A Phase IIa, Multi-centre, Randomised, Double-blind, Placebo Controlled, Clinical Study Investigating the Safety, Tolerability and Pharmacokinetics of MCI-186 in Subjects With Acute Ischemic Stroke

Tanabe Pharma Corporation3 sites in 3 countries36 target enrollmentFebruary 1, 2009

ConditionsAcute Ischemic Stroke (AIS)

InterventionsMCI-186 Placebo

Overview

Phase: Phase 2
Intervention: MCI-186
Conditions: Acute Ischemic Stroke (AIS)
Sponsor: Tanabe Pharma Corporation
Enrollment: 36
Locations: 3
Primary Endpoint: Number of Participants That Experienced Adverse Events
Status: Completed
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The objectives of this study are to assess the safety, tolerability and local tolerance, and to investigate the plasma levels and terminal elimination half life of MCI-186, and to review the routine clinical and neurological assessments data of MCI-186 in subjects with acute ischemic stroke.

Registry

clinicaltrials.gov

Start Date

February 1, 2009

End Date

November 1, 2010

Last Updated

3 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Tanabe Pharma Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Full functional independence prior to the present stroke (as evidenced by a pre-morbid modified Rankin Scale score of 0-2
•Clinical diagnosis of acute stroke with CT scan ruling out intracranial hemorrhage
•Onset of symptoms within 1-24 hours of commencement of infusion of study drug
•Measurable deficit on NIHSS (as evidenced by a score of 3-15)
•Full consciousness (i.e. the score for NIHSS item 1a=0)
•Written valid informed consent is obtained from the subject or his/her next of kin or legal representative if the subject is fully conscious (i.e. the score for NIHSS item 1a = 0) but unable to read and/or sign the ICF, in accordance with National legislation and local IRB requirements

Exclusion Criteria

•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
•Subjects with severe illness with life expectancy less than 6 months
•Body weight in excess of 120 kg
•Subjects who have received rTPA or other thrombolytics (e.g. urokinase, streptokinase, reteplase, tenecteplase) within the previous 24 hours
•Likelihood of forbidden concomitant therapy such as vascular surgery, coronary artery bypass graft (CABG), valve replacement, or carotid endarterectomy (CEA)
•Evidence of cerebral herniation
•Subjects with confounding neurological diseases such as dementia
•Subjects with CADASIL, Moya Moya, or carotid dissection
•Subjects who have experienced a stroke within the previous 3 months (Note: subjects who have recently experienced a TIA, but whose premorbid mRS prior to their stroke is 0-2, will be allowed to enter the study)
•Evidence from admission imaging tests of infarction involving \>1/3 of MCA territory, or entire ACA territory involvement, or internal carotid artery (ICA) occlusions without coexisting separate occlusion of the middle cerebral artery (because of the difficulty distinguishing between chronic and acute ICA lesions in such subjects)