Efficacy and Safety Trial With S 44819 After Recent Ischemic Cerebral Event

Servier

Status and phase: Completed; Phase 2

Conditions: Post Stroke Recovery

Treatments: Drug: S 44819 300 mg twice a day; Drug: Placebo; Drug: S 44819 150 mg twice a day

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02877615

CL2-44819-004

UTN number: U1111-1180-8991 (Other Identifier)

2016-001005-16 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to assess the efficacy and safety of S 44819 in enhancing functional recovery after an ischemic stroke.

Enrollment: 585 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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585 participants in 3 patient groups, including a placebo group

S 44819 150 mg twice a day

Experimental group

Treatment:

Drug: S 44819 150 mg twice a day

S 44819 300 mg twice a day

Experimental group

Treatment:

Drug: S 44819 300 mg twice a day

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo