Efficacy and safety trial with S 44819 after recent ischemic cerebral event
- Conditions
- Post stroke recoveryMedDRA version: 20.0 Level: PT Classification code 10061256 Term: Ischaemic stroke System Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2016-001005-16-SI
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 580
- Patients aged between 18 and 85 years (both inclusive)
- Acute ischemic stroke that occured between 48 hours (2 days) and 192 hours (8 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
- 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 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
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.;<br> 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)<br> - To assess the safety and tolerability of S 44819.<br> ;Primary end point(s): Modified Rankin Scale (mRS) after 90 days treatment;Timepoint(s) of evaluation of this end point: Up to 90 days
- Secondary Outcome Measures
Name Time Method