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
  Purpose

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 Intervention Phase
Ischemic Stroke
Drug: placebo
Drug: SA4503 Low
Drug: SA4503 High
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • NIHSS [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: February 2008
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: P
Placebo
Drug: placebo
Oral administration
Experimental: A1
SA4503
Drug: SA4503 Low
Oral administration
Experimental: A2
SA4503
Drug: SA4503 High
Oral administration

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639249

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

No publications provided

Responsible Party: Kazumasa Takao, M's Science Corporation
ClinicalTrials.gov Identifier: NCT00639249     History of Changes
Other Study ID Numbers: ME1-2, EudraCT number: 2007-004840-60
Study First Received: March 14, 2008
Last Updated: July 28, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on August 01, 2014