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    Summary
    EudraCT Number:2015-005033-53
    Sponsor's Protocol Code Number:EG-01-1962-03
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-09-14
    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 ConcernedCzechia - SUKL
    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
    Multicentrické, randomizované, dvojitě-zaslepené, placebem-kontrolované klinické hodnocení fáze 3, s paralelními skupinami, hodnotící účinnost a bezpečnost, srovnávající EG-1962 se standardní léčbou ústně podávaným nimodipinem u dospělých se subarachnoidálním krvácením z aneurysmatu
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An international clinical study to compare a new investigational (not yet approved) treatment called EG-1962 to compare against the current standard of care, oral nimodipine, for the improvement of symptoms you may experience after a brain hemorrhage
    A.3.2Name or abbreviated title of the trial where available
    Newton 2
    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 Address300 Connell Drive, Suite 4000
    B.5.3.2Town/ cityBerkeley Heights, NJ
    B.5.3.3Post code07922
    B.5.3.4CountryUnited States
    B.5.4Telephone number19083445257
    B.5.5Fax number19087901212
    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 bleeding in the space between your brain and surrounding membrane. Bleeding results from the rupture of an abnormal bulge in a blood vessel in your 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 19.1
    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 19.1
    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 (catheter, CTA or MRA) and repaired by neurosurgical clipping or endovascular coiling
    3. Subarachnoid hemorrhage on computed tomography (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 aSAH is defined as the time the subject was last know 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 control 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. Subjekty mužského i ženského pohlaví ve věku od 18 do 75 let včetně
    2. Prasklé sakulární aneuryzma potvrzené angiografií (katetr, CTA nebo MRA) opravené neurochirurgickým clippingem nebo endovaskulárním coilingem
    3. Subarachnoidální krvácení na CT snímku (před opravou) stupně 2-4 na modifikované Fisherově stupnici (difúzní [sraženina je přítomna v obou hemisférách] husté nebo řídké či lokálně zhuštěné)
    4. Zavedená zevní komorová drenáž
    5. Stupeň 2, 3 nebo 4 podle WFNS dle zhodnocení ve fázi před randomizací po opravě aneuryzmatu, avšak před randomizací
    6. Subjekt musí být schopen dostat intraventrikulární HP do 48 hodin po nástupu aSAH a do 4 hodin od začátku přípravy suspenze intraventrikulárního HP v lékárně. Nástup aSAH je definován jako doba, kdy subjekt začne pociťovat první příznaky aSAH (např. silná bolest hlavy nebo ztráta vědomí, kterou nahlásí buď samotný subjekt nebo svědek). Je-li subjekt nalezen v bezvědomí, je nástup aSAH definován jako doba, kdy bylo naposledy známo, že je subjekt v normálním stavu.
    7. Subjekty ženského pohlaví, u nichž nelze vyloučit případně otěhotnění, musí mít ve fázi před randomizací negativní těhotenský test (z moče nebo séra) a musí souhlasit s používáním požadované antikoncepce nejméně 30 dní po skončení Období léčby. Subjekty mužského pohlaví musí souhlasit s používáním požadované antikoncepce nejméně 30 dní po skončení Období léčby.
    8. Podepsaný informovaný souhlas od subjektu nebo jeho zákonného zástupce po provedení opravy aneuryzmatu a zároveň před provedením jakýchkoliv úkonů specifických pro studii
    9. Subjekt je schopen a ochoten dodržovat harmonogram následných kontrol
    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. Intracranial 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 Prerandomization Phase
    8. Hemodynamically 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 required prior to randomization
    10. Symptoms or electrocardiogram 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/Independent Ethics Committee
    15. Known hypersensitivity to nimodipine or other dihydropyridine calcium channel antagonists, poly-D, L-lactide-co-glycolide (PLGA), or hyaluronic acid
    1. Podstatná komplikace při opravě aneuryzmatu jako je například silné intraoperační krvácení, otok mozku, arteriální oklzue nebo nemožnost zajistit prasklé aneuryzma
    2. Angiografický vazospazmus před randomizací
    3. Klinicky nebo radiologicky potvrzený cerebrální infarkt s neurologickým deficitem
    4. Nitrolební tlak >30 mm Hg po dobu >4 hodin kdykoliv během Fáze před randomizací
    5. Značné intraventrikulární krvácení
    6. Oprava aneuryzmatu, která si vyžaduje stent pro odklon řečiště nebo coiling za pomocí stentu a duální protidestičkovou léčbu
    7. U subjektu se v horizontu 90 dní předpokládá podstoupení opravy dalších aneuryzmat, jsou-li identifikována četná aneuryzmata v rámci Fáze před randomizací
    8. Hemodynamická nestabilita během Fáze před randomizací (tj. systolický krevnítlak (STK) <100 mm Hg, který si vyžaduje tekutinovou resuscitaci koloidními nebo krystaloidními roztoky >6 L)
    9. Kardiopulmonální resuscitace nutná před randomizací
    10. Příznaky nebo EKG známky akutního infarktu myokardu nebo nestabilní anginy pectoris před randomizací
    11. EKG nebo fyzický nález kompatibilní se srdeční blokádou druhého nebo třetího stupně nebo srdeční arytmií asociovanou s hemodynamickou nestabilitou
    12. Echokardiografické vyšetření, je-li prováděno v rámci standardní péče před randomizací, vykazuje ejekční frakci levé komory <40%
    13. Závažné nebo nestabilní potíže či onemocnění (např. zjištěný signifikantní neurologický deficit, rakovina, hematologické nebo srdeční onemocnění) nebo chronické onemocnění (např. onemocnění jater, onemocnění ledvin nebo psychiatrické poruchy), které by podle úsudku zkoušejícího mohlo zvýšit riziko spojené s účastí ve studii nebo podáním HP nebo které může být překážkou při interpretaci výsledků studie
    14. Subjekty, kterým byl podán hodnocený přípravek nebo se zúčastnily jiné intervenční klinické studie v době 30 dní před randomizací. Subjekty zúčastněné v neintervenční studii, která nemá žádný vliv na hodnocení EG-1962 nebo enterálního nimodipinu mohou být do studie zařazeny v souladu se zásadami místní Etické komise
    15. Známá hypersenzitivita na nimodipin nebo jiné dihydropidinové blokátory vápníkového kanálu, poly-D, L-mléčnou-co-glykolovou (PLGA) nebo hyaluronovou kyselinu
    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 concerned4
    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
    Hong Kong
    Israel
    New Zealand
    Singapore
    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 state20
    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)
    Standard of care treatment and follow-up
    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 Decision2017-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-03
    P. End of Trial
    P.End of Trial StatusCompleted
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    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
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