---
title: Safety and Effectiveness of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke
nct_id: NCT00061022
overall_status: COMPLETED
phase: PHASE3
sponsor: AstraZeneca
study_type: INTERVENTIONAL
primary_condition: Cerebral Stroke
countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czechia, France, Germany, Greece, Hong Kong, Hungary, Israel, Mexico, New Zealand, Philippines, Poland, Portugal, Russia, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan, United Kingdom
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00061022.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00061022"
ct_last_update_post_date: 2010-11-15
last_seen_at: "2026-05-12T06:23:47.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Safety and Effectiveness of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke

**Official Title:** SAINT (Stroke - Acute Ischemic - NXY Treatment) A Double Blind, Randomized, Placebo Controlled, Parallel Group, Multicenter, Phase IIb/III Study to Assess the Efficacy and Safety of Intravenous NXY-059 in Acute Ischemic Stroke

**NCT ID:** [NCT00061022](https://clinicaltrials.gov/study/NCT00061022)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 3200
- **Lead Sponsor:** AstraZeneca
- **Conditions:** Cerebral Stroke, Stroke, Acute, Cerebrovascular Stroke, Ischemic Attack, Transient
- **Start Date:** 2003-05
- **Completion Date:** 2006-09
- **CT.gov Last Update:** 2010-11-15

## Brief 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Males and females
* Acute ischemic stroke with limb weakness
* Onset of symptoms within 6 hours
* Full functional independence prior to the present stroke

Exclusion Criteria:

