A Study to Evaluate the Effects of YM872 on Stroke Lesion Volume in Acute Stroke Patients

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ClinicalTrials.gov Identifier: NCT00044070

Recruitment Status : Completed

First Posted : August 20, 2002

Last Update Posted : April 3, 2006

Sponsor:

Collaborator:

Astellas Pharma US, Inc.

Information provided by:

Astellas Pharma Inc

Tracking Information

First Submitted Date ^ICMJE

August 16, 2002

First Posted Date ^ICMJE

August 20, 2002

Last Update Posted Date

April 3, 2006

Study Start Date ^ICMJE

December 2000

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study to Evaluate the Effects of YM872 on Stroke Lesion Volume in Acute Stroke Patients

Official Title ^ICMJE

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Effects of YM872 on Lesion Volume as Measured by Diffusion, Perfusion, and FLAIR Magnetic Resonance Imaging in Patients With Acute Ischemic Stroke

Brief Summary

This study will investigate the effects of a potential neuroprotectant compound, YM872, in the treatment of acute ischemic stroke. The study will determine if a 24-hour infusion of YM872, given within 6 hours of stroke onset, reduces the ischemic lesion volume as measured by MRI at 28 days after the infusion is given. The clinical effects of YM872 will also be determined by neurological function and disability scores at follow up visits through Day 90 of the study.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Masking: Double
Primary Purpose: Treatment

Condition ^ICMJE

Cerebrovascular Accident

Intervention ^ICMJE

Drug: YM872 (zonampanel)

Study Arms ^ICMJE

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Original Enrollment ^ICMJE

Not Provided

Study Completion Date ^ICMJE

January 2003

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients who have suffered an acute ischemic stroke and can be evaluated and treatment initiated within 6 hours after the onset of symptoms (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 have a three dimensionally measurable lesion compatible with an acute ischemic stroke measured using MRI.
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.
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.
Other criteria as specified in the study protocol

Exclusion Criteria:

Patients who have received alteplase (t-PA) for the current stroke episode. It is assumed that all patients who are eligible will receive treatment with t-PA.
Patients who have disability and functional limitations prior to the current stroke episode (e.g. deficit resulting from a prior stroke).
Patients who have brain hemorrhage.
Patients who have stroke of the brainstem or cerebellum.
Patients who cannot be evaluated using MRI due to the presence of a pacemaker, claustrophobia, need for sedation, etc.
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.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Austria, Belgium, Canada, Germany, South Africa, United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00044070

Other Study ID Numbers ^ICMJE

872-CL-003

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Astellas Pharma Inc

Collaborators ^ICMJE

Astellas Pharma US, Inc.

Investigators ^ICMJE

Not Provided

PRS Account

Astellas Pharma Inc

Verification Date

March 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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