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Stroke drug study halted early: new dosing regimen tested in 17 patients

NCT ID NCT03346538

Disease control Sponsor: Shionogi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 2 times

Summary

This study aimed to find the best dose of MCI-186 for people who had an acute ischemic stroke. It compared a new way of giving the drug (a bolus followed by continuous infusion) with the standard twice-daily dosing for 14 days. The trial was terminated early and included only 17 participants, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

17 people

The number who actually took part.

Started

Nov 2017

Finished

May 2018

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

ischemic stroke

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute ischemic stroke

Contacts and locations

Locations

  • Investigational site 01

    Hokkaido, Japan

  • Investigational site 02

    Gunma, Japan

  • Investigational site 03

    Osaka, Japan

  • Investigational site 04

    Yamaguchi, Japan

  • Investigational site 05

    Fukuoka, Japan

  • Investigational site 06

    Hyōgo, Japan

  • Investigational site 07

    Fukushima, Japan

  • Investigational site 08

    Fukushima, Japan

  • Investigational site 09

    Fukuoka, Japan

  • Investigational site 10

    Fukui, Japan

  • Investigational site 11

    Fukuoka, Japan

  • Investigational site 12

    Fukuoka, Japan

  • Investigational site 13

    Aichi, Japan

  • Investigational site 14

    Shimane, Japan

  • Investigational site 15

    Gifu, Japan

  • Investigational site 16

    Nagano, Japan

  • Investigational site 17

    Tokyo, Japan

  • Investigational site 18

    Fukuoka, Japan

  • Investigational site 19

    Chiba, Japan

  • Investigational site 20

    Nagano, Japan

  • Investigational site 21

    Fukuoka, Japan

  • Investigational site 22

    Hokkaido, Japan

  • Investigational site 23

    Gifu, Japan

  • Investigational site 24

    Kochi, Japan

  • Investigational site 25

    Osaka, Japan

  • Investigational site 26

    Yamaguchi, Japan

  • Investigational site 27

    Numakunai, Japan

  • Investigational site 28

    Chiba, Japan

  • Investigational site 29

    Tochigi, Japan

  • Investigational site 30

    Hyōgo, Japan

  • Investigational site 31

    Saitama, Japan

  • Investigational site 32

    Fukuoka, Japan

  • Investigational site 33

    Ehime, Japan

  • Investigational site 34

    Yamagata, Japan

  • Investigational site 35

    Miyagi, Japan

  • Investigational site 36

    Tochigi, Japan

  • Investigational site 37

    Fukuoka, Japan

  • Investigational site 38

    Saga, Japan

  • Investigational site 39

    Aomori, Japan

  • Investigational site 40

    Kanagawa, Japan

  • Investigational site 41

    Okinawa, Japan

  • Investigational site 42

    Hyōgo, Japan

  • Investigational site 43

    Ishikawa, Japan

  • Investigational site 44

    Okayama, Japan

  • Investigational site 45

    Tokyo, Japan

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