Dose Finding Study of MCI-186 in Acute Ischemic Stroke

NCT03346538 | Terminated Phase 2 Results

• 1 other identifier: MCI-186-J20
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 45

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With National Institutes of Health Stroke Scale (NIHSS) Score Improved.

  NIHSS is a scale to objectively quantify the neurologic impairment caused by a stroke. Possible scores range from 0 (no stroke symptoms) to 40(severe stroke).

  Baseline up to Day 7

Secondary Outcomes (4)

• Comparison of National Institutes of Health Stroke Scale (NIHSS)

  Day 14, at discharge(from Day15 to after 3 months) and after 3 months

• Number of Participants With Modified Rankin Scale (mRS) 0-1 at Each Evaluations

  at discharge(from Day15 to after 3 months) and after 3 months

• Comparison of Barthel Index (BI)

  at discharge(from Day15 to after 3 months) and after 3 months

• Comparison of Functional Independence Measure (FIM)

  at discharge(from Day15 to after 3 months) and after 3 months

Study Arms (3)

Continuous infusion high-dose group (Group H)

EXPERIMENTAL

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.

Drug: Continuous infusion high-dose MCI-186; Drug: Approved dosing regimen placebo

Continuous infusion low-dose group (Group L)

EXPERIMENTAL

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.

Drug: Continuous infusion low-dose MCI-186; Drug: Approved dosing regimen placebo

Approved dosing regimen group (control group)

EXPERIMENTAL

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.

Drug: Continuous infusion placebo; Drug: Approved dosing regimen MCI-186

Interventions

Continuous infusion high-dose MCI-186 DRUG

intravenous injection

Continuous infusion high-dose group (Group H)

Continuous infusion low-dose MCI-186 DRUG

intravenous injection

Continuous infusion low-dose group (Group L)

Continuous infusion placebo DRUG

intravenous injection

Approved dosing regimen group (control group)

Approved dosing regimen MCI-186 DRUG

intravenous injection

Approved dosing regimen group (control group)

Approved dosing regimen placebo DRUG

intravenous injection

Continuous infusion high-dose group (Group H); Continuous infusion low-dose group (Group L)

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (45)

Investigational site 13

Aichi, Japan

Location

Investigational site 39

Aomori, Japan

Location

Investigational site 19

Chiba, Japan

Location

Investigational site 28

Chiba, Japan

Location

Investigational site 33

Ehime, Japan

Location

Investigational site 10

Fukui, Japan

Location

Investigational site 05

Fukuoka, Japan

Location

Investigational site 09

Fukuoka, Japan

Location

Investigational site 11

Fukuoka, Japan

Location

Investigational site 12

Fukuoka, Japan

Location

Investigational site 18

Fukuoka, Japan

Location

Investigational site 21

Fukuoka, Japan

Location

Investigational site 32

Fukuoka, Japan

Location

Investigational site 37

Fukuoka, Japan

Location

Investigational site 07

Fukushima, Japan

Location

Investigational site 08

Fukushima, Japan

Location

Investigational site 15

Gifu, Japan

Location

Investigational site 23

Gifu, Japan

Location

Investigational site 02

Gunma, Japan

Location

Investigational site 01

Hokkaido, Japan

Location

Investigational site 22

Hokkaido, Japan

Location

Investigational site 06

Hyōgo, Japan

Location

Investigational site 30

Hyōgo, Japan

Location

Investigational site 42

Hyōgo, Japan

Location

Investigational site 43

Ishikawa, Japan

Location

Investigational site 40

Kanagawa, Japan

Location

Investigational site 24

Kochi, Japan

Location

Investigational site 35

Miyagi, Japan

Location

Investigational site 16

Nagano, Japan

Location

Investigational site 20

Nagano, Japan

Location

Investigational site 27

Numakunai, Japan

Location

Investigational site 44

Okayama, Japan

Location

Investigational site 41

Okinawa, Japan

Location

Investigational site 03

Osaka, Japan

Location

Investigational site 25

Osaka, Japan

Location

Investigational site 38

Saga, Japan

Location

Investigational site 31

Saitama, Japan

Location

Investigational site 14

Shimane, Japan

Location

Investigational site 29

Tochigi, Japan

Location

Investigational site 36

Tochigi, Japan

Location

Investigational site 17

Tokyo, Japan

Location

Investigational site 45

Tokyo, Japan

Location

Investigational site 34

Yamagata, Japan

Location

Investigational site 04

Yamaguchi, Japan

Location

Investigational site 26

Yamaguchi, Japan

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Edaravone

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Antipyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma Corporation

cti-inq-ml.JP@ml.tanabe-pharma.com

Please email

Study Officials

• General Manager

  Tanabe Pharma Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: November 17, 2017
• Study Start: November 17, 2017
• Primary Completion: May 14, 2018
• Study Completion: May 14, 2018
• Last Updated: January 8, 2026
• Results First Posted: January 9, 2025

Record last verified: 2025-12

Locations

JP (45)