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

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00075959

Enrollment

600

Registered

2004-01-14

Start date

2004-08-31

Completion date

2006-01-31

Last updated

2013-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracerebral Hemorrhage

Keywords

Stroke, cerebral vascular accident, CVA, Hemorrhage, Intracerebral Hemorrhage (ICH), Brain Attack, Cataplexy

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.

Interventions

DRUGNXY-059

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Global disability on modified Rankin scale at 90 days	—

Secondary

Measure	Time frame
NIH stroke scale	—
Barthel Index	—
Stroke Impact Scale	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026