Efficacy and Safety Trial With S 44819 After Recent Ischemic Cerebral Event
NCT ID: NCT02877615
Last Updated: 2020-03-11
Study Results
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Basic Information
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COMPLETED
PHASE2
585 participants
INTERVENTIONAL
2016-12-19
2019-03-10
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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S 44819 150 mg twice a day
S 44819 150 mg twice a day
One sachet of S 44819 150 mg and one sachet of placebo twice a day
S 44819 300 mg twice a day
S 44819 300 mg twice a day
Two sachets of S 44819 150 mg twice a day
Placebo
Placebo
Two sachets of placebo twice a day
Interventions
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S 44819 150 mg twice a day
One sachet of S 44819 150 mg and one sachet of placebo twice a day
S 44819 300 mg twice a day
Two sachets of S 44819 150 mg twice a day
Placebo
Two sachets of placebo twice a day
Eligibility Criteria
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Inclusion Criteria
* Acute ischemic stroke that occured between 72 hours (3 days) and 192 hours (8 days) (both inclusive) before inclusion
Exclusion Criteria
* Positive urinary or blood pregnancy test (for female patients of child bearing potential)
* Any clinically significant findings from the local laboratory test likely to interfere with the ability to participate in the study and / or with the study outcome
* Severe renal impairment detected in the local laboratory test
* Severe hepatic impairment or liver enzymes abnormalities found in the local laboratory test
* Stroke due to cerebral venous thrombosis
* Brain MRI showing a severe microangiopathy
* Brain imaging showing an acute haemorrhagic stroke or a symptomatic haemorrhagic transformation of the brain infarct
* Qualifying ischemic cerebral event older than 192 hours at inclusion
* Any clinically relevant abnormalities detected during the examinations likely to interfere with study procedures or study outcome,
* Repeated prolongation of ECG QTcF
* Patient or authorised representative refusing to attend study visits or to take part in the study
18 Years
85 Years
ALL
No
Sponsors
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ADIR, a Servier Group company
INDUSTRY
Institut de Recherches Internationales Servier
OTHER
Responsible Party
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Locations
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Royal Adelaide Hospital Department of Neurology
Adelaide, , Australia
Sunshine Coast Hospital
Birtinya, , Australia
Monash Medical Centre Department of Neurology
Clayton, , Australia
Lyell McEwin Hospital Neurology Department
Elizabeth Vale, , Australia
Gosford Hospital Neurosciences Department
Gosford, , Australia
Austin Health Neurology Department
Heidelberg, , Australia
Royal Brisbane & Women's Hospital Department of Neurology
Herston, , Australia
Alfred Health
Melbourne, , Australia
Royal Melbourne Hospital Department of Neurology
Parkville, , Australia
Gold Coast University Hospital
Southport, , Australia
AZ Sint-Lucas Neurologie
Bruges, , Belgium
AZ. St. Jan
Bruges, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
Jessa Ziekenhuis Dienst Neurologie
Hasselt, , Belgium
UZ Leuven Campus Gasthuisberg
Leuven, , Belgium
Les Cliniques Saint-Joseph
Liège, , Belgium
Sint Andries Ziekenhuis Dienst Neurologie
Tielt, , Belgium
Hospital das Clinicas da Faculdade de Medicina de Botucatu
Botucatu, , Brazil
Clínica Neurológica e Neurocirúrgica de Joinville
Joinville, , Brazil
Hospital Carlos Fernando Malzone Departamento de Neurologia
Matão, , Brazil
IMV Pesquisa Neurológica Setor de Pesquisa Clinica
Porto Alegre, , Brazil
Hospital Sao Lucas da Pontificia Universidade Catolica RS Setor de Pesquisa Clínica
Porto Alegre, , Brazil
Hospital das Clinicas da Fac. de Med. de Ribeirao Preto Unidade de Emergencia - Centro de Estudo
Ribeirão Preto, , Brazil
Hospital das Clinicas da Fac. de med. de Ribeirao Preto Unidade de Emergiancia
Ribeirão Preto, , Brazil
Hospital Quinta D'or Departamento de Neurologia
Rio de Janeiro, , Brazil
