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    Summary
    EudraCT Number:2015-002142-31
    Sponsor's Protocol Code Number:547-SSE-301
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-11-06
    Trial results View 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 number2015-002142-31
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SAGE-547 INJECTION IN THE TREATMENT OF SUBJECTS WITH SUPER-REFRACTORY STATUS EPILEPTICUS
    Een gerandomiseerde, dubbelblinde, placebogecontroleerde studie ter beoordeling van de werkzaamheid en veiligheid van SAGE-547 injectie voor de behandeling van proefpersonen met super-refractaire status epilepticus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF A NEW DRUG (SAGE-547) INJECTION IN THE TREATMENT OF SUBJECTS WITH SUPER-REFRACTORY STATUS EPILEPTICUS
    A.3.2Name or abbreviated title of the trial where available
    STATUS trial
    A.4.1Sponsor's protocol code number547-SSE-301
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02477618
    A.5.4Other Identifiers
    Name:IND numberNumber:117901
    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 SponsorSage Therapeutics
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSAGE THERAPEUTICS
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSAGE Therapeutics
    B.5.2Functional name of contact pointMedical Director
    B.5.3 Address:
    B.5.3.1Street Address215 First Street
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02142
    B.5.3.4CountryUnited States
    B.5.4Telephone number001617229-5234
    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 No
    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.3.2Product code SAGE-547
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot available yet
    D.3.9.1CAS number 516-54-1
    D.3.9.2Current sponsor codeSAGE-547
    D.3.9.3Other descriptive nameallopregnanolone
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    SUPER-REFRACTORY STATUS EPILEPTICUS (SRSE)
    SUPER-REFRACTAIRE STATUS EPILEPTICUS
    E.1.1.1Medical condition in easily understood language
    STATUS EPILEPTICUS NOT RESPONDING TO ANY OF THE CONVENTIONAL THERAPY REGIMEN
    Status epilepticus reageert niet op een van de conventionele
    therapieregime
    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 19.1
    E.1.2Level PT
    E.1.2Classification code 10041962
    E.1.2Term Status epilepticus
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the response to a 144-hour (6 day) continuous intravenous infusion of SAGE-547 compared to placebo administered to support the weaning of all third-line agents in adult subjects with SRSE, and for the response to endure at least 24 hours after cessation of the SAGE-547 or placebo infusion (primary response).
    Vaststellen wat de respons is op een 144 uur (6 dagen) durende continue intraveneuze infusie van SAGE-547 vergeleken met placebo, toegediend ter ondersteuning van de afbouw van alle derdelijnsgeneesmiddelen bij volwassenen proefpersonen met SRSE, en opdat de respons ten minste 24 uur dient te duren na de beëindiging van de infusie met SAGE-547 of placebo (primaire respons).
    E.2.2Secondary objectives of the trial
    To compare between SAGE-547 and placebo: time between meeting primary response endpoint and re-institution of any third-line agent for seizure or burst suppression up to V12; secondary response, (success of weaning the subject off all third-line agents before end of the first infusion; time between meeting the secondary response endpoint and re-institution of any third-line agent for seizure or burst suppression up to V12; Change in the Clinical Global Impression scale up to V12; number of days after the end of the first infusion of study drug that the subject does not have status epilepticus, up to V12; number of days after end of the first infusion of study drug that the subject does not have seizures (convulsive and non-convulsive) up to V12; number of separate episodes of status epilepticus occurring up to V12; the proportion of subjects with a new diagnosis of epilepsy after V11.
    To determine safety and tolerability of a 144-hour infusion of SAGE-547.
    .
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenomic sub-study. Included in the main study protocol version amendment 4 dated 18 August 2016.

    The objective of this research is to collect and store blood sample for possible DNA extraction and exploratory research into how genes or specific genetic variation may influence response (i.e. distribution, safety, tolerability, and efficacy) to SAGE-547.
    Farmacogenomische sub- studie. Inbegrepen in het hoofdonderzoek protocol
    versie wijziging 4 dd 18 augustus 2016 .

