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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00639249
• Other study ID #: ME1-2
• Secondary ID: EudraCT number:
• Status: Completed
• Phase: Phase 2
• First received: March 14, 2008
• Last updated: July 28, 2009
• Start date: February 2008

Study information

• Verified date: July 2009
• Source: M's Science Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• placebo
Oral administration
• SA4503 Low
Oral administration
• SA4503 High
Oral administration

Locations

Country	Name	City	State
United Kingdom	Southern General Hospital	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
M's Science Corporation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability		4 weeks	Yes
Secondary	NIHSS		4 weeks	No