Irmandade Santa Casa de Misericordia de Sao Paulo Ambulatório de Neurologia
São Paulo, , Brazil
UNIFESP - Universidade Federal de Sao Paulo Centro de Pesquisa em Neurologia
São Paulo, , Brazil
University of Alberta
Edmonton, , Canada
Charles LeMoyne Hospital-CISSS de la Monteregie-Centre
Greenfield Park, , Canada
Montreal General Hospital
Montreal, , Canada
Saint John Regional Hospital
Saint John, , Canada
Fakultni nemocnice Brno Neurologicka klinika
Brno, , Czechia
Fakultni nemocnice u sv. Anny Neurologicka klinika
Brno, , Czechia
Nemocnice Jihlava
Jihlava, , Czechia
Vseobecna fakultni nemocnice II. interni klinika VFN a 1. LF UK
Prague, , Czechia
CHU Bdx-Hôpital Pellegrin-Tripode Service de Neurologie
Bordeaux, , France
Hôpital Sud-Francilien Unité Neurovasculaire
Corbeil-Essonnes, , France
CHU Henri Mondor Service de Neurologie
Créteil, , France
CHU de Bicêtre Service de neurologie
Le Kremlin-Bicêtre, , France
CHRU-Hôpital Roger Salengro Service de Neurologie
Lille, , France
CHU-Hôpital Gui de Chaulliac Unité de Neuropshysiologie Clinique
Montpellier, , France
Hôpital Lariboisière, Fernand-Vidal Service de Neurologie
Paris, , France
Hôpital Sainte-Anne Service de Neurologie
Paris, , France
CHU-Hôpital de la Milétrie Service de Neurologie
Poitiers, , France
Klinikum Altenburger Land GmbH Neurologische Klinik
Altenburg, , Germany
Neurologische Klinik GmbH, Bad Neustadt
Bad Neustadt an der Saale, , Germany
Vivantes Klinikum Neukölln Klinik für Neurologie mit Stroke Unit
Berlin, , Germany
Universitätsklinikum Erlangen Neurologische Klinik
Erlangen, , Germany
Universitaetsklinikum Essen Neurologische Universitätsklinik Essen
Essen, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Klinik und Poliklinik für
Mainz, , Germany
Johannes Wesling Klinik Minden Klinik für Neurologie
Minden, , Germany
Kreisklinikum Siegen Klinik fuer Neurologie
Siegen, , Germany
Universitätsklinik der Eberhard-Karls Universtiät Tübingen Hertie-Institut für Klinische Hirnforschung
Tübingen, , Germany
Universitätsklinikum Ulm Neurologische Klinik (RKU)
Ulm, , Germany
Semmelweis Egyetem Neurologiai Klinika
Budapest, , Hungary
Bajcsy-Zsilinszky Korhaz es Rendelointezet Neurologiai Osztaly
Budapest, , Hungary
Szent Janos Korhaz Neurologiai osztaly
Budapest, , Hungary
Honved Korhaz Stroke reszleg
Budapest, , Hungary
Orszagos Idegsebeszeti Tudomanyos Intezet
Budapest, , Hungary
Petz Aladar Megyei Oktato Korhaz Neurologiai Osztaly
Győr, , Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz Neurologiai Osztaly
Kaposvár, , Hungary
Flor Ferenc Korhaz Neurologia
Kistarcsa, , Hungary
B-A-Z Megyei Korhaz es Egyetemi Oktato Korhaz Stroke, Er- es Neurologiai, Toxikologiai Osztaly
Miskolc, , Hungary
Kanizsai Dorottya Korhaz Neurologiai Osztaly
Nagykanizsa, , Hungary
Josa Andras Oktatokorhaz Neurologiai Osztaly
Nyíregyháza, , Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont Neurologiai Klinika
Pécs, , Hungary
Soproni Erzsebet Oktato Korhaz Neurologiai Osztaly
Sopron, , Hungary
Szegedi Tudomanyegyetem Szent-Gyorgy Albert Klinikai Kozpont
Szeged, , Hungary
Vito FAZZI U.O. semplice Stroke Unit
Lecce, , Italy
Ospedale San Giuseppe UOC di Neurologia e Stroke Unit
Milan, , Italy
Ospedale San Raffaele
Milan, , Italy
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
Zuyderland Medisch Centrum Afdeling Neurologie
Heerlen, , Netherlands
UMC St Radboud Afdeling Neurologie
Nijmegen, , Netherlands
Canisius Wilhelmina Ziekenhuis Afdeling Neurologie
Nijmegen, , Netherlands
Erasmus MC Afdeling Neurologie
Rotterdam, , Netherlands
Isala Klinieken Afdeling Neurologie
Zwolle, , Netherlands
Samodzielny Publiczny Wojewodzki Szpital Specjalistyczny Oddzial Neurologiczny i Oddzial Udarowy
Chełm, , Poland
M. Kopernika Provincial Specialist Hospital Dpt of Neurology
Gdansk, , Poland
Szpital Specjalistyczny sw. Lukasza Oddzial Neurologii i Oddzial Udarowy
Gmina Końskie, , Poland
Samodzielny Publiczny Szpital Kliniczny nr7 SUM w Katowicach Oddzial Neurologii z Pododdzialem Udarowym
Katowice, , Poland
Miejskie Centrum Medyczne Jonscher Szpital Dr K. Jonschera
Lodz, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie Oddzial Neurologii
