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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001592-37 | EudraCT Number |
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The purpose of the study is to assess the efficacy of a new serotonin-norepinephrine reuptake inhibitor (SNRI) nin functional recovery after ischemic stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| F2695 | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F2695 | Drug | 75 mg OD in 2 capsules |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with a Modified Rankin Scale (mRS) less than or equal to 1 at Week 12 | week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with NIHSS score less than or equal to 5 at Week 12 | week 12 | |
| Percentage of patients with at least one moderate to severe depressive | Baseline to week 12 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| François Chollet | Hôpital Purpan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques Universitaires Saint Luc | Brussels | Belgium | ||||
| Universitair Ziekenhuis Gent |
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| Drug |
2 capsules |
|
| Change from baseline to Week 12 of the mean NIHSS total and motor scores |
| baseline to week 12 |
| Safety and tolerability assessed by the investigator including SAEs, AEs, vital signs, ECG,physical examination and laboratory tests | baseline to week 12 |
| Percentage of patients with a mRS score less than or equal to 2 at Week 12 | baseline to week 12 |
| Ghent |
| Belgium |
| Universitaire Ziekenhuis Gasthuisberg | Leuven | Belgium |
| Clinique Saint-Joseph | Liège | Belgium |
| Regional Ziekenhuis Sint-Trudo | Sint-Truiden | Belgium |
| Sint-Andriesziekenhuis | Tielt | Belgium |
| Academisch Ziekenhuis Sint Augustinus | Wilrijk | Belgium |
| Fakultní nemocnice u sv. Anny v Brne | Brno | Czechia |
| Fakultní nemocnice Hradec Králové | Hradec Kralové | Czechia |
| Litomyšlská Nemocnice, a.s. | Litomyšl | Czechia |
| Fakultní nemocnice Olomouc | Olomouc | Czechia |
| Fakultní Nemocnice Ostrava | Ostrava | Czechia |
| Vítkovická nemocnice a.s. | Ostrava - Vítkovice | Czechia |
| Hopital Jean Minjoz Centre Hospitalier Universitaire Besancon | Besançon | France |
| Clinique des Cèdres | Cornebarrieu | France |
| Centre Hospitalier de Lens | Lens | France |
| Hôpital Roger Salengro | Lille | France |
| Groupe Hospitalier Paris Saint Joseph | Paris | France |
| Hopital Lariboisière | Paris | France |
| Centre Hospitalier Universitaire de Poitiers Hôpital de la Milétrie | Poitiers | France |
| Centre Hospitalier Universitaire de Saint Etienne, Hôpital Nord | Saint-Priest-en-Jarez | France |
| Hôpital Purpan | Toulouse | France |
| Neurologische Klinik GmbH | Bad Neustadt/Saale | Germany |
| Universitätsklinik Charité, Campus Mitte | Berlin | Germany |
| Universitätsklinikum Bonn | Bonn | Germany |
| Universitätsklinikum Erlangen | Erlangen | Germany |
| Universitätsklinikum Essen | Essen | Germany |
| Freiburger Universitätsklinik | Freiburg im Breisgau | Germany |
| Asklepios Klinik Altona | Hamburg | Germany |
| Universitätsklinikum Leipzig | Leipzig | Germany |
| Universitätsklinikum Münster | Münster | Germany |
| Asklepios Fachklinikum Teupitz | Teupitz | Germany |
| Jahn Ferenc Dél-pesti Kórház | Budapest | Hungary |
| Magyar Honvédség Honvédkórház | Budapest | Hungary |
| Semmelweis Egyetem Neurológiai Klinika | Budapest | Hungary |
| Debreceni Egyetem Orvos- és Egészségtudományi Centrum | Debrecen | Hungary |
| Petz Aladár Megyei Oktató Kórház | Győr | Hungary |
| Kaposi Mór Megyei Oktató Kórhaz | Kaposvár | Hungary |
| BAZ Megyei és Egyetemi Oktató Kórház | Miskolc | Hungary |
| Kanizsai Dorottya Kórház | Nagykanizsa | Hungary |
| Jósa András Oktató Kórház | Nyíregyháza | Hungary |
| Soproni Erzsébet Oktató Kórház | Sopron | Hungary |
| Fejér Megyei Szent György Kórház | Székesfehérvár | Hungary |
| Azienda Sanitaria Ospedaliera "San Giovanni Battista" | Foligno | Italy |
| Azienda Ospedaliera San Gerardo | Monza | Italy |
| IRCCS "Istituto Neurologico C. Mondino" | Pavia | Italy |
| Ospedale Santa Maria della Misericordia | Perugia | Italy |
| IRCCS Fondazione Santa Lucia | Roma | Italy |
| Istituto Clinico Humanitas | Rozzano | Italy |
| Hospital Garcia de Orta | Almada | Portugal |
| Hospitais da Universidade de Coimbra | Coimbra | Portugal |
| Hospital de Santa Maria | Lisbon | Portugal |
| Centro Hospitalar do Porto / Hospital Geral de Santo António | Porto | Portugal |
| Hospital de São João | Porto | Portugal |
| Municipal Healthcare Institution "Municipal Clinical Hospital # 3" | Chelyabinsk | Russia |
| Professor S.V. Ochapovsky Territorial Clinical Hospital #1 | Krasnodar | Russia |
| Clinical Hospital Number 31 | Moscow | Russia |
| Non-state Healthcare Institution "N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway | Moscow | Russia |
| Scientific Research Neurology Institute of Russian Academy of Medical Services | Moscow | Russia |
| State Budget Healthcare Institution "City clinical hospital #20" | Moscow | Russia |
| State Institution of Healthcare of Moscow City "City Clinical Hospital #61" | Moscow | Russia |
| State Institution "Saint Petersburg I.I. Dzhanelidze Research Institute of Emergency" | Petersburg Saint | Russia |
| Municipal Medical Institute "N.I.Pirogov City Clinical hospital #1" | Samara | Russia |
| State Healthcare Institution "Samara M.I.Kalinin Regional Clinical Hospital" | Samara | Russia |
| Smolensk State Medical Academy of RosZdrav | Smolensk | Russia |
| Bashkirian State Medical University | Ufa | Russia |
| Regional Hospital #1, Ekaterinburg | Yekaterinburg | Russia |
| Hospital General de Albacete | Albacete | Spain |
| Hospital Universitari Germans Trias i Pujol | Badalona | Spain |
| Hospital Santa Creu i Sant Pau | Barcelona | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain |
| Hospital Universitario de Girona Doctor Josep Trueta | Girona | Spain |
| Hospital Clínico San Carlos | Madrid | Spain |
| Hospital Universitario La Princesa | Madrid | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | Spain |
| Hospital Clínico Universitario de Santiago de Compostela | Santiago de Compostela | Spain |
| Hospital de Tortosa Verge de la Cinta | Tortosa | Spain |
| Hospital Clinico Universitario de Valladolid | Valladolid | Spain |
| Danderyds Sjukhus AB | Danderyd | Sweden |
| Sahlgrenska Universitetsjukhuset | Gothenburg | Sweden |
| Universitetssjukhuset Linköping | Linköping | Sweden |
| Skånes Universitetssjukhus i Lund | Lund | Sweden |
| Mora lasarett | Mora | Sweden |
| Kärnsjukhuset i Skövde-KSS | Skövde | Sweden |
| Universitätsspital Basel | Basel | Switzerland |
| Centre Hospitalier Universitaire Vaudois | Lausanne | Switzerland |
| Klinik Hirslanden | Zurich | Switzerland |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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