* Unconsciousness
* Subjects who are unlikely to complete the infusion of investigational product and/or are unlikely to undergo active medical management during that period due to a severe clinical condition.
* Severe illness with life expectancy less than 6 months.
* Known severe kidney disorder.
* Current known alcohol or illicit drug abuse or dependence.
* Pregnant or breast-feeding.
* Treatment with acetazolamide and methotrexate is not permitted during the infusion
* Participation in a previous clinical study within 30 days.
* Meets all other exclusion criteria.
```

## Interventions

- **NXY-059** (DRUG)

## Primary Outcomes

- **Global disability on modified Rankin scale at 90 days.**

## Secondary Outcomes

- **NIH stroke scale**
- **Barthel Index**
- **Stroke Impact Scale**
- **EQ-5D all at 90 days**
- **Safety outcomes**

## Locations (256)

- Research Site, Birmingham, Alabama, United States
- Research Site, Phoenix, Arizona, United States
- Research Site, Fort Smith, Arkansas, United States
- Research Site, Arcadia, California, United States
- Research Site, Concord, California, United States
- Research Site, Englewood, California, United States
- Research Site, La Jolla, California, United States
- Research Site, La Mesa, California, United States
- Research Site, Los Angeles, California, United States
- Research Site, Oceanside, California, United States
- Research Site, Palo Alto, California, United States
- Research Site, Poway, California, United States
- Research Site, Sacramento, California, United States
- Research Site, San Diego, California, United States
- Research Site, San Jose, California, United States
- Research Site, Englewood, Colorado, United States
- Research Site, Danbury, Connecticut, United States
- Research Site, Fairfield, Connecticut, United States
- Research Site, Delray Beach, Florida, United States
- Research Site, Fort Lauderdale, Florida, United States
- Research Site, Lakeland, Florida, United States
- Research Site, Lane Panama City, Florida, United States
- Research Site, Melbourne, Florida, United States
- Research Site, Naples, Florida, United States
- Research Site, Ocala, Florida, United States
- Research Site, Orlando, Florida, United States
- Research Site, Port Charlotte, Florida, United States
- Research Site, Sarasota, Florida, United States
- Research Site, Tampa, Florida, United States
- Research Site, Weston, Florida, United States
- Research Site, Decatur, Georgia, United States
- Research Site, Lithonia, Georgia, United States
- Research Site, Chicago, Illinois, United States
- Research Site, Des Plaines, Illinois, United States
- Research Site, Elk Grove Village, Illinois, United States
- Research Site, Maywood, Illinois, United States
- Research Site, Oak Park, Illinois, United States
- Research Site, Fort Wayne, Indiana, United States
- Research Site, Cedar Rapids, Iowa, United States
- Research Site, Des Moines, Iowa, United States
- Research Site, Louisville, Kentucky, United States
- Research Site, Marrero, Louisiana, United States
- Research Site, South Weymouth, Massachusetts, United States
- Research Site, Worcester, Massachusetts, United States
- Research Site, Ann Arbor, Michigan, United States
- Research Site, East Lansing, Michigan, United States
- Research Site, Pontiac, Michigan, United States
- Research Site, Golden Valley, Minnesota, United States
- Research Site, Kansas City, Missouri, United States
- Research Site, Springfield, Missouri, United States
- Research Site, Great Falls, Montana, United States
- Research Site, Lincoln, Nebraska, United States
- Research Site, Reno, Nevada, United States
- Research Site, Edison, New Jersey, United States
- Research Site, Long Branch, New Jersey, United States
- Research Site, Lumberton, New Jersey, United States
- Research Site, Morristown, New Jersey, United States
- Research Site, Neptune City, New Jersey, United States
- Research Site, Red Bank, New Jersey, United States
- Research Site, Ridgewood, New Jersey, United States
- Research Site, Summit, New Jersey, United States
- Research Site, Toms River, New Jersey, United States
- Research Site, Trenton, New Jersey, United States
- Research Site, Buffalo, New York, United States
- Research Site, Flushing, New York, United States
- Research Site, New Hyde, New York, United States
- Research Site, Rochester, New York, United States
- Research Site, Schenectady, New York, United States
- Research Site, Asheville, North Carolina, United States
- Research Site, Chapel Hill, North Carolina, United States
- Research Site, Charlotte, North Carolina, United States
- Research Site, Durham, North Carolina, United States
- Research Site, Greensboro, North Carolina, United States
- Research Site, Salisbury, North Carolina, United States
- Research Site, Winston-Salem, North Carolina, United States
- Research Site, Cleveland, Ohio, United States
- Research Site, Toledo, Ohio, United States
- Research Site, Youngstown, Ohio, United States
- Research Site, Portland, Oregon, United States
- Research Site, Tualatin, Oregon, United States
- Research Site, Abington, Pennsylvania, United States
- Research Site, Doylestown, Pennsylvania, United States
- Research Site, Lancaster, Pennsylvania, United States
- Research Site, Philadelphia, Pennsylvania, United States
- Research Site, Pittsburgh, Pennsylvania, United States
- Research Site, Beaufort, South Carolina, United States
- Research Site, Bristol, Tennessee, United States
- Research Site, Memphis, Tennessee, United States
- Research Site, Houston, Texas, United States
- Research Site, Lubbock, Texas, United States
- Research Site, Virginia Beach, Virginia, United States
- Research Site, Olympia, Washington, United States
- Research Site, Seattle, Washington, United States
- Research Site, Tacoma, Washington, United States
- Research Site, Charleston, West Virginia, United States
- Research Site, Madison, Wisconsin, United States
- Research Site, Marshfield, Wisconsin, United States
- Research Site, Milwaukee, Wisconsin, United States
- Research Site, Boulogne Sur Mer, Argentina
- Research Site, Buenos Aires, Argentina
- Research Site, Capital Federal, Argentina
- Research Site, Ciudad de Buenos Aires, Argentina
- Research Site, Córdoba, Argentina
- Research Site, Mar del Plata, Argentina
- Research Site, Bedford Park, Australia
- Research Site, Box Hill, Australia
- Research Site, Camperdown, Australia
- Research Site, Gosford, Australia
- Research Site, Heidelberg, Australia
- Research Site, New Lambton, Australia
- Research Site, Parkville, Australia
- Research Site, Klosterneuburg, Austria
- Research Site, Linz, Austria
- Research Site, Salzburg, Austria
- Research Site, Sankt Pölten, Austria
