Efficacy and Safety Trial With S 44819 After Recent Ischemic Cerebral Event
Randomized Efficacy and Safety Trial With Oral S 44819 After Recent Ischemic Cerebral Event. International, Multi-centre, Randomized, Doubleblind Placebo-controlled Phase II Study. (RESTORE BRAIN Study)
3 other identifiers
interventional
585
15 countries
121
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2016
121 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2016
CompletedFirst Posted
Study publicly available on registry
August 24, 2016
CompletedStudy Start
First participant enrolled
December 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2019
CompletedMarch 11, 2020
March 1, 2020
2.2 years
July 20, 2016
March 9, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Modified Rankin Scale (mRS)
Up to 90 days
Secondary Outcomes (10)
National Institutes of Health Stroke Scale (NIHSS) total score
Selection visit Day 0 Day 5 Day 30 Day 60 Day 90 Day 105
Barthel Index (BI) total score
Day 30 Day 60 Day 90 Day 105
Montreal Cognitive Assessment scale (Moca) total score
Day 30 Day 90
Trail Making Test (TMT) time for part A
Day 30 Day 90
Adverse events
Through study completion, an average of 3 months
- +5 more secondary outcomes
Study Arms (3)
S 44819 150 mg twice a day
EXPERIMENTALS 44819 300 mg twice a day
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
One sachet of S 44819 150 mg and one sachet of placebo twice a day
Eligibility Criteria
You may qualify if:
- Patients aged between 18 and 85 years (both inclusive)
You may not qualify if:
- Any non-selection criteria, which could have occurred after the selection visit
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (121)
Royal Adelaide Hospital Department of Neurology
Adelaide, 5000, Australia
Sunshine Coast Hospital
Birtinya, 4575, Australia
Monash Medical Centre Department of Neurology
Clayton, 3168, Australia
Lyell McEwin Hospital Neurology Department
Elizabeth Vale, 5112, Australia
Gosford Hospital Neurosciences Department
Gosford, 2250, Australia
Austin Health Neurology Department
Heidelberg, VIC 3084, Australia
Royal Brisbane & Women's Hospital Department of Neurology
Herston, 4029, Australia
Alfred Health
Melbourne, 3004, Australia
Royal Melbourne Hospital Department of Neurology
Parkville, 3050, Australia
Gold Coast University Hospital
Southport, QLD 4215, Australia
AZ Sint-Lucas Neurologie
Bruges, 8000, Belgium
AZ. St. Jan
Bruges, 8000, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, 2650, Belgium
Jessa Ziekenhuis Dienst Neurologie
Hasselt, 3500, Belgium
UZ Leuven Campus Gasthuisberg
Leuven, 3000, Belgium
Les Cliniques Saint-Joseph
Liège, 4000, Belgium
Sint Andries Ziekenhuis Dienst Neurologie
Tielt, 8700, Belgium
Hospital das Clinicas da Faculdade de Medicina de Botucatu
Botucatu, 18618-970, Brazil
Clínica Neurológica e Neurocirúrgica de Joinville
Joinville, 89202-165, Brazil
Hospital Carlos Fernando Malzone Departamento de Neurologia
Matão, 15990-000, Brazil
IMV Pesquisa Neurológica Setor de Pesquisa Clinica
Porto Alegre, 90110-270, Brazil
Hospital Sao Lucas da Pontificia Universidade Catolica RS Setor de Pesquisa Clínica
Porto Alegre, 90610-000, Brazil
Hospital das Clinicas da Fac. de Med. de Ribeirao Preto Unidade de Emergencia - Centro de Estudo
Ribeirão Preto, 14015-130, Brazil
Hospital das Clinicas da Fac. de med. de Ribeirao Preto Unidade de Emergiancia
Ribeirão Preto, 14015-130, Brazil
Hospital Quinta D'or Departamento de Neurologia
Rio de Janeiro, 20941-150, Brazil
Irmandade Santa Casa de Misericordia de Sao Paulo Ambulatório de Neurologia
São Paulo, 01221-020, Brazil
UNIFESP - Universidade Federal de Sao Paulo Centro de Pesquisa em Neurologia
São Paulo, 04039-032, Brazil
University of Alberta
Edmonton, T6G 2G3, Canada
Charles LeMoyne Hospital-CISSS de la Monteregie-Centre
Greenfield Park, J4V 2H1, Canada
Montreal General Hospital
