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    Summary
    EudraCT Number:2010-020603-79
    Sponsor's Protocol Code Number:AB08004
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-01-05
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2010-020603-79
    A.3Full title of the trial
    A prospective, multicentre, randomised, double-blind, placebo-controlled, 3-parallel groups, phase 2 study to evaluate efficacy and safety of 12 weeks treatment with masitinib versus placebo in patients with acute ischemic stroke receiving stroke unit care with or without rt-PA therapy.
    Prospektívna, multicentrická, randomizovaná, dvojito zaslepená, placebom kontrolovaná, s tromi paralelnými skupinami, štúdia fázy II na zhodnotenie účinnosti a bezpečnosti 12 týždňovej liečby s masitinibom oproti placebu u pacientov s akútnou cievnou mozgovou príhodou, ktorí sa liečia na jednotke starostlivosti o cievnu mozgovú príhodu s alebo bez rt-PA terapie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of masitinib in acute ischemic stroke
    Zhodnotenie masitinibu u akútnej cievnej ischemickej mozgovej príhody
    A.4.1Sponsor's protocol code numberAB08004
    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 SponsorAB Science
    B.1.3.4CountryFrance
    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 supportABScience
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationABScience
    B.5.2Functional name of contact pointMariia Pavliuk
    B.5.3 Address:
    B.5.3.1Street Address3 avanue George V
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75008
    B.5.3.4CountryFrance
    B.5.4Telephone number0033 147 20 05 82
    B.5.5Fax number0033 147 20 24 11
    B.5.6E-mailmariia.pavliuk@ab-science.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namemasitinib
    D.3.2Product code AB1010 tablets
    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 INNMasitinib mesylate
    D.3.9.1CAS number 790-299-79-5
    D.3.9.2Current sponsor codeAB1010
    D.3.9.3Other descriptive nameNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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
    patients suffering from Acute Ischemic Stroke
    Pacienti trpiaci akútnou ischemickou cievnou mozgovou príhodou
    E.1.1.1Medical condition in easily understood language
    Stroke
    Akútna ischemická cievna mozgová príhoda
    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 18.1
    E.1.2Level LLT
    E.1.2Classification code 10023027
    E.1.2Term Ischaemic stroke NOS
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to compare efficacy and safety of 3 and 4.5mg/kg/jour masitinib versus placebo in patients with acute ischemic stroke receiving stroke unit care with or without rt-PA therapy.
    Cieľom je porovnať bezpečnosť a účinnosť masitinibu v dávke 3 a 4.5 mg/kg/deň oproti placebu u pacientov s akútnou cievnou mozgovou príhodou, ktorí sa liečia na jednotke starostlivosti s ischemickou cievnou mozgovou príhodou s alebo bez rt-PA terapie.
    E.2.2Secondary objectives of the trial
    Secondary endpoints
    · Neurological deficit measured by National Institute of Health Stroke Scale (NIHSS) score at Hour 2, Hour 24, Week 2, Week 4, Week 8 and Week 12
    · Volume of cerebral infarction measured by MRI at baseline, Week 2 and Week 12
    · Hemorrhage rate secondary to rt-PA treatment measured by MRI at H24
    · Recanalization rate on patients with documented arterial occlusion during W0-W12 period
    · Overall survival and Survival Rate at Week 12
    · Stroke Specific Quality of Life Scale (SS-QOL) score at Week 1, Week 2, Week 4, Week 8 and Week 12
    Safety endpoints
    Adverse events (AEs), laboratory assessments (biochemistry, haematology and urinalysis), physical examination,
    vital signs and ECGs
    Sekundárne ciele:
    • Neurologické poškodenie zmerané podľa National Institute of Health Stroke Scale (NIHSS) skóre v hodine 2, hodine 24, týždni 2, týždni 4, týždni 8 a týždni 12.
