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

This study has been completed.

First Received: January 12, 2004 Last Updated: March 18, 2009 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00075959

Purpose

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.

Condition	Intervention	Phase
Intracerebral Hemorrhage	Drug: NXY-059	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study
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)

Resource links provided by NLM:

Drug Information available for: Disufenton sodium

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Global disability on modified Rankin scale at 90 days

Secondary Outcome Measures:

NIH stroke scale
Barthel Index
Stroke Impact Scale

Estimated Enrollment:	600
Study Start Date:	July 2004
Study Completion Date:	January 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00075959

Show 64 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca NXY-059 Medical Science Director, MD

AstraZeneca

More Information

No publications provided

Study ID Numbers:	SA-NXY-0012, 0012, CHANT
Study First Received:	January 12, 2004
Last Updated:	March 18, 2009
ClinicalTrials.gov Identifier:	NCT00075959 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Stroke
cerebral vascular accident
CVA
Hemorrhage

Intracerebral Hemorrhage (ICH)
Brain Attack
Cataplexy

Additional relevant MeSH terms:

Cerebral Hemorrhage
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Disufenton sodium
Intracranial Hemorrhages

Cardiovascular Agents
Hemorrhage
Brain Diseases
Protective Agents
Cerebrovascular Disorders
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 27, 2009