Safety and Effectiveness of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke

Phase 3 Completed 3200 enrolled AstraZeneca

RandomizedFactorialDouble-blindTreatment

Summary

This study will determine if NXY-059 will improve recovery from an acute stroke. The study is designed to look at both overall recovery and recovery of motor function, for example muscle strengthen and coordination.

Timeline

Start: 2003-05
Primary completion: 2006-09
Completion: 2006-09

Outcome

Missed primary endpoint

paper The distribution of scores on the modified Rankin scale did not differ PMID 17687131 ↗

paper P=0.33 by the Cochran-Mantel-Haenszel test PMID 17687131 ↗

Publications

Shuaib A, Lees KR, Lyden P, Grotta J, Davalos A, Davis SM, Diener HC, Ashwood T, Wasiewski WW, Emeribe U; SAINT II Trial Investigators. NXY-059 for the treatment of acute ischemic stroke. N Engl J Med. 2007 Aug 9;357(6):562-71. doi: 10.1056/NEJMoa070240.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	DISUFENTON	Small molecule	—	Intravenous