    • Barthelov test merania aktivity každodenného života v týždni 2 a 12
    • Objem cerebrálneho infarktu meraný CT skenom na zaraďovacej návšteve, v týždni 2 a v týždni 12
    • Miera krvácania sekundárneho pre rt-PA liečbu meranú CT skenom v hodine 24
    • Miera rekanalizácie u pacientov so zdokumentovanou arteriálnou oklúziou počas obdobia T0 – T12
    • Celkové prežitie a miera prežitie v týždni 12
    • Špecifická škála kvality života pacientov s cievnou mozgovou príhodou (SS-QOL) v týždni 1, týždni 2, týždni 4, týždni 8 a týždni 12

    Bezpečnostné ciele
    Nežiaduce účinky (AE), laboratórne hodnotenie (biochémia, hematológia a urinalýza), fyzikálne vyšetrenie, vitálne znaky a EKG.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patient age 18 to 75 years old
    2. Patient with a clinical diagnosis of acute stroke consistent with acute hemispheric cerebral infarction including hemiparesis and/ or hemiplegia involving the arm, leg, or both
    3. Patient / representative able to understand the patient card and to follow the patient card procedures in case of signs or symptoms of severe neutropenia or severe cutaneous toxicity.
    4. Patient with symptom onset of ≤ 12 hours before the start of treatment and symptoms present for ≥ 1 hour
    5. Patient with NIHSS score ≥ 8 with at least 2 points from section 5 and 6 (motor)
    6. Patient with pre-stroke Modified Ranking Scale < 1
    7. Patient fully conscious
    8. Patient functionally independent before the stroke (Barthel Index score = 100)
    9. Patient weighing more than 50 kg and with a Body Mass Index (BMI) between 18 and 35 kg/m²
    10. Patient with adequate organ functions defined as:
    • Absolute neutrophil count (ANC) ≥ 2.0 x 109/L
    • Hemoglobin ≥ 10g/dL
    • Platelets (PTL) ≥ 100 x 109/L
    • AST/ALT ≤ 3x ULN
    • Bilirubin ≤ 1.5x ULN
    • Creatinin clearance > 60 mL/min (Cockcroft and Gault formula)
    • Albuminemia >1 x LLN
    • Proteinuria < 30 mg/dL (1+) on the dipstick. If proteinuria is ≥ +1 on the dipstick, 24 hours proteinuria must be < 1.5g/24 hours.
    11. twoFemale patient of childbearing potential
    (entering the study after a menstrual period and who have a negative pregnancy test), who agrees to use two highly effective methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake
    12. Male patients must use medically acceptable methods of contraception if his female partner is pregnant, from the time of the first administration of the study drug until three months following administration of the last dose of study drug. Male patients must use two highly effective methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake
    13. Patient able and willing to comply with study procedures as per protocol
    14. Patient or her/his representative able to understand, sign, and date the written informed consent form at baseline visit prior to any protocol-specific procedures
    15. Patient affiliated to a social security regimen
    1. Pacient alebo pacientka vo veku 18 až 75 rokov
    2. Pacient s klinickou diagnózou akútnej mozgovej cievnej príhody s akútnou hemisférickou cerebrálnou infarkciou vrátane hemiparézy a/alebo hemiplégie vrátane ruky, nohy, alebo oboch.
    3. Pacient/zástupca pacienta schopný porozumieť karte pacienta a postupovať podľa postupov na nej uvedených v prípade príznakov alebo symptómov ťažkej neutropénie alebo ťažkej kožnej toxicity, počas prvých 2 mesiacov liečby.
