Safety and Preliminary Efficacy Study of SA4503 in Subjects Recovering From Ischemic Stroke

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and tolerability of SA4503 in patients recovering from a recent stroke. Secondary, to evaluate the efficacy of SA4503 compared to placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M's Science Corporation
• Treatments: SA 4503

Criteria

Key Inclusion Criteria:

• Males or females 18 years of age or older

• Experienced a stroke from 48 to 72 hours before randomization

• A total score of >/=4 on the NIHSS, or >/=2 on the upper or lower extremity motor scores of the NIHSS

• Medically and neurologically stable within 24 hours prior to randomization

Key Exclusion Criteria:

• Patients with transient ischemic attack

• Patients with stroke in progression

• Unstable cardiac, hepatic, or renal disease, or other major medical disorder