Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
12,008
Countries
20
Sites
275
Prevention of ischemic stroke in patients post acute non-cardioembolic ischemic stroke or high-risk transient ischemic attack
Efficacy To evaluate whether the oral FXIa inhibitor asundexian is superior to placebo on top of background antiplatelet therapy in reducing ischemic stroke in patients after an acute non-cardioembolic ischemic stroke or high-risk Transient ischemic attack (TIA) Safety To compare the incidence of International Society …
Key facts
- Sponsor
- Bayer AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 18 Jan 2023 → 24 Oct 2025
- Decision date (initial)
- 2023-10-02
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Bayer AG, D-51368, Leverkusen, Germany
External identifiers
- EU CT number
- 2023-503793-20-00
- EudraCT number
- 2022-001067-27
- ClinicalTrials.gov
- NCT05686070
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others, Safety, Pharmacokinetic, Pharmacogenetic, Pharmacodynamic, Efficacy, Prophylaxis
Efficacy
To evaluate whether the oral FXIa inhibitor asundexian is superior to placebo on top of background antiplatelet therapy in reducing ischemic stroke in patients after an acute non-cardioembolic ischemic stroke or high-risk Transient ischemic attack (TIA)
Safety
To compare the incidence of International Society on Thrombosis and Hemostasis (ISTH) major bleeding for asundexian and placebo on top of antiplatelet therapy in patients after an acute noncardioembolic ischemic stroke or high-risk TIA
Secondary objectives 3
- Efficacy To evaluate whether asundexian is superior to placebo on top of antiplatelet therapy in reducing the occurrence of composite and individual efficacy endpoints
- Safety To compare asundexian and placebo on top of antiplatelet therapy with respect to individual bleeding endpoints
- Net clinical benefit To further compare the benefit and risk of asundexian and placebo with respect to a composite of efficacy and safety endpoints
Conditions and MedDRA coding
Prevention of ischemic stroke in patients post acute non-cardioembolic ischemic stroke or high-risk transient ischemic attack
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10072760 | Transient ischemic attack | 10029205 |
| 20.0 | PT | 10049165 | Cerebrovascular accident prophylaxis | 100000004865 |
| 22.1 | LLT | 10055221 | Ischemic stroke | 10029205 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency, Pharmaceuticals And Medical Devices Agency
- EMA paediatric investigation plan (PIP)
- EMEA-003144-PIP01-21
- Plan to share IPD
- No
- IPD plan description
- Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-503794-38-00 | (19767 OCEANIC-AF) A multicenter, international, randomized, active comparator-controlled, double-blind, double-dummy, parallel-group, 2-arm, Phase 3 study to compare the efficacy and safety of the oral FXIa inhibitor asundexian (BAY 2433334) with apixaban for the prevention of stroke or systemic embolism in male and female participants aged 18 years and older with atrial fibrillation at risk for stroke | Bayer AG |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Participants must be >= 18 years of age
- Acute non-cardioembolic stroke or high-risk TIA
- Systemic or cerebrovascular atherosclerosis or acute non-lacunar infarct
Exclusion criteria 3
- Ischemic stroke <= 7 days before the index event
- Index stroke following procedures or strokes due to other rare causes
- History of atrial fibrillation/flutter, left ventricular thrombus, mechanic valve or other cardioembolic source of stroke requiring anticoagulation
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Time to first occurrence of ischemic stroke
- Time to first occurrence of ISTH major bleeding
Secondary endpoints 16
- Time to first occurrence of all strokes (ischemic and hemorrhagic)
- Time to first occurrence of composite of Cardiovascular (CV) death, myocardial infarction (MI) or stroke
- Time to first occurrence of composite of all-cause mortality, MI or stroke
- Time to first occurrence of disabling stroke (mRS >= 3 at 90 days)
- Time to first occurrence of all-cause mortality
- Time to first occurrence of transient ischemic attack (TIA)
- Time to first occurrence of composite of ISTH major or clinically relevant non-major bleeding
- Time to first occurrence of ISTH clinically relevant non-major bleeding
- Time to first occurrence of symptomatic intracranial hemorrhage
- Time to first occurrence of hemorrhagic stroke
- Time to first occurrence of fatal bleeding
- Time to first occurrence of minor bleeding
- Time to first occurrence of composite of ischemic stroke or ISTH major bleeding
- Time to first occurrence of composite of CV death, all stroke, MI or ISTH major bleeding
- Time to first occurrence of composite of all-cause mortality, disabling stroke, fatal bleeding, symptomatic intracranial hemorrhage
- Time to first occurrence of ischemic stroke in the first 90 days
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD7514744 · Product
- Active substance
- Asundexian
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 47500 mg milligram(s)
- Max treatment duration
- 31 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- BAYER AG
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
Placebo for test product BAY 2433334
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bayer AG
- Sponsor organisation
- Bayer AG
- Address
- Kaiser-Wilhelm-Allee 1, Wiesdorf Wiesdorf
- City
- Leverkusen
- Postcode
- 51373
- Country
- Germany
Scientific contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Public contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Third parties 6
| Organisation | City, country | Duties |
|---|---|---|
| Nuvisan GmbH ORG-100011873
|
Neu-Ulm, Germany | Other |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Other, Laboratory analysis |
| Mlm Medical Labs GmbH ORG-100043721
|
Mönchengladbach, Germany | Other |
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Interactive response technologies (IRT) |
| PHRI Population Health Research Institute International ORG-100030045
|
Hamilton, Canada | Other |
| University Of Calgary ORG-100023448
|
Calgary, Canada | Other |
Locations
20 EU/EEA countries · 275 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 150 | 11 |
| Belgium | Ended | 220 | 11 |
| Bulgaria | Ended | 440 | 16 |
| Czechia | Ended | 245 | 15 |
| Denmark | Ended | 200 | 8 |
| Finland | Ended | 110 | 5 |
| France | Ended | 576 | 29 |
| Germany | Ended | 290 | 25 |
| Greece | Ended | 455 | 17 |
| Hungary | Ended | 250 | 16 |
| Italy | Ended | 425 | 22 |
| Latvia | Ended | 118 | 4 |
| Lithuania | Ended | 100 | 5 |
| Netherlands | Ended | 125 | 10 |
| Norway | Ended | 60 | 6 |
| Poland | Ended | 240 | 14 |
| Portugal | Ended | 325 | 12 |
| Slovakia | Ended | 250 | 15 |
| Spain | Ended | 550 | 26 |
| Sweden | Ended | 94 | 8 |
| Rest of world
Canada, Taiwan, United Kingdom, China, Korea, Republic of, Switzerland, Turkey, United States, Brazil, Colombia, Russian Federation, Israel, Singapore, India, Australia, Japan, Argentina, Malaysia
|
— | 6,785 | — |
Investigational sites
Medical University of Vienna
Neurology, Waehringer Guertel 18-20, Alsergrund, Vienna
Medizinische Universitaet Innsbruck
Neurology, Anichstrasse 35, 6020, Innsbruck
Kepler Universitaetsklinikum GmbH
Neurology, Krankenhausstrasse 9, 4020, Linz
Medical University Of Graz
Neurology, Neue Stiftingtalstrasse 6, 8010, Graz
Krankenhaus Der Barmherzigen Brueder Wien
Neurology, Johannes-Von-Gott-Platz 1, Leopoldstadt, Vienna
Kardinal Schwarzenberg Klinikum GmbH
Neurology, Kardinal Schwarzenbergplatz 1, 5620, Schwarzach Im Pongau
Krankenhaus Nord Klinik Floridsdorf
Neurology, Bruenner Strasse 68, Floridsdorf, Vienna
Vivit Institute
Neurology, Carinagasse 47, 6800, Feldkirch
Noe LGA Gesundheit Thermenregion GmbH
Neurology, Schwester-Maria-Restituta-Gasse 12, 2340, Moedling
Noe LGA Gesundheit Region Mitte GmbH
Neurology, Dunant-Platz 1, 3100, St. Poelten
Konvent Der Barmherzigen Brueder
Neurology, Seilerstaette 2, 4020, Linz
Hopital Erasme
Neurology, Lennikse Baan 808, 1070, Anderlecht
CHC MontLegia
Neurology, Boulev. De Patience Et Beajonc 2, 4000, Liege
UZ Leuven
Neurology, Herestraat 49, 3000, Leuven
Cliniques Universitaires Saint-Luc
Neurology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Jessa Ziekenhuis
Neurology, Stadsomvaart 11, 3500, Hasselt
Universitair Ziekenhuis Gent
Neurology, Corneel Heymanslaan 10, 9000, Gent
Vitaz
Neurology, Moerlandstraat 1, 9100, Sint-Niklaas
UZ Brussel
Neurology, Laarbeeklaan 101, 1090, Jette
Algemeen Ziekenhuis Groeninge
Neurology, President Kennedylaan 4, 8500, Kortrijk
Algemeen Ziekenhuis Damiaan Oostende
Neurology, Gouwelozestraat 100, 8400, Ostend
Az St-Jan Brugge-Oostende A.V.
