A Study to Evaluate the Effects of YM872 on Brain Function and Disability When Administered in Combination With Alteplase (Tissue Plasminogen Activator)

A Multicenter, Stratified, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Neurologic Function and Disability in Patients With Acute Ischemic Stroke Given Tissue Plasminogen Activator Plus YM872 or Tissue Plasminogen Activator Plus Placebo

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00044057

Enrollment

Unknown

Registered

2002-08-20

Start date

2000-12-31

Completion date

2003-01-31

Last updated

2006-04-03

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

Conditions

Acute Ischemic Stroke

Keywords

ARTIST

Brief summary

The purpose of this study is to determine if YM872 in combination with t-PA can reduce disability and brain damage from stroke. YM872 or placebo will be given as a continuous intravenous (iv) infusion for 24 hours. It is important that the study medication, YM872 or placebo, is administered prior to the completion of the t-PA administration. The clinical effects of YM872 in addition to t-PA will be determined by assessing neurological function and disability scores at follow up visits through Day 90 of the study.

Interventions

DRUGYM872 (zonampanel), t-PA (alteplase)

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with acute ischemic stroke who are treated with alteplase within 3 hours of stroke onset (Onset is defined as the time that which the patient was last seen in a normal state, or bedtime for unwitnessed strokes occurring during the night). * Patients who are able to provide written informed consent or have consent provided by a legally authorized representative. * Patients who are at least 18 years of age. * Patients who have a National Institutes of Health Stroke Scale (NIHSS) score of at least 7 but not more than 23 and who are conscious. * Other criteria as specified in the study protocol

Exclusion criteria

* Patients who are not eligible to receive treatment with alteplase (t-PA) due to brain hemorrhage, risk for hemorrhage, or other criteria. * Patients who have stroke of the brainstem or cerebellum. * Patients who have renal (kidney) disease or insufficiency. * Patients who have active epilepsy or convulsions during the current stroke episode. * Patients who are IV drug users or are inebriated. * Patients who have a history of drug-related anaphylaxis. * Patients who have taken sedatives, anticonvulsants, or any medication with sedating effects in the 10 days prior study enrollment. * Patients who have taken more than 1.3 g of aspirin per day in the 2 days prior to enrollment. * Patients who have a known vitamin hypersensitivity. * Other

Countries

Austria, Belgium, Canada, Germany, United States

Outcome results

None listed

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