A Phase 2, Double-blind Study of S-005151 in Patients with Acute Ischemic Stroke

Phase 2

Completed

• Conditions: Acute Ischemic Stroke

• Registration Number: JPRN-jRCT2080224879
• Lead Sponsor: SHIONOGI & CO., LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-18
• Study Completion: 2022-01-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Main Inclusion Criteria
- Patients diagnosed with supratentorial ischemic stroke on magnetic resonance imaging (MRI)
- Patients who can be enrolled within 24 hours from 4.5 hours after the onset of ischemic stroke
- Patients with neurologic signs corresponding to 8-22 on the National Institute of Health Stroke Scale (NIHSS) score and who have not experienced a rapid change in neurologic signs within 30 minutes before enrollment
etc

Exclusion Criteria

Main Exclusion Criteria
- Patients with a disability corresponding to mRS score of >=2 before the onset of ischemic stroke
- Patients who have undergone thrombolysis or intravascular recanalization therapy within 90 days before obtaining informed consent.
- Patients with a history of stroke or intracranial hemorrhage that caused neurological events within 90 days before obtaining informed consent.
- Patients diagnosed with a transient ischemic attack
- Patients who cannot have MRI
etc

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>mRS 90 days after the first dose

Secondary Outcome Measures

Name	Time	Method
safety<br>efficacy<br>Main Secondary Outcome<br><br>Safety<br>- Adverse events, vital signs (blood pressure, pulse rate, body temperature, respiratory rate), electrocardiogram, clinical laboratory tests<br><br>Efficacy<br>- mRS at each visit other than day 90<br>- Proportion of subjects with mRS of <=1, <=2, and 5 or 6 at each visit<br>etc