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

Phase 2

Completed

• Conditions: Ischemic Stroke
• Interventions: Drug: placebo; Drug: SA4503 Low; Drug: SA4503 High

• Registration Number: NCT00639249
• Lead Sponsor: M's Science Corporation

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-03-14
• Study First Submitted QC: 2008-03-14
• Study First Posted: 2008-03-20
• Primary Completion: 2009-06
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-28
• Last Update Posted: 2009-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P	placebo	Placebo
A1	SA4503 Low	SA4503
A2	SA4503 High	SA4503

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	4 weeks

Secondary Outcome Measures

Name	Time	Method
NIHSS	4 weeks

Trial Locations

Locations (1)

Southern General Hospital; 🇬🇧 Glasgow, United Kingdom