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

Recruiting

Phase 2 Results N/A

Trial Description

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

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Two sachets of placebo twice a day
    ARM 1: Kind: Experimental
    Label: Placebo
  • S 44819 150 mg twice a day Drug
    Intervention Desc: One sachet of S 44819 150 mg and one sachet of placebo twice a day
    ARM 1: Kind: Experimental
    Label: S 44819 150 mg twice a day
  • S 44819 300 mg twice a day Drug
    Intervention Desc: Two sachets of S 44819 150 mg twice a day
    ARM 1: Kind: Experimental
    Label: S 44819 300 mg twice a day

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Modified Rankin Scale (mRS) Up to 90 days No
Secondary National Institutes of Health Stroke Scale (NIHSS) total score Selection visit Day 0 Day 5 Day 30 Day 60 Day 90 Day 105 No
Secondary Barthel Index (BI) total score Day 30 Day 60 Day 90 Day 105 No
Secondary Montreal Cognitive Assessment scale (Moca) total score Day 30 Day 90 No
Secondary Trail Making Test (TMT) time for part A Day 30 Day 90 No
Secondary Adverse events Through study completion, an average of 3 months No
Secondary Suicidal ideation and suicidal behavior using the Columbia-Suicide Severity Rating Scale (C-SSRS) Day 5 Day 30 Day 60 Day 90 Day 105 No
Secondary Body weight Selection visit Day 30 Day 60 Day 90 Day 105 No
Secondary Vital signs (supine for Systolic and Diastolic Blood Pressure) Selection visit Day 0 Day 5 Day 30 Day 60 Day 90 Day 105 No
Secondary 12 lead-ECG Day 0 Day 5 Day 30 Day 60 Day 90 Day 105 No
Secondary Trail Making Test (TMT) time for part B Day 30 Day 90 No

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