    4. Pacient s počiatkom symptómu ≤ 12 hodín pred začiatkom liečby a symptómami prítomnými ≥ 1 hodina
    5. Pacient s NIHSS skóre ≥ 8 s aspoň 2 bodmi od sekcie 5 a 6 (motorika)
    6. Pacient s modifikovanou Rankinovou škálou < 1 pred cievnou mozgovou príhodou
    7. Pacient plne pri vedomí
    8. Pacient funkčne nezávislý pred cievnou mozgovou príhodou (skóre Barthelovho testu = 100)
    9. Pacient vážiaci viac než ˃ 50 kg a s Body Mass Indexom (BMI) medzi 18 a 35 kg/m2.
    10. Pacient s normálnou funkciou orgánov definovanou:
    • absolútnym počtom neutrofilov (ANC) ≥ 2 x 109/l
    • hemoglobínom ≥ 10g/dl
    • krvnými doštičkami (PLT) ≥ 100 x 109/l
    • AST/ALT ≤ 3x ULN
    • bilirubínom ≤ 1,5 x ULN
    • klírens kreatinínu > 60 ml/min
    • albuminémia ≥ 1 x LLN
    • proteinúria < 30 mg/dl (+1) hodnota na testovacom papieriku (dipstick). Pokiaľ je proteinúria ≥ +1 na dispticku, 24 hodinová proteinúria musí byť ≤ 1,5 g/24 hodín.
    • negatívna cytológia moču
    • negatívny NMP22 test (iba pre Európu a USA)
    11. Pacientky vo fertilnom veku (vstupujúce do štúdie po menštruácii a s negatívnym tehotenským testom) ,
    ktoré súhlasia s používaním dvoch vysoko účinných metód lekársky prijateľnej antikoncepcie (jednej pre
    pacienta a jedna pre partnera) počas štúdie a počas 3 mesiacov po poslednom podaní študijnej medikácie.
    Prijateľné formy antikoncepcie sú:
    • Dokumentované zavedenie vnútromaternicového telieska (hormonálne/s meďou) alebo použitie bariérového spôsobu ochrany (kondóm alebo pesar [diafragma alebo cervikálny klobúčik] v kombinácii so spermicídnou penou/gélom/krémom/čiapikmi).
    • Dokumentované podviazanie vaječníkov (ženská sterilizácia). Okrem toho by mal byť tiež používaný beriérový spôsob ochrany (kondóm alebo pesar [diafragma alebo cervikálny klobúčik] v kombinácii so spermicídnou penou/gélom/krémom/čiapikmi).
    • Bariérová metóda: Kondóm a okluzívny kryt diafragma alebo cervikálny klobúčik) v kombinácii so spermicídnou penou/gélom/krémom/čiapikmi
    • Akékoľvek iné metódy antikoncepcie so zdokumentovanou mierou zlyhania < 1 % za rok
    • Abstinencia
    10. Mužskí pacienti musia používať lekársky prijateľné formy antikoncepcie, pokiaľ je ich partnerka tehotná,
    alebo od doby prvého podania hodnoteného prípravku až do troch mesiacov po poslednej dávke skúšaného
    lieku. Prijateľné formy sú:
    • kondóm
    • chirurgická sterilizácia (vasektómia so zdokumentovanou azoospermiou) , je treba používať aj kondóm
    Mužskí pacienti musia počas štúdie a 3 mesiace po poslednej liečbe používať dve metódy lekársky prijateľnej vysoko účinnej antikoncepcie (jednu pacient a druhú partnerka). Prijateľné formy antikoncepcie sú:
    • kondóm alebo pesar (diafragma alebo cervikálny klobúčik) v kombinácii so spermicídnou penou/gélom/krémom/čiapikmi.
    • chirurgická sterilizácia (vasektómia so zdokumentovanou azoospermiou) a bariérový spôsob ochrany (kondóm alebo pesar [diafragma alebo cervikálny klobúčik] v kombinácii so spermicídnou penou/gélom/krémom/čiapikmi).
    • Vaša partnerka používa perorálnu antikoncepciu (kombinované tablety s estrogénom či progesterónom), injekcie progesterónu či podkožné implantáty a bariérový spôsob ochrany (kondóm alebo pesar [diafragma alebo cervikálny klobúčik] v kombinácii so spermicídnou penou/gélom/krémom/čiapikmi).
    • lekárom predpísaná antikoncepčná náplasť a bariérová metóda (kondóm alebo pesar [diafragma alebo cervikálny klobúčik] v kombinácii so spermicídnou penou/gélom/krémom/číapikmi).