Montreal, H3G 1A4, Canada
Saint John Regional Hospital
Saint John, E2L 4L2, Canada
Fakultni nemocnice Brno Neurologicka klinika
Brno, 625 00, Czechia
Fakultni nemocnice u sv. Anny Neurologicka klinika
Brno, 656 91, Czechia
Nemocnice Jihlava
Jihlava, 586 33, Czechia
Vseobecna fakultni nemocnice II. interni klinika VFN a 1. LF UK
Prague, 128 08, Czechia
CHU Bdx-Hôpital Pellegrin-Tripode Service de Neurologie
Bordeaux, 33076, France
Hôpital Sud-Francilien Unité Neurovasculaire
Corbeil-Essonnes, 91106, France
CHU Henri Mondor Service de Neurologie
Créteil, 94010, France
CHU de Bicêtre Service de neurologie
Le Kremlin-Bicêtre, 94270, France
CHRU-Hôpital Roger Salengro Service de Neurologie
Lille, 59037, France
CHU-Hôpital Gui de Chaulliac Unité de Neuropshysiologie Clinique
Montpellier, 34295, France
Hôpital Lariboisière, Fernand-Vidal Service de Neurologie
Paris, 75010, France
Hôpital Sainte-Anne Service de Neurologie
Paris, 75674, France
CHU-Hôpital de la Milétrie Service de Neurologie
Poitiers, 86021, France
Klinikum Altenburger Land GmbH Neurologische Klinik
Altenburg, 04600, Germany
Neurologische Klinik GmbH, Bad Neustadt
Bad Neustadt an der Saale, 97616, Germany
Vivantes Klinikum Neukölln Klinik für Neurologie mit Stroke Unit
Berlin, 12351, Germany
Universitätsklinikum Erlangen Neurologische Klinik
Erlangen, 91054, Germany
Universitaetsklinikum Essen Neurologische Universitätsklinik Essen
Essen, 45147, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Klinik und Poliklinik für
Mainz, 55131, Germany
Johannes Wesling Klinik Minden Klinik für Neurologie
Minden, 32429, Germany
Kreisklinikum Siegen Klinik fuer Neurologie
Siegen, 57076, Germany
Universitätsklinik der Eberhard-Karls Universtiät Tübingen Hertie-Institut für Klinische Hirnforschung
Tübingen, 72076, Germany
Universitätsklinikum Ulm Neurologische Klinik (RKU)
Ulm, 89081, Germany
Semmelweis Egyetem Neurologiai Klinika
Budapest, 1083, Hungary
Bajcsy-Zsilinszky Korhaz es Rendelointezet Neurologiai Osztaly
Budapest, 1106, Hungary
Szent Janos Korhaz Neurologiai osztaly
Budapest, 1125, Hungary
Honved Korhaz Stroke reszleg
Budapest, 1134, Hungary
Orszagos Idegsebeszeti Tudomanyos Intezet
Budapest, 1145, Hungary
Petz Aladar Megyei Oktato Korhaz Neurologiai Osztaly
Győr, 9024, Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz Neurologiai Osztaly
Kaposvár, 7400, Hungary
Flor Ferenc Korhaz Neurologia
Kistarcsa, 2143, Hungary
B-A-Z Megyei Korhaz es Egyetemi Oktato Korhaz Stroke, Er- es Neurologiai, Toxikologiai Osztaly
Miskolc, 3526, Hungary
Kanizsai Dorottya Korhaz Neurologiai Osztaly
Nagykanizsa, 8800, Hungary
Josa Andras Oktatokorhaz Neurologiai Osztaly
Nyíregyháza, 4400, Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont Neurologiai Klinika
Pécs, 7623, Hungary
Soproni Erzsebet Oktato Korhaz Neurologiai Osztaly
Sopron, 9400, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgy Albert Klinikai Kozpont
Szeged, 6725, Hungary
Vito FAZZI U.O. semplice Stroke Unit
Lecce, 73100, Italy
Ospedale San Giuseppe UOC di Neurologia e Stroke Unit
Milan, 20123, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Ospedale Sacro Cuore Don Calabria Negrar NEUROLOGY DEPT
Negrar, 37020, Italy
Istituto Neurologico mediterraneo NEUROMED Dipartimento di Medicina Riabilitativa e Specialistica Repar
Pozzilli, 86077, Italy
Policlinico Umberto I Emergency Department Stroke Unit
Rome, 00161, Italy
Zuyderland Medisch Centrum Afdeling Neurologie
Heerlen, 6419 PC, Netherlands
UMC St Radboud Afdeling Neurologie
Nijmegen, 6525 GA, Netherlands
Canisius Wilhelmina Ziekenhuis Afdeling Neurologie
Nijmegen, 6532 SZ, Netherlands
Erasmus MC Afdeling Neurologie
Rotterdam, 3015 GD, Netherlands
Isala Klinieken Afdeling Neurologie
Zwolle, 8011 JW, Netherlands
Samodzielny Publiczny Wojewodzki Szpital Specjalistyczny Oddzial Neurologiczny i Oddzial Udarowy
Chełm, 22-100, Poland
