Effect of F2695 on Functional Recovery After Ischemic Stroke
NCT ID: NCT01639014
Last Updated: 2015-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
532 participants
INTERVENTIONAL
2012-07-31
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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F2695
F2695
75 mg OD in 2 capsules
placebo
placebo
2 capsules
Interventions
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F2695
75 mg OD in 2 capsules
placebo
2 capsules
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Pierre Fabre Medicament
INDUSTRY
Responsible Party
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Principal Investigators
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François Chollet
Role: PRINCIPAL_INVESTIGATOR
Hôpital Purpan
Locations
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Cliniques Universitaires Saint Luc
Brussels, , Belgium
Universitair Ziekenhuis Gent
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
Countries
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Other Identifiers
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2012-001592-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
F02695 LP 2 05
Identifier Type: -
Identifier Source: org_study_id
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