Trial Outcomes & Findings for Dose Finding Study of MCI-186 in Acute Ischemic Stroke (NCT NCT03346538)

Last Updated: 2026-01-08

Results Overview

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).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

17 participants

Primary outcome timeframe

Baseline up to Day 7

Results posted on

2026-01-08

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.	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.
Overall Study STARTED	7	4	6
Overall Study COMPLETED	4	1	5
Overall Study NOT COMPLETED	3	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.
Overall Study Physician Decision	0	1	0
Overall Study Withdrawal by Subject	3	2	0
Overall Study One subject of control group who discontinued prior to initiation of study drug administration.	0	0	1

Baseline Characteristics

Dose Finding Study of MCI-186 in Acute Ischemic Stroke

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Continuous Infusion High-dose Group (Group H) n=7 Participants 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 Low-dose Group (Group L) n=3 Participants 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.	Approved Dosing Regimen Group (Control Group) n=5 Participants 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.	Total n=15 Participants Total of all reporting groups
Age, Continuous	76.3 years STANDARD_DEVIATION 6.8 • n=18 Participants	75.7 years STANDARD_DEVIATION 7.4 • n=17 Participants	64.4 years STANDARD_DEVIATION 11.2 • n=35 Participants	72.2 years STANDARD_DEVIATION 9.8 • n=42 Participants
Sex: Female, Male Female	6 Participants n=18 Participants	2 Participants n=17 Participants	3 Participants n=35 Participants	11 Participants n=42 Participants
Sex: Female, Male Male	1 Participants n=18 Participants	1 Participants n=17 Participants	2 Participants n=35 Participants	4 Participants n=42 Participants
Race/Ethnicity, Customized Japanese	7 Participants n=18 Participants	3 Participants n=17 Participants	5 Participants n=35 Participants	15 Participants n=42 Participants
Race/Ethnicity, Customized Non-Japanese	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants	0 Participants n=42 Participants

PRIMARY outcome

Timeframe: Baseline up to Day 7

Population: Among the randomised of 17 subjects, the baseline participants consisted of 15 subjects, excluding 1 who withdrew their consent after randomization and 1 who discontinued prior to initiation of study drug administration.

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).

Outcome measures

Outcome measures
Measure	Continuous Infusion Low-dose Group (Group L) n=3 Participants 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.	Approved Dosing Regimen Group (Control Group) n=5 Participants 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 High-dose Group (Group H) n=7 Participants 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.
Number of Participants With National Institutes of Health Stroke Scale (NIHSS) Score Improved. Day 6	1 Participants	1 Participants	3 Participants
Number of Participants With National Institutes of Health Stroke Scale (NIHSS) Score Improved. Day 7	1 Participants	1 Participants	3 Participants
Number of Participants With National Institutes of Health Stroke Scale (NIHSS) Score Improved. Day 1	0 Participants	0 Participants	0 Participants
Number of Participants With National Institutes of Health Stroke Scale (NIHSS) Score Improved. Day 2	0 Participants	1 Participants	2 Participants
Number of Participants With National Institutes of Health Stroke Scale (NIHSS) Score Improved. Day 3	0 Participants	1 Participants	2 Participants
Number of Participants With National Institutes of Health Stroke Scale (NIHSS) Score Improved. Day 4	0 Participants	1 Participants	2 Participants
Number of Participants With National Institutes of Health Stroke Scale (NIHSS) Score Improved. Day 5	0 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Continuous Infusion Low-dose Group (Group L) n=3 Participants 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.	Approved Dosing Regimen Group (Control Group) n=5 Participants 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 High-dose Group (Group H) n=7 Participants 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.
Comparison of National Institutes of Health Stroke Scale (NIHSS) Day 14	2.5 units on a scale Standard Deviation 2.1	2.8 units on a scale Standard Deviation 1.5	3.7 units on a scale Standard Deviation 6.1
Comparison of National Institutes of Health Stroke Scale (NIHSS) at discharge	2.0 units on a scale Standard Deviation 1.4	3.3 units on a scale Standard Deviation 1.5	3.5 units on a scale Standard Deviation 5.1
Comparison of National Institutes of Health Stroke Scale (NIHSS) after 3 months	0.0 units on a scale Standard Deviation NA Standard Deviation not calculable for 1 participant.	1.8 units on a scale Standard Deviation 0.8	3.3 units on a scale Standard Deviation 3.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Continuous Infusion Low-dose Group (Group L) n=3 Participants 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.	Approved Dosing Regimen Group (Control Group) n=5 Participants 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 High-dose Group (Group H) n=7 Participants 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.
Number of Participants With Modified Rankin Scale (mRS) 0-1 at Each Evaluations at discharge	1 Participants	3 Participants	4 Participants
Number of Participants With Modified Rankin Scale (mRS) 0-1 at Each Evaluations after 3 months	1 Participants	3 Participants	2 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Continuous Infusion Low-dose Group (Group L) n=3 Participants 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.	Approved Dosing Regimen Group (Control Group) n=5 Participants 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 High-dose Group (Group H) n=7 Participants 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.
Comparison of Barthel Index (BI) at discharge	72.5 units on a scale Standard Deviation 38.9	83.3 units on a scale Standard Deviation 28.9	80 units on a scale Standard Deviation 36.7
Comparison of Barthel Index (BI) after 3 months	100 units on a scale Standard Deviation NA Standard Deviation not calculable for 1 participant.	100 units on a scale Standard Deviation 0	90 units on a scale Standard Deviation 17.3

