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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02877615




Registration number
NCT02877615
Ethics application status
Date submitted
20/07/2016
Date registered
24/08/2016

Titles & IDs
Public title
Efficacy and Safety Trial With S 44819 After Recent Ischemic Cerebral Event
Scientific 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)
Secondary ID [1] 0 0
2016-001005-16
Secondary ID [2] 0 0
CL2-44819-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Stroke Recovery 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - S 44819 150 mg twice a day
Treatment: Drugs - S 44819 300 mg twice a day
Treatment: Drugs - Placebo

Experimental: S 44819 150 mg twice a day -

Experimental: S 44819 300 mg twice a day -

Placebo comparator: Placebo -


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

Treatment: Drugs: S 44819 300 mg twice a day
Two sachets of S 44819 150 mg twice a day

Treatment: Drugs: Placebo
Two sachets of placebo twice a day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Modified Rankin Scale (mRS)
Timepoint [1] 0 0
Up to 90 days
Secondary outcome [1] 0 0
National Institutes of Health Stroke Scale (NIHSS) total score
Timepoint [1] 0 0
Selection visit Day 0 Day 5 Day 30 Day 60 Day 90 Day 105
Secondary outcome [2] 0 0
Barthel Index (BI) total score
Timepoint [2] 0 0
Day 30 Day 60 Day 90 Day 105
Secondary outcome [3] 0 0
Montreal Cognitive Assessment scale (Moca) total score
Timepoint [3] 0 0
Day 30 Day 90
Secondary outcome [4] 0 0
Trail Making Test (TMT) time for part A
Timepoint [4] 0 0
Day 30 Day 90
Secondary outcome [5] 0 0
Adverse events
Timepoint [5] 0 0
Through study completion, an average of 3 months
Secondary outcome [6] 0 0
Suicidal ideation and suicidal behavior using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Timepoint [6] 0 0
Day 5 Day 30 Day 60 Day 90 Day 105
Secondary outcome [7] 0 0
Body weight
Timepoint [7] 0 0
Selection visit Day 30 Day 60 Day 90 Day 105
Secondary outcome [8] 0 0
Vital signs (supine for Systolic and Diastolic Blood Pressure)
Timepoint [8] 0 0
Selection visit Day 0 Day 5 Day 30 Day 60 Day 90 Day 105
Secondary outcome [9] 0 0
12 lead-ECG
Timepoint [9] 0 0
Day 0 Day 5 Day 30 Day 60 Day 90 Day 105
Secondary outcome [10] 0 0
Trail Making Test (TMT) time for part B
Timepoint [10] 0 0
Day 30 Day 90

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/12/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/03/2019
Sample size
Target
Accrual to date
Final
585
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital Department of Neurology - Adelaide
Recruitment hospital [2] 0 0
Sunshine Coast Hospital - Birtinya
Recruitment hospital [3] 0 0
Monash Medical Centre Department of Neurology - Clayton
Recruitment hospital [4] 0 0
Lyell McEwin Hospital Neurology Department - Elizabeth Vale
Recruitment hospital [5] 0 0
Gosford Hospital Neurosciences Department - Gosford
Recruitment hospital [6] 0 0
Austin Health Neurology Department - Heidelberg
Recruitment hospital [7] 0 0
Royal Brisbane & Women's Hospital Department of Neurology - Herston
Recruitment hospital [8] 0 0
Alfred Health - Melbourne
Recruitment hospital [9] 0 0
Royal Melbourne Hospital Department of Neurology - Parkville
Recruitment hospital [10] 0 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
4575 - Birtinya
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [5] 0 0
2250 - Gosford
Recruitment postcode(s) [6] 0 0
VIC 3084 - Heidelberg
Recruitment postcode(s) [7] 0 0
4029 - Herston
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment postcode(s) [9] 0 0
3050 - Parkville
Recruitment postcode(s) [10] 0 0
QLD 4215 - Southport
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brugge
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Belgium
State/province [2] 0 0
Edegem
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Belgium
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Hasselt
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Belgium
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Leuven
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Belgium
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Liege
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Belgium
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Tielt
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Brazil
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Botucatu
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Brazil
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Joinville
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Brazil
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Matão
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Brazil
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Porto Alegre
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Brazil
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Ribeirao Preto
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Ribeirão Preto
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Rio de Janeiro
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Brazil
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Sao Paulo
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Canada
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Edmonton
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Canada
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Greenfield Park
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Canada
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Montreal
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Canada
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Saint John
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Czechia
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Brno
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Czechia
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Jihlava
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Czechia
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Praha
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France
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Bordeaux
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France
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Corbeil-essonnes
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France
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Creteil
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France
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Le Kremlin-Bicêtre
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France
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Lille
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Montpellier
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France
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Paris
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France
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Poitiers
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Germany
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Altenburg
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Germany
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Bad Neustadt An Der Saale
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Germany
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Berlin
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Germany
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Erlangen
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Germany
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Essen
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Germany
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Mainz
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Germany
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Minden
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Germany
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Siegen
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Germany
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Tübingen
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ULM
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Budapest
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Gyor
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Kistarcsa
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Miskolc
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Nyiregyhaza
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Pecs
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Sopron
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Hungary
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Szeged
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Italy
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Lecce
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Italy
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Milano
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Italy
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Negrar
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Italy
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Pozzilli
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Rome
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Korea, Republic of
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Busan
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Daegu
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Korea, Republic of
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Gwangju
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Korea, Republic of
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Seongnam
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Korea, Republic of
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Seoul
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Netherlands
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Heerlen
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Netherlands
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Nijmegen
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Rotterdam
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Netherlands
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Zwolle
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Chelm
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Gdansk
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Katowice
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Konskie
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Lodz
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Lublin
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Rybnik
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Sandomierz
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Warszawa
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Spain
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Albacete
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Badalona
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Barcelona
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Girona
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Madrid
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Spain
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San Sebastian
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Spain
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Sevilla
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Spain
State/province [80] 0 0
Valencia
Country [81] 0 0
Sweden
State/province [81] 0 0
Hassleholm
Country [82] 0 0
Sweden
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Linkoping
Country [83] 0 0
Sweden
State/province [83] 0 0
Skovde
Country [84] 0 0
Sweden
State/province [84] 0 0
Stockholm
Country [85] 0 0
Sweden
State/province [85] 0 0
Uppsala
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Bath
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Glasgow
Country [88] 0 0
United Kingdom
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Harrow
Country [89] 0 0
United Kingdom
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Leicester
Country [90] 0 0
United Kingdom
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London
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United Kingdom
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Nottingham
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United Kingdom
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Poole
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Sheffield
Country [94] 0 0
United Kingdom
State/province [94] 0 0
Stoke on Trent

Funding & Sponsors
Primary sponsor type
Other
Name
Institut de Recherches Internationales Servier
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
ADIR, a Servier Group company
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
After Marketing Authorisation in EEA or US if the study is used for the approval.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://clinicaltrials.servier.com


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Chabriat H, Bassetti CL, Marx U, Audoli-Inthavong ... [More Details]


Results not provided in https://clinicaltrials.gov/study/NCT02877615