- Research Site, Vienna, Austria
- Research Site, Antwerp, Belgium
- Research Site, Bruges, Belgium
- Research Site, Leuven, Belgium
- Research Site, Belo Horizonte, Brazil
- Research Site, Curitiba, Brazil
- Research Site, Goiânia, Brazil
- Research Site, Porto Alegre, Brazil
- Research Site, Rio de Janeiro, Brazil
- Research Site, São Paulo, Brazil
- Research Site, Pleven, Bulgaria
- Research Site, Plovdiv, Bulgaria
- Research Site, Rousse, Bulgaria
- Research Site, Sofia, Bulgaria
- Research Site, Varna, Bulgaria
- Research Site, Barrie, Canada
- Research Site, Calgary, Canada
- Research Site, Edmonton, Canada
- Research Site, Greenfield Park, Canada
- Research Site, Halifax, Canada
- Research Site, Kitchener, Canada
- Research Site, Lethbridge, Canada
- Research Site, Lévis, Canada
- Research Site, Mississauga, Canada
- Research Site, Montreal, Canada
- Research Site, Ottawa, Canada
- Research Site, Penticton, Canada
- Research Site, Québec, Canada
- Research Site, Saint John, Canada
- Research Site, Saskatoon, Canada
- Research Site, Thunder Bay, Canada
- Research Site, Toronto, Canada
- Research Site, Trois-Rivières, Canada
- Research Site, Vancouver, Canada
- Research Site, Victoriaville, Canada
- Research Site, Windsor, Canada
- Research Site, Santiago, Chile
- Research Site, Beijing, China
- Research Site, Guangzhou, China
- Research Site, Shanghai, China
- Research Site, Hradec Králové, Czechia
- Research Site, Olomouc, Czechia
- Research Site, Ostrava, Czechia
- Research Site, Pardubice, Czechia
- Research Site, Pelhřimov, Czechia
- Research Site, Prague, Czechia
- Research Site, Belfort, France
- Research Site, Besançon, France
- Research Site, Bordeaux, France
- Research Site, Bourg-en-Bresse, France
- Research Site, Créteil, France
- Research Site, Le Chesnay, France
- Research Site, Lille, France
- Research Site, Marseille, France
- Research Site, Montbéliard, France
- Research Site, Montpellier, France
- Research Site, Paris, France
- Research Site, Perpignan, France
- Research Site, Toulouse, France
- Research Site, Freiburg im Breisgau, Germany
- Research Site, Hamburg, Germany
- Research Site, Heidelberg, Germany
- Research Site, Leipzig, Germany
- Research Site, Minden, Germany
- Research Site, Wiesbaden, Germany
- Research Site, Athens, Greece
- Research Site, Heraklion, Greece
- Research Site, Ioannina, Greece
- Research Site, Thessaloniki, Greece
- Research Site, Chai Wan, Hong Kong
- Research Site, Hong Kong, Hong Kong
- Research Site, Budapest, Hungary
- Research Site, Debrecen, Hungary
- Research Site, Győr, Hungary
- Research Site, Kistarcsa, Hungary
- Research Site, Ashkelon, Israel
- Research Site, Beersheba, Israel
- Research Site, Hadera, Israel
- Research Site, Haifa, Israel
- Research Site, Holon, Israel
- Research Site, Jerusalem, Israel
- Research Site, Nahariya, Israel
- Research Site, Petah Tikva, Israel
- Research Site, Tel Aviv, Israel
- Research Site, Tel Litwinsky, Israel
- _and 56 more_

## Recent Field Changes (last 30 days)

- `locations.research site|zapopan, jalisco||mexico` — added _(2026-05-12)_
- `locations.research site|grafton||new zealand` — added _(2026-05-12)_
- `locations.research site|manila||philippines` — added _(2026-05-12)_
- `locations.research site|pasay||philippines` — added _(2026-05-12)_
- `locations.research site|quezon city||philippines` — added _(2026-05-12)_
- `locations.research site|częstochowa||poland` — added _(2026-05-12)_
- `locations.research site|gdansk||poland` — added _(2026-05-12)_
- `locations.research site|katowice||poland` — added _(2026-05-12)_
- `locations.research site|kielce||poland` — added _(2026-05-12)_
- `locations.research site|krakow||poland` — added _(2026-05-12)_
- `locations.research site|lodz||poland` — added _(2026-05-12)_
- `locations.research site|lublin||poland` — added _(2026-05-12)_
- `locations.research site|opole||poland` — added _(2026-05-12)_
- `locations.research site|siedlce||poland` — added _(2026-05-12)_
- `locations.research site|szczecin||poland` — added _(2026-05-12)_
- `locations.research site|warsaw||poland` — added _(2026-05-12)_
- `locations.research site|zabrze||poland` — added _(2026-05-12)_
- `locations.research site|amadora||portugal` — added _(2026-05-12)_
- `locations.research site|coimbra||portugal` — added _(2026-05-12)_
- `locations.research site|lisbon||portugal` — added _(2026-05-12)_
- `locations.research site|porto||portugal` — added _(2026-05-12)_
- `locations.research site|setúbal||portugal` — added _(2026-05-12)_
- `locations.research site|moscow||russia` — added _(2026-05-12)_
- `locations.research site|saint petersburg||russia` — added _(2026-05-12)_
- `locations.research site|lovoca||slovakia` — added _(2026-05-12)_
- `locations.research site|martin||slovakia` — added _(2026-05-12)_
- `locations.research site|nitra||slovakia` — added _(2026-05-12)_
- `locations.research site|ziliha||slovakia` — added _(2026-05-12)_
- `locations.research site|cape town||south africa` — added _(2026-05-12)_
- `locations.research site|george||south africa` — added _(2026-05-12)_
- `locations.research site|morningside||south africa` — added _(2026-05-12)_
- `locations.research site|somerset west||south africa` — added _(2026-05-12)_
- `locations.research site|anyang||south korea` — added _(2026-05-12)_
- `locations.research site|seoul||south korea` — added _(2026-05-12)_
- `locations.research site|barcelona||spain` — added _(2026-05-12)_
- `locations.research site|girona||spain` — added _(2026-05-12)_
- `locations.research site|madrid||spain` — added _(2026-05-12)_
- `locations.research site|santiago(a coruña)||spain` — added _(2026-05-12)_
- `locations.research site|aarau||switzerland` — added _(2026-05-12)_
- `locations.research site|basel||switzerland` — added _(2026-05-12)_
- `locations.research site|bern||switzerland` — added _(2026-05-12)_
- `locations.research site|lausanne||switzerland` — added _(2026-05-12)_
- `locations.research site|sankt gallen||switzerland` — added _(2026-05-12)_
- `locations.research site|zurich||switzerland` — added _(2026-05-12)_
- `locations.research site|taichung||taiwan` — added _(2026-05-12)_
- `locations.research site|taipei||taiwan` — added _(2026-05-12)_
- `locations.research site|taoyuan hsien||taiwan` — added _(2026-05-12)_
- `locations.research site|edinburgh||united kingdom` — added _(2026-05-12)_
- `locations.research site|glasgow||united kingdom` — added _(2026-05-12)_
- `locations.research site|newcastle upon tyne||united kingdom` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00061022.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00061022*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*