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Post Stroke RecoveryPhase 2NCT02877615

Efficacy and Safety Trial With S 44819 After Recent Ischemic Cerebral Event

A Phase 2 study testing S 44819 150 mg twice a day and S 44819 300 mg twice a day in people with Post Stroke Recovery, run by Institut de Recherches Internationales Servier at 121 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to assess the efficacy and safety of S 44819 in enhancing functional recovery after an ischemic stroke. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Post Stroke Recovery
What is being tested?
S 44819 150 mg twice a day and S 44819 300 mg twice a day
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
585 participants
Where
121 sitesin 15 countries
Study dates
19 Dec 2016to 10 Mar 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

121 sites in 15 countries.

121 sites in 15 countries

Hungary14 sites

  • Semmelweis Egyetem Neurologiai Klinika

    Budapest, 1083

  • Bajcsy-Zsilinszky Korhaz es Rendelointezet Neurologiai Osztaly

    Budapest, 1106

  • Szent Janos Korhaz Neurologiai osztaly

    Budapest, 1125

  • Honved Korhaz Stroke reszleg

    Budapest, 1134

  • Orszagos Idegsebeszeti Tudomanyos Intezet

    Budapest, 1145

  • Petz Aladar Megyei Oktato Korhaz Neurologiai Osztaly

    Győr, 9024

  • Somogy Megyei Kaposi Mor Oktato Korhaz Neurologiai Osztaly

    Kaposvár, 7400

  • Flor Ferenc Korhaz Neurologia

    Kistarcsa, 2143

  • B-A-Z Megyei Korhaz es Egyetemi Oktato Korhaz Stroke, Er- es Neurologiai, Toxikologiai Osztaly

    Miskolc, 3526

  • Kanizsai Dorottya Korhaz Neurologiai Osztaly

    Nagykanizsa, 8800

  • Josa Andras Oktatokorhaz Neurologiai Osztaly

    Nyíregyháza, 4400

  • Pecsi Tudomanyegyetem Klinikai Kozpont Neurologiai Klinika

    Pécs, 7623

  • Soproni Erzsebet Oktato Korhaz Neurologiai Osztaly

    Sopron, 9400

  • Szegedi Tudomanyegyetem Szent-Gyorgy Albert Klinikai Kozpont

    Szeged, 6725

Other trials in Hungary

Spain12 sites

  • H. General de Albacete Servicio de Neurología

    Albacete, 02006

  • H. Germans Trias I Pujol Servicio de Neurología

    Badalona, 08916

  • H. del Mar Neurología

    Barcelona, 08003

  • H. Valle de Hebrón Servicio de Neurología

    Barcelona, 08035

  • H. Clinic de Barcelona Comprehensive Stroke Center

    Barcelona, 08036

  • Hospital Universitari de Bellvitge Servicio de Neurología-Unidad de Ictus-Planta 9

