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Acute Ischemic StrokePhase 2NCT03346538

Dose Finding Study of MCI-186 in Acute Ischemic Stroke

A Phase 2 study testing Continuous infusion high-dose MCI-186, Continuous infusion low-dose MCI-186 and Approved dosing regimen MCI-186 in people with Acute Ischemic Stroke, run by Shionogi at 45 sites in Japan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 85 years
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
Continuous infusion high-dose MCI-186, Continuous infusion low-dose MCI-186 and Approved dosing regimen MCI-186
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
17 participants
Where
45 sitesJapan
Study dates
17 Nov 2017to 14 May 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

45 sites in 1 country.

45 sites in 1 country

Japan45 sites

  • Investigational site 13

    Aichi

  • Investigational site 39

    Aomori

  • Investigational site 19

    Chiba

  • Investigational site 28

    Chiba

  • Investigational site 33

    Ehime

  • Investigational site 10

    Fukui

  • Investigational site 05

    Fukuoka

  • Investigational site 09

    Fukuoka

  • Investigational site 11

    Fukuoka

  • Investigational site 12

    Fukuoka

  • Investigational site 18

    Fukuoka

  • Investigational site 21

    Fukuoka

  • Investigational site 32

    Fukuoka

  • Investigational site 37

    Fukuoka

  • Investigational site 07

    Fukushima

  • Investigational site 08

    Fukushima

  • Investigational site 15

    Gifu

  • Investigational site 23

    Gifu

  • Investigational site 02

    Gunma

  • Investigational site 01

    Hokkaido

  • Investigational site 22

    Hokkaido

  • Investigational site 06

    Hyōgo

  • Investigational site 30

    Hyōgo

  • Investigational site 42

    Hyōgo

  • Investigational site 43

    Ishikawa

  • Investigational site 40

    Kanagawa

  • Investigational site 24

    Kochi

  • Investigational site 35

    Miyagi

  • Investigational site 16

    Nagano

  • Investigational site 20

    Nagano

  • Investigational site 27

    Numakunai

  • Investigational site 44

    Okayama

  • Investigational site 41

    Okinawa

  • Investigational site 03

    Osaka

  • Investigational site 25

    Osaka

  • Investigational site 38

    Saga

  • Investigational site 31

    Saitama

  • Investigational site 14

    Shimane

  • Investigational site 29

    Tochigi

  • Investigational site 36

    Tochigi

  • Investigational site 17

    Tokyo

  • Investigational site 45

    Tokyo

  • Investigational site 34

    Yamagata

  • Investigational site 04

    Yamaguchi

  • Investigational site 26

    Yamaguchi

Other trials in Japan

About this study

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.

Being tested
Continuous infusion high-dose MCI-186, Continuous infusion low-dose MCI-186, Continuous infusion placebo, Approved dosing regimen MCI-186, Approved dosing regimen placebo
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous infusion high-dose MCI-186Drug

    intravenous injection

  • Continuous infusion low-dose MCI-186Drug

    intravenous injection

  • Continuous infusion placeboDrug

    intravenous injection

  • Approved dosing regimen MCI-186Drug

    intravenous injection

  • Approved dosing regimen placeboDrug

    intravenous injection

Study groups in NCT03346538
Study groupRoleWhat they receive
Continuous infusion high-dose group (Group H)ExperimentalHigh-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.
Receives: Drug: Continuous infusion high-dose MCI-186; Drug: Approved dosing regimen placebo
Continuous infusion low-dose group (Group L)ExperimentalLow-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.
Receives: Drug: Continuous infusion low-dose MCI-186; Drug: Approved dosing regimen placebo
Approved dosing regimen group (control group)ExperimentalA 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.
Receives: Drug: Continuous infusion placebo; Drug: Approved dosing regimen MCI-186

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Baseline up to Day 7

Secondary outcomes (4)

  1. Comparison of National Institutes of Health Stroke Scale (NIHSS)

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

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

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

    mRS is a scale for measuring the degree of disability caused by a stroke. Possible scores range from Grade 0 (no symptoms) to Grade 6 (death). Number of Participants with Modified Rankin Scale (mRS) 0-1 are evaluated.

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

  3. Comparison of Barthel Index (BI)

    BI is a scale for measuring performance in Activities of Daily Living (ADL). Possible scores range from 0 (worst) to 100 (best).

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

  4. Comparison of Functional Independence Measure (FIM)

    FIM is a scale used to evaluate the functional status. Possible scores range from 18 (worst) to 126 (best).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2017
  2. Study start17 Nov 2017
  3. Primary completion14 May 2018
  4. Study completion14 May 2018

Why it stopped: Business objectives have changed.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03346538
Sponsor's protocol ID
MCI-186-J20
Status last verified
Jun 2026
First submitted
2 Nov 2017
Last updated
16 Jul 2026
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Continuous infusion high-dose MCI-186, Continuous infusion low-dose MCI-186 and Approved dosing regimen MCI-186 in people with Acute Ischemic Stroke, run by Shionogi at 45 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With National Institutes of Health Stroke Scale (NIHSS) Score Improved. (time frame: Baseline up to Day 7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03346538.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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