    • Vaša partnerka podstúpila zdokumentované zavedenie vnútromaternicového telieska (hormonálne/s meďou) či použitie bariérového spôsobu ochrany ((kondóm alebo pesar [diafragma alebo cervikálny klobúčik] v kombinácii so spermicídnou penou/gélom/krémom/čiapikmi).
    • abstinencia iba pokiaľ je to v súlade s preferovaným a obvyklým životným štýlom subjektu
    11. Pacient schopný a ochotný podrobiť sa postupom podľa študijného protokolu
    12. Pacient alebo jeho zástupca schopný porozumieť, podpísať a datovať formulár informovaného súhlasu na baseline návšteve uskutočnenej predtým, než pacient podstúpi akúkoľvek procedúru vyžadovanú protokolom
    E.4Principal exclusion criteria
    1. Patient with a clinical diagnosis of acute stroke consistent with intracerebral hemorrhage
    2. Patient inability to swallow study treatment tablets (tablets cannot be crushed, chewed or divided).
    3. Patient with neurological sequellae from previous illness
    4. Patient having cardiac disorders defined by at least one of the following conditions:
    · Patient with recent cardiac history (within 6 months) of:
    - Acute coronary syndrome
    - Acute heart failure (class III or IV of the NYHA classification)
    - Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular
    fibrillation, resuscitated sudden death)
    · Patient with cardiac failure class III or IV of the NYHA classification
    · Patient with severe conduction disorders which are not prevented by permanent pacing (atrioventricular
    block 2 and 3, sino-atrial block)
    · Syncope without known aetiology within 3 months
    · Uncontrolled severe hypertension, according to the judgment of the investigator, or symptomatic
    hypertension
    5. Patient with severe concurrent illness and/or with life expectancy < 6 months
    6. Patient with history of primary malignancy < 5 years, except treated basal cell skin cancer or cervical carcinoma in situ
    7. Patient with a known diagnosis of human immunodeficiency virus (HIV) infection
    8. Pregant or nursing female
    9. Patient with history of poor compliance or history of drug/alcohol abuse, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent.
    1. Pacient s klinickou diagnózou akútnej cievnej mozgovej príhody konzistentnej s intracerebrálnym krvácaním
    2. pacient neschopný prehltnúť tablety študijného liečiva (tablety nemôžu byť rozdrvené, rozkúsané alebo rozdelené)
    3. Pacient s neurologickým poškodením z predchádzajúcej choroby
    4. Pacient so srdečnými ochoreniami, definovanými aspoň jedným z nasledujúcich kritérií:
    • Pacient s anamnézou srdcových porúch (počas predchádzajúcich 6 mesiacov)
    - akútny koronárny syndróm
    - akútne srdcové zlyhanie (trieda III alebo IV podľa NYHA klasifikácie)
    - signifikantná ventrikulárna arytmia (pretrvávajúca ventrikulárna tachykardia, ventrikulárna fibrilácia, resuscitovaná náhla smrť)
    • Pacient so srdcovým zlyhaním definovaným triedou III alebo IV podľa NYHA klasifikácie
    • Pacient s vážnymi poruchami vedenia, ktorým sa nedá predísť stálou reguláciou rytmu (atrioventrikulárna prekážka 2. a 3. stupňa, sinoatriálny blok)
    • Synkópa bez známej príčiny počas posledných 3 mesiacov
    • Nekontrolovateľný vážne vysoký krvný tlak, podľa rozhodnutia skúšajúceho, alebo symptomatický vysoký krvný tlak
    5. Pacient s ťažkou prebiehajúcou chorobou a/alebo s očakávanou dĺžkou života < 6 mesiacov
    6. Pacient s históriou primárnej malignity < 5 rokov, s výnimkou liečenej rakoviny kože bazálnych buniek alebo rakoviny hrdla maternice in situ
    7. Pacient so známou diagnózou infekcie ľudského vírusu imunodeficiencie (HIV)
    8. Tehotná alebo dojčiaca žena
    9. Pacienti s anamnézou nespolupráce s pokynmi; s anamnézou závislosti na drogách/alkohole alebo konzumujúci nadmerné množstvo alkoholických nápojov, čo by mohlo ovplyvniť schopnosť spolupracovať s pokynmi protokolu štúdie; pacienti, trpiaci súčasným alebo minulým psychiatrickým ochorením, ktoré by mohlo ovplyvniť schopnosť spolupracovať s protokolom štúdie alebo poskytnúť informovaný súhlas
    E.5 End points
    E.5.1Primary end point(s)
    •Modified Rankin Scale score at week 2 and 12 defining success as score value inferior or equal to 2.
