Post Stroke Recovery Clinical Trial
Official title:
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)
| Verified date | March 2020 |
| Source | Servier |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to assess the efficacy and safety of S 44819 in enhancing functional recovery after an ischemic stroke.
| Status | Completed |
| Enrollment | 585 |
| Est. completion date | March 10, 2019 |
| Est. primary completion date | March 10, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility |
Inclusion criteria : - Patients aged between 18 and 85 years (both inclusive) - Acute ischemic stroke that occured between 72 hours (3 days) and 192 hours (8 days) (both inclusive) before inclusion Exclusion criteria : - 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 - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Australia | 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 | |
| Belgium | AZ Sint-Lucas Neurologie | Brugge | |
| Belgium | AZ. St. Jan | Brugge | |
| Belgium | Universitair Ziekenhuis Antwerpen | Edegem | |
| Belgium | Jessa Ziekenhuis Dienst Neurologie | Hasselt | |
| Belgium | UZ Leuven Campus Gasthuisberg | Leuven | |
| Belgium | Les Cliniques Saint-Joseph | Liege | |
| Belgium | Sint Andries Ziekenhuis Dienst Neurologie | Tielt | |
| Brazil | 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 | Hospital Sao Lucas da Pontificia Universidade Catolica RS Setor de Pesquisa Clínica | Porto Alegre | |
| 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 | 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 | Sao Paulo | |
| Brazil | UNIFESP - Universidade Federal de Sao Paulo Centro de Pesquisa em Neurologia | Sao Paulo | |
| Canada | 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 | |
| Czechia | 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 | Praha | |
| France | CHU Bdx-Hôpital Pellegrin-Tripode Service de Neurologie | Bordeaux | |
| France | Hôpital Sud-Francilien Unité Neurovasculaire | Corbeil-essonnes | |
| France | CHU Henri Mondor Service de Neurologie | Creteil | |
| 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 | |
| Germany | 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 | |
| Hungary | Bajcsy-Zsilinszky Korhaz es Rendelointezet Neurologiai Osztaly | Budapest | |
| Hungary | Honved Korhaz Stroke reszleg | Budapest | |
| Hungary | Orszagos Idegsebeszeti Tudomanyos Intezet | Budapest | |
| Hungary | Semmelweis Egyetem Neurologiai Klinika | Budapest | |
| Hungary | Szent Janos Korhaz Neurologiai osztaly | Budapest | |
| Hungary | Petz Aladar Megyei Oktato Korhaz Neurologiai Osztaly | Gyor | |
| 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 | Nyiregyhaza | |
| Hungary | Pecsi Tudomanyegyetem Klinikai Kozpont Neurologiai Klinika | Pecs | |
| Hungary | Soproni Erzsebet Oktato Korhaz Neurologiai Osztaly | Sopron | |
| Hungary | Szegedi Tudomanyegyetem Szent-Gyorgy Albert Klinikai Kozpont | Szeged | |
| Italy | Vito FAZZI U.O. semplice Stroke Unit | Lecce | |
| Italy | Ospedale San Giuseppe UOC di Neurologia e Stroke Unit | Milano | |
| Italy | Ospedale San Raffaele | Milano | |
| 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 | |
| Korea, Republic of | Dong-A University Medical Center Department of Neurology | Busan | |
| Korea, Republic of | Inje University Busan Paik Hospital | Busan | |
| Korea, Republic of | Kyungpook National University Hospital Department of Neurology | Daegu | |
| Korea, Republic of | Chonnam National University Hospital Department of Neurology | Gwangju | |
| Korea, Republic of | Seoul National University Bundang Hospital Department of Orthopaedic | Seongnam | |
| Korea, Republic of | ASAN Medical Center Department of Neurology | Seoul | |
| Korea, Republic of | Kyung Hee University Hospital | Seoul | |
