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

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Acute Ischemic Stroke

Intervention / Treatment
-----------------
* Drug: YM872 (zonampanel), t-PA (alteplase)


Participation Criteria
=================
Eligibility Criteria
-----------------
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 exclusion criteria as specified by the study protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: YM872 (zonampanel), t-PA (alteplase)|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ARTIST