Post stroke recovery MedDRA version: 19.0 Level: PT Classification code 10061256 Term: Ischaemic stroke System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: S44819
Product Code: S44819
Pharmaceutical Form: Powder for oral suspension
Current Sponsor code: S44819
Other descriptive
Sponsors
Institut de Recherches Internationales Servier
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients aged between 18 and 80 years (both inclusive) - Acute ischemic stroke that occured at least 72 hours (3 days) and less than 144 hours (6 days) (both inclusive) before inclusion. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 145 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 435
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 - 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 MRI showing an acute lesion in brain stem or cerebellum - Brain imaging showing an acute haemorrhagic stroke or a symptomatic haemorrhagic transformation of the brain infarct - Qualifying ischemic cerebral event older than 144 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 |
|---|---|
| Secondary Objective: - To assess the efficacy of the two doses of S 44819 versus placebo in stroke recovery using neurological evaluation (NIHSS), activities of daily living test (BI) and cognitive performance tests (Moca, TMT) - To assess the safety and tolerability of S 44819. ;Timepoint(s) of evaluation of this end point: Up to 90 days;Main Objective: To demonstrate the superiority of at least one of the two doses of S 44819 versus placebo on functional recovery from ischemic stroke measured with the modified Rankin Scale (mRS) after 90 days of treatment.;Primary end point(s): Modified Rankin Scale (mRS) after 90 days treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - National Institutes of Health Stroke Scale (NIHSS) total score - Barthel Index (BI) total score - Montreal Cognitive Assessment scale (Moca) total score - Trail Making Test (TMT) time for part A and time for part B - Safety criteria: adverse events, suicidal ideation and suicidal behaviour using the C-SSRS, body weight, BMI, vital signs (supine for Systolic and Diastolic Blood Pressure), 12 lead-ECG, laboratory parameters (haematology and biochemistry) ; Timepoint(s) of evaluation of this end point: NIHSS: ASSE D0 D5 D30 D60 D90 D105 BI: D30 D60 D90 D105 Moca/TMT: D30 D90 Adverse events: all over the study C-SSRS: D5 D30 D60 D90 D105 Physical examination: ASSE D0 D5 D30 D60 D90 D105 Supine vital signs (SBP/DBP): ASSE D0 D5 D30 D60 D90 D105 12-lead ECG: D0 D5 D30 D60 D90 D105 Body weight: ASSE D30 D60 D90 D105 Local biochemistry + haematology : D0 Central biochemistry + haematology: D0 D30 D60 D90 D105 | — |
Countries
Australia, Belgium, Brazil, Canada, Czech Republic, France, Germany, Hungary, Italy, Netherlands, Poland, Slovenia, Spain, Sweden, United Kingdom
Contacts
Public ContactClinical Studies Department
Institut de Recherches Internationales Servier (I.R.I.S.)
Outcome results
None listed