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    Summary
    EudraCT Number:2015-002142-31
    Sponsor's Protocol Code Number:547-SSE-301
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-08-05
    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 ConcernedGermany - BfArM
    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
    EINE RANDOMISIERTE, DOPPELBLINDE, PLACEBO-KONTROLLIERTE STUDIE ZUM NACHWEIS DER WIRKSAMKEIT UND SICHERHEIT VON SAGE-547 ZUR INJEKTION BEI DER BEHANDLUNG VON PATIENTEN MIT SUPERREFRAKTÄREM 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
    Klinische Studie zur Untersuchung der Wirksamkeit und Sicherheit von einem neuen Medikament BEWERTEN (SAGE-547) Injektion zur Behandlung der Patienten mit SUPER-refraktären Status epilepticus
    A.3.2Name or abbreviated title of the trial where available
    STATUS trial
    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 Concentrate for solution for 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 placeboConcentrate for solution for 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)
    SUPERREFRAKTÄREM STATUS EPILEPTICUS
    E.1.1.1Medical condition in easily understood language
    STATUS EPILEPTICUS NOT RESPONDING TO ANY OF THE CONVENTIONAL THERAPY REGIMEN
    Status epilepticus reagiert nicht auf irgendeines der herkömmlichen Therapie-Schema
    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 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).
    Ermittlung der Response auf eine 144-stündige (6-tägige) intravenöse Dauerinfusion von SAGE-547 im Vergleich zu Placebo, verabreicht zur Unterstützung des Absetzens aller Drittlinien-Medikamente bei Erwachsenen und Kindern mit SRSE, und der Response, die über mindestens 24 Stunden nach Abschluss der Infusion von SAGE-547 oder Placebo (primäre Response) anhält.
    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.
    Vergleich zwischen SAGE-547 und Placebo Bezug auf die Zeit ab Erreichen des Endpunkts der primären Response bis zur Wiedereinleitung eines Drittlinien-Medikaments wegen Anfall oder Burst Suppression bis zur V12;sekundäre Response, definiert als erfolgreiches Absetzen aller Drittlinien-Medikamente vor Beendigung der ersten Infusion von SAGE-547 oder Placebo;Zeit ab Erreichen des Endpunkts der sekundären Response, bis zur Wiedereinleitung eines Drittlinien-Medikaments wegen Anfall oder Burst Suppression während des Zeitraums bis zur V12;Änderungen in der CGI-Skala bis zur V12;Tagen nach Abschluss der ersten Infusion des Prüfpräparats bis zur V12, an denen der Prüfungsteilnehmer keinen Status epilepticus hat;Tagen nach Abschluss der ersten Infusion des Prüfpräparats bis zur V12 an denen der Prüfungsteilnehmer keine Anfälle hat;getrennten Episoden eines Status epilepticus bis zur V12; Prüfungsteilnehmern mit erneuter Epilepsie-Diagnose nach V11; Sicherheit und Verträglichkeit von 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 12 September 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.
    Pharmakogenomische Teilstudie. In der Hauptstudie Protokollversion Änderung 4 vom12 September 2016 enthalten.

    Das Ziel dieser Forschung ist es, sammeln und speichern Blutprobe auf mögliche DNA-Extraktion und orientierende Forschung in, wie Gene oder bestimmte genetische Variation kann Antwort beeinflussen (Verteilung, Sicherheit, Verträglichkeit und Wirksamkeit) an SAGE-547
    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 one 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.Patienten ab 18 Jahren
    2.Patienten, die:
    •Nicht angesprochen haben auf die Behandlung mit mindestens einem Erstlinien-Medikament (z. B. Benzodiazepin oder einem anderen Antiepileptikum der ersten Wahl) entsprechend der klinischen Standardversorgung, und
    •Nicht angesprochen haben auf die Behandlung mit mindestens einem Zweitlinien-Medikament (wie Phenytoin, Fosphenytoin, Valproinsäure, Phenobarbital, Levetiracetam oder andere Antiepileptika zur Notbehandlung) entsprechend der klinischen Standardversorgung, und
    •Noch nicht mit einem Drittlinien-Medikament behandelt worden sind, aber auf eine Intensivtherapiestation aufgenommen wurden, um mindestens ein Drittlinien-Medikament über mindestens 24 Stunden zu erhalten. Oder bei denen null oder mehrere vorherige Versuche, ein Drittlinien-Medikament abzusetzen, versagt hat bzw. haben und die zu diesem Zeitpunkt unter Dauerinfusion von einem oder mehreren Drittlinien-Medikamenten sind und ein Burst oder Anfall Suppression-Muster im EEG aufweisen. Oder bei denen ein oder mehrere vorherige Versuche, ein Drittlinien-Medikament abzusetzen, versagt hat bzw. haben und jetzt entweder nicht unter einer intravenösen Dauerinfusion von mindestens einem Drittlinien-Medikament sind oder unter einer intravenösen Dauerinfusion von einem oder mehreren Drittlinien-Medikamenten sind, aber kein Burst oder Anfall Suppression-Muster im EEG aufweisen.
    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:
    -a GFR low enough to warrant dialysis but for whatever reason, dialysis that would 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 measure.
    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.Patientinnen, die schwanger sind.
    2.Patienten mit einer bekannten Allergie gegen Progesteron, Allopregnanolon oder einen der sonstigen Bestandteile von SAGE-547.