    Het doel van dit onderzoek is het verzamelen en opslaan bloedmonster voor
    mogelijke DNA-extractie en verkennend onderzoek naar hoe genen of
    specifieke genetische variatie respons ( dwz distributie, veiligheid, verdraagbaarheid en werkzaamheid ) naar SAGE - 547 kunnen beïnvloeden.
    E.3Principal inclusion criteria
    1. Subjects 18 years of age and older.
    2. Subjects who have:
    • Failed to respond to the administration of at least one first-line agent (e.g., benzodiazepine or other emergent initial AED treatment), according to institution standard of care, and;
    • Failed to respond to at least one second-line agent (e.g., phenytoin, fosphenytoin, valproate, phenobarbital, levetiracetam or other urgent control AED), according to institution standard of care, and;
    • Not previously been administered a third-line agent but have been admitted to an intensive care unit with the intent of administering at least one third-line agent for at least 24 hours; or who have previously failed zero or more wean attempts from third-line agents and are now on continuous intravenous infusions of one or more third-line agent and in an EEG burst or seizure suppression pattern; or who have previously failed one or more wean attempts from third-line agents and are now either not on a continuous intravenous infusion of at least one third-line agent or are on a continuous intravenous infusion of one or more third-line agent but not in an EEG burst or seizure suppression pattern.
    1.Proefpersonen moeten 18 jaar of ouder zijn.
    2.Proefpersonen die:
    •niet reageerden op de toediening van ten minste één eerstelijnsgeneesmiddel (bv. benzodiazepine of andere dringende initiële anti-epileptische behandeling), in overeenstemming met de zorgstandaard van de instelling, en;
    •niet reageerden op ten minste één tweedelijnsgeneesmiddel (bv. fenitoïne, fosfenitoïne, valproaat, fenobarbital, levetiracetam of andere dringende anti-epileptische middelen ter beheersing van aanvallen), in overeenstemming met de zorgstandaard van de instelling, en; eerder geen derdelijnsgeneesmiddel toegediend kregen maar werden opgenomen op de intensive care met als doel ten minste één derdelijnsgeneesmiddel toegediend te krijgen gedurende minstens 24 uur; of bij wie geen of meerdere afbouwpogingen van derdelijnsgeneesmiddelen niet geslaagd zijn en die nu aan continue intraveneuze infusies van één of meer derdelijnsgeneesmiddel(en) liggen en in een burst of aanvals-suppressie patroon van het EEG zitten; of bij wie een of meerdere afbouwpogingen van derdelijnsgeneesmiddelen niet geslaagd zijn en nu ofwel niet aan een continue intraveneuze infusie van ten minste één derdelijnsgeneesmiddel liggen ofwel aan een continue intraveneuze infusie van een of meerdere derdelijnsgeneesmiddelen liggen maar niet in een burst-suppressie patroon van het EEG zitten of in een aanvals-onderdrukkend patroon.
    E.4Principal exclusion criteria
    1. Subjects who are pregnant.
    2. Subjects with a known allergy to progesterone or allopregnanolone or any excipients in SAGE-547.
    3. Subjects with SRSE due to anoxic/hypoxic encephalopathy with highly malignant/malignant EEG features (Westhall, Rosetti et al. 2016).
    4. Subjects who have any of the following: a. a GFR low enough to warrant dialysis but for whatever reason, dialysis that would adequately remove Captisol® is not planned; b. severe cardiogenic or vasodilatory shock requiring two or more pressors that is not related to third-line agent use; c. fulminant hepatic failure; d. no reasonable expectation of recovery (for instance, a likely outcome is persistent vegetative state) or life-expectancy, in the opinion of the investigator, of less than 30 days;
    5. Subjects who are being administered more than three third-line agents concomitantly or in whom the qualifying wean cannot be completed within 24 hours, or who are being administered a third-line agent for other indications such as management of raised intra-cranial pressure that would preclude weaning according to this protocol.
    6. Subjects with a living will that does not allow heroic measures.
    7. Subjects who have been exposed to an investigational medication or device within 30 days; the exception to this is that participation in the Established Status Epilepticus Treatment Trial or ESETT within 30 days of screening for the 547-SSE-301 trial is allowed.
    8. Subjects who have been treated or randomized in this trial or any other trial employing SAGE-547 previously (i.e., subjects may not have received study drug/placebo and then re-enroll).
    1.Personen die zwanger zijn.
    2.Proefpersonen met een bekende allergie voor progesteron of allopregnanolon of voor hulpstoffen die aanwezig zijn in SAGE-547.
    3.Proefpersonen met SRSE vanwege anoxische/hypoxische encefalopathie met hoge malige/maligne EEG kenmerken.
    4.Proefpersonen die aan een van de volgende beschrijvingen voldoen: a.een glomerulusfiltratiesnelheid (GFR) die laag genoeg is om dialyse te rechtvaardigen, maar om welke reden dan ook een dialyse die Captisol® afdoende zou verwijderen is niet gepland; b.ernstige cardiogene of vaatverwijdende shock waardoor twee of meer bloeddrukverhogende middelen nodig zijn, en die geen verband houdt met het gebruik van derdelijnsgeneesmiddelen; c.Fulminant leverfalen; d.geen redelijke herstelverwachting (bijvoorbeeld, patiënt zal wellicht in een vegetatieve toestand blijven) of een levensverwachting, naar het oordeel van de onderzoeker, van minder dan 30 dagen;
    5.Proefpersonen die gelijktijdig meer dan drie derdelijnsgeneesmiddelen toegediend krijgen of bij wie de kwalificerende afbouw niet binnen de 24 uur bewerkstelligd kan worden, of die een derdelijnsgeneesmiddel toegediend krijgen voor andere indicaties zoals de beheersing van verhoogde intracraniële druk die afbouw volgens dit protocol zou uitsluiten.
    6.Proefpersonen met een “living will” (“levend testament”) waarin geen plaats is voor heroïsche maatregelen. 7.Proefpersonen die tijdens de laatste 30 dagen blootgesteld werden aan een onderzoeksmedicatie of -hulpmiddel; uitzondering hierop is deelname aan de Established Status Epilepticus Treatment Trial (of ESETT) binnen 30 dagen van de screening voor de 547-SSE-301 proef, wat wel toegestaan is.
    8.Proefpersonen die eerder warden behandeld of warden gerandomiseerd in deze trial of welke andere trial dan ook waarin SAGE-547 werd toegediend (d.w.z. proefpersonen mogen geen studiemedicatie/placebo hebben ontvangen en vervolgens opnieuw geincludeerd worden).
    E.5 End points
    E.5.1Primary end point(s)
    Success or failure, with success defined as weaning the subject off all third-line agents before completion of the first blinded infusion of SAGE-547 or placebo, and not having to re-institute any third-line agent for seizure or burst suppression during the 24 hours after the end of the first infusion of SAGE-547 or placebo, and concurrent signs of physiologic brain activity as determined by EEG (primary response).
    Succes of falen, waarbij succes gedefinieerd wordt als het afbouwen bij de proefpersoon van alle derdelijnsgeneesmiddelen vóór de voltooiing van de eerste geblindeerde infusie van SAGE-547 of placebo, en het niet opnieuw hoeven instellen van een derdelijnsgeneesmiddel voor onderdrukking van aanvallen of burst-suppression tijdens de eerste 24 uur na het einde van de eerste infusie van SAGE-547 of placebo, en gelijktijdig optredende tekenen van fysiologische hersenactiviteit zoals bepaald door EEG (primaire respons).
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 hours after the end of study drug infusion.
    24 uur na het einde van het infuus met studie geneesmiddel
    E.5.2Secondary end point(s)
    1. The time between meeting the primary response endpoint and the re-institution of any third-line agent for seizure or burst suppression up to Visit 12;
    2. Secondary response, defined as success of weaning the subject off all third-line agents before the end of the first SAGE-547 or placebo infusion;
    3. The time between meeting the secondary response endpoint, defined in (2) above, and the re-institution of any third-line agent for seizure or burst suppression up to Visit 12;
    4. The assessment of clinical status as measured by change in the CGI from Visit 1 (Screening) and to Visit 12;
    5. The number of days after the end of the first study drug infusion that the subject does not have status epilepticus, up to Visit 12;
    6. The number of days after the end of the first study drug infusion that the subject does not have seizures (convulsive and non-convulsive) up to Visit 12;
    7. The number of separate episodes of status epilepticus occurring up to Visit 12;
    8. The proportion of subjects with a new diagnosis of epilepsy after Visit 11.

