Efficacy and Safety Trial With S 44819 After Recent Ischemic Cerebral Event
- Conditions
- Post Stroke Recovery
- Interventions
- Drug: S 44819 150 mg twice a dayDrug: S 44819 300 mg twice a dayDrug: Placebo
- Registration Number
- NCT02877615
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
The purpose of this study is to assess the efficacy and safety of S 44819 in enhancing functional recovery after an ischemic stroke.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 585
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description S 44819 150 mg twice a day S 44819 150 mg twice a day - S 44819 300 mg twice a day S 44819 300 mg twice a day - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Modified Rankin Scale (mRS) Up to 90 days
- Secondary Outcome Measures
Name Time Method 12 lead-ECG Day 0 Day 5 Day 30 Day 60 Day 90 Day 105 Safety criterion
Montreal Cognitive Assessment scale (Moca) total score Day 30 Day 90 Efficacy criterion
Trail Making Test (TMT) time for part A Day 30 Day 90 Efficacy criterion
National Institutes of Health Stroke Scale (NIHSS) total score Selection visit Day 0 Day 5 Day 30 Day 60 Day 90 Day 105 Efficacy criterion
Barthel Index (BI) total score Day 30 Day 60 Day 90 Day 105 Efficacy criterion
Adverse events Through study completion, an average of 3 months Safety criterion
Body weight Selection visit Day 30 Day 60 Day 90 Day 105 Safety criterion
Vital signs (supine for Systolic and Diastolic Blood Pressure) Selection visit Day 0 Day 5 Day 30 Day 60 Day 90 Day 105 Safety criterion
Trail Making Test (TMT) time for part B Day 30 Day 90 Efficacy criterion
Suicidal ideation and suicidal behavior using the Columbia-Suicide Severity Rating Scale (C-SSRS) Day 5 Day 30 Day 60 Day 90 Day 105 Safety criterion
Trial Locations
- Locations (121)
Wojewodzki Szpital Specjalistyczny SPZOZ nr 3 w Rybniku
🇵🇱Rybnik, Poland
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
🇵🇱Warszawa, Poland
Szpital Specjalistyczny Ducha Swietego w Sandomierzu Oddzial Neurologii
🇵🇱Sandomierz, Poland
Irmandade Santa Casa de Misericordia de Sao Paulo Ambulatório de Neurologia
🇧🇷Sao Paulo, Brazil
Lyell McEwin Hospital Neurology Department
🇦🇺Elizabeth Vale, Australia
Hospital das Clinicas da Faculdade de Medicina de Botucatu
🇧🇷Botucatu, Brazil
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Saint John Regional Hospital
🇨🇦Saint John, Canada
Vseobecna fakultni nemocnice II. interni klinika VFN a 1. LF UK
🇨🇿Praha, Czechia
Canisius Wilhelmina Ziekenhuis Afdeling Neurologie
🇳🇱Nijmegen, Netherlands
Erasmus MC Afdeling Neurologie
🇳🇱Rotterdam, Netherlands
Isala Klinieken Afdeling Neurologie
🇳🇱Zwolle, Netherlands
Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
Gold Coast University Hospital
🇦🇺Southport, Australia
Fakultni nemocnice Brno Neurologicka klinika
🇨🇿Brno, Czechia
CHU Bdx-Hôpital Pellegrin-Tripode Service de Neurologie
🇫🇷Bordeaux, France
CHU Henri Mondor Service de Neurologie
🇫🇷Creteil, France
Neurologische Klinik GmbH, Bad Neustadt
🇩🇪Bad Neustadt An Der Saale, Germany
Dong-A University Medical Center Department of Neurology
🇰🇷Busan, Korea, Republic of
Royal Melbourne Hospital Department of Neurology
🇦🇺Parkville, Australia
Petz Aladar Megyei Oktato Korhaz Neurologiai Osztaly
🇭🇺Gyor, Hungary
Hospital das Clinicas da Fac. de med. de Ribeirao Preto Unidade de Emergiancia
🇧🇷Ribeirão Preto, Brazil
University of Alberta
🇨🇦Edmonton, Canada
Hôpital Lariboisière, Fernand-Vidal Service de Neurologie
