Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2015-002142-31
    Sponsor's Protocol Code Number:547-SSE-301
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-10-22
    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 ConcernedDenmark - DHMA
    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
    ET RANDOMISERET, DOBBELTBLINDET, PLACEBOKONTROLLERET FORSØG TIL VURDERING AF VIRKNINGEN OG SIKKERHEDEN AF SAGE 547-INJEKTION TIL BEHANDLING AF FORSØGSPERSONER MED SUPERREFRAKTÆR 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
    STATUS FORSØG
    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)
    SUPERREFRAKTÆR STATUS EPILEPTICUS
    E.1.1.1Medical condition in easily understood language
    STATUS EPILEPTICUS NOT RESPONDING TO ANY OF THE CONVENTIONAL THERAPY REGIMEN
    STATUS EPILEPTICUS IKKE RESPONDEREDE PÅ KONVENTIONELL BEHANDLING
    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 19.0
    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 and pediatric subjects with SRSE, and for the response to endure at least 24 hours after cessation of the SAGE-547 or placebo infusion (primary response).
    At påvise respons på en 144 timers (6 dages) kontinuerlig, intravenøs infusion af SAGE-547 sammenlignet med placebo administreret som støtte til udtrapning af alle 3. linje stoffer hos voksne og pædiatriske forsøgspersoner med SRSE, og at responset varer ved i mindst 24 timer efter afslutningen på infusionen af SAGE-547 eller placebo (primære 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.
    At sammenligne SAGE-547 og placebo: hvor lang tid der går fra, at det primære endepunkt for respons opnås, indtil eventuelle 3. linje stoffer for anfald eller burst-suppression genoptages indtil B12; vellykket udtrapning af alle forsøgspersonens 3. linje stoffer inden afslutningen på den første infusion SAGE-547 eller placebo; hvor lang tid der går fra, at det sekundære endepunkt defineret ovenfor opnås, indtil eventuelle 3. linje stoffer for anfald eller burst-suppression genoptages indtil B12; ændringen i CGI-skala indtil B12; at bestemme det antal dage efter afslutningen på den første infusion forsøgslægemiddel, som forsøgspersonen ikke har status epilepticus indtil B12 og, som forsøgspersonen ikke har anfald indtil B12; antallet af separate episoder af status epilepticus, som forekommer indtil B12; forsøgspersoner med en ny epilepsidiagnose efter B11; At påvise sikkerheden og tolerabiliteten af en 144-timers infusion af 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.
    Farmakogenomisk sub-studie. Inkluderet i hovedundersøgelsen protokolversion ændringsforslag 4 af 18. august 2016.

    Formålet med denne forskning er at indsamle og opbevare blodprøve for mulig DNA-ekstraktion og sonderende forskning i, hvordan gener eller specifik genetisk variation kan påvirke respons (dvs. distribution, sikkerhed, tolerabilitet og effekt) til SAGE-547
    E.3Principal inclusion criteria
    1. Subjects eighteen (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.Forsøgspersonen er atten (18) år gammel eller derover.
    2.Forsøgspersoner, som:
    •Ikke responderede på administrationen af mindst et 1. linje stof (f.eks. benzodiazepin eller anden ny førstegangs AED-behandling) i henhold til hospitalets standardpleje og
    •Ikke responderede på mindst ét 2. linje stof (f.eks. phenytoin, fosphenytoin, valproat, phenobartial, levetiracetam eller andet akut kontrol-AED) i henhold til hospitalets standardpleje
    • Ikke tidligere har fået administreret et 3. linje stof, men er blevet indlagt på en intensivafdeling med henblik på at få administreret mindst ét 3. linje stof i mindst 24 timer, eller som har et eller flere tidligere mislykkede udtrapningsforsøg fra 3. linje stoffer, og som nu er på kontinuerlige, intravenøse infusioner af et eller flere 3. linje stoffer og er i et EEG burst eller konvulsioner suppressionsmønster, eller for hvem et eller flere tidligere forsøg på udtrapning af et 3. linje stof ikke er lykkedes og nu enten ikke er på en kontinuerlig, intravenøs infusion af mindst ét 3. linje stof, eller som nu er på en kontinuerlig, intravenøs infusion af et eller flere 3. linje stoffer, men ikke er i et EEG burst eller konvulsioner suppressionsmønster.
    E.4Principal exclusion criteria
    1. Subjects who are pregnant.
    2. Subjects with a known allergy to progesterone or allopregnanolone.
    3. Subjects with SRSE due to anoxic/hypoxic encephalopathy, with highly malignant/malignant EEG features (Westhall, Rossetti et al. 2016)
    4. Subjects who have any of the following:
    -GFR low enough to warrant dialysis but for whatever reason, dialysis that would not adequately remove Captisol®is not planned;
    -severe cardiogenic or vasodilatory shock requiring two or more pressors that is not related to third-line agent use;
    -fulminant hepatic failure;
    -no reasonable expectation of recovery (for instance, a likely outcome is persistent vegetative state) or life-expectancy, in the experience of the investigator, is less than 30 days;
    5. Subjects who are being administered more than three third-line agents concomitantly or for whom the qualifying wean cannot be completed within 24 hours or who are being administered a third-line agent for indications such as 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.Forsøgspersoner, som er gravide.