Neurology, Ruddershove 10, 8000, Brugge
Second Multiprofile Hospital For Active Treatment - Sofia EAD
Department of Neurological Diseases, Bulevard Hristo Botev 120, 1202, Sofiya
Military Medical Academy
Department of Neurological Diseases, Georgi Kothcev Str 6, 5800, Pleven
University Hospital Queen Govanna
Clinic for intensive treatment of neurological diseases, Ulitsa Byalo More 8, 1527, Sofiya
University Multiprofessional Hospital For Active Treatment Kanev AD
Department of General and Vascular Neurology, Ulitsa Tsirkovna Nezavisimost 2, 7000, Ruse
University Multiprofile Hospital For Active Treatment Pulmed Ltd.
First Clinic for Neurological Diseases, Ulitsa Perushtitsa 1a, 4002, Plovdiv
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
Department of Neurological Diseases, Krasno Selo, Bulevard Gen Totleben 21, Sofiya
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Clinic of Neurology, Ulitsa Georgi Kochev 8-A, 5803, Pleven
Multidisciplinary Hospital For Active Treatment Haskovo AD
Department of Neurological Diseases, Bulevard Siedinenie 49, 6304, Haskovo
Medical Center Saint Naum EOOD
Clinic for intensive care of Neurological diseases, Ulitsa D-R Lyuben Rusev 1, 1113, Sofiya
Multiprofile Hospital For Active Treatment St Panteleimon Plovdiv Ltd.
Department of Neurological Diseases, Bulevard Nikola Vaptsarov 9, 4004, Plovdiv
Acibadem City Clinic Tokuda University Hospital EAD
Clinic of Neurology and Sleep Medicine, Bulevard Nikola Yonkov Vaptsarov 51b, 1407, Sofiya
University Hospital St. Anna
Clinic of Neurological Diseases, Ulitsa Dimitir Mollov 1, 1750, Sofiya
Multiprofile Hospital For Active Treatment Pazardzik AD
Department of Neurological Diseases, Ulitsa Bolnichna 15, 4400, Pazardzhik
Multiprofile Hospital For Active Treatment Sveti Ivan Rilski 2003 OOD
Department of Neurological Diseases, Ulitsa Ivan Vazov 26, 2600, Dupnitsa
MBAL Sveta Marina EAD
First Clinic of Neurological Diseases, Hristo Smirnenski Str 1, 9010, Varna
MHAT National Heart Hospital EAD
Clinic of Neurological Diseases, Ulitsa Konyovitsa 65, 1309, Sofiya
Krajska nemocnice Liberec a.s.
Komplexní cerebrovaskularní centrum - Neurologický JIP A, Husova 1430/34, 460 01, Liberec I-Stare Mesto
Krajska zdravotni a.s.
Neurologické oddělení - Komplexní cerebrovaskulární centrum, Socialni Pece 3316/12a, Severni Terasa, Usti Nad Labem
Fakultni Thomayerova nemocnice
Neurologická klinika 3. LF UK a FTN - Iktové centrum, Videnska 800, Krc, Prague 4
Nemocnice Pardubickeho kraje a.s.
Neurologická klinika, Kyjevska 44 Pardubicky, 530 03, Pardubice
Nemocnice Na Homolce
Neurologické oddělení, Roentgenova 37/2, Motol, Prague 5
Krajska zdravotni a.s.
Neurologické oddělení – Iktové centrum, Kochova 1185, 430 01, Chomutov
Fakultni Nemocnice Kralovske Vinohrady
Neurologická klinika a MS Centrum, Srobarova 1150/50, Vinohrady, Prague 10
Karvinska Hornicka Nemocnice a.s.
Neurologické oddělení, Zakladatelska 975/22, 735 06, Nove Mesto
Ustredni Vojenska Nemocnice Vojenska Fakultni Nemocnice Praha
Neurologické oddělení - Cerebrovaskulární centrum, U Vojenske Nemocnice 1200, 169 02, Prague 6
Nemocnice Jihlava prispevkova organizace
Neurologické oddělení, Vrchlickeho 4630/59, 586 01, Jihlava 1
Krajska Nemocnice T Bati a.s.
Neurologické oddělení, Havlickovo Nabrezi 600, 760 01, Zlin
Nemocnice AGEL Ostrava-Vitkovice a.s.
Neurologické oddělení, Zaluzanskeho 1192/15, Vitkovice, Ostrava
Fakultni Nemocnice Ostrava
Neurologická klinika, 17. Listopadu 1790/5, 708 00, Poruba
Fakultni Nemocnice U Sv Anny V Brne
I.Neurologická klinika, Pekarska 53, Stare Brno, Brno-Stred
Nemocnice Ceske Budejovice a.s.
