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

Summary

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

Timeline

Start

2003-06

Primary completion

2005-02

Completion

2005-02

Outcome

Met primary endpoint

paper The administration of NXY-059 within six hours after the onset of acute ischemic stroke significantly improved the primary outcome (reduced disability at 90 days) PMID 16467546 ↗

paper NXY-059 significantly improved the overall distribution of scores on the modified Rankin scale, as compared with placebo (P=0.038 PMID 16467546 ↗

Publications

• Results Lees KR, Zivin JA, Ashwood T, Davalos A, Davis SM, Diener HC, Grotta J, Lyden P, Shuaib A, Hardemark HG, Wasiewski WW; Stroke-Acute Ischemic NXY Treatment (SAINT I) Trial Investigators. NXY-059 for acute ischemic stroke. N Engl J Med. 2006 Feb 9;354(6):588-600. doi: 10.1056/NEJMoa052980.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	DISUFENTON	Small molecule	—	Intravenous

Indications