🇫🇷Paris, France
Vito FAZZI U.O. semplice Stroke Unit
🇮🇹Lecce, Italy
Samodzielny Publiczny Wojewodzki Szpital Specjalistyczny Oddzial Neurologiczny i Oddzial Udarowy
🇵🇱Chelm, Poland
Samodzielny Publiczny Szpital Kliniczny nr7 SUM w Katowicach Oddzial Neurologii z Pododdzialem Udarowym
🇵🇱Katowice, Poland
Sint Andries Ziekenhuis Dienst Neurologie
🇧🇪Tielt, Belgium
Hospital Quinta D'or Departamento de Neurologia
🇧🇷Rio de Janeiro, Brazil
UNIFESP - Universidade Federal de Sao Paulo Centro de Pesquisa em Neurologia
🇧🇷Sao Paulo, Brazil
Universitätsklinikum Erlangen Neurologische Klinik
🇩🇪Erlangen, Germany
M. Kopernika Provincial Specialist Hospital Dpt of Neurology
🇵🇱Gdansk, Poland
Semmelweis Egyetem Neurologiai Klinika
🇭🇺Budapest, Hungary
Honved Korhaz Stroke reszleg
🇭🇺Budapest, Hungary
CHU-Hôpital de la Milétrie Service de Neurologie
🇫🇷Poitiers, France
Seoul National University Bundang Hospital Department of Orthopaedic
🇰🇷Seongnam, Korea, Republic of
Skaraborgs Sjukhus Skovde Strokenheten
🇸🇪Skovde, Sweden
Danderyds Sjukhus Medicinmottagningen
🇸🇪Stockholm, Sweden
CHRU-Hôpital Roger Salengro Service de Neurologie
🇫🇷Lille, France
Akademiska Sjukhuset Strokeavdelningen 85B
🇸🇪Uppsala, Sweden
CHU-Hôpital Gui de Chaulliac Unité de Neuropshysiologie Clinique
🇫🇷Montpellier, France
Soproni Erzsebet Oktato Korhaz Neurologiai Osztaly
🇭🇺Sopron, Hungary
Szpital Specjalistyczny sw. Lukasza Oddzial Neurologii i Oddzial Udarowy
🇵🇱Konskie, Poland
Zuyderland Medisch Centrum Afdeling Neurologie
🇳🇱Heerlen, Netherlands
UMC St Radboud Afdeling Neurologie
🇳🇱Nijmegen, Netherlands
Hassleholms Sjukhus Stroke- och rehabiliteringsavdelningen 9
🇸🇪Hassleholm, Sweden
H. General de Albacete Servicio de Neurología
🇪🇸Albacete, Spain
ASAN Medical Center Department of Neurology
🇰🇷Seoul, Korea, Republic of
H. Valle de Hebrón Servicio de Neurología
🇪🇸Barcelona, Spain
Pecsi Tudomanyegyetem Klinikai Kozpont Neurologiai Klinika
🇭🇺Pecs, Hungary
Kyungpook National University Hospital Department of Neurology
🇰🇷Daegu, Korea, Republic of
H. Germans Trias I Pujol Servicio de Neurología
🇪🇸Badalona, Spain
Northwick Park Hospital Neurology
🇬🇧Harrow, United Kingdom
Royal United Hospital Older People's Unit
🇬🇧Bath, United Kingdom
University Hospital Department of Neurology
🇸🇪Linkoping, Sweden
Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital
🇬🇧Sheffield, United Kingdom
Ospedale Sacro Cuore Don Calabria Negrar NEUROLOGY DEPT
🇮🇹Negrar, Italy
Istituto Neurologico mediterraneo NEUROMED Dipartimento di Medicina Riabilitativa e Specialistica Repar
🇮🇹Pozzilli, Italy
Policlinico Umberto I Emergency Department Stroke Unit
🇮🇹Rome, Italy
Hospital Sao Lucas da Pontificia Universidade Catolica RS Setor de Pesquisa Clínica
🇧🇷Porto Alegre, Brazil
Charles LeMoyne Hospital-CISSS de la Monteregie-Centre
🇨🇦Greenfield Park, Canada
Montreal General Hospital
🇨🇦Montreal, Canada
Nottingham City Hospital
🇬🇧Nottingham, United Kingdom
H. Universitario de Donosti Servicio de Neurología
🇪🇸San Sebastian, Spain
H. Josep Trueta Servicio de Neurología
🇪🇸Girona, Spain
Universitätsklinik der Eberhard-Karls Universtiät Tübingen Hertie-Institut für Klinische Hirnforschung
🇩🇪Tübingen, Germany
Kanizsai Dorottya Korhaz Neurologiai Osztaly
🇭🇺Nagykanizsa, Hungary
Klinikum Altenburger Land GmbH Neurologische Klinik
🇩🇪Altenburg, Germany
Bajcsy-Zsilinszky Korhaz es Rendelointezet Neurologiai Osztaly
🇭🇺Budapest, Hungary
H. Ramón y Cajal Servicio de Neurología
🇪🇸Madrid, Spain