Neurologické oddělení, B. Nemcove 585/54, 370 01, Ceske Budejovice
Region Midtjylland
Neurologisk afdeling NIDO, Hospitalsparken 15, 7400, Herning
Rigshospitalet
Neurologisk afdeling, Valdemar Hansens Vej 1-23, 2600, Glostrup
Bispebjerg Hospital
Neurologisk afd. Nielsine Nielsensvej 11.a, Bispebjerg Bakke 23, 2400, Copenhagen Nv
Region Midtjylland
Neurologisk afdeling, Palle Juul-Jensens Boulevard 175, 8200, Aarhus N
Aalborg University Hospital
Nuerologisk afdeling, Moelleparkvej 10, 9000, Aalborg
Herlev Hospital
Neurologisk afdeling, Borgmester Ib Juuls Vej 1, 2730, Herlev
Odense University Hospital
Neurologisk afdeling N, J B Winsloews Vej 4, 5000, Odense C
Lillebaelt Hospital
Neurologisk Afdeling, Sygehusvej 24, 6000, Kolding
HUS Helsinki University Hospital
Neurology, Haartmaninkatu 4, 00290, Helsinki
Turku University Hospital
Acute Stroke Unit, Neurocenter, Hameentie 11, 20520, Turku
Pohjois-Savon hyvinvointialue
Neurocenter, Department of Neurology, Puijonlaaksontie 2, P. O. Box 1711, Kuopio
Wellbeing Services County Of North Karelia Siun Sote
Neurology, Tikkamaentie 16, 80210, Joensuu
Tampere University Hospital
Tays Research Services, Teiskontie 35, 33520, Tampere
Centre Hospitalier Universitaire De Nice
Unité NeuroVasculaire de recours PACA Est, 30 Voie Romaine, 06000, Nice
Centre Hospitalier Universitaire De Dijon
Service de Neurologie Générale, Vasculaire et Dégénérative, 14 Rue Paul Gaffarel, 21000, Dijon
Centre Hospitalier Regional Universitaire De Tours
Service de Neurologie - Unité NeuroVasculaire, 2 Boulevard Tonnelle, 37000, Tours
Centre Hospitalier Sainte Anne Paris
Neurologie, 1 Rue Cabanis, 75014, Paris
Centre Hospitalier Universitaire De Lille
Service de Neurologie et Pathologie Neurovasculaire - 5eme étage Nord, Rue Emile Laine, 59037, Lille Cedex
Hospices Civils De Lyon
Neurologie vasculaire, 59 Boulevard Pinel, 69500, Bron
Groupement Des Hopitaux De L'Institut Catholique De Lille
Service de Neurologie - Unité Neurovasculaire, 115 Rue Du Grand But, Bp 50249 Lille, Lomme Cedex
Centre Hospitalier Sud Francilien
Neurologie et Unité Neurovasculaire, 40 Avenue Serge Dassault, 91100, Corbeil Essonnes
Hopital Fondation Adolphe De Rothschild
Service de Neurologie, 25 Rue Manin, 75019, Paris
Assistance Publique Hopitaux De Paris
Service des Urgences Cerebro-Vasculaires, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
Assistance Publique Hopitaux De Paris
Service NeuroVasculaire, 104 Boulevard Raymond Poincare, 92380, Garches
CHRU De Nancy
Unité Neurovasculaire - Bâtiment Neurologie, 29 Avenue Du Mal De Lattre De Tassigny, 54000, Nancy
Besancon University Hospital Center
Neurologie, 2 Place Saint Jacques, Cs 51804, Besancon Cedex
Centre Hospitalier Universitaire De Toulouse
Département de Neurologie, 1 Place Du Docteur Joseph Baylac, 31300, Toulouse
Assistance Publique Hopitaux De Marseille
Service de Neurologie - Unité NeuroVasculaire, 144 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Universitaire De Bordeaux
Service de Neurologie - Unité Neurovasculaire 9e étage, Place Amelie Raba Leon, 33000, Bordeaux
Assistance Publique Hopitaux De Paris
Service de Neurologie, 46 Rue Henri Huchard, 75877, Paris Cedex 18
Centre Hospitalier Universitaire De Rennes
Servide de neurologie, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Le Mans
Service de Neurologie, 194 Avenue Rubillard, 72037, Le Mans Cedex 9
Centre Hospitalier Universitaire Reims
Service de Neurologie, Rue Du General Koenig, 51092, Reims Cedex
Centre Hospitalier De Boulogne Sur Mer
Service de Neurologie - Unité Neurovasculaire, 12 Allee Jacques Monod, 62200, Boulogne-Sur-Mer
Centre Hospitalier Universitaire De Nimes
Service de Neurologie, 4 Place Du Professeur Robert Debre, Bp 40026, Nimes Cedex 9
Assistance Publique Hopitaux De Paris
Service de Neurologie, 78 Rue Du General Leclerc, 94270, Le Kremlin-Bicetre
Hospital Foch
Service de Neurologie - Unité Neurovasculaire, 40 Rue Worth, 92150, Suresnes
Direction Centrale Du Service De Sante Des Armees
Neurologie, 2 Boulevard Sainte Anne, Bp 600, Toulon Cedex 9
Centre Hospitalier Regional Et Universitaire De Brest
Service de Neurologie, Boulevard Tanguy Prigent, 29200, Brest
Les Hopitaux Universitaires De Strasbourg
Service de Neurologie, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Centre Hospitalier Universitaire De Nantes
Unite NeuroVasculaire, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Assistance Publique Hopitaux De Paris
Service de Neurologie, 2 Rue Ambroise Pare, 75010, Paris
Asklepios Kliniken Hamburg GmbH
Neurologie, Alphonsstrasse 14, Marienthal, Hamburg
Klinikum Altenburger Land GmbH
Neurologie, Am Waldessaum 10, 04600, Altenburg
Universitaetsklinikum Heidelberg AöR
Abteilung Neurologie, Im Neuenheimer Feld 400, Neuenheim, Heidelberg
Universitaetsklinikum Duesseldorf AöR
Klinik für Neurologie, Moorenstrasse 5, Bilk, Duesseldorf
Medizinische Hochschule Hannover
Klinik für Neurologie, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Vivantes Netzwerk fuer Gesundheit GmbH
Klinik für Neurologie und Stroke Unit, Rudower Strasse 48, Buckow, Berlin
Staedtisches Klinikum Dresden
Klinik für Neurologie, Friedrichstrasse 41, Friedrichstadt, Dresden
Asklepios Kliniken Hamburg GmbH
Abteilung für Neurologie, Ruebenkamp 220, 22291, Hamburg
SRH Wald-Klinikum Gera GmbH
Klinik für Neurologie, Strasse Des Friedens 122, Debschwitz, Gera
GFO Kliniken Troisdorf, Betriebsstaette St. Johannes
Betriebsstaette St. Johannes, Wilhelm-Busch-Str. 9, 53844, Troisdorf
Martin-Luther-Universitaet Halle-Wittenberg
Universitaets- und Poliklinik für Neurologie, Ernst-Grube-Strasse 40, Kroellwitz, Halle (Saale)
Asklepios Kliniken Hamburg GmbH
Abteilung für Neurologie, Paul-Ehrlich-Strasse 1, Othmarschen, Hamburg
Medical Center - University Of Freiburg
Klinik für Neurologie und Neurophysiologie, Breisacher Strasse 64, Stuehlinger, Freiburg Im Breisgau
Justus-Liebig-Universitaet Giessen
Neurologie, Klinikstrasse 33, 35392, Giessen
Alfried Krupp von Bohlen und Halbach-Krankenhaus gGmbH
Klinik für Neurologie, Alfried-Krupp-Strasse 21, 45117, Essen
Rhoen-Klinikum AG
Klinik für Akutneurologie/ Stroke Unit und Intensivmedizin, Von-Guttenberg-Strasse 11, Herschfeld, Bad Neustadt A.D.Saale
Goethe University Frankfurt
Klinik für Neurologie, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Universitaetsklinikum Bonn AöR
Klinik und Poliklinik für Neurologie, Venusberg-Campus 1, Venusberg, Bonn
Universitaetsklinikum Ulm AöR
Neurologische Klinik, Oberer Eselsberg 45, Eselsberg, Ulm
Universitaet Leipzig
Klinik und Poliklinik für Neurologie, Liebigstrasse 20, Zentrum-Suedost, Leipzig
Universitaetsklinikum Erlangen AöR
Neurologische Klinik Kopfkliniken, Schwabachanlage 6, Innenstadt, Erlangen
Universitaetsmedizin Goettingen
Klinik fuer Neurologie, Robert-Koch-Strasse 40, Weende, Goettingen
Johannes Gutenberg University Mainz
Studienzentrum der Klinik und Poliklinik für Neurologie, Langenbeckstrasse 1, 55101, Mainz
Technische Universitat Dresden
Klinik und Poliklinik für Neurologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsmedizin Greifswald KöR
Klinik und Poliklinik für Neurologie, Ferdinand-Sauerbruch-Strasse, 17489, Greifswald
Eginitio Hospital
1st Department of Neurology, Vassilissas Sofias Avenue 74, 115 28, Athens
University General Hospital Of Heraklion
Department of Neurology, Stavrakia And Voutes, 715 00, Heraklion
Evaggelismos Hospital
Department of Neurology, Ipsiladou 45-47, 106 76, Athens
General University Hospital Of Larissa
Department of Neurology, P. O. Box 1425, 411 10, Larissa
Metropolitan Hospital
Stroke Unit, Ethnarchi Makariou 11, 185 47, Pireas
General Hospital Of Athens Korgialenio Benakio H.R.C.
