Intracerebral HemorrhagePhase 2NCT00075959
Safety of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke
A Phase 2 study testing NXY-059 in people with Intracerebral Hemorrhage, run by AstraZeneca at 64 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- NXY-059
- How many people
- 600 participants
- Where
- 64 sitesUnited States
- Study dates
- Aug 2004to Jan 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
64 sites in 1 country.
64 sites in 1 country
United States64 sites
Research Site
Abington, Pennsylvania
Research Site
Akron, Ohio
Research Site
Ann Arbor, Michigan
Research Site
Arlington Heights, Illinois
Research Site
Atlanta, Georgia
Research Site
Birmingham, Alabama
Research Site
Bristol, Tennessee
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Carmichael, California
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Cleveland, Ohio
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Danbury, Connecticut
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Danville, Pennsylvania
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Decatur, Georgia
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Des Moines, Iowa
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Duluth, Georgia
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Durham, North Carolina
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East Lansing, Michigan
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Edison, New Jersey
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Fort Smith, Arkansas
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Fort Wayne, Indiana
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Hershey, Pennsylvania
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Holmdel, New Jersey
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Honolulu, Hawaii
Research Site
Houston, Texas
Research Site
Kansas City, Missouri
Research Site
Lawrenceville, Georgia
Research Site
Louisville, Kentucky
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Lubbock, Texas
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Madison, Wisconsin
Research Site
Manhasset, New York
Research Site
Marrero, Louisiana
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Marshfield, Wisconsin
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Maywood, Illinois
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Melbourne, Florida
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Memphis, Tennessee
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Morristown, New Jersey
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Ocala, Florida
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Oklahoma City, Oklahoma
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Olympia, Washington
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Omaha, Nebraska
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Philadelphia, Pennsylvania
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Pittsburgh, Pennsylvania
Research Site
Pompano Beach, Florida
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Port Charlotte, Florida
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Punta Gorda, Florida
Research Site
Reno, Nevada
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Ridgewood, New Jersey
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Robbinsdale, Minnesota
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Sacramento, California
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San Diego, California
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San Jose, California
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Santa Rosa, California
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Schenectady, New York
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Scottsdale, Arizona
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Shreveport, Louisiana
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South Weymouth, Massachusetts
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Summit, New Jersey
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Tampa, Florida
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Toledo, Ohio
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Virginia Beach, Virginia
Research Site
Walnut Creek, California
Research Site
Weston, Florida
Research Site
Winston-Salem, North Carolina
Research Site
Worcester, Massachusetts
Research Site
Youngstown, Ohio
About this 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)
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.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- NXY-059
- Keywords
- Stroke, cerebral vascular accident, CVA, Hemorrhage, Intracerebral Hemorrhage (ICH), Brain Attack, Cataplexy
- Medical subject headings
- Cerebral Hemorrhage, Stroke, Hemorrhage, Cataplexy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NXY-059Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Global disability on modified Rankin scale at 90 days
Secondary outcomes (3)
NIH stroke scale
Barthel Index
Stroke Impact Scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2004 (estimated)
- Study startAug 2004
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca NXY-059 Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00075959
- Sponsor's protocol ID
- SA-NXY-0012
- Other IDs
- 0012, CHANT
- Status last verified
- Jan 2013
- First submitted
- 12 Jan 2004
- Last updated
- 4 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00075959
- Acronym / sponsor ID
- SA-NXY-0012
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Stroke, cerebral vascular accident, CVA, Hemorrhage, Intracerebral Hemorrhage (ICH), Brain Attack, Cataplexy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 14 Jan 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NXY-059 | Drug | – |
Primary outcome
Global disability on modified Rankin scale at 90 days
3 secondary outcomes
NIH stroke scale
Barthel Index
Stroke Impact Scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AstraZeneca NXY-059 Medical Science Director, MD study director
AstraZeneca
64 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NXY-059 in people with Intracerebral Hemorrhage, run by AstraZeneca at 64 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global disability on modified Rankin scale at 90 days. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2013.