Clinical trial NCT02877615: Efficacy and Safety Trial With S 44819 After Recent Ischemic Cerebral Event
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post Stroke Recovery
Lead sponsor: Servier
Sponsor class: INDUSTRY
Collaborators: name: ADIR, a Servier Group company
First posted: 2016-08-24
Enrollment: 585
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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