Department of Neurology, Athanasaki 2 Str, 115 26, Athens
General Hospital Of Athens G Gennimatas
Department of Neurology, Messogion Avenue 154, 115 27, Athens
General University Hospital Of Patras
Department of Neurology, Rio, 265 04, Patras
University General Hospital Of Thessaloniki Ahepa
1st Department of Neurology, 1st St Kiriakidis Str, 546 36, Thessaloniki
401 General Military Hospital Of Athens
Department of Neurology, Panagioti Kanellopoulou Av 1, 115 25, Athens
Geniko Nosokomeio Thessalonikis George Papanikolaou
3rd Department of Neurology, Exochi, 570 10, Thessaloniki
University General Hospital Attikon
2nd Department of Neurology, Rimini Street 1, 124 62, Athens
General Hospital Of Thessaloniki Papageorgiou
3rd Department of Internal Medicine, Ring Road Of Thessaloniki, Ministry Of Pavlos Melas, Efkarpia
University General Hospital Of Thessaloniki Ahepa
2nd Department of Neurology, 1st St Kiriakidis Str, 546 36, Thessaloniki
Athens Naval Hospital
Department of Neurology, Dinokratous 70, 115 21, Athens
University General Hospital Of Ioannina
Department of Neurology, Niarchou Stavrou Avenue, 455 00, Ioannina
University General Hospital Of Alexandroupoli
Department of Neurology, 6th Km Alex Polis Makris, Dragana, Alexandroupoli
Kanizsai Dorottya Korhaz
Neurologia és stroke osztály, Szekeres Jozsef Utca 2-8, 8800, Nagykanizsa
University Of Debrecen
Neurológiai Klinika, Moricz Zsigmond Korut 22, 4032, Debrecen
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Neurológia, Szent Istvan Utca 68, 4400, Nyiregyhaza
Kistarcsai Flor Ferenc Korhaz
Neurológia és Stroke Osztály, Semmelweis Ter 1, 2143, Kistarcsa
University Of Pecs
Neurológiai Klinika, Stroke Tanszék, Ifjusag Utja 13, 7624, Pecs
Bajai Szent Rokus Korhaz
Neurológiai Osztály, Rokus Utca 10, 6500, Baja
Central Hospital Of Northern Pest Military Hospital
Ideggyógyászati Osztály, Robert Karoly Korut 44, 1134, Budapest XIII
Semmelweis University
Neurológiai Klinika, Balassa J Utca 6, 1083, Budapest
Soproni Erzsebet Oktato Korhaz Es Rehabilitacios Intezet
Neurológia, Gyori Ut 15, 9400, Sopron
Semmelweis University
Idegsebészeti és Neurointervenciós Klinika, Amerikai Ut 57, 1145, Budapest XIV
Budapesti Jahn Ferenc Del Pesti Korhaz Es Rendelointezet
Neurológiai Osztály, Koves Ut 1, 1204, Budapest
University Of Szeged
Neurológiai Klinika, Semmelweis Utca 6, 6725, Szeged
Zala Varmegyei Szent Rafael Korhaz
Neurológiai Osztály, Zrinyi Miklos Utca 1, 8900, Zalaegerszeg
Budapesti Bajcsy-Zsilinszky Korhaz Es Rendelointezet
Neurológiai Osztály, Maglodi Ut 89-91, Kerulet, Budapest
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Neurológiai Osztály, Vasvari Pal Utca 2-4, 9024, Gyor
Szent Damjan Goeroegkatolikus Korhaz
Neurológiai és Stroke Osztály, Arpad Utca 26, 4600, Kisvarda
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d'Aragona
Neurologia - Stroke Unit, Largo Citta' D'ippocrate 1, 84131, Salerno
Universita' Degli Studi Di Verona
Neurologia - Stroke Unit,, Piazzale Aristide Stefani 1, 37126, Verona
Careggi University Hospital
Stroke Unit, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
IRCCS Ospedale Sacro Cuore Don Calabria
Neurologia - Stroke Center, Via Don Angelo Sempreboni 5, 37024, Negrar
Universita' Degli Studi Di Messina
Stroke Unit, Via Consolare Valeria 1, 98125, Messina
Hospital Santa Maria Della Misericordia
Medicina Interna Vascolare d’Urgenza - Stroke Unit, Piazzale Giorgio Menghini 1, 06129, Perugia
Azienda Unita Sanitaria Locale Della Romagna
Neurologia, Via Alcide De Gasperi 8, 48121, Ravenna
Ospedale San Raffaele S.r.l.
