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

Phase 1

Conditions: Post stroke recovery
MedDRA version: 19.0Level: PTClassification code 10061256Term: Ischaemic strokeSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2016-001005-16-SE

Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 585

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

- 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
- Absence of signed informed consent by the patient, patients unable to provide informed consent: patients with aphasia (verbal Glasgow Coma Scale (GCS) score < 5 and NIHSS score > 0 on item 9), patients with impaired consciousness (GCS < 14, Reaction Level Scale (RLS)>1, NIHSS total score = 1 on item 1

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.;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.;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
Secondary end point(s): - National Institutes of Health Stroke Scale (NIHSS) total score<br>- Barthel Index (BI) total score<br>- Montreal Cognitive Assessment scale (Moca) total score<br>- Trail Making Test (TMT) time for part A and time for part B<br>- 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<br>BI: D30 D60 D90 D105<br>Moca/TMT: D30 D90 <br>Adverse events: all over the study<br>C-SSRS: D5 D30 D60 D90 D105<br>Physical examination: ASSE D0 D5 D30 D60 D90 D105<br>Supine vital signs (SBP/DBP): ASSE D0 D5 D30 D60 D90 D105<br>12-lead ECG: D0 D5 D30 D60 D90 D105<br>Body weight: ASSE D30 D60 D90 D105<br>Local biochemistry + haematology : D0<br>Central biochemistry + haematology: D0 D30 D60 D90 D105

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