    3.Patienten mit SRSE aufgrund einer anoxisch-hypoxischen Enzephalopathie, mit hoch malignen/malignen EEG Funktionen (Westhall, Rossetti et al. 2016).
    4.Patienten, bei denen eine der folgenden Umstände vorliegt:
    a. Eine niedrige GFR die eine Dialyse erfordert, aber aus beliebigen Gründen, eineDialyse durch die Captisol® nicht angemessen entfernt werden könnte ist nicht geplant.
    b.Ein schwerwiegender kardiogener oder vasodilatorischer Schock, der einen oder mehrere Vasopressoren erfordert und nicht mit der Anwendung des Drittlinien-Medikaments in Zusammenhang steht.
    c.Fulminantes Leberversagen.
    d.Wenn eine Besserung nicht zu erwarten ist (beispielsweise, wenn ein persistierender vegetativer Zustand das wahrscheinliche Ergebnis ist) oder die Lebenserwartung nach Ermessen des Prüfers weniger als 30 Tage beträgt.
    5.Patienten, denen gleichzeitig mehr als drei Drittlinien-Medikamente verabreicht werden oder bei denen das qualifizierende Absetzen nicht innerhalb von 24 Stunden abgeschlossen werden kann, oder denen ein Drittlinien-Medikament wegen anderer Indikationen verabreicht wurde, wie z. B. zur Kontrolle eines erhöhten intrakraniellen Drucks, was das Absetzen der Medikamente entsprechend diesem Prüfplan ausschließen würde.
    6.Patienten, deren Patientenverfügung keine großangelegten Maßnahmen erlaubt.
    7.Patienten, bei denen innerhalb von 30 Tagen ein Prüfpräparat (Arzneimittel oder Medizinprodukt) angewendet worden ist. Hiervon ausgenommen ist eine Teilnahme an der ESETT-Studie – Established Status Epilepticus Treatment Trial – , die innerhalb von 30 Tagen vor dem Screening für die 547-SSE-301-Studie möglich ist.
    8.Patienten, die bereits in diese Studie oder andere Studien mit SAGE-547 behandelt oder randomisiertwurden (d. h. es ist nicht möglich, dass Patienten Prüfpräparat/Placebo erhalten haben um sich erneut rekrutieren zu lassen).
    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).
    Erfolg oder Versagen, wobei Erfolg definiert ist als das Absetzen aller Drittlinien-Medikamente vor Beendigung der ersten, verblindeten Infusion von SAGE-547 oder Placebo, ohne dass bis mindestens 24 Stunden nach Beendigung der ersten Infusion von SAGE-547 oder Placebo wieder ein Drittlinien-Medikaments wegen Anfall oder Burst Suppression eingesetzt werden muss, sowie entsprechende Anzeichen einer physiologischen Hirnaktivität im EEG (primäre Response).
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 hours after the end of study drug infusion.
    24 Stunden nach dem Ende der Studienmedikation Infusion.
    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.Zeit ab Erreichen des Endpunkts der primären Response bis zur Wiedereinleitung einer Drittlinien-Therapie wegen Anfall oder Burst Suppression während des Zeitraums bis zur Visite 12.
    2.Sekundäre Response, definiert als erfolgreiches Absetzen aller Drittlinien-Medikamente vor Beendigung der ersten Infusion von SAGE-547 oder Placebo.
    3.Zeit ab Erreichen des Endpunkts der sekundären Response, wie oben unter Punkt (2) definiert, bis zur Wiedereinleitung einer Drittlinien-Therapie wegen Anfall oder Burst Suppression während des Zeitraums bis zur Visite 12.
    4.Beurteilung des klinischen Status anhand der Änderungen in der CGI-Skala ab Visite 1 (Screening) bis Visite 12.
    5.Anzahl von Tagen nach Beendigung der ersten Infusion des Prüfpräparats bis zur Visite 12, an denen der Patient keinen Status epilepticus hat.
    6.Anzahl von Tagen nach Beendigung der ersten Infusion des Prüfpräparats bis zur Visite 12, an denen der Patient keine (konvulsiven oder nichtkonvulsiven) Anfälle hat.
    7.Anzahl der getrennten Episoden eines Status epilepticus, die bis zur Visite 12 auftreten.
    8.Anteil der Patienten mit erneuter Epilepsie-Diagnose nach Visite 11.
    Sicherheits-Endpunkte:
    1.Unerwünschte Ereignisse und Behandlungen
    2.Labortests (Blutbild, Serumchemie und Urinanalyse)
    3.Vitalzeichen (Blutdruck, Herzfrequenz, Körpertemperatur und Körpergewicht)
    4.EKG-Parameter
    5.Mortalität
    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
    Wirksamkeit: bis zu besuchen 12 oder bis zu besuchen 11 fur Endpunkt # 8.
    Sicherheit:
    AEs und Medikamente: V1-V12
    EKG und Vitalfunktionen: V1, V3-V10
    Labortests: V1, V3, V4, V6, V8, V10, V11
    Sterblichkeit: V12
    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 concerned6
    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 years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 2015-08-05. 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
    Patienten, die nicht in der Lage, persönlich zu geben ihre Zustimmung zu der Studie, weil komatösen oder geistiger Behinderung
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    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
    Laut Standard der Versorgung
    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 Decision2016-08-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-08-11
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