The purpose of this study is to assess the efficacy and safety of S 44819 in enhancing functional recovery after an ischemic stroke.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
585
One sachet of S 44819 150 mg and one sachet of placebo twice a day
Two sachets of S 44819 150 mg twice a day
Two sachets of placebo twice a day
Modified Rankin Scale (mRS)
Time frame: Up to 90 days
National Institutes of Health Stroke Scale (NIHSS) total score
Efficacy criterion
Time frame: Selection visit Day 0 Day 5 Day 30 Day 60 Day 90 Day 105
Barthel Index (BI) total score
Efficacy criterion
Time frame: Day 30 Day 60 Day 90 Day 105
Montreal Cognitive Assessment scale (Moca) total score
Efficacy criterion
Time frame: Day 30 Day 90
Trail Making Test (TMT) time for part A
Efficacy criterion
Time frame: Day 30 Day 90
Adverse events
Safety criterion
Time frame: Through study completion, an average of 3 months
Suicidal ideation and suicidal behavior using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Safety criterion
Time frame: Day 5 Day 30 Day 60 Day 90 Day 105
Body weight
Safety criterion
Time frame: Selection visit Day 30 Day 60 Day 90 Day 105
Vital signs (supine for Systolic and Diastolic Blood Pressure)
Safety criterion
Time frame: Selection visit Day 0 Day 5 Day 30 Day 60 Day 90 Day 105
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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, Australia
...and 111 more locations
12 lead-ECG
Safety criterion
Time frame: Day 0 Day 5 Day 30 Day 60 Day 90 Day 105
Trail Making Test (TMT) time for part B
Efficacy criterion
Time frame: Day 30 Day 90