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

This study has been completed.
Sponsor:
Information provided by:
M's Science Corporation
ClinicalTrials.gov Identifier:
NCT00639249
First received: March 14, 2008
Last updated: July 28, 2009
Last verified: July 2009

March 14, 2008
July 28, 2009
February 2008
June 2009   (final data collection date for primary outcome measure)
Safety and tolerability [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00639249 on ClinicalTrials.gov Archive Site
NIHSS [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Preliminary Efficacy Study of SA4503 in Subjects Recovering From Ischemic Stroke
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

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:

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Ischemic Stroke
  • Drug: placebo
    Oral administration
  • Drug: SA4503 Low
    Oral administration
  • Drug: SA4503 High
    Oral administration
  • Placebo Comparator: P
    Placebo
    Intervention: Drug: placebo
  • Experimental: A1
    SA4503
    Intervention: Drug: SA4503 Low
  • Experimental: A2
    SA4503
    Intervention: Drug: SA4503 High
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
Not Provided
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00639249
ME1-2, EudraCT number: 2007-004840-60
Yes
Kazumasa Takao, M's Science Corporation
M's Science Corporation
Not Provided
Principal Investigator: Keith W Muir, MD Southern General Hospital, Glasgow
M's Science Corporation
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP