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

A Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Phase IIa Study of Safety and Motor Function Restoration in Subjects Treated With SA4503 Following Acute Ischemic Stroke

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.

Further study details as provided by M's Science Corporation:

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