Efficacy and safety trial with S 44819 after recent ischemic cerebral event

Phase 1

Conditions: Post stroke recovery
MedDRA version: 20.0Level: PTClassification code 10061256Term: Ischaemic strokeSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2016-001005-16-GB

Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 580

Inclusion Criteria

- Patients aged between 18 and 85 years (both inclusive)
- Acute ischemic stroke that occurred between 72 hours (3 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

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 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