    Barcelona, 08907

  • H. Universitario de Donosti Servicio de Neurología

    Donostia / San Sebastian, 20080

  • H. Josep Trueta Servicio de Neurología

    Girona, 17007

  • H. Universitario La Princesa Servicio de Neurología

    Madrid, 28006

  • H. Ramón y Cajal Servicio de Neurología

    Madrid, 28034

  • H. Virgen del Rocío Servicio de Neurología

    Seville, 41013

  • Hospital Universitario La Fe Servicio de Neurología

    Valencia, 46026

Other trials in Spain

Australia10 sites

  • Royal Adelaide Hospital Department of Neurology

    Adelaide, 5000

  • Sunshine Coast Hospital

    Birtinya, 4575

  • Monash Medical Centre Department of Neurology

    Clayton, 3168

  • Lyell McEwin Hospital Neurology Department

    Elizabeth Vale, 5112

  • Gosford Hospital Neurosciences Department

    Gosford, 2250

  • Austin Health Neurology Department

    Heidelberg, VIC 3084

  • Royal Brisbane & Women's Hospital Department of Neurology

    Herston, 4029

  • Alfred Health

    Melbourne, 3004

  • Royal Melbourne Hospital Department of Neurology

    Parkville, 3050

  • Gold Coast University Hospital

    Southport, QLD 4215

Other trials in Australia

Brazil10 sites

  • Hospital das Clinicas da Faculdade de Medicina de Botucatu

    Botucatu, 18618-970

  • Clínica Neurológica e Neurocirúrgica de Joinville

    Joinville, 89202-165

  • Hospital Carlos Fernando Malzone Departamento de Neurologia

    Matão, 15990-000

  • IMV Pesquisa Neurológica Setor de Pesquisa Clinica

    Porto Alegre, 90110-270

  • Hospital Sao Lucas da Pontificia Universidade Catolica RS Setor de Pesquisa Clínica

    Porto Alegre, 90610-000

  • Hospital das Clinicas da Fac. de Med. de Ribeirao Preto Unidade de Emergencia - Centro de Estudo

    Ribeirão Preto, 14015-130

  • Hospital das Clinicas da Fac. de med. de Ribeirao Preto Unidade de Emergiancia

    Ribeirão Preto, 14015-130

  • Hospital Quinta D'or Departamento de Neurologia

    Rio de Janeiro, 20941-150

  • Irmandade Santa Casa de Misericordia de Sao Paulo Ambulatório de Neurologia

    São Paulo, 01221-020

  • UNIFESP - Universidade Federal de Sao Paulo Centro de Pesquisa em Neurologia

    São Paulo, 04039-032

Other trials in Brazil

Germany10 sites

  • Klinikum Altenburger Land GmbH Neurologische Klinik

    Altenburg, 04600

  • Neurologische Klinik GmbH, Bad Neustadt

    Bad Neustadt an der Saale, 97616

  • Vivantes Klinikum Neukölln Klinik für Neurologie mit Stroke Unit

    Berlin, 12351

  • Universitätsklinikum Erlangen Neurologische Klinik

    Erlangen, 91054

  • Universitaetsklinikum Essen Neurologische Universitätsklinik Essen

    Essen, 45147

  • Universitätsmedizin der Johannes Gutenberg-Universität Klinik und Poliklinik für

    Mainz, 55131

  • Johannes Wesling Klinik Minden Klinik für Neurologie

    Minden, 32429

  • Kreisklinikum Siegen Klinik fuer Neurologie

    Siegen, 57076

  • Universitätsklinik der Eberhard-Karls Universtiät Tübingen Hertie-Institut für Klinische Hirnforschung

    Tübingen, 72076

  • Universitätsklinikum Ulm Neurologische Klinik (RKU)

    Ulm, 89081

Other trials in Germany

France9 sites

  • CHU Bdx-Hôpital Pellegrin-Tripode Service de Neurologie

    Bordeaux, 33076

  • Hôpital Sud-Francilien Unité Neurovasculaire

    Corbeil-Essonnes, 91106

  • CHU Henri Mondor Service de Neurologie

    Créteil, 94010

  • CHU de Bicêtre Service de neurologie

    Le Kremlin-Bicêtre, 94270

  • CHRU-Hôpital Roger Salengro Service de Neurologie

    Lille, 59037

  • CHU-Hôpital Gui de Chaulliac Unité de Neuropshysiologie Clinique

    Montpellier, 34295

  • Hôpital Lariboisière, Fernand-Vidal Service de Neurologie

    Paris, 75010

  • Hôpital Sainte-Anne Service de Neurologie

    Paris, 75674

  • CHU-Hôpital de la Milétrie Service de Neurologie

    Poitiers, 86021

Other trials in France

Poland9 sites

  • Samodzielny Publiczny Wojewodzki Szpital Specjalistyczny Oddzial Neurologiczny i Oddzial Udarowy

    Chełm, 22-100

  • M. Kopernika Provincial Specialist Hospital Dpt of Neurology

    Gdansk, 80-803

  • Szpital Specjalistyczny sw. Lukasza Oddzial Neurologii i Oddzial Udarowy

    Gmina Końskie, 26-200

  • Samodzielny Publiczny Szpital Kliniczny nr7 SUM w Katowicach Oddzial Neurologii z Pododdzialem Udarowym

