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

March 14, 2008
March 20, 2008
July 29, 2009
February 2008
June 2009   (Final data collection date for primary outcome measure)
Safety and tolerability [ Time Frame: 4 weeks ]
Same as current
Complete list of historical versions of study NCT00639249 on Archive Site
NIHSS [ Time Frame: 4 weeks ]
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:
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
    Intervention: Drug: placebo
  • Experimental: A1
    Intervention: Drug: SA4503 Low
  • Experimental: A2
    Intervention: Drug: SA4503 High
Urfer R, Moebius HJ, Skoloudik D, Santamarina E, Sato W, Mita S, Muir KW; Cutamesine Stroke Recovery Study Group. Phase II trial of the Sigma-1 receptor agonist cutamesine (SA4503) for recovery enhancement after acute ischemic stroke. Stroke. 2014 Nov;45(11):3304-10. doi: 10.1161/STROKEAHA.114.005835. Epub 2014 Sep 30.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
EudraCT number: 2007-004840-60
Not Provided
Not Provided
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