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    Summary
    EudraCT Number:2015-005033-53
    Sponsor's Protocol Code Number:EG-01-1962-03
    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:2016-09-02
    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 number2015-005033-53
    A.3Full title of the trial
    Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study Comparing EG-1962 to Standard of Care Oral Nimodipine in Adults with Aneurysmal Subarachnoid Hemorrhage.
    Eine multizentrische, randomisierte, doppelblinde, placebokontrollierte Parallelgruppenstudie der Phase III zur Wirksamkeit und Sicherheit von EG-1962 im Vergleich zur Standardtherapie (orales Nimodipin) bei erwachsenen Patienten mit einer Subarachnoidalblutung infolge einer Aneurysmenruptur.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to compare the investigational drug EG-1962 with standard of care oral nimodipine in adults with Subarachnoid Hemorrhage caused by a ruptured aneurysm.
    Eine klinische Studie zum Vergleich des Prüfpräparates EG-1962 mit der Standardbehandlung orales Nimodipin bei Erwachsenen mit Hirnblutung infolge einer Aneurysmaruptur.
    A.3.2Name or abbreviated title of the trial where available
    Newton 2 Trial
    Newton 2 Studie
    A.4.1Sponsor's protocol code numberEG-01-1962-03
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02790632
    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 SponsorEdge Therapeutics, Inc
    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 supportEdge Therapeutics, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEdge Therapeutics, Inc
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address200 Connell Drive, Suite 1600
    B.5.3.2Town/ cityBerkeley Heights, NJ
    B.5.3.3Post code07922
    B.5.3.4CountryUnited States
    B.5.4Telephone number+19083445257
    B.5.5Fax number+19087901212
    B.5.6E-mailregdocs@edgetherapeutics.com
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/15/1554 - EMA/OD/088/15
    D.3 Description of the IMP
    D.3.1Product nameEG-1962
    D.3.2Product code EG-1962
    D.3.4Pharmaceutical form Powder and solvent for prolonged-release suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraventricular use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNIMODIPINE
    D.3.9.1CAS number 66085-59-4
    D.3.9.2Current sponsor codeEG-1962
    D.3.9.4EV Substance CodeSUB09297MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Nimotop
    D.2.1.1.2Name of the Marketing Authorisation holderBayer PLC
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.1Product nameNimodipine
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNIMODIPINE
    D.3.9.1CAS number 66085-59-4
    D.3.9.4EV Substance CodeSUB09297MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    D.8.4Route of administration of the placeboIntraventricular use (Noncurrent)
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Aneurysmal subarachnoid hemorrhage (aSAH)
    E.1.1.1Medical condition in easily understood language
    Subarachnoid hemorrhage is a bleeding in the space between the brain and surrounding membrane. Bleeding results from the rupture of an abnormal bulge in a blood vessel in the brain (brain aneurysm).
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10072200
    E.1.2Term Asymptomatic subarachnoid hemorrhage
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10042320
    E.1.2Term Subarachnoid hemorrhage
    E.1.2System Organ Class 100000004863
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of intraventricular EG-1962 to standard of care oral nimodipine in subjects with aSAH.
    E.2.2Secondary objectives of the trial
    To determine the safety of intraventricular EG-1962 compared to standard of care oral nimodipine in subjects with aSAH.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female between the ages of 18 to 75 years, inclusive
    2. Ruptured saccular aneurysm confirmed by angiography (CTA, MRA or catheter) and repaired
    by neurosurgical clipping or endovascular coiling
    3. Subarachnoid hemorrhage on CT scan (pre-repair) of grade 2-4 on the modified Fisher scale
    (diffuse [clot present in both hemispheres] thick or thin, or local thick)
    4. External ventricular drain in place
    5. WFNS grade 2, 3, or 4 assessed during the Pre-randomization Phase after repair of the
    aneurysm but prior to randomization
    6. The subject must be able to receive intraventricular IP within 48 hours after the onset of aSAH and within 4 hours after the start time of intraventricular IP suspension in the pharmacy. Onset of aSAH is defined as the time the subject experiences the first symptom of aSAH (e.g., severe headache or loss of consciousness reported either by the subject or by a witness). If found unconscious, the onset of SAH is defined as the time the subject was last known normal