Lublin, , Poland
Wojewodzki Szpital Specjalistyczny SPZOZ nr 3 w Rybniku
Rybnik, , Poland
Szpital Specjalistyczny Ducha Swietego w Sandomierzu Oddzial Neurologii
Sandomierz, , Poland
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
Warsaw, , Poland
Inje University Busan Paik Hospital
Busan, , South Korea
Dong-A University Medical Center Department of Neurology
Busan, , South Korea
Kyungpook National University Hospital Department of Neurology
Daegu, , South Korea
Chonnam National University Hospital Department of Neurology
Gwangju, , South Korea
Seoul National University Bundang Hospital Department of Orthopaedic
Seongnam, , South Korea
Kyung Hee University Hospital
Seoul, , South Korea
ASAN Medical Center Department of Neurology
Seoul, , South Korea
H. General de Albacete Servicio de Neurología
Albacete, , Spain
H. Germans Trias I Pujol Servicio de Neurología
Badalona, , Spain
H. del Mar Neurología
Barcelona, , Spain
H. Valle de Hebrón Servicio de Neurología
Barcelona, , Spain
H. Clinic de Barcelona Comprehensive Stroke Center
Barcelona, , Spain
Hospital Universitari de Bellvitge Servicio de Neurología-Unidad de Ictus-Planta 9
Barcelona, , Spain
H. Universitario de Donosti Servicio de Neurología
Donostia / San Sebastian, , Spain
H. Josep Trueta Servicio de Neurología
Girona, , Spain
H. Universitario La Princesa Servicio de Neurología
Madrid, , Spain
H. Ramón y Cajal Servicio de Neurología
Madrid, , Spain
H. Virgen del Rocío Servicio de Neurología
Seville, , Spain
Hospital Universitario La Fe Servicio de Neurología
Valencia, , Spain
Hassleholms Sjukhus Stroke- och rehabiliteringsavdelningen 9
Hässleholm, , Sweden
University Hospital Department of Neurology
Linköping, , Sweden
Skaraborgs Sjukhus Skovde Strokenheten
Skövde, , Sweden
Danderyds Sjukhus Medicinmottagningen
Stockholm, , Sweden
Akademiska Sjukhuset Strokeavdelningen 85B
Uppsala, , Sweden
Royal United Hospital Older People's Unit
Bath, , United Kingdom
Queen Elizabeth University Hospital
Glasgow, , United Kingdom
Northwick Park Hospital Neurology
Harrow, , United Kingdom
Leicester Royal Infirmary Dpt of Neurology
Leicester, , United Kingdom
St George's University Hospitals Stroke Research office
London, , United Kingdom
Nottingham City Hospital
Nottingham, , United Kingdom
Poole NHS Foundation Trust Stroke Unit
Poole, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital
Sheffield, , United Kingdom
Royal Stoke University Hospital Stroke Team Office
Stoke-on-Trent, , United Kingdom
Countries
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References
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Chabriat H, Bassetti CL, Marx U, Picarel-Blanchot F, Sors A, Gruget C, Saba B, Wattez M, Audoli ML, Hermann DM. Randomized Efficacy and Safety Trial with Oral S 44819 after Recent ischemic cerebral Event (RESTORE BRAIN study): a placebo controlled phase II study. Trials. 2020 Feb 3;21(1):136. doi: 10.1186/s13063-020-4072-2.
Chabriat H, Bassetti CL, Marx U, Audoli-Inthavong ML, Sors A, Lambert E, Wattez M, Hermann DM; RESTORE BRAIN study investigators. Safety and efficacy of GABAA alpha5 antagonist S44819 in patients with ischaemic stroke: a multicentre, double-blind, randomised, placebo-controlled trial. Lancet Neurol. 2020 Mar;19(3):226-233. doi: 10.1016/S1474-4422(20)30004-1.
Study Documents
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Document Type: Study Protocol
View DocumentDocument Type: Individual Participant Data Set
View DocumentDocument Type: Statistical Analysis Plan
View DocumentDocument Type: Informed Consent Form
View DocumentDocument Type: Clinical Study Report
View DocumentDocument Type: Study-level clinical trial data
View DocumentRelated Links
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Scientific publication
Scientific publication
Other Identifiers
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2016-001005-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
UTN number: U1111-1180-8991
Identifier Type: OTHER
Identifier Source: secondary_id
CL2-44819-004
Identifier Type: -
Identifier Source: org_study_id
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