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

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

Official Title
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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)

Conditions
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Post Stroke Recovery

Intervention / Treatment
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* Drug: S 44819 150 mg twice a day
* Drug: S 44819 300 mg twice a day
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S 44819 150 mg twice a day<br> | Drug: S 44819 150 mg twice a day<br>* One sachet of S 44819 150 mg and one sachet of placebo twice a day<br>|
| Experimental: S 44819 300 mg twice a day<br> | Drug: S 44819 300 mg twice a day<br>* Two sachets of S 44819 150 mg twice a day<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Two sachets of placebo twice a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Scale (mRS) |  | Up to 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Barthel Index (BI) total score | Efficacy criterion | Day 30 Day 60 Day 90 Day 105 | 
| Montreal Cognitive Assessment scale (Moca) total score | Efficacy criterion | Day 30 Day 90 | 
| Trail Making Test (TMT) time for part A | Efficacy criterion | Day 30 Day 90 | 
| Adverse events | Safety criterion | Through study completion, an average of 3 months | 
| 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 | 
| Body weight | Safety criterion | Selection visit Day 30 Day 60 Day 90 Day 105 | 
| 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 | 
| 12 lead-ECG | Safety criterion | Day 0 Day 5 Day 30 Day 60 Day 90 Day 105 | 
| Trail Making Test (TMT) time for part B | Efficacy criterion | Day 30 Day 90 |