Post Stroke Recovery
Conditions
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.
Interventions
DRUGS 44819 150 mg twice a day
One sachet of S 44819 150 mg and one sachet of placebo twice a day
DRUGS 44819 300 mg twice a day
Two sachets of S 44819 150 mg twice a day
DRUGPlacebo
Two sachets of placebo twice a day
Sponsors
ADIR, a Servier Group company
Institut de Recherches Internationales Servier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified Rankin Scale (mRS) | Up to 90 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Barthel Index (BI) total score | Day 30 Day 60 Day 90 Day 105 | Efficacy criterion |
| Montreal Cognitive Assessment scale (Moca) total score | Day 30 Day 90 | Efficacy criterion |
| Trail Making Test (TMT) time for part A | Day 30 Day 90 | Efficacy criterion |
| Adverse events | Through study completion, an average of 3 months | Safety criterion |
| National Institutes of Health Stroke Scale (NIHSS) total score | Selection visit Day 0 Day 5 Day 30 Day 60 Day 90 Day 105 | Efficacy criterion |
| Body weight | Selection visit Day 30 Day 60 Day 90 Day 105 | Safety criterion |
| Vital signs (supine for Systolic and Diastolic Blood Pressure) | Selection visit Day 0 Day 5 Day 30 Day 60 Day 90 Day 105 | Safety criterion |
| 12 lead-ECG | Day 0 Day 5 Day 30 Day 60 Day 90 Day 105 | Safety criterion |
| Trail Making Test (TMT) time for part B | Day 30 Day 90 | Efficacy criterion |
| Suicidal ideation and suicidal behavior using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Day 5 Day 30 Day 60 Day 90 Day 105 | Safety criterion |
Countries
Australia, Belgium, Brazil, Canada, Czechia, France, Germany, Hungary, Italy, Netherlands, Poland, South Korea, Spain, Sweden, United Kingdom
Outcome results
None listed