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

Phase 2 Completed 60 enrolled M's Science Corporation

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2008-02
Primary completion: 2009-06
Completion: —

Outcome

Missed primary endpoint

paper No significant effect was observed on the primary efficacy measure (change in National Institutes of Health Stroke Scale from baseline to day 56) PMID 25270629 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	cutamesine	Unknown	1 mg	Oral
Subject	cutamesine	Unknown	3 mg	Oral