    Katowice, 40-635

  • Miejskie Centrum Medyczne Jonscher Szpital Dr K. Jonschera

    Lodz, 93-113

  • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie Oddzial Neurologii

    Lublin, 20-954

  • Wojewodzki Szpital Specjalistyczny SPZOZ nr 3 w Rybniku

    Rybnik, 44-200

  • Szpital Specjalistyczny Ducha Swietego w Sandomierzu Oddzial Neurologii

    Sandomierz, 27-600

  • Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

    Warsaw, 02-957

Other trials in Poland

United Kingdom9 sites

  • Royal United Hospital Older People's Unit

    Bath, BA1 3NG

  • Queen Elizabeth University Hospital

    Glasgow

  • Northwick Park Hospital Neurology

    Harrow, HA1 3UJ

  • Leicester Royal Infirmary Dpt of Neurology

    Leicester, LE1 5WW

  • St George's University Hospitals Stroke Research office

    London, SW17 0QT

  • Nottingham City Hospital

    Nottingham, NG5 1PB

  • Poole NHS Foundation Trust Stroke Unit

    Poole, BH15 2JB

  • Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

    Sheffield, S10 2JF

  • Royal Stoke University Hospital Stroke Team Office

    Stoke-on-Trent, ST4 6QG

Other trials in United Kingdom

Belgium7 sites

  • AZ Sint-Lucas Neurologie

    Bruges, 8000

  • AZ. St. Jan

    Bruges, 8000

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

  • Jessa Ziekenhuis Dienst Neurologie

    Hasselt, 3500

  • UZ Leuven Campus Gasthuisberg

    Leuven, 3000

  • Les Cliniques Saint-Joseph

    Liège, 4000

  • Sint Andries Ziekenhuis Dienst Neurologie

    Tielt, 8700

Other trials in Belgium

South Korea7 sites

  • Inje University Busan Paik Hospital

    Busan, 47392

  • Dong-A University Medical Center Department of Neurology

    Busan, 49201

  • Kyungpook National University Hospital Department of Neurology

    Daegu, 41944

  • Chonnam National University Hospital Department of Neurology

    Gwangju, 61469

  • Seoul National University Bundang Hospital Department of Orthopaedic

    Seongnam, 13620

  • Kyung Hee University Hospital

    Seoul, 02447

  • ASAN Medical Center Department of Neurology

    Seoul, 05505

Other trials in South Korea

Italy6 sites

  • Vito FAZZI U.O. semplice Stroke Unit

    Lecce, 73100

  • Ospedale San Giuseppe UOC di Neurologia e Stroke Unit

    Milan, 20123

  • Ospedale San Raffaele

    Milan, 20132

  • Ospedale Sacro Cuore Don Calabria Negrar NEUROLOGY DEPT

    Negrar, 37020

  • Istituto Neurologico mediterraneo NEUROMED Dipartimento di Medicina Riabilitativa e Specialistica Repar

