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OpenTrials
Completed

NCT Number: NCT00075959

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

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.

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Key information

Conditions

Intracerebral Hemorrhage Brain Diseases Cardiovascular Diseases Cataplexy Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Disorders of Excessive Somnolence Dyssomnias Hemorrhage Intracranial Hemorrhages Mental Disorders Narcolepsy Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sleep Disorders, Intrinsic Sleep Wake Disorders Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NXY-059

Drug

Primary outcomes

  1. Global disability on modified Rankin scale at 90 days

Secondary outcomes

  1. NIH stroke scale

  2. Barthel Index

  3. Stroke Impact Scale

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Jan 14, 2004
Registry last updated
Jan 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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