Clinical Trial Summary

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Phase

Phase 3

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Funding Agency/Sponsor

Industry

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Disease

Other

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Enrollment Eligibility

Primary Inclusion Criteria:
- Male or female subjects ≥18 years of age
- Clinical diagnosis of ischemic stroke involving cerebral cortex
- Occurrence of a moderate to moderately severe stroke with a persistent neurologic
deficit documented by a NIHSS score of 8 to 20 (inclusive) that does not change by ≥4
points during the initial screening period
- A mRS score of 0 or 1 prior to the onset of symptoms of the current stroke
Primary Exclusion Criteria:
- Presence of a lacunar or a brainstem infarct
- Comatose state
- Brain hemorrhage
- Major neurological event such as stroke or clinically significant head trauma within 6
months of enrollment into the study

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