Effect of F2695 on Functional Recovery After Ischemic Stroke
- Registration Number
- NCT01639014
- Lead Sponsor
- Pierre Fabre Medicament
- Brief Summary
The purpose of the study is to assess the efficacy of a new serotonin-norepinephrine reuptake inhibitor (SNRI) nin functional recovery after ischemic stroke.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 532
- Male or female patient, 18 to 80 years of age
- Confirmed acute ischemic stroke within the past 2 - 10 days
- Unilateral motor deficit,
- National Institutes of Health stroke scale (NIHSS) motor score >= 5
- Modified Rankin Scale (mRS) of 4 or 5
- Able and willing to comply with the site rehabilitation program requirements
- Aphasia
- Severe post-stroke condition
- Active depressive episode
- Intra-cerebral hemorrhage
- Use of anti-depressant drugs
- Cardiac rhythm disorder
- Uncontrolled arterial hypertension
- Other severe acute or chronic medical or psychiatric condition.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo - F2695 F2695 -
- Primary Outcome Measures
Name Time Method Percentage of patients with a Modified Rankin Scale (mRS) less than or equal to 1 at Week 12 week 12
- Secondary Outcome Measures
Name Time Method Change from baseline to Week 12 of the mean NIHSS total and motor scores baseline to week 12 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 Percentage of patients with a mRS score less than or equal to 2 at Week 12 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
Trial Locations
- Locations (87)
Clinique Saint-Joseph
🇧🇪Liege, Belgium
Regional Ziekenhuis Sint-Trudo
🇧🇪Sint-Truiden, Belgium
Litomyšlská Nemocnice, a.s.
🇨🇿Litomyšl, Czech Republic
Universitair Ziekenhuis Gent
🇧🇪Ghent, Belgium
Fakultní nemocnice u sv. Anny v Brne
🇨🇿Brno, Czech Republic
Fakultní nemocnice Hradec Králové
🇨🇿Hradec Kralové, Czech Republic
Fakultní nemocnice Olomouc
🇨🇿Olomouc, Czech Republic
Vítkovická nemocnice a.s.
🇨🇿Ostrava - Vítkovice, Czech Republic
Fakultní Nemocnice Ostrava
🇨🇿Ostrava, Czech Republic
Magyar Honvédség Honvédkórház
🇭🇺Budapest, Hungary
Jahn Ferenc Dél-pesti Kórház
🇭🇺Budapest, Hungary
Debreceni Egyetem Orvos- és Egészségtudományi Centrum
🇭🇺Debrecen, Hungary
Petz Aladár Megyei Oktató Kórház
🇭🇺Gyor, Hungary
Hospital de Santa Maria
🇵🇹Lisboa, Portugal
Kaposi Mór Megyei Oktató Kórhaz
🇭🇺Kaposvár, Hungary
Kanizsai Dorottya Kórház
🇭🇺Nagykanizsa, Hungary
Jósa András Oktató Kórház
🇭🇺Nyíregyháza, Hungary
BAZ Megyei és Egyetemi Oktató Kórház
🇭🇺Miskolc, Hungary
Fejér Megyei Szent György Kórház
🇭🇺Székesfehérvár, Hungary
Soproni Erzsébet Oktató Kórház
🇭🇺Sopron, Hungary
Clinical Hospital Number 31
🇷🇺Moscow, Russian Federation
Hospitais da Universidade de Coimbra
🇵🇹Coimbra, Portugal
Hospital de São João
🇵🇹Porto, Portugal
Smolensk State Medical Academy of RosZdrav
🇷🇺Smolensk, Russian Federation
Regional Hospital #1, Ekaterinburg
🇷🇺Ekaterinburg, Russian Federation
Professor S.V. Ochapovsky Territorial Clinical Hospital #1
🇷🇺Krasnodar, Russian Federation
State Institution "Saint Petersburg I.I. Dzhanelidze Research Institute of Emergency"
🇷🇺Petersburg Saint, Russian Federation
Municipal Medical Institute "N.I.Pirogov City Clinical hospital #1"
🇷🇺Samara, Russian Federation
State Budget Healthcare Institution "City clinical hospital #20"