Neurologia-Stoke Unit, Via Olgettina 60, 20132, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Neurologia, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
Neurologia, Via Antonio Cardarelli 9, 80131, Naples
Azienda Ospedaliero Universitaria Parma
Emergenza-Urgenza, Viale Antonio Gramsci 14, 43126, Parma
Azienda Ospedaliera Policlinico Universitario Tor Vergata
U.T. Neurovascolare - C.R.R. Centro Malattie Cerebro Vascolari, Viale Oxford 81, 00133, Rome
Azienda Ospedaliero Universitaria Delle Marche
Clinica Neurologica, Via Conca 71, 60126, Ancona
Azienda Ospedaliera Papa Giovanni XXIII
Neurologia, Piazza Oms 1, 24127, Bergamo
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Neurologia, Via Trabucco 180, 90146, Palermo
Ospedale Vito Fazzi Lecce
Neurologia - Stroke Unit, Piazza Filippo Muratore 1, 73100, Lecce
Azienda Ospedaliera Universitaria Senese
Stroke Unit, Strada Delle Scotte 14, 53100, Siena
Azienda Unita Sanitaria Locale Di Bologna
Neurologia e Rete Stroke metropolitana, Via Castiglione 29, 40124, Bologna
Azienda Sanitaria Locale Citta Di Torino
Neurologia e Stroke Unit, Via San Secondo 29, 10128, Turin
Azienda Sanitaria Universitaria Friuli Centrale
Neurologia e Stroke Unit, Piazzale Santa Maria Della Misericordia 15, 33100, Udine
Azienda Sanitaria Locale Avezzano Sulmona L'Aquila
Neurologia e Stroke Unit, Via Saragat Localita Campo Di Pile, 67100, L'Aquila
Azienda Sociosanitaria Ligure 2
Neurologia, Piazza Sandro Pertini 10, 17100, Savona
Rezeknes Slimnica SIA
Neurology department, 18. Novembra Iela 41, LV-4601, Rezekne
Pauls Stradins Clinical University Hospital
Neurology department, Pilsonu Iela 13, 1002, Riga
Rigas Austrumu kliniska universitates slimnica SIA
Clinic of neurology and neurosurgery, Hipokrata Iela 2, 1038, Riga
Jekabpils regionala slimnica SIA
Stroke unit, Andreja Pormala Iela 125, 5201, Jekabpils
Republican Siauliai Hospital
Department of neurology, V. Kudirkos G. 99, Siauliu M. Sav., Siauliai
Vilniaus universiteto ligonine Santaros klinikos VšĮ
Clinic of neurology and neurosurgery, Santariskiu G. 2, Vilniaus M. Sav., Vilnius
Alytaus apskrities S. Kudirkos ligonine VšĮ
Department of neurology, Ligonines G 12, Alytaus M Sav, Alytus
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Stroke unit, Eiveniu G. 2, Kauno M. Sav., Kaunas
Viesoji įstaiga Respublikine Vilniaus universitetine ligonine
II department of neurology, Siltnamiu G. 29, Vilniaus M. Sav., Vilnius
Haga Hospital
Neurology, Els Borst-Eilersplein 275, 2545 AA, 's-Gravenhage
Universitair Medisch Centrum Utrecht
Neurology, Heidelberglaan 100, 3584 CX, Utrecht
Zuyderland Medisch Centrum Stichting
Neurology, Henri Dunantstraat 5, 6419 PC, Heerlen
Amsterdam UMC
Neurology, De Boelelaan 1117, 1081 HV, Amsterdam
Sint Antonius Ziekenhuis Stichting
Neurology, Koekoekslaan 1, 3435 CM, Nieuwegein
Jeroen Bosch Ziekenhuis
Neurology, Henri Dunantstraat 1, 5223 GZ, 's-Hertogenbosch
OLVG Stichting
Neurology, Oosterpark 9, 1091 AC, Amsterdam
Catharina Ziekenhuis Stichting
Neurology, Michelangelolaan 2, 5623 EJ, Eindhoven
Isala Klinieken Stichting
Neurology, Dokter Van Heesweg 2, 8025 AB, Zwolle
Maasstad Ziekenhuis Stichting
Neurology, Maasstadweg 21, 3079 DZ, Rotterdam
Oslo University Hospital HF
Nevrologisk avdeling, Taarnbygget, Kirkeveien 166, Oslo
Helse Moere Og Romsdal HF
Medisinsk avdeling, slag og alderdomssjukdommar, Aalesund sjukehus, Aasehaugen 1, 6017, Aalesund
Helse Moere Og Romsdal HF
Avdeling for medisin og nevrologi, Molde sjukehus, Aasehaugen 1, 6017, Aalesund
Sykehuset Oestfold HF Kalnes
Nevrologisk avdeling, Kalnesveien 300, 1714, Graalum
Helse Bergen HF
Nevrologisk avdeling, Jonas Lies Vei 65, 5021, Bergen
Akershus University Hospital
Nevrologisk avdeling, Sykehusveien 25, 1474, Loerenskog
Szpital Wolski Im. Dr Anny Gostynskiej Sp. z o.o.
Oddział Neurologiczny, Ul. Ulica Marcina Kasprzaka 17, 01-211, Warsaw
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie
Klinika Neurologii, Oddział Udarowy i Wczesnej Rehabilitacji Poudarowej, Ul. Dr. K. Jaczewskiego 8, 20-954, Lublin
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Klinika Neurologiczna, Ulica Szaserow 128, 04-141, Warsaw
Uniwersytecki Szpital Kliniczny W Bialymstoku
Klinika Neurologii i Oddział Udarowy, Ul. Marii Curie-Sklodowskiej 24a, 15-276, Bialystok
Wojewodzki Szpital Specjalistyczny Im. Sw. Jadwigi W Opolu
Oddział Neurologii dla dorosłych B, Ul. Wodociagowa 4, 45-001, Opole
Samodzielny Publiczny Specjalistyczny Szpital Zachodni Im.Sw.Jana Pawla II
Oddział Neurologiczny i Pododdział Udarowy, Ul. Daleka 11, 05-825, Grodzisk Mazowiecki
Instytut Psychiatrii I Neurologii
Klinika II Neurologii, Sobieskiego 9 Street, 02-957, Warsaw
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Klinika Neurochirurgii i Neurologii, Centrum Interwencyjnego Leczenia Udarów Mózgu, Ul. Kornela Ujejskiego 75, 85-168, Bydgoszcz
Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach
Oddział Neurologii z Pododdziałem Udarowym, Ul. Ziolowa 45/47, 40-635, Katowice
Copernicus Podmiot Leczniczy Sp. z o.o.
Oddział Neurologiczny, Ul. Nowe Ogrody 1/6, 80-803, Gdansk
Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
Oddział Neurologii i Udarów Mózgu z Pododdziałem Udarów Mózgu, Os. Zlotej Jesieni 1, 31-826, Cracow
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im Prof. Tadeusza Sokolowskiego Pomorskiego Uniwersytetu Medycznego W Szczecinie
Klinika Neurologii z Pododdziałem Udarowym, Ul. Unii Lubelskiej 1, 71-252, Szczecin
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Oddział Neurologiczny, Oddział Udarowy z Wczesną Rehabilitacją Neurologiczną, Ul. Pabianicka 62, 93-513, Lodz
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Oddział Kliniczny Neurologii, Ul. Macieja Jakubowskiego 2, 30-688, Krakow
Unidade Local De Saude De Almada-Seixal E.P.E.
Neurology, Avenida Torrado Da Silva, 2805-267, Almada
Unidade Local De Saude De Santo Antonio E.P.E.
Neurology, Largo Professor Abel Salazar, 4050-011, Porto
Unidade Local De Saude De Coimbra E.P.E.
Neurology, Praceta Professor Mota Pinto, 3004-561, Coimbra
Unidade Local de Saude de Sao Joao E.P.E.
Neurology, Alameda Professor Hernani Monteiro, 4200-319, Porto
Unidade Local De Saude Da Regiao De Aveiro E.P.E.
Internal Medicine, Avenida De Artur Ravara, 3814-501, Aveiro
Unidade Local De Saude Da Regiao De Leiria E.P.E.
Urgency, Rua Das Olhalvas, 2410-197, Leiria
Unidade Local De Saude De Matosinhos E.P.E.
Neurology, Rua Doutor Eduardo Torres, 4464-513, Senhora Da Hora
Hospital Da Luz S.A.