    • Úspech liečby, ako je hodnotený modifikovanou Rankinovou škálou (mRS) skóre ≤ 2 počas štúdie.
    E.5.1.1Timepoint(s) of evaluation of this end point
    weeks 2 and 12
    týždeň 2 a 12
    E.5.2Secondary end point(s)
    Secondary endpoints
    · Neurological deficit measured by National Institute of Health Stroke Scale (NIHSS) score at Hour 2, Hour 24, Week 2, Week 4, Week 8 and Week 1
    · Barthel Index measure of activity of daily living at Week 2 and 12
    · Volume of cerebral infarction measured by MRI at baseline, Week 2 and Week 12
    · Hemorrhage rate secondary to rt-PA treatment measured by MRI at H24
    · Recanalization rate on patients with documented arterial occlusion during W0-W12 period
    · Overal Survival Rate and survival rate at Week 12
    · Stroke Specific Quality of Life Scale (SS-QOL) score at Week 1, Week 2, Week 4, Week 8 and Week 12
    Safety endpoints
    Adverse events (AEs), laboratory assessments (biochemistry, haematology and urinalysis), physical examination,
    vital signs and ECGs
    • Zmena od baseline v mRS skóre
    • Zmena od baseline v NIHSS skóre
    • Zmena od baseline v Barthelovom teste
    • Percento úspechu v NIHSS skóre. Úspech je definovaný ako skóre ≤ 1.
    • Percento úspechu v Barthelovom indexe. Úspech je definovaný ako skóre ≥ 95.
    • Percento zmeny od randomizácie v objeme mozgovej mŕtvice meranej CT skenom
    • Miera krvácania je definovaná ako počet pacientov, ktorí mali krvácanie po rt-PA liečbe zo všetkých rt-PA liečených pacientov. Toto je merané CT skenom.
    • Miera rekanalizácie je definovaná ako počet pacientov so zdokumentovanou arteriálnou oklúziou, ktorí mali prínos z rekanalizácie zo všetkých pacientov so zdokumentovanou arteriálnou oklúziou. Toto je merané CT skenom.
    • Miera prežitia je definovaná ako miera pacientov nažive z randomizovaných pacientov.
    • Zmena od baseline v stupnici kvality života špecifickej pre cievnu mozgovú príhodu (SS-QOL) skóre
    Bezpečnosť
    Výskyt nežiaducich účinkov (AEs) a zmien, ktoré sa objavujú za liečbu vo fyzikálnom vyšetrení, vitálnych znakoch (krvný tlak, pulz a telesná teplota), EKG a klinických laboratórnych testoch (biochémia, hematológia, a urinalýza).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Hour 2, Hour 24, Week 2, Week 4, Week 8 and Week 12
    Hodina 2, hodina 24, týždeň 2,4,8 a 12
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 trial3
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Posledná návšteva posledného pacienta
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 years6
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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
    Some patients could be unable to give written consent due to the Stroke's disease. In these cases, the patient will give an oral consent and a witness will sign for her/him.
    Niektorí pacienti nemusia byť schopní poskytnúť písomný súhlas počas mozgovej príhody. V takých prípadoch možu dať ústny súhlas a informovaný súhlas podpíše svedok.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 48
    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)
    not different
    nie je odlišná
    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 Decision2016-02-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-16
    P. End of Trial
    P.End of Trial StatusOngoing
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