Orszagos Idegsebeszeti Tudomanyos Intezet
🇭🇺Budapest, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgy Albert Klinikai Kozpont
🇭🇺Szeged, Hungary
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Chonnam National University Hospital Department of Neurology
🇰🇷Gwangju, Korea, Republic of
Johannes Wesling Klinik Minden Klinik für Neurologie
🇩🇪Minden, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Klinik und Poliklinik für
🇩🇪Mainz, Germany
Universitätsklinikum Ulm Neurologische Klinik (RKU)
🇩🇪ULM, Germany
H. del Mar Neurología
🇪🇸Barcelona, Spain
St George's University Hospitals Stroke Research office
🇬🇧London, United Kingdom
H. Clinic de Barcelona Comprehensive Stroke Center
🇪🇸Barcelona, Spain
H. Virgen del Rocío Servicio de Neurología
🇪🇸Sevilla, Spain
Hospital Universitario La Fe Servicio de Neurología
🇪🇸Valencia, Spain
Queen Elizabeth University Hospital
🇬🇧Glasgow, United Kingdom
Leicester Royal Infirmary Dpt of Neurology
🇬🇧Leicester, United Kingdom
Royal Stoke University Hospital Stroke Team Office
🇬🇧Stoke on Trent, United Kingdom
Poole NHS Foundation Trust Stroke Unit
🇬🇧Poole, United Kingdom
Royal Adelaide Hospital Department of Neurology
🇦🇺Adelaide, Australia
Sunshine Coast Hospital
🇦🇺Birtinya, Australia
Monash Medical Centre Department of Neurology
🇦🇺Clayton, Australia
Alfred Health
🇦🇺Melbourne, Australia
Royal Brisbane & Women's Hospital Department of Neurology
🇦🇺Herston, Australia
Austin Health Neurology Department
🇦🇺Heidelberg, Australia
Gosford Hospital Neurosciences Department
🇦🇺Gosford, Australia
AZ. St. Jan
🇧🇪Brugge, Belgium
AZ Sint-Lucas Neurologie
🇧🇪Brugge, Belgium
Jessa Ziekenhuis Dienst Neurologie
🇧🇪Hasselt, Belgium
Les Cliniques Saint-Joseph
🇧🇪Liege, Belgium
Hospital Carlos Fernando Malzone Departamento de Neurologia
🇧🇷Matão, Brazil
Clínica Neurológica e Neurocirúrgica de Joinville
🇧🇷Joinville, Brazil
IMV Pesquisa Neurológica Setor de Pesquisa Clinica
🇧🇷Porto Alegre, Brazil
Hospital das Clinicas da Fac. de Med. de Ribeirao Preto Unidade de Emergencia - Centro de Estudo
🇧🇷Ribeirao Preto, Brazil
Fakultni nemocnice u sv. Anny Neurologicka klinika
🇨🇿Brno, Czechia
Nemocnice Jihlava
🇨🇿Jihlava, Czechia
CHU de Bicêtre Service de neurologie
🇫🇷Le Kremlin-Bicêtre, France
Hôpital Sud-Francilien Unité Neurovasculaire
🇫🇷Corbeil-essonnes, France
Hôpital Sainte-Anne Service de Neurologie
🇫🇷Paris, France
Vivantes Klinikum Neukölln Klinik für Neurologie mit Stroke Unit
🇩🇪Berlin, Germany
Universitaetsklinikum Essen Neurologische Universitätsklinik Essen
🇩🇪Essen, Germany
Kreisklinikum Siegen Klinik fuer Neurologie
🇩🇪Siegen, Germany
Somogy Megyei Kaposi Mor Oktato Korhaz Neurologiai Osztaly
🇭🇺Kaposvár, Hungary
Szent Janos Korhaz Neurologiai osztaly
🇭🇺Budapest, Hungary
Flor Ferenc Korhaz Neurologia
🇭🇺Kistarcsa, Hungary
Josa Andras Oktatokorhaz Neurologiai Osztaly
🇭🇺Nyiregyhaza, Hungary
B-A-Z Megyei Korhaz es Egyetemi Oktato Korhaz Stroke, Er- es Neurologiai, Toxikologiai Osztaly
🇭🇺Miskolc, Hungary
Ospedale San Raffaele
🇮🇹Milano, Italy
Ospedale San Giuseppe UOC di Neurologia e Stroke Unit
🇮🇹Milano, Italy
Hospital Universitari de Bellvitge Servicio de Neurología-Unidad de Ictus-Planta 9
🇪🇸Barcelona, Spain
H. Universitario La Princesa Servicio de Neurología
🇪🇸Madrid, Spain
Miejskie Centrum Medyczne Jonscher Szpital Dr K. Jonschera
🇵🇱Lodz, Poland
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie Oddzial Neurologii
🇵🇱Lublin, Poland
UZ Leuven Campus Gasthuisberg
🇧🇪Leuven, Belgium