Neurology, Avenida Lusiada 100, 1500-650, Lisbon
Unidade Local De Saude De Lisboa Ocidental E.P.E.
Neurology, Rua Da Junqueira 126, 1349-019, Lisbon
Unidade Local De Saude De Santa Maria E.P.E.
Neurology, Avenida Professor Egas Moniz, 1649-035, Lisbon
Unidade Local de Saude do Algarve E.P.E.
Neurology, Rua Leao Penedo S/n, 8000-386, Faro
Unidade Local De Saude De Amadora Sintra E.P.E.
Neurology, Itinerario Complementar 19, 2720-276, Amadora
Dolnooravska Nemocnica S Poliklinikou Mudr. L. N. Jegeho
Neurologicke oddelenie, Nemocnicna 1944/10, 026 01, Dolny Kubin
Nemocnica AGEL Komarno s.r.o.
Neurologicke oddelenie, Medercska 39, 945 01, Komarno
Univerzitna Nemocnica Martin
Neurologicka klinika JLF UK a UNM, Kollarova 2, 036 01, Martin
Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu Liptovsky Mikulas
Neurologicke oddelenie, Palucanska 25, Paludzka, Liptovsky Mikulas
University Hospital Bratislava
I.neurologicka klinika LF UK a UNB, Mickiewiczova 13, Stare Mesto, Bratislava
Fakultna Nemocnica Nitra
Neurologicka klinika, Spitalska 6, Stare Mesto, Nitra
Penta Hospitals SK a.s.
Neurologicke oddelenie, Srobarova 1, 979 01, Rimavska Sobota
Fakultna Nemocnica Trnava
Neurologicke oddelenie, Andreja Zarnova 11, 917 02, Trnava
Nemocnica AGEL Levoca a.s.
Neurologicke oddelenie, Probstnerova Cesta 2/3082, 054 01, Levoca
Vranovska nemocnica a.s.
Neurologicke oddelenie, B 177, M. R. Stefanika 187, Vranov Nad Toplou
Nemocnica s poliklinikou Spisska Nova Ves a.s.
Neurologicke oddelenie, Jana Janskeho 1, 052 01, Spisska Nova Ves
University Hospital Bratislava
Neurologicka klinika SZU a UNB, Ruzinovska 6, Ruzinov, Bratislava
University Hospital Bratislava
II. neurologicka klinika LF UK a UNB, Limbova 5, Nove Mesto, Bratislava
Nemocnica Ziar nad Hronom a Banska Stiavnica s.r.o.
Neurologicke oddelenie, Sladkovicova 11, 965 01, Ziar Nad Hronom
Fakultna Nemocnica S Poliklinikou J. A. Reimana Presov
Oddelenie neurologie, Jana Holleho 5898/14, 080 01, Presov
Hospital Universitari Vall D Hebron
Neurology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Germans Trias I Pujol
Neurology, Carretera Canyet 1a Planta, 08916, Badalona
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Neurology, Avinguda De L'alcalde Rovira Roure 80, 25196, Lleida
Hospital Clinico Universitario De Valladolid
Stroke Unit, Avenida Ramon Y Cajal 3, 47003, Valladolid
Bellvitge University Hospital
Neurology, Carrer De La Feixa Llarga S/n, 08907, L'hospitalet De Llobregat
University Clinical Hospital Virgen De La Arrixaca
Neurology, Carretera De Cartagena Sn, El Palmar, Murcia
Hospital Universitario Rey Juan Carlos
Neurology, Calle Gladiolo S/n, 28933, Mostoles
Complexo Hospitalario Universitario De Vigo
Neurology, Estrada Clara Campoamor N 341, 36312, Vigo
Complexo Hospitalario Universitario A Coruna
Neurology, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Universitario 12 De Octubre
Neurology, Bloque D, Avenida De Cordoba Sn, Madrid
Complexo Hospitalario Universitario De Santiago
Neurology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario Y Politecnico La Fe
Unidad de isquemia, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario La Paz
Neurology, Paseo Castellana 261, 28046, Madrid
Hospital Universitario De La Princesa
Neurology, Calle De Diego De Leon 62, 28006, Madrid
Hospital Universitario Ramon Y Cajal
Neurology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Ruber Juan Bravo
Neurology, Calle De Juan Bravo 39, 28006, Madrid
Hospital Universitari De Girona Doctor Josep Trueta
Neurology, Avinguda De Franca S/n, 17007, Girona
Hospital General Universitario De Albacete
Neurology, Calle Hermanos Falco 37, 02006, Albacete
Hospital Universitario De Cruces
Neurology, Cruces Plaza S/n, 48903, Barakaldo
Hospital Universitario De Leon
Neurology, C Altos De Nava S/n, 24071, Leon
Hospital Universitari Joan XXIII De Tarragona
Stroke unit, Calle Del Doctor Mallafre Guasch 4, 43005, Tarragona
Hospital Universitario Virgen De La Macarena
Neurology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital De La Santa Creu I Sant Pau
Neurology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Clinico Universitario De Valencia
Neurology, Avenida Blasco Ibanez 17, 46010, Valencia
University Hospital Virgen Del Rocio S.L.
Neurology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital General Universitario Gregorio Maranon
Neurology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Region Jaemtland Haerjedalen
Kliniskt Forskningscentrum, Kyrkgatan 12, 831 50, Ostersund
Soedersjukhuset AB
VO Internmedicin, sektion för akut intermedicin och neurologi, Sjukhusbacken 10, Hogalid, Stockholm
Karolinska University Hospital
Vårdavdelning Neuro 1, Eugeniavagen 3, 171 64, Solna
Region Skane Skanes Universitetssjukhus
Department Neurology, Entregatan 7, 222 42, Lund
Uppsala University Hospital
Strokeavdelning 85B, Akademiska Sjukhuset, 751 85, Uppsala
Danderyds Sjukhus AB
Medicinmottagningen, Morbygardsvagen 88, 182 88, Danderyd
Karolinska University Hospital
R82 Vårdavdelning Neuro 1, Halsovagen, Flemingsberg, Huddinge
Sahlgrenska University Hospital-Vastra Gotalandsregionen
Institute of Neuroscience and Physiology, Bla Straket 5, 413 46, Goteborg
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2023-01-18 | 2025-10-23 | 2023-01-31 | 2025-02-19 | |
| Belgium | 2023-02-21 | 2025-10-23 | 2023-03-01 | 2025-02-19 | |
| Bulgaria | 2023-03-02 | 2025-10-23 | 2023-03-06 | 2025-02-19 | |
| Czechia | 2023-02-16 | 2025-10-23 | 2023-03-15 | 2025-02-19 | |
| Denmark | 2023-01-30 | 2025-10-23 | 2023-01-31 | 2025-02-19 | |
| Finland | 2023-02-02 | 2025-10-23 | 2023-02-07 | 2025-02-19 | |
| France | 2023-02-22 | 2025-10-23 | 2023-02-28 | 2025-02-19 | |
| Germany | 2023-04-03 | 2025-10-23 | 2023-04-04 | 2025-02-19 | |
| Greece | 2023-02-21 | 2025-10-23 | 2023-02-22 | 2025-02-19 | |
| Hungary | 2023-01-20 | 2025-10-23 | 2023-01-26 | 2025-02-19 | |
| Italy | 2023-02-09 | 2025-10-23 | 2023-02-14 | 2025-02-19 | |
| Latvia | 2023-02-14 | 2025-10-23 | 2023-02-19 | 2025-02-19 | |
| Lithuania | 2023-03-10 | 2025-10-23 | 2023-03-24 | 2025-02-19 | |
| Netherlands | 2023-02-27 | 2025-10-23 | 2023-03-01 | 2025-02-19 | |
| Norway | 2023-03-03 | 2025-10-23 | 2023-05-04 | 2025-02-19 | |
| Poland | 2023-02-27 | 2025-10-23 | 2023-03-01 | 2025-02-19 | |
| Portugal | 2023-05-08 | 2025-10-23 | 2023-05-12 | 2025-02-19 | |
| Slovakia | 2023-02-01 | 2025-10-23 | 2023-02-09 | 2025-02-19 | |
| Spain | 2023-01-27 | 2025-10-23 | 2023-02-10 | 2025-02-19 | |
| Sweden | 2023-07-05 | 2025-10-23 | 2023-08-07 | 2025-02-19 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 124 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-503793-20-00_EL_for publication | 3 |
| Protocol (for publication) | D1_Protocol 2023-503793-20-00_EN_For Publication | 3 |
| Recruitment arrangements (for publication) | EC-IRB submission ES 20604 recruitment information For Publication | 1 |