🇷🇺Moscow, Russian Federation
State Healthcare Institution "Samara M.I.Kalinin Regional Clinical Hospital"
🇷🇺Samara, Russian Federation
Centre Hospitalier Universitaire Vaudois
🇨🇭Lausanne, Switzerland
Klinik Hirslanden
🇨🇭Zürich, Switzerland
Scientific Research Neurology Institute of Russian Academy of Medical Services
🇷🇺Moscow, Russian Federation
Bashkirian State Medical University
🇷🇺Ufa, Russian Federation
Universitätsspital Basel
🇨🇭Basel, Switzerland
Azienda Sanitaria Ospedaliera "San Giovanni Battista"
🇮🇹Foligno, Italy
Istituto Clinico Humanitas
🇮🇹Rozzano, Italy
Hopital Lariboisière
🇫🇷Paris, France
Cliniques Universitaires Saint Luc
🇧🇪Brussels, Belgium
IRCCS "Istituto Neurologico C. Mondino"
🇮🇹Pavia, Italy
Neurologische Klinik GmbH
🇩🇪Bad Neustadt/Saale, Germany
Universitätsklinik Charité, Campus Mitte
🇩🇪Berlin, Germany
Asklepios Klinik Altona
🇩🇪Hamburg, Germany
Universitätsklinikum Leipzig
🇩🇪Leipzig, Germany
Ospedale Santa Maria della Misericordia
🇮🇹Perugia, Italy
Hôpital Purpan
🇫🇷Toulouse, France
Freiburger Universitätsklinik
🇩🇪Freiburg, Germany
Centre Hospitalier de Lens
🇫🇷Lens, France
Centre Hospitalier Universitaire de Saint Etienne, Hôpital Nord
🇫🇷Saint Priest en Jarez, France
Asklepios Fachklinikum Teupitz
🇩🇪Teupitz, Germany
Universitätsklinikum Essen
🇩🇪Essen, Germany
Hopital Jean Minjoz Centre Hospitalier Universitaire Besancon
🇫🇷Besançon, France
Hôpital Roger Salengro
🇫🇷Lille, France
Centre Hospitalier Universitaire de Poitiers Hôpital de la Milétrie
🇫🇷Poitiers, France
Universitätsklinikum Bonn
🇩🇪Bonn, Germany
Azienda Ospedaliera San Gerardo
🇮🇹Monza, Italy
Clinique des Cèdres
🇫🇷Cornebarrieu, France
Sahlgrenska Universitetsjukhuset
🇸🇪Göteborg, Sweden
Mora lasarett
🇸🇪Mora, Sweden
Semmelweis Egyetem Neurológiai Klinika
🇭🇺Budapest, Hungary
Universitätsklinikum Münster
🇩🇪Münster, Germany
Centro Hospitalar do Porto / Hospital Geral de Santo António
🇵🇹Porto, Portugal
Universitetssjukhuset Linköping
🇸🇪Linköping, Sweden
IRCCS Fondazione Santa Lucia
🇮🇹Roma, Italy
Hospital Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Hospital Garcia de Orta
🇵🇹Almada, Portugal
Municipal Healthcare Institution "Municipal Clinical Hospital # 3"
🇷🇺Chelyabinsk, Russian Federation
Hospital Universitario La Princesa
🇪🇸Madrid, Spain
Hospital de Tortosa Verge de la Cinta
🇪🇸Tortosa, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Kärnsjukhuset i Skövde-KSS
🇸🇪Skövde, Sweden
State Institution of Healthcare of Moscow City "City Clinical Hospital #61"
🇷🇺Moscow, Russian Federation
Hospital General de Albacete
🇪🇸Albacete, Spain
Hospital Universitario de Girona Doctor Josep Trueta
🇪🇸Gerona, Spain
Hospital Clinico Universitario de Valladolid
🇪🇸Valladolid, Spain
Danderyds Sjukhus AB
🇸🇪Danderyd, Sweden
Hospital Clínico Universitario de Santiago de Compostela
🇪🇸Santiago de Compostela, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Universitätsklinikum Erlangen
🇩🇪Erlangen, Germany
Universitaire Ziekenhuis Gasthuisberg
🇧🇪Leuven, Belgium
Academisch Ziekenhuis Sint Augustinus
🇧🇪Wilrijk, Belgium
Sint-Andriesziekenhuis
🇧🇪Tielt, Belgium
Groupe Hospitalier Paris Saint Joseph
🇫🇷Paris, France
Non-state Healthcare Institution "N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway
🇷🇺Moscow, Russian Federation
Skånes Universitetssjukhus i Lund
🇸🇪Lund, Sweden