    Pozzilli, 86077

  • Policlinico Umberto I Emergency Department Stroke Unit

    Rome, 00161

Other trials in Italy

Netherlands5 sites

  • Zuyderland Medisch Centrum Afdeling Neurologie

    Heerlen, 6419 PC

  • UMC St Radboud Afdeling Neurologie

    Nijmegen, 6525 GA

  • Canisius Wilhelmina Ziekenhuis Afdeling Neurologie

    Nijmegen, 6532 SZ

  • Erasmus MC Afdeling Neurologie

    Rotterdam, 3015 GD

  • Isala Klinieken Afdeling Neurologie

    Zwolle, 8011 JW

Other trials in Netherlands

Sweden5 sites

  • Hassleholms Sjukhus Stroke- och rehabiliteringsavdelningen 9

    Hässleholm, 281 25

  • University Hospital Department of Neurology

    Linköping, 581 85

  • Skaraborgs Sjukhus Skovde Strokenheten

    Skövde, 541 85

  • Danderyds Sjukhus Medicinmottagningen

    Stockholm, 182 88

  • Akademiska Sjukhuset Strokeavdelningen 85B

    Uppsala, 751 85

Other trials in Sweden

Canada4 sites

  • University of Alberta

    Edmonton, T6G 2G3

  • Charles LeMoyne Hospital-CISSS de la Monteregie-Centre

    Greenfield Park, J4V 2H1

  • Montreal General Hospital

    Montreal, H3G 1A4

  • Saint John Regional Hospital

    Saint John, E2L 4L2

Other trials in Canada

Czechia4 sites

  • Fakultni nemocnice Brno Neurologicka klinika

    Brno, 625 00

  • Fakultni nemocnice u sv. Anny Neurologicka klinika

    Brno, 656 91

  • Nemocnice Jihlava

    Jihlava, 586 33

  • Vseobecna fakultni nemocnice II. interni klinika VFN a 1. LF UK

    Prague, 128 08

Other trials in Czechia

About this study

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)

The purpose of this study is to assess the efficacy and safety of S 44819 in enhancing functional recovery after an ischemic stroke.

Being tested
S 44819 150 mg twice a day, S 44819 300 mg twice a day, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • S 44819 150 mg twice a dayDrug

    One sachet of S 44819 150 mg and one sachet of placebo twice a day

  • S 44819 300 mg twice a dayDrug

    Two sachets of S 44819 150 mg twice a day

  • PlaceboDrug

    Two sachets of placebo twice a day

Study groups in NCT02877615
Study groupRoleWhat they receive
S 44819 150 mg twice a dayExperimentalNot described
Receives: Drug: S 44819 150 mg twice a day
S 44819 300 mg twice a dayExperimentalNot described
Receives: Drug: S 44819 300 mg twice a day
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Modified Rankin Scale (mRS)

    Measured: Up to 90 days

Secondary outcomes (10)

  1. National Institutes of Health Stroke Scale (NIHSS) total score

    Efficacy criterion

    Measured: Selection visit Day 0 Day 5 Day 30 Day 60 Day 90 Day 105

  2. Barthel Index (BI) total score

    Efficacy criterion

    Measured: Day 30 Day 60 Day 90 Day 105

  3. Montreal Cognitive Assessment scale (Moca) total score

    Efficacy criterion

    Measured: Day 30 Day 90

  4. Trail Making Test (TMT) time for part A

    Efficacy criterion

    Measured: Day 30 Day 90

  5. Adverse events

    Safety criterion

    Measured: Through study completion, an average of 3 months

  6. Suicidal ideation and suicidal behavior using the Columbia-Suicide Severity Rating Scale (C-SSRS)

    Safety criterion

    Measured: Day 5 Day 30 Day 60 Day 90 Day 105

  7. Body weight

    Safety criterion

    Measured: Selection visit Day 30 Day 60 Day 90 Day 105

  8. Vital signs (supine for Systolic and Diastolic Blood Pressure)

    Safety criterion

    Measured: Selection visit Day 0 Day 5 Day 30 Day 60 Day 90 Day 105

  9. 12 lead-ECG

    Safety criterion

    Measured: Day 0 Day 5 Day 30 Day 60 Day 90 Day 105

  10. Trail Making Test (TMT) time for part B

    Efficacy criterion

    Measured: Day 30 Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2016 (estimated)
  2. Study start19 Dec 2016
  3. Primary completion10 Mar 2019
  4. Study completion10 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
585 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02877615
Sponsor's protocol ID
CL2-44819-004
Other IDs
2016-001005-16, UTN number: U1111-1180-8991, 2016
Status last verified
Mar 2020
First submitted
20 Jul 2016
Last updated
11 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 32014032

  • 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.

    PubMed 32085836

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing S 44819 150 mg twice a day and S 44819 300 mg twice a day in people with Post Stroke Recovery, run by Institut de Recherches Internationales Servier at 121 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 121 sites in Hungary, Spain, Australia, Brazil, Germany and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Rankin Scale (mRS) (time frame: Up to 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02877615, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.

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