Status:
COMPLETED
Safety and Preliminary Efficacy Study of SA4503 in Subjects Recovering From Ischemic Stroke
Lead Sponsor:
M's Science Corporation
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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:
Eligibility Criteria
Inclusion
- Key
- 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
- Patients with transient ischemic attack
- Patients with stroke in progression
- Unstable cardiac, hepatic, or renal disease, or other major medical disorder
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00639249
Start Date
February 1 2008
Last Update
July 29 2009
Active Locations (1)
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1
Southern General Hospital
Glasgow, United Kingdom