| Recruitment arrangements (for publication) | EC-IRB submission PT 20604 Recruitment information For publication | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_CZ_CZ_Procedure Template_public | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_EN_AT_Procedure Template_public | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_EN_ES_Procedure Template_public | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_EN_IT_procedure template_public | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_EN_NL_Procedure Template_public | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_EN_NO_Recruitment and Informed Consent Procedure_public | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_EN_Procedure Template_public | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_EN_PT_Procedure Template_public | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FR_FR_Procedure Template_public | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_FR_FR_ICF Tabletop_public | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_FR_FR_Patient Booklet_public | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_FR_FR_Study leaflet_public | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_HU_HU_GP letter_public | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_HU_HU_Study drug instructions_public | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_NL_NL_ICF Table top_public | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_NL_NL_Patient booklet_public | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_NL_NL_Study Trifold Leaflet_public | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_PT_PT_Patient booklet_public | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_PT_Study Leaflet_public | 1 |
| Recruitment arrangements (for publication) | Recruitment and Retention 20604 CZ CZ Instruction of medication usage For publication | 1 |
| Recruitment arrangements (for publication) | Recruitment and Retention 20604 ICF Tabletop for publication | 1 |
| Recruitment arrangements (for publication) | Recruitment and Retention 20604 Patient booklet for publication | 1 |
| Recruitment arrangements (for publication) | Recruitment and Retention 20604 Study Leaflet for publication | 1 |
| Recruitment arrangements (for publication) | Recruitment and Retention CZ CZ 20604 ICF Tabletop For publication | 1 |
| Recruitment arrangements (for publication) | Recruitment and Retention CZ CZ 20604 Patient Booklet For publication | 1 |
| Recruitment arrangements (for publication) | Recruitment and Retention CZ CZ 20604 Study drug intake V4 V7 For publication | 1 |
| Recruitment arrangements (for publication) | Recruitment and Retention CZ CZ 20604 Study Leaflet For publication | 1 |
| Recruitment arrangements (for publication) | Recruitment and Retention DE 20604 Leaflet For publication | 1 |
| Recruitment arrangements (for publication) | Recruitment and Retention DE 20604 Tabletop For publication | 1 |
| Recruitment arrangements (for publication) | Recruitment and Retention DE AT 20604 ICF tabletop For publication | 1 |
| Recruitment arrangements (for publication) | Recruitment and Retention DE AT 20604 Patient booklet For publication | 1 |
| Recruitment arrangements (for publication) | Recruitment and Retention DE AT 20604 Study leaflet For publication | 1 |
| Recruitment arrangements (for publication) | Recruitment and Retention ES ES 20604 ICF Tabletop For Publication | 1 |
| Recruitment arrangements (for publication) | Recruitment and Retention ES ES 20604 Patient flyer For Publication | 1 |
| Recruitment arrangements (for publication) | Recruitment and Retention ES ES 20604 Study flyer For Publication | 1 |
| Recruitment arrangements (for publication) | Recruitment and Retention HU HU 20604 ICF tabletop For publication | 1 |
| Recruitment arrangements (for publication) | Recruitment and Retention HU HU 20604 Patient booklet For publication | 1 |
| Recruitment arrangements (for publication) | Recruitment and Retention HU HU 20604 Study drug intake For publication | 1 |
| Recruitment arrangements (for publication) | Recruitment and Retention HU HU 20604 Study leaflet For publication | 1 |
| Recruitment arrangements (for publication) | Recruitment and Retention IT 20604 ICF Tabletop For Publication | 1 |
| Recruitment arrangements (for publication) | Recruitment and Retention IT 20604 Patient Booklet For Publication | 1 |
| Recruitment arrangements (for publication) | Recruitment and Retention IT 20604 Study Leaflet For Publication | 1 |
| Recruitment arrangements (for publication) | Recruitment and Retention Patient booklet For publication | 1 |
| Subject information and informed consent form (for publication) | ICF Expecting parents - female NO 20604 for publication | 1 |
| Subject information and informed consent form (for publication) | ICF Other ES 20604 Data Protection Appendix For Publication | 1 |
| Subject information and informed consent form (for publication) | IL1_ICF_PT_PT_Other 3_public | 2 |
| Subject information and informed consent form (for publication) | L1_ICF_CZ_CZ_ICF - Core clean_public | 7 |
| Subject information and informed consent form (for publication) | L1_ICF_CZ_CZ_ICF - Core short version clean_public | 7 |
| Subject information and informed consent form (for publication) | L1_ICF_CZ_CZ_Other 1_public | 3 |
| Subject information and informed consent form (for publication) | L1_ICF_CZ_CZ_Other 3_public | 2 |
| Subject information and informed consent form (for publication) | L1_ICF_CZ_CZ_Other 4_public | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_CZ_CZ_Other 5_public | 3 |
| Subject information and informed consent form (for publication) | L1_ICF_DE_AT_main_public | 5 |
| Subject information and informed consent form (for publication) | L1_ICF_DE_AT_Other1_public | 3 |
| Subject information and informed consent form (for publication) | L1_ICF_DE_AT_Other2_public | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_DE_AT_Other3_public | 2 |
| Subject information and informed consent form (for publication) | L1_ICF_DE_AT_Other4_public | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_DE_DE_Core Legal Representative_public | 3 |
| Subject information and informed consent form (for publication) | L1_ICF_DE_DE_Core_public | 4 |
| Subject information and informed consent form (for publication) | L1_ICF_DE_DE_Other 1_public | 2.1 |
| Subject information and informed consent form (for publication) | L1_ICF_DE_DE_Other 4_public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF_DE_DE_Other 5_public | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_DE_DE_Other 6_public | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_EN_PT_Study Main English_public_obsolete | 3 |
| Subject information and informed consent form (for publication) | L1_ICF_ES_ES_Expecting Parents Female_public | 3 |
| Subject information and informed consent form (for publication) | L1_ICF_ES_ES_Main_public | 4 |
| Subject information and informed consent form (for publication) | L1_ICF_ES_ES_Other 1_public | 4 |
| Subject information and informed consent form (for publication) | L1_ICF_ES_ES_Other 2_public | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_ES_ES_Other 3_public | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_ES_ES_Study Update_public | 3.1 |
| Subject information and informed consent form (for publication) | L1_ICF_FR_FR_Main ICF Addendum_public | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_FR_FR_Main ICF_public | 3 |
