Dose Finding Study of MCI-186 in Acute Ischemic Stroke

Phase 2

Terminated

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: Continuous infusion low-dose MCI-186; Drug: Continuous infusion high-dose MCI-186; Drug: Continuous infusion placebo; Drug: Approved dosing regimen MCI-186; Drug: Approved dosing regimen placebo

• Registration Number: NCT03346538
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-02
• Study First Submitted QC: 2017-11-14
• Study Start: 2017-11-17
• Study First Posted: 2017-11-17
• Primary Completion: 2018-05-14
• Study Completion: 2018-05-14
• Results First Submitted: 2024-09-24
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-25
• Last Update Submitted: 2024-11-25
• Results First Posted: 2025-01-09
• Last Update Posted: 2025-01-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Approved dosing regimen group (control group)	Approved dosing regimen MCI-186	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.
Continuous infusion low-dose group (Group L)	Continuous infusion low-dose MCI-186	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.
Continuous infusion high-dose group (Group H)	Continuous infusion high-dose MCI-186	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.
Continuous infusion high-dose group (Group H)	Approved dosing regimen placebo	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.
Approved dosing regimen group (control group)	Continuous infusion placebo	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.
Continuous infusion low-dose group (Group L)	Approved dosing regimen placebo	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With National Institutes of Health Stroke Scale (NIHSS) Score Improved.	Baseline up to Day 7	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).

Secondary Outcome Measures

Name	Time	Method
Comparison of National Institutes of Health Stroke Scale (NIHSS)	Day 14, at discharge(from Day15 to after 3 months) and after 3 months	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).
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	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.
Comparison of Barthel Index (BI)	at discharge(from Day15 to after 3 months) and after 3 months	BI is a scale for measuring performance in Activities of Daily Living (ADL). Possible scores range from 0 (worst) to 100 (best).
Comparison of Functional Independence Measure (FIM)	at discharge(from Day15 to after 3 months) and after 3 months	FIM is a scale used to evaluate the functional status. Possible scores range from 18 (worst) to 126 (best).

Trial Locations

Locations (45)

Investigational site 03; 🇯🇵 Osaka, Japan

Investigational site 12; 🇯🇵 Fukuoka, Japan

Investigational site 20; 🇯🇵 Nagano, Japan

Investigational site 10; 🇯🇵 Fukui, Japan

Investigational site 28; 🇯🇵 Chiba, Japan

Investigational site 21; 🇯🇵 Fukuoka, Japan

Investigational site 37; 🇯🇵 Fukuoka, Japan

Investigational site 08; 🇯🇵 Fukushima, Japan

Investigational site 15; 🇯🇵 Gifu, Japan

Investigational site 24; 🇯🇵 Kochi, Japan

Investigational site 35; 🇯🇵 Miyagi, Japan

Investigational site 44; 🇯🇵 Okayama, Japan

Investigational site 25; 🇯🇵 Osaka, Japan

Investigational site 05; 🇯🇵 Fukuoka, Japan

Investigational site 07; 🇯🇵 Fukushima, Japan

Investigational site 27; 🇯🇵 Iwate, Japan

Investigational site 41; 🇯🇵 Okinawa, Japan

Investigational site 36; 🇯🇵 Tochigi, Japan

Investigational site 18; 🇯🇵 Fukuoka, Japan

Investigational site 30; 🇯🇵 Hyogo, Japan

Investigational site 43; 🇯🇵 Ishikawa, Japan

Investigational site 31; 🇯🇵 Saitama, Japan

Investigational site 13; 🇯🇵 Aichi, Japan

Investigational site 17; 🇯🇵 Tokyo, Japan

Investigational site 45; 🇯🇵 Tokyo, Japan

Investigational site 39; 🇯🇵 Aomori, Japan

Investigational site 19; 🇯🇵 Chiba, Japan

Investigational site 09; 🇯🇵 Fukuoka, Japan

Investigational site 11; 🇯🇵 Fukuoka, Japan

Investigational site 32; 🇯🇵 Fukuoka, Japan

Investigational site 42; 🇯🇵 Hyogo, Japan

Investigational site 26; 🇯🇵 Yamaguchi, Japan

Investigational site 38; 🇯🇵 Saga, Japan

Investigational site 29; 🇯🇵 Tochigi, Japan

Investigational site 34; 🇯🇵 Yamagata, Japan

Investigational site 04; 🇯🇵 Yamaguchi, Japan

Investigational site 33; 🇯🇵 Ehime, Japan

Investigational site 23; 🇯🇵 Gifu, Japan

Investigational site 01; 🇯🇵 Hokkaido, Japan

Investigational site 22; 🇯🇵 Hokkaido, Japan

Investigational site 06; 🇯🇵 Hyogo, Japan

Investigational site 02; 🇯🇵 Gunma, Japan

Investigational site 40; 🇯🇵 Kanagawa, Japan

Investigational site 16; 🇯🇵 Nagano, Japan

Investigational site 14; 🇯🇵 Shimane, Japan