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

M's Science Corporation60 enrolled

Overview

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:

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Ischemic Stroke

Interventions

placeboDRUG

Oral administration

SA4503 LowDRUG

Oral administration

SA4503 HighDRUG

Oral administration

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Southern General Hospital

Glasgow, United Kingdom

Outcomes

Primary Outcomes

Safety and tolerability

Time frame: 4 weeks

Secondary Outcomes

NIHSS

Time frame: 4 weeks

Data from ClinicalTrials.gov

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