    Safety endpoints:
    1.Adverse events and medications;
    2.Laboratory testing (hematology, serum chemistry, and urinalysis);
    3.Vital signs (blood pressure, heart rate, temperature, and weight);
    4.ECG parameters;
    5.Mortality.
    1.De tijd tussen het bereiken van het eindpunt van de primaire respons en de herinstelling van welk derdelijnsgeneesmiddel dan ook voor onderdrukking van aanvallen of burst-suppression tot aan Bezoek 12;
    2.Secundaire respons, gedefinieerd als succes bij het geleidelijk afbouwen bij de proefpersoon van alle derdelijnsgeneesmiddelen vóór het einde van de eerste infusie van SAGE-547 of placebo;
    3.De tijd tussen het bereiken van het eindpunt van de secundaire respons, hierboven onder (2) gedefinieerd, en de herinstelling van welk derdelijnsgeneesmiddel dan ook voor onderdrukking van aanvallen of burst-suppression tot aan Bezoek 12;
    4.De beoordeling van de klinische status zoals gemeten door de verandering in de CGI van Bezoek 1 (Screening) tot aan Bezoek 12;
    5.Het aantal dagen na beëindiging van de eerste infusie van het onderzoeksgeneesmiddel gedurende welke de proefpersoon geen status epilepticus heeft, tot aan Bezoek 12;
    6.Het aantal dagen na beëindiging van de eerste infusie van het onderzoeksgeneesmiddel gedurende welke de proefpersoon geen aanvallen (convulsieve en niet-convulsieve) heeft, tot aan Bezoek 12;
    7.Het aantal afzonderlijke episoden van status epilepticus die voorvielen tot aan Bezoek 12;
    8.Het percentage proefpersonen met een nieuwe epilepsiediagnose na Bezoek 11.