    2.Forsøgspersoner med kendt overfølsomhed over for progesteron eller allopregnanolon eller et eller flere af hjælpestofferne i SAGE-547.
    3.Forsøgspersoner med SRSE, som skyldes anoksisk/hypoksisk encefalopati, med meget maligne / maligne EEG funktioner (Westhall, Rossetti et al. 2016)
    4.Forsøgspersoner, som har et eller flere af følgende:
    a. Et GFR, der er lavt nok til berettige dialyse uanset grund, men dialyse som ikke i tilstrækkelig grad vil kunne fjerne Captisol® er ikke planlagt
    b.Svært kardiogent eller vasodilatorisk shock, som kræver to eller flere pressorstoffer, som ikke er relateret til brugen af 3. linje stoffer
    c.Fulminant leversvigt
    d.Ingen rimelig forventning om bedring (et sandsynligt udfald kunne f.eks. være persisterende vegetativ tilstand), eller at forsøgspersonens forventede levetid, ifølge investigatorens faglige skøn, er mindre end 30 dage
    5.Forsøgspersoner, som får administreret mere end tre 3. linje stoffer samtidigt, eller for hvem den kvalificerende udtrapning ikke kan gennemføres på 24 timer, eller som får administreret et 3. linje stof for andre indikationer, f.eks. behandling af forhøjet intrakranielt tryk, som kunne udelukke udtrapning i henhold til denne protokol.
    6.Forsøgspersoner med et livstestamente, som ikke ønsker genoplivning.
    7.Forsøgspersoner, som har været eksponeret for et forsøgslægemiddel eller -instrument inden for 30 dage, dog undtagen deltagelse i forsøget ESETT (Established Status Epilepticus Treatment Trial) inden for 30 dage fra screening for 547-SSE-301-forsøget, hvilket er tilladt.
    8.Forsøgspersoner, som tidligere har været behandlet eller randomiseret i dette forsøg eller et andet forsøg, som brugte SAGE-547 (dvs. forsøgspersoner kan ikke har modtaget undersøgelsens lægemiddel eller placebo og derefter blive inkluderet igen).
    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 eller fiasko, hvor succes er defineret som udtrapning af forsøgspersonen fra alle 3. linje stoffer, inden den første infusion blindet SAGE-547 eller placebo er færdig, og uden at et 3. linje stof for kramper eller burst-suppression skal genoptages i 24 timer efter afslutningen på den første infusion SAGE-547 eller placebo, og samtidige tegn på fysiologisk hjerneaktivitet påvist ud fra EEG (primære respons)
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 hours after the end of study drug infusion.
    24 timer efter afslutningen af infusionen forsøgsmedicinen.
    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.Hvor lang tid der går fra, at det primære endepunkt for respons opnås, og indtil eventuelle 3. linje stoffer for kramper eller burst-suppression genoptages indtil Besøg 12.
    2.Sekundært respons, defineret som vellykket udtrapning af alle 3. linje stoffer inden afslutningen på den første infusion SAGE-547 eller placebo.
    3.Hvor lang tid der går fra, at det sekundære endepunkt for respons opnås, defineret i (2) ovenfor, indtil eventuelle 3. linje stoffer for anfald eller burst-suppression genoptages indtil Besøg 12.
    4.Vurderingen af klinisk status, som måles ud fra ændringen i CGI fra Besøg 1 (Screening) til Besøg 12.
    5.Antal dage efter afslutningen på den første infusion af forsøgslægemidlet, som forsøgspersonen ikke har status epilepticus indtil Besøg 12.
    6.Antal dage efter afslutningen på den første infusion af forsøgslægemidlet, som forsøgspersonen ikke har anfald (konvulsive og ikke-konvulsive) indtil Besøg 12.
    7.Antal separate episoder af status epilepticus, som forekommer indtil Besøg 12.
    8.Andelen af forsøgspersoner med en ny epilepsidiagnose efter Besøg 11.
    Sikkerhedsmæssige endepunkter:
    1.Utilsigtede hændelser og lægemidler
    2.Laboratorieprøver (hæmatologi, serumkemi og urinanalyse)
    3.Vitale værdier (blodtryk, hjertefrekvens, temperatur og vægt)
    4.EKG-parametre
    5.Mortalitet.
    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
    Effekt: op til at besøge 12 eller efter besøg 11 til end-point # 8.
    sikkerhed:
    AES og medicin: B1-B12
    EKG og vitale tegn: B1, B3-B10
    Laboratorieundersøgelser: B1, B3, B4, B6, B8, B10, B11:
    Dødelighed: B12
    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 concerned2
    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
    Canada
    Denmark
    Estonia
    Finland
    France
    Germany
    Hungary
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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 2015-10-22. 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
    Emner er usandsynligt, at være i stand til at samtykke sig for studiet på grund af koma eller psykisk uarbejdsdygtighed
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    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
    Ifølge standard for pleje
    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 Decision2015-10-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-08-11
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Apr 27 15:04:08 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA