Overview

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