| Subject information and informed consent form (for publication) | L1_ICF_FR_FR_Other 1_public | 1.2 |
| Subject information and informed consent form (for publication) | L1_ICF_FR_FR_Other 3_public | 2.1 |
| Subject information and informed consent form (for publication) | L1_ICF_HU_HU_Core authorised person_public | 4 |
| Subject information and informed consent form (for publication) | L1_ICF_HU_HU_Core regain legal capacity_public | 4 |
| Subject information and informed consent form (for publication) | L1_ICF_HU_HU_Core_public | 4 |
| Subject information and informed consent form (for publication) | L1_ICF_HU_HU_Other 1 authorised person_public | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_HU_HU_Other 1 regain legal capacity_public | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_HU_HU_Other 1_public | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_HU_HU_Other 2_public | 2 |
| Subject information and informed consent form (for publication) | L1_ICF_HU_HU_Other 3 authorised person_public | 3 |
| Subject information and informed consent form (for publication) | L1_ICF_HU_HU_Other 3 regain legal capacity_public | 3 |
| Subject information and informed consent form (for publication) | L1_ICF_HU_HU_Other 3_public | 3 |
| Subject information and informed consent form (for publication) | L1_ICF_HU_HU_Other 4 authorised person_public | 2 |
| Subject information and informed consent form (for publication) | L1_ICF_HU_HU_Other 4 regain legal capacity_public | 2 |
| Subject information and informed consent form (for publication) | L1_ICF_HU_HU_Other 4_public | 2 |
| Subject information and informed consent form (for publication) | L1_ICF_IT_IT_Core _public | 6 |
| Subject information and informed consent form (for publication) | L1_ICF_IT_IT_other 1 _public | 3 |
| Subject information and informed consent form (for publication) | L1_ICF_IT_IT_other 3 _public | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_IT_IT_other 4 _public | 2 |
| Subject information and informed consent form (for publication) | L1_ICF_NL_NL_Other 1_public | 4 |
| Subject information and informed consent form (for publication) | L1_ICF_NL_NL_Other 2_public | 4 |
| Subject information and informed consent form (for publication) | L1_ICF_NL_NL_Other 3_public | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_NL_NL_Other 4_public | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_NL_NL_Other_public | 4 |
| Subject information and informed consent form (for publication) | L1_ICF_NO_NO_ICF core_public | 5 |
| Subject information and informed consent form (for publication) | L1_ICF_PT_PT Study Main_public | 5 |
| Subject information and informed consent form (for publication) | L1_ICF_PT_PT_Information Sheet and Consent Form for Expecting Parents:Female Study Participant_publ | 2 |
| Subject information and informed consent form (for publication) | L1_ICF_PT_PT_Study Update_public | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Public_Other 2_FR_FR | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject info material_HU_HU_Emergency Contact Card_public | 2 |
| Subject information and informed consent form (for publication) | Subject Questionnaires and Scales CZ EQ-5D-5L For publication | 1 |
| Subject information and informed consent form (for publication) | Subject Questionnaires and Scales HU HU 20604 EQ-5D-5L For publication | 1.3 |
| Synopsis of the protocol (for publication) | D1_Synopsis of Protocol ES ES _2023-503793-20-00_public | 3 |
| Synopsis of the protocol (for publication) | D1_Synopsis of Protocol_BG_BG_2023-503793-20-00_public | 3 |
| Synopsis of the protocol (for publication) | D1_Synopsis of Protocol_CZ_CZ_2023-503793-20-00_public | 3 |
| Synopsis of the protocol (for publication) | D1_Synopsis of Protocol_DE_AT_2023-503793-20-00_public | 3 |
| Synopsis of the protocol (for publication) | D1_Synopsis of Protocol_EL_GR_2023-503793-20-00_public | 3 |
| Synopsis of the protocol (for publication) | D1_Synopsis of Protocol_EN_2023-503793-20-00_Public | 3 |
| Synopsis of the protocol (for publication) | D1_Synopsis of Protocol_FR_FR_2023-503793-20-00_public | 3 |
| Synopsis of the protocol (for publication) | D1_Synopsis of Protocol_HU_HU_2023-503793-20-00_public | 3 |
| Synopsis of the protocol (for publication) | D1_Synopsis of Protocol_IT_IT_2023-503793-20-00_Public | 3 |
| Synopsis of the protocol (for publication) | D1_Synopsis of Protocol_LT_LT_2023-503793-20-00_public | 3 |
| Synopsis of the protocol (for publication) | D1_Synopsis of Protocol_NL_NL_2023-503793-20-00_public | 3 |
| Synopsis of the protocol (for publication) | D1_Synopsis of Protocol_NO_NO_2023-503793-20-00_public | 3 |
| Synopsis of the protocol (for publication) | D1_Synopsis of Protocol_PL_PL_2023-503793-20-00_public | 3 |
| Synopsis of the protocol (for publication) | D1_Synopsis of Protocol_PT_PT_2023-503793-20-00_public | 1 |
| Synopsis of the protocol (for publication) | D1_Synopsis of Protocol_SK_SK_2023-503793-20-00_public | 3 |
| Synopsis of the protocol (for publication) | D1_Synopsis of Protocol_SV_SE_2023-503793-20-00_public | 3 |
Application history
21 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-14 | Sweden | Acceptable 2023-09-27
|
2023-09-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-21 | Sweden | Acceptable 2024-03-04
|
2024-03-04 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-04-16 | Acceptable 2024-03-04
|
2024-04-16 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-05-31 | Sweden | Acceptable 2024-08-21
|
2024-08-21 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-09-10 | Sweden | Acceptable 2024-08-21
|
2024-09-10 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-09-11 | Acceptable | 2024-09-18 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-09-12 | Acceptable | 2024-09-24 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-09-16 | Acceptable | 2024-11-14 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-11-11 | Acceptable | 2024-11-26 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-12-03 | Acceptable | 2024-12-18 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-12-19 | Sweden | Acceptable 2025-03-10
|
2025-03-10 |
| 12 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-05-15 | Acceptable | 2025-07-28 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-05-19 | Acceptable | 2025-05-23 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-06-04 | Acceptable | 2025-09-01 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-12 | 2025-06-04 | Acceptable | 2025-07-29 | |
| 16 | SUBSTANTIAL MODIFICATION | SM-13 | 2025-06-05 | Acceptable | 2025-07-07 | |
| 17 | SUBSTANTIAL MODIFICATION | SM-14 | 2025-07-30 | Acceptable | 2025-09-02 | |
| 18 | SUBSTANTIAL MODIFICATION | SM-15 | 2025-07-31 | Acceptable | 2025-08-12 | |
| 19 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-09-04 | Sweden | Acceptable | 2025-09-04 |
| 20 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-10-02 | Sweden | Acceptable | 2025-10-02 |
| 21 | SUBSTANTIAL MODIFICATION | SM-16 | 2025-10-02 | Acceptable | 2025-10-29 |