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

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00044070
First received: August 16, 2002
Last updated: March 31, 2006
Last verified: March 2006
  Purpose

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.


Condition Intervention Phase
Cerebrovascular Accident
Drug: YM872 (zonampanel)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Astellas Pharma Inc:

Study Start Date: December 2000
Estimated Study Completion Date: January 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044070

  Show 89 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma US, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00044070     History of Changes
Other Study ID Numbers: 872-CL-003
Study First Received: August 16, 2002
Last Updated: March 31, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
ARTIST
Acute ischemic stroke

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on October 19, 2014