Safety and Preliminary Efficacy Study of SA4503 in Subjects Recovering From Ischemic Stroke
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Status:
This study has been completed.
Purpose:
To evaluate the safety and tolerability of SA4503, an orally active selective and potent sigma-1 receptor agonist, in patients with an acute ischemic stroke relative to placebo. Secondary endpoints will examine the efficacy of SA4503 compared to placebo.
Interventions:
SA4503
A potent and selective sigma-1 receptor agonist.
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Location(s):
United Kingdom, Spain, Czech
Year Started:
2008
Year Finished:
2009
Design:
Interventional, randomized, double-blind, placebo-controlled, dose-escalation study.
Inclusion Criteria
1)ischemic stroke within 48 to 72 hours after symptom onset
2)NIHSS of 2 or higher on the upper or lower extremity motor scores of the NIHSS
3)medically and neurologically stable for 24 hours prior to randomization
Exclusion Criteria
1)Patients with transient ischemic attack or stroke in progression
2)prior history of brain stem stroke or stroke with any residual deficits
3)unstable cardiac, hepatic, or renal disease, or other major medical disorder
Patient Involvement:
Eligible patients will be randomized to receive either SA4503 or placebo orally once daily for 28 days. Study duration will be 28 days of treatment with a 28-day follow-up period.
Primary Outcome:
Safety and tolerability will be assessed by adverse events including clinical changes and abnormal laboratories at 28 days and 56 days.
Secondary Outcome:
Efficacy endpoints will be NIHSS, Barthel Index, and modified Rankin Scale at 28 days and 56 days.
Source of Information:
Correspondence with Kazumasa Takao on 3/26/08-jh.
M's Science Corporation
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Web Links and Publications:
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This information last updated on: 4/27/2010
Reviewed on: 07/16/2009.
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