NCT00821821

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2009-02-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2009-01-14
• Last updated: 2026-01-08
• Results posted: 2014-05-12

Locations

3 sites across 3 countries: Finland, Netherlands, United Kingdom