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

Primary Purpose

Intracerebral Hemorrhage

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NXY-059
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracerebral Hemorrhage focused on measuring Stroke, cerebral vascular accident, CVA, Hemorrhage, Intracerebral Hemorrhage (ICH), Brain Attack, Cataplexy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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Outcomes

Primary Outcome Measures

Global disability on modified Rankin scale at 90 days

Secondary Outcome Measures

NIH stroke scale
Barthel Index
Stroke Impact Scale

Full Information

First Posted
January 12, 2004
Last Updated
January 3, 2013
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00075959
Brief Title
Safety of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracerebral Hemorrhage
Keywords
Stroke, cerebral vascular accident, CVA, Hemorrhage, Intracerebral Hemorrhage (ICH), Brain Attack, Cataplexy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
Double
Allocation
Randomized
Enrollment
600 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
NXY-059
Primary Outcome Measure Information:
Title
Global disability on modified Rankin scale at 90 days
Secondary Outcome Measure Information:
Title
NIH stroke scale
Title
Barthel Index
Title
Stroke Impact Scale

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca NXY-059 Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
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Birmingham
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Alabama
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United States
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Scottsdale
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Fort Smith
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Carmichael
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Sacramento
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San Diego
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San Jose
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Santa Rosa
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Walnut Creek
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Danbury
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Melbourne
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Ocala
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Tampa
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Weston
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Atlanta
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Decatur
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Duluth
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Lawrenceville
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Louisville
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Marrero
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Shreveport
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Reno
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Edison
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Holmdel
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Morristown
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Ridgewood
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Summit
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Manhasset
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Schenectady
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Durham
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Winston Salem
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Akron
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Cleveland
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Toledo
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Youngstown
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Oklahoma City
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Abington
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Danville
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Hershey
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Philadelphia
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Memphis
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Houston
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Lubbock
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Virginia Beach
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Olympia
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Madison
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United States
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Marshfield
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United States

12. IPD Sharing Statement

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

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