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

CHANT (Cerebral Hemorrhage And NXY Treatment) A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter, Phase IIb Study to Assess the Safety and Tolerability of Intravenous Infusion of NXY-059 in Adult Patients With Acute Intracerebral Hemorrhage (ICH)

This study will determine if NXY-059 is safe in patients with an acute stroke caused by bleeding in the central nervous system. The primary objective was to assess the safety and tolerability of NXY-059 compared to placebo.

Study Overview

• Status: Completed
• Conditions: Intracerebral Hemorrhage
• Intervention / Treatment: Drug: NXY-059

• Study Type: Interventional
• Enrollment: 600
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States
      • Research Site
  • Arizona
    • Scottsdale, Arizona, United States
      • Research Site
  • Arkansas
    • Fort Smith, Arkansas, United States
      • Research Site
  • California
    • Carmichael, 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
    • Santa Rosa, California, United States
      • Research Site
    • Walnut Creek, California, United States
      • Research Site
  • Connecticut
    • Danbury, Connecticut, United States
      • Research Site
  • Florida
    • Melbourne, Florida, United States
      • Research Site
    • Ocala, Florida, United States
      • Research Site
    • Pompano Beach, Florida, United States
      • Research Site
    • Port Charlotte, Florida, United States
      • Research Site
    • Punta Gorda, Florida, United States
      • Research Site
    • Tampa, Florida, United States
      • Research Site
    • Weston, Florida, United States
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States
      • Research Site
    • Decatur, Georgia, United States
      • Research Site
    • Duluth, Georgia, United States
      • Research Site
    • Lawrenceville, Georgia, United States
      • Research Site
  • Hawaii
    • Honolulu, Hawaii, United States
      • Research Site
  • Illinois
    • Arlington Heights, Illinois, United States
      • Research Site
    • Maywood, Illinois, United States
      • Research Site
  • Indiana
    • Fort Wayne, Indiana, United States
      • Research Site
  • Iowa
    • Des Moines, Iowa, United States
      • Research Site
  • Kentucky
    • Louisville, Kentucky, United States
      • Research Site
  • Louisiana
    • Marrero, Louisiana, United States
      • Research Site
    • Shreveport, Louisiana, United States
      • Research Site
  • Massachusetts
    • South Weymouth, Massachusetts, United States
      • Research Site
    • Worcester, Massachusetts, United States
      • Research Site
  • Michigan
    • Ann Arbor, Michigan, United States
      • Research Site
    • East Lansing, Michigan, United States
      • Research Site
  • Minnesota
    • Robbinsdale, Minnesota, United States
      • Research Site
  • Missouri
    • Kansas City, Missouri, United States
      • Research Site
  • Nebraska
    • Omaha, Nebraska, United States
      • Research Site
  • Nevada
    • Reno, Nevada, United States
      • Research Site
  • New Jersey
    • Edison, New Jersey, United States
      • Research Site
    • Holmdel, New Jersey, United States
      • Research Site
    • Morristown, New Jersey, United States
      • Research Site
    • Ridgewood, New Jersey, United States
      • Research Site
    • Summit, New Jersey, United States
      • Research Site
  • New York
    • Manhasset, New York, United States
      • Research Site
    • Schenectady, New York, United States
      • Research Site
  • North Carolina
    • Durham, North Carolina, United States
      • Research Site
    • Winston Salem, North Carolina, United States
      • Research Site
  • Ohio
    • Akron, Ohio, United States
      • Research Site
    • Cleveland, Ohio, United States
      • Research Site
    • Toledo, Ohio, United States
      • Research Site
    • Youngstown, Ohio, United States
      • Research Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
      • Research Site
  • Pennsylvania
    • Abington, Pennsylvania, United States
      • Research Site
    • Danville, Pennsylvania, United States
      • Research Site
    • Hershey, Pennsylvania, United States
      • Research Site
    • Philadelphia, Pennsylvania, United States
      • Research Site
    • Pittsburgh, Pennsylvania, United States
      • Research Site
  • Tennessee
    • Bristol, Tennessee, United States
      • Research Site
    • Memphis, Tennessee, United States
      • Research Site
  • Texas
    • Houston, Texas, United States
      • Research Site
    • Lubbock, Texas, United States
      • Research Site
  • Virginia
    • Virginia Beach, Virginia, United States
      • Research Site
  • Washington
    • Olympia, Washington, United States
      • Research Site
  • Wisconsin
    • Madison, Wisconsin, United States
      • Research Site
    • Marshfield, Wisconsin, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males and females
• Intracerebral Hemorrhage as the cause of stroke symptoms
• 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 7 days.
• Meets all other exclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Global disability on modified Rankin scale at 90 days

Secondary Outcome Measures

Outcome Measure
NIH stroke scale
Barthel Index
Stroke Impact Scale

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start: August 1, 2004
• Primary Completion (Actual): January 1, 2006
• Study Completion (Actual): January 1, 2006

Study Registration Dates

• First Submitted: January 12, 2004
• First Submitted That Met QC Criteria: January 13, 2004
• First Posted (Estimate): January 14, 2004

Study Record Updates

• Last Update Posted (Estimate): January 4, 2013
• Last Update Submitted That Met QC Criteria: January 3, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Stroke; Hemorrhage; CVA; Cataplexy; cerebral vascular accident; Intracerebral Hemorrhage (ICH); Brain Attack
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Disufenton sodium
• Other Study ID Numbers: SA-NXY-0012; 0012; CHANT