (36) Health Survey, at 6 months).
    - Haematoma thickness (after 2 weeks).
    - Haematoma recurrence: Recurrence of symptoms and neurological sign after initial improvement with persistence, recurrence or increase of CSDH on CT-scan (within the first 6 months).
    - Complications (during hospital stay and DXM therapy).
    - Mortality (within the first 3 months).
    - Drug related adverse events.
    - Duration of hospital stay.
    - Costs.
    E.5.2.1Timepoint(s) of evaluation of this end point
    As specified in E5.2
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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 Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Surgery (by performing a burr hole craniostomy)
    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 concerned3
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    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: 85
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 85
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    If a patient is not capable to give written informed consent (due to neurological deficits), the next of kin (e.g. the legal representative) will be asked to provide written informed consent.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state170
    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 Decision2016-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-20
    P. End of Trial
    P.End of Trial StatusOngoing
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