Dose Finding Study of MCI-186 in Acute Ischemic Stroke

NCT ID: NCT03346538

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-17
• Study Completion Date: 2018-05-14

Brief Summary

To investigate the efficacy and safety of MCI-186 (bolus followed by continuous infusion) in acute ischemic stroke patients through a double-blind, parallel-group comparison with the existing MCI-186 dosing regimen (administration twice daily for 14 days) as the control.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Continuous infusion high-dose group (Group H)

High-dose MCI-186 will be administered as a bolus, and then as a continuous infusion. In addition, a placebo will be administered as an intravenous infusion twice a day over 30 minutes.

Group Type: EXPERIMENTAL

Continuous infusion high-dose MCI-186

Intervention Type: DRUG

intravenous injection

Approved dosing regimen placebo

Intervention Type: DRUG

intravenous injection

Continuous infusion low-dose group (Group L)

Low-dose MCI-186 will be administered as a bolus, and then as a continuous infusion. In addition, a placebo will be administered as an intravenous infusion twice a day over 30 minutes.

Group Type: EXPERIMENTAL

Continuous infusion low-dose MCI-186

Intervention Type: DRUG

intravenous injection

Approved dosing regimen placebo

Intervention Type: DRUG

intravenous injection

Approved dosing regimen group (control group)

A placebo will be administered as a bolus, and then as a continuous infusion. In addition, MCI-186 30 mg will be administered as an intravenous infusion twice a day over 30 minutes.

Group Type: EXPERIMENTAL

Continuous infusion placebo

Intervention Type: DRUG

intravenous injection

Approved dosing regimen MCI-186

Intervention Type: DRUG

intravenous injection

Interventions

Continuous infusion high-dose MCI-186

intravenous injection

Intervention Type: DRUG

Continuous infusion low-dose MCI-186

intravenous injection

Intervention Type: DRUG

Continuous infusion placebo

intravenous injection

Intervention Type: DRUG

Approved dosing regimen MCI-186

intravenous injection

Intervention Type: DRUG

Approved dosing regimen placebo

intravenous injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients from whom written consent to study participation has been obtained, either from the patient personally or from the patient's legal guardian
• Patients with age at consent between 20 and 85 years, inclusive
• Patients for whom study treatment can be initiated within 24 hours after onset
• Patients with confirmed new ischemic area only in the supratentorial region on MRI
• Patients with neurological signs equivalent to between 4 and 22, inclusive, on the NIHSS

Exclusion Criteria

• Patients with disability equivalent to an mRS score of 2 or more from before onset
• Patients being treated with antibiotics for an infection at registration
• Patients who have received or are planning to receive treatment for their primary disease with a prohibited concomitant medication (e.g., a thrombolytic drug) or with a prohibited concomitant therapy (e.g., intravascular therapy)
• Patients for whom the (sub)investigator judges the efficacy endpoints (e.g., NIHSS, mRS, BI) that have been selected for this study can not be measured appropriately, such as patients who are not expected to achieve improvement of 4 or more on the NIHSS because of nerve symptoms that have been present since before the onset of cerebral infarction, Alzheimer's dementia patients, or Parkinson's disease patients
• Patients with severe consciousness disturbances (Japan coma scale ≥ 100)
• Patients with clear concurrent peripheral vascular disease or peripheral neuropathy for whom the (sub)investigator judges the neurological tests could not be performed properly
• Patients with severe renal impairment (e.g., patients with eGFR < 30)
• Patients with severe hepatic impairment (e.g., ALT, AST, or gamma-GTP > 2.5 X ULN)
• Patients with platelet count < 100,000/mm3
• Patients diagnosed by MRI on admission with a disease other than stroke (e.g., intracranial bleeding, subarachnoid bleeding, arteriovenous malformations, Moyamoya disease, brain tumor) or with cerebral aneurysm with a maximum diameter > 7 mm
• Patients with prior or current drug abuse or alcohol dependence
• Patients with prior (or current) malignant tumor within 5 years before stroke onset
• Patients with a past history of hypersensitivity to edaravone drug products
• Patients with concurrent heart disease severe enough to warrant admission and treatment (e.g., acute myocardial infarction, cardiac failure) and with problems with their overall condition judged by the (sub)investigator to be unsuitable for study participation
• Patients for whom MRI tests cannot be performed
• Male or female patients who do not consent to practice contraception from the date of consent until the day after the administration of the last dose of study drug
• Patients who are pregnant or nursing, or who could be pregnant
• Patients who have received other investigational drugs in the 12 weeks prior to consent acquisition
• Patients with body weight ≥ 100 kg
• Patients otherwise judged unsuitable for study participation by the (sub)investigator

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanabe Pharma Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

General Manager

Role: STUDY_DIRECTOR

Tanabe Pharma Corporation

Locations

Investigational site 13

Aichi, , Japan

Investigational site 39

Aomori, , Japan

Investigational site 19

Chiba, , Japan

Investigational site 28

Chiba, , Japan

Investigational site 33

Ehime, , Japan

Investigational site 10

Fukui, , Japan

Investigational site 05

Fukuoka, , Japan

Investigational site 09

Fukuoka, , Japan

Investigational site 11

Fukuoka, , Japan

Investigational site 12

Fukuoka, , Japan

Investigational site 18

Fukuoka, , Japan

Investigational site 21

Fukuoka, , Japan

Investigational site 32

Fukuoka, , Japan

Investigational site 37

Fukuoka, , Japan

Investigational site 07

Fukushima, , Japan

Investigational site 08

Fukushima, , Japan

Investigational site 15

Gifu, , Japan

Investigational site 23

Gifu, , Japan

Investigational site 02

Gunma, , Japan

Investigational site 01

Hokkaido, , Japan

Investigational site 22

Hokkaido, , Japan

Investigational site 06

Hyōgo, , Japan

Investigational site 30

Hyōgo, , Japan

Investigational site 42

Hyōgo, , Japan

Investigational site 43

Ishikawa, , Japan

Investigational site 40

Kanagawa, , Japan

Investigational site 24

Kochi, , Japan

Investigational site 35

Miyagi, , Japan

Investigational site 16

Nagano, , Japan

Investigational site 20

Nagano, , Japan

Investigational site 27

Numakunai, , Japan

Investigational site 44

Okayama, , Japan

Investigational site 41

Okinawa, , Japan

Investigational site 03

Osaka, , Japan

Investigational site 25

Osaka, , Japan

Investigational site 38

Saga, , Japan

Investigational site 31

Saitama, , Japan

Investigational site 14

Shimane, , Japan

Investigational site 29

Tochigi, , Japan

Investigational site 36

Tochigi, , Japan

Investigational site 17

Tokyo, , Japan

Investigational site 45

Tokyo, , Japan

Investigational site 34

Yamagata, , Japan

Investigational site 04

Yamaguchi, , Japan

Investigational site 26

Yamaguchi, , Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MCI-186-J20

Identifier Type: -

Identifier Source: org_study_id