| Netherlands | Zuyderland Medisch Centrum Afdeling Neurologie | Heerlen | |
| Netherlands | Canisius Wilhelmina Ziekenhuis Afdeling Neurologie | Nijmegen | |
| Netherlands | UMC St Radboud Afdeling Neurologie | Nijmegen | |
| Netherlands | Erasmus MC Afdeling Neurologie | Rotterdam | |
| Netherlands | Isala Klinieken Afdeling Neurologie | Zwolle | |
| Poland | Samodzielny Publiczny Wojewodzki Szpital Specjalistyczny Oddzial Neurologiczny i Oddzial Udarowy | Chelm | |
| Poland | M. Kopernika Provincial Specialist Hospital Dpt of Neurology | Gdansk | |
| Poland | Samodzielny Publiczny Szpital Kliniczny nr7 SUM w Katowicach Oddzial Neurologii z Pododdzialem Udarowym | Katowice | |
| Poland | Szpital Specjalistyczny sw. Lukasza Oddzial Neurologii i Oddzial Udarowy | Konskie | |
| 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 | Warszawa | |
| Spain | H. General de Albacete Servicio de Neurología | Albacete | |
| Spain | H. Germans Trias I Pujol Servicio de Neurología | Badalona | |
| Spain | H. Clinic de Barcelona Comprehensive Stroke Center | Barcelona | |
| Spain | H. del Mar Neurología | Barcelona | |
| Spain | H. Valle de Hebrón Servicio de Neurología | Barcelona | |
| Spain | Hospital Universitari de Bellvitge Servicio de Neurología-Unidad de Ictus-Planta 9 | Barcelona | |
| Spain | H. Josep Trueta Servicio de Neurología | Girona | |
| Spain | H. Ramón y Cajal Servicio de Neurología | Madrid | |
| Spain | H. Universitario La Princesa Servicio de Neurología | Madrid | |
| Spain | H. Universitario de Donosti Servicio de Neurología | San Sebastian | |
| Spain | H. Virgen del Rocío Servicio de Neurología | Sevilla | |
| Spain | Hospital Universitario La Fe Servicio de Neurología | Valencia | |
| Sweden | Hassleholms Sjukhus Stroke- och rehabiliteringsavdelningen 9 | Hassleholm | |
| Sweden | University Hospital Department of Neurology | Linkoping | |
| Sweden | Skaraborgs Sjukhus Skovde Strokenheten | Skovde | |
| Sweden | Danderyds Sjukhus Medicinmottagningen | Stockholm | |
| Sweden | Akademiska Sjukhuset Strokeavdelningen 85B | Uppsala | |
| United Kingdom | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Institut de Recherches Internationales Servier | ADIR, a Servier Group company |
Australia, Belgium, Brazil, Canada, Czechia, France, Germany, Hungary, Italy, Korea, Republic of, Netherlands, Poland, Spain, Sweden, United Kingdom,
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 GABA(A) a5 antagonist S44819 in patients with ischaemic stroke: a multicentre, double-blind, randomise — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Modified Rankin Scale (mRS) | Up to 90 days | ||
| Secondary | National Institutes of Health Stroke Scale (NIHSS) total score | Efficacy criterion | Selection visit Day 0 Day 5 Day 30 Day 60 Day 90 Day 105 | |
| Secondary | Barthel Index (BI) total score | Efficacy criterion | Day 30 Day 60 Day 90 Day 105 | |
| Secondary | Montreal Cognitive Assessment scale (Moca) total score | Efficacy criterion | Day 30 Day 90 | |
| Secondary | Trail Making Test (TMT) time for part A | Efficacy criterion | Day 30 Day 90 | |
| Secondary | Adverse events | Safety criterion | Through study completion, an average of 3 months | |
| Secondary | Suicidal ideation and suicidal behavior using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Safety criterion | Day 5 Day 30 Day 60 Day 90 Day 105 | |
| Secondary | Body weight | Safety criterion | Selection visit Day 30 Day 60 Day 90 Day 105 | |
| Secondary | Vital signs (supine for Systolic and Diastolic Blood Pressure) | Safety criterion | Selection visit Day 0 Day 5 Day 30 Day 60 Day 90 Day 105 | |
| Secondary | 12 lead-ECG | Safety criterion | Day 0 Day 5 Day 30 Day 60 Day 90 Day 105 | |
| Secondary | Trail Making Test (TMT) time for part B | Efficacy criterion | Day 30 Day 90 |