M. Kopernika Provincial Specialist Hospital Dpt of Neurology
Gdansk, 80-803, Poland
Szpital Specjalistyczny sw. Lukasza Oddzial Neurologii i Oddzial Udarowy
Gmina Końskie, 26-200, Poland
Samodzielny Publiczny Szpital Kliniczny nr7 SUM w Katowicach Oddzial Neurologii z Pododdzialem Udarowym
Katowice, 40-635, Poland
Miejskie Centrum Medyczne Jonscher Szpital Dr K. Jonschera
Lodz, 93-113, Poland
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie Oddzial Neurologii
Lublin, 20-954, Poland
Wojewodzki Szpital Specjalistyczny SPZOZ nr 3 w Rybniku
Rybnik, 44-200, Poland
Szpital Specjalistyczny Ducha Swietego w Sandomierzu Oddzial Neurologii
Sandomierz, 27-600, Poland
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
Warsaw, 02-957, Poland
Inje University Busan Paik Hospital
Busan, 47392, South Korea
Dong-A University Medical Center Department of Neurology
Busan, 49201, South Korea
Kyungpook National University Hospital Department of Neurology
Daegu, 41944, South Korea
Chonnam National University Hospital Department of Neurology
Gwangju, 61469, South Korea
Seoul National University Bundang Hospital Department of Orthopaedic
Seongnam, 13620, South Korea
Kyung Hee University Hospital
Seoul, 02447, South Korea
ASAN Medical Center Department of Neurology
Seoul, 05505, South Korea
H. General de Albacete Servicio de Neurología
Albacete, 02006, Spain
H. Germans Trias I Pujol Servicio de Neurología
Badalona, 08916, Spain
H. del Mar Neurología
Barcelona, 08003, Spain
H. Valle de Hebrón Servicio de Neurología
Barcelona, 08035, Spain
H. Clinic de Barcelona Comprehensive Stroke Center
Barcelona, 08036, Spain
Hospital Universitari de Bellvitge Servicio de Neurología-Unidad de Ictus-Planta 9
Barcelona, 08907, Spain
H. Universitario de Donosti Servicio de Neurología
Donostia / San Sebastian, 20080, Spain
H. Josep Trueta Servicio de Neurología
Girona, 17007, Spain
H. Universitario La Princesa Servicio de Neurología
Madrid, 28006, Spain
H. Ramón y Cajal Servicio de Neurología
Madrid, 28034, Spain
H. Virgen del Rocío Servicio de Neurología
Seville, 41013, Spain
Hospital Universitario La Fe Servicio de Neurología
Valencia, 46026, Spain
Hassleholms Sjukhus Stroke- och rehabiliteringsavdelningen 9
Hässleholm, 281 25, Sweden
University Hospital Department of Neurology
Linköping, 581 85, Sweden
Skaraborgs Sjukhus Skovde Strokenheten
Skövde, 541 85, Sweden
Danderyds Sjukhus Medicinmottagningen
Stockholm, 182 88, Sweden
Akademiska Sjukhuset Strokeavdelningen 85B
Uppsala, 751 85, Sweden
Royal United Hospital Older People's Unit
Bath, BA1 3NG, United Kingdom
Queen Elizabeth University Hospital
Glasgow, United Kingdom
Northwick Park Hospital Neurology
Harrow, HA1 3UJ, United Kingdom
Leicester Royal Infirmary Dpt of Neurology
Leicester, LE1 5WW, United Kingdom
St George's University Hospitals Stroke Research office
London, SW17 0QT, United Kingdom
Nottingham City Hospital
Nottingham, NG5 1PB, United Kingdom
Poole NHS Foundation Trust Stroke Unit
Poole, BH15 2JB, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital
Sheffield, S10 2JF, United Kingdom
Royal Stoke University Hospital Stroke Team Office
Stoke-on-Trent, ST4 6QG, United Kingdom
Related Publications (2)
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.
PMID: 32014032BACKGROUNDChabriat 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.
PMID: 32085836RESULT
Related Links
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2016
First Posted
August 24, 2016
Study Start
December 19, 2016
Primary Completion
March 10, 2019
Study Completion
March 10, 2019
Last Updated
March 11, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- After Marketing Authorisation in EEA or US if the study is used for the approval.
- Access Criteria
- Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. They can ask all interventional clinical studies: * submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.