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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00639249
Recruitment Status : Completed
First Posted : March 20, 2008
Last Update Posted : July 29, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Drug: placebo Drug: SA4503 Low Drug: SA4503 High Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : February 2008
Actual Primary Completion Date : June 2009

Arm Intervention/treatment
Placebo Comparator: P
Drug: placebo
Oral administration
Experimental: A1
Drug: SA4503 Low
Oral administration
Experimental: A2
Drug: SA4503 High
Oral administration

Primary Outcome Measures :
  1. Safety and tolerability [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. NIHSS [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00639249

United Kingdom
Southern General Hospital
Glasgow, United Kingdom
Sponsors and Collaborators
M's Science Corporation
Principal Investigator: Keith W Muir, MD Southern General Hospital, Glasgow

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Kazumasa Takao, M's Science Corporation Identifier: NCT00639249     History of Changes
Other Study ID Numbers: ME1-2
EudraCT number: 2007-004840-60
First Posted: March 20, 2008    Key Record Dates
Last Update Posted: July 29, 2009
Last Verified: July 2009

Additional relevant MeSH terms:
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
SA 4503
Nootropic Agents