    7. Female subjects of child-bearing potential must have a negative pregnancy test (urine or serum) during the Pre-randomization Phase and must agree to use adequate birth control for at least 30 days following the end of the Treatment Period. Male subjects must agree to use adequate birth for at least 30 days after the end of the Treatment Period
    8. Signed informed consent from the subject or the subject’s legal representative after the
    completion of aneurysm repair but prior to any study-specific procedures being performed
    9. Able and willing to comply with follow up visit schedule
    1. Männliche und weibliche Patienten im Alter zwischen 18 und 75 Jahren (einschließlich)
    2. Vorliegen eines durch eine Angiographie (CRA, MRA oder Katheter) belegten rupturierten sakkulären Aneurysmas, das mit einem neurochirurgischen Clipping oder endovaskulären Coiling versorgt wurde
    3. Subarachnoidale Blutung, nachweisbar in der computertomographischen Aufnahme (vor Behandlung) vom Grad 2-4 auf der modifizierten Fisher-Skala (diffus [Thrombus in beiden Hemisphären], dick oder dünn, oder lokal verdickt)
    4. Patient wurde mit einer externen ventrikulären Drainage versorgt
    5. WFNS-Graduierung 2, 3 oder 4, bestimmt in der Prä-Randomisierungsphase nach der Versorgung des Aneurysmas, aber vor der Randomisierung
    6. Der Patient muss in der Lage sein, innerhalb von 48 Stunden nach Eintreten der SAr und innerhalb von 4 Stunden nach Beginn der Zubereitung der Prüfpräparat-Suspension in der Apotheke eine intraventrikuläre Infusion mit dem Prüfpräparat zu erhalten. Als Zeitpunkt des Eintretens der SAr gilt der Zeitpunkt, zu dem der Patient die ersten Symptome einer SAr feststellt (z. B. starke Kopfschmerzen oder Bewusstseinsverlust, berichtet durch den Patienten selbst oder einen Zeugen). Wenn der Patient bewusstlos aufgefunden wird, gilt der Zeitpunkt, zu dem er zum letzten Mal nachweislich symptomfrei war, als Zeitpunkt des Eintretens
    7. Für weibliche Patienten im gebärfähigen Alter muss ein negativer Schwangerschaftstest (Urin oder Serum) während der Prä-Randomisierungsphase vorliegen, und sie müssen einwilligen, über einen Zeitraum von mindestens 30 Tagen nach dem Ende des Behandlungszeitraums eine geeignete Verhütungsmethode anzuwenden. Männliche Patienten müssen einwilligen, über einen Zeitraum von mindestens 30 Tagen nach Ende des Behandlungszeitraums eine geeignete Verhütungsmethode anzuwenden
    8. Vorliegen einer unterschriebenen Einwilligungserklärung des Patienten oder seines gesetzlichen Vertreters nach Abschluss der chirurgischen Versorgung des Aneurysmas, aber vor Beginn jedweder studienbezogenen Maßnahmen
    9. Willens und in der Lage, den Untersuchungsplan für die Nachbeobachtung einzuhalten
    E.4Principal exclusion criteria
    1. Major complication during aneurysm repair such as, but not limited to, massive intraoperative hemorrhage, brain swelling, arterial occlusion, or inability to secure the ruptured aneurysm
    2. Angiographic vasospasm prior to randomization
    3. Clinical or radiological evidence of a cerebral infarction with neurological deficit
    4. Increased intracranial (ICP) pressure >30 mm Hg lasting >4 hours anytime during the Prerandomization Phase
    5. Substantial intraventricular hemorrhage
    6. Aneurysm repair requiring flow diverting stent or stent-assisted coiling and dual antiplatelet
    therapy
    7. Subject is expected to undergo repair of additional aneurysms within 90 days in cases where
    multiple aneurysms were identified during the Pre-randomization PhaseHemodynamically unstable during the Pre-randomization Phase (i.e., systolic blood pressure (SBP) <100 mm Hg, requiring >6 L colloid, or crystalloid fluid resuscitation)
    9. Cardiopulmonary resuscitation was required during the Pre-randomization Phase
    10. Symptoms or electrocardiogram (ECG) signs of acute myocardial infarction or unstable angina pectoris prior to randomization
    11. Electrocardiogram evidence and/or physical findings compatible with second or third degree heart block or of cardiac arrhythmia associated with hemodynamic instability
    12. Echocardiogram, if performed as part of standard of care before randomization, revealing a left ventricular ejection fraction <40%
    13. Severe or unstable concomitant condition or disease (e.g., known significant neurologic deficit, cancer, hematologic or coronary disease), or chronic condition (e.g., liver disease, kidney disease or psychiatric disorder), that, in the opinion of the investigator, may increase the risk associated with study participation or IP administration, or may interfere with the interpretation of study results
    14. Subjects who have received an investigational product or participated in another interventional clinical study within 30 days prior to randomization. Subjects participating in a
    non-interventional study that has no bearing on assessment of EG-1962 or enteral nimodipine
    may be enrolled per guidelines of the local Institutional Review Board (IRB)/Independent
