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)
Data Collection
Brain Diseases+7
+ Cardiovascular Diseases
+ Central Nervous System Diseases
Treatment Study
Summary
Study start date: August 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.600 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 64 locations
Research Site
Scottsdale, United StatesResearch Site
Fort Smith, United StatesResearch Site
Carmichael, United States