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Safety and Pharmacokinetics of MCI-186 in Subjects With Acute Ischemic Stroke

NCT00821821 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-01-08

Study results available
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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.

Conditions

  • Acute Ischemic Stroke (AIS)

Interventions

DRUG

MCI-186

Cohort 1: Edaravone: circa 1000 mg / 72-hour infusion Cohort 2: Edaravone: circa 2000 mg / 72-hour infusion

DRUG

Placebo

Cohort1:circa 1000mg / 72-hour infusion matching placebo Cohort2:circa 2000mg / 72-hour infusion matching placebo

Sponsors & Collaborators

  • Tanabe Pharma Corporation

    lead INDUSTRY

Principal Investigators

  • Professor · Information at Mitsubishi Pharma Europe

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • Finland
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00821821 on ClinicalTrials.gov