    Ethics Committee (IEC)
    15. Known hypersensitivity to nimodipine or other dihydropyridine calcium channel antagonists, poly-D, L-lactide-co-glycolide (PLGA), or hyaluronic acid
    1. Schwerwiegende Komplikationen während der chirurgischen Versorgung des Aneurysmas, wie zum Beispiel: massive intraoperative Blutungen, Schwellung des Gehirns, Arterienverschluss oder gescheiterter Verschluss des rupturierten Aneurysmas
    2. Angiographisch belegte Vasospasmen vor der Randomisierung
    3. Klinischer oder radiologischer Nachweis eines Hirninfarkts mit neurologischen Ausfällen
    4. Intrakranieller Druck > 30 mmHg über einen Zeitraum von > 4 Stunden in einem beliebigen Zeitraum während der Prä-Randomisierungsphase
    5. Massive intraventrikuläre Blutung
    6. Aneurysmenreparatur, bei der ein ableitender Stent oder ein Stent-unterstütztes Coiling mit dualer Thrombozytenaggregationshemmung erforderlich ist
    7. Patienten, bei denen davon ausgegangen wird, dass ein weiteres Aneurysma innerhalb von 90 Tagen chirurgisch versorgt werden muss, weil während der Prä-Randomisierungsphase mehrere Aneurysmen festgestellt wurden
    8. Hämodynamische Instabilität während der Prä-Randomisierungsphase (d. h. systolischer Blutdruck (SBH) < 100 mmHg, der eine Flüssigkeitsreanimation mit > 6 l kolloidaler oder kristalloider Infusionslösung erforderlich macht)
    9. Kardiopulmonale Wiederbelebung vor der Randomisierung erforderlich
    10. Symptome oder elektrokardiographische Anzeichen eines akuten Myokardinfarktes oder einer instabilen Angina pectoris vor der Randomisierung
    11. Elektrokardiographischer Nachweis und/oder körperliche Befunde, die auf das Vorliegen eines Herzblocks 2. oder 3. Grades oder einer Herzrhythmusstörung mit hämodynamischer Instabilität hinweisen
    12. Echokardiographie, wenn sie als Teil der Standardversorgung vor der Randomisierung durchgeführt wird und eine linksventrikuläre Ejektionsfraktion von < 40 % zeigt
    13. Schwerwiegende oder instabile Begleiterkrankungen (z. B. bekannte signifikante neurologische Defizite, Krebs, Erkrankungen von Blut oder Herz) oder chronische Erkrankungen (z. B. Erkrankungen der Leber oder Niere oder psychische Erkrankungen), die nach Einschätzung des Prüfarztes das mit einer Teilnahme an der Studie oder Verabreichung des Prüfpräparates verbundene Risiko erhöhen oder die Auswertung der Studienergebnisse beeinträchtigen könnten
    14. Patienten, die innerhalb von 30 Tagen vor der Randomisierung ein anderes in der klinischen Entwicklung befindliches Präparat erhalten haben oder an einer anderen interventionellen Studie teilgenommen haben. Patienten, die an einer nicht-interventionellen Studie teilnehmen, die keine Auswirkungen auf die Bewertung von EG-1962 oder enteral verabreichtem Nimodipin hat, können entsprechend den Richtlinien des IRB/der unabhängigen Ethikkommission vor Ort in die Studie aufgenommen werden
    15. Bekannte Überempfindlichkeit gegenüber Nimodipin oder einem anderen Dyhydropyridin-Kalziumkanalblocker, Poly-D-Lactid-co-Glycoid (PLGA) oder Hyaluronsäure
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects with a favorable outcome measured on the Extended Glasgow Outcome Scale (GOSE) at Day 90 by a blinded assessor
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 90
    E.5.2Secondary end point(s)
    Proportion of subjects with favorable neurocognitive outcome at Day 90 measured by the Montreal Cognitive Assessment (MoCA) by a blinded assessor
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 90
    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 No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) 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) Yes
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    Canada
    Czech Republic
    Denmark
    Finland
    Germany
    Israel
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 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: 249
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 125
    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 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
    In case the subject is not capable to give consent personally, the signed informed consent will be obtained from the subject’s legal representative after the completion of aneurysm repair but prior to any study-specific procedures being performed.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state84
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 374
    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)
    After the subject has ended participation in the trial, further treatment will be standard of care at the discretion of the investigator and/or treating physician.
    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 Decision2017-01-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-06-21
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