    Veiligheidseindpunten:
    1.Bijwerkingen en medicaties;
    2.Laboratoriumonderzoek (hematologie, serumchemie en urineonderzoek);
    3.Vitale functies (bloeddruk, hartslag, temperatuur en gewicht);
    4.ECG-parameters;
    5.Mortaliteit.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy: up to visit 12 or after visit 11 for end-point # 8.
    Safety:
    AEs and medications: V1-V12
    ECG and vital signs: V1, V3-V10
    Lab tests: V1, V3, V4, V6, V8, V10,V11
    Mortality: V12

    Retreatment period:
    AE and medications: V3R-V12R
    ECG and vital signs: V3R-V10R
    Lab tests: V3R, V4R, V6R, V8R, V10R, V11R
    Mortality: V12R
    Werkzaamheid: tot aan B12 of na B11 voor eindpunt #8

    Veiligheid:
    Bijwerkingen en medicaties: B1-B12
    ECG en vitale functies: B1, B3-B10
    Laboratoriumonderzoek: B1, B3, B4, B6, B8, B10, B11
    Mortaliteit: B12

    Herbehandeling periode
    Bijwerkingen en medicaties: B3R- B12R
    ECG en vitale functies: B3R-B10R
    Laboratoriumonderzoek: B3R, B4R, B6R, B8R, B10R, B11R
    Mortaliteit: B12R
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Belgium
    Bulgaria
    Canada
    Denmark
    Estonia
    Finland
    France
    Germany
    Hungary
    Ireland
    Israel
    Italy
    Netherlands
    Serbia
    Spain
    Sweden
    United Kingdom
    United States
    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
    LBLP = laatste bezoek van de laatste proefpersoon
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months10
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 28
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 14
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 14
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 84
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 28
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2015-11-06. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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
    Subjects are unlikely to be able to consent themselves for the study due to coma or mental incapacity
    Proefpersonen zullen waarschijnlijk niet in staat zijn om toestemming te verlenen voor de studie doordat ze in coma zijn of geestelijk onbekwaam
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 140
    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)
    According to standard of care
    Volgens standard zorg
    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 Decision2015-11-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-12
    P. End of Trial
    P.End of Trial StatusCompleted
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