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Continuous Infusion Low-dose Group (Group L) n=3 Participants 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.	Approved Dosing Regimen Group (Control Group) n=5 Participants 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 High-dose Group (Group H) n=7 Participants 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.
Comparison of Functional Independence Measure (FIM) at discharge	91.5 units on a scale Standard Deviation 41.7	121.8 units on a scale Standard Deviation 4.1	102.2 units on a scale Standard Deviation 33.8
Comparison of Functional Independence Measure (FIM) after 3 months	125.0 units on a scale Standard Deviation NA Standard Deviation not calculable for 1 participant.	123.4 units on a scale Standard Deviation 2.5	93.7 units on a scale Standard Deviation 54.3

Adverse Events

Continuous Infusion High-dose Group (Group H)

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Continuous Infusion Low-dose Group (Group L)

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Approved Dosing Regimen Group (Control Group)

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Continuous Infusion High-dose Group (Group H) n=7 participants at risk 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 Low-dose Group (Group L) n=3 participants at risk 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.	Approved Dosing Regimen Group (Control Group) n=5 participants at risk 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.
Hepatobiliary disorders Hepatic mass	0.00% 0/7 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/3 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	20.0% 1/5 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.
Nervous system disorders Transient ischaemic attack	14.3% 1/7 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/3 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/5 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/7 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	33.3% 1/3 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/5 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.

Other adverse events

Additional Information

Clinical Trials, Information Desk

Tanabe Pharma Corporation

Phone: Please email

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Measure	Continuous Infusion High-dose Group (Group H) n=7 participants at risk 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 Low-dose Group (Group L) n=3 participants at risk 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.	Approved Dosing Regimen Group (Control Group) n=5 participants at risk 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.
Blood and lymphatic system disorders Leukopenia	14.3% 1/7 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/3 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/5 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.
Gastrointestinal disorders Cheilitis	14.3% 1/7 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/3 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/5 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.
Gastrointestinal disorders Constipation	42.9% 3/7 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	33.3% 1/3 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	20.0% 1/5 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.
Gastrointestinal disorders Haemorrhoids	14.3% 1/7 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/3 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/5 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.
Gastrointestinal disorders Stomatitis	14.3% 1/7 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/3 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/5 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.
Infections and infestations Cystitis	14.3% 1/7 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/3 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/5 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.
Infections and infestations Fungal skin infection	0.00% 0/7 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/3 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	20.0% 1/5 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.
Infections and infestations Urinary tract infection	0.00% 0/7 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	33.3% 1/3 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/5 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.
Injury, poisoning and procedural complications Radius fracture	14.3% 1/7 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/3 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/5 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.
Musculoskeletal and connective tissue disorders Arthralgia	14.3% 1/7 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/3 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/5 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	0.00% 0/7 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	33.3% 1/3 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/5 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.
Musculoskeletal and connective tissue disorders Pain in extremity	14.3% 1/7 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/3 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/5 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.
Nervous system disorders Cerebral infarction	0.00% 0/7 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/3 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	20.0% 1/5 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.
Nervous system disorders Dementia	14.3% 1/7 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/3 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/5 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.
Nervous system disorders Headache	28.6% 2/7 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/3 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	20.0% 1/5 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.
Nervous system disorders Hypoaesthesia	0.00% 0/7 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/3 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	20.0% 1/5 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.
Psychiatric disorders Delirium	14.3% 1/7 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	33.3% 1/3 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/5 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.
Respiratory, thoracic and mediastinal disorders Epistaxis	14.3% 1/7 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/3 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/5 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/7 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	33.3% 1/3 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/5 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	0.00% 0/7 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/3 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	20.0% 1/5 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/7 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	33.3% 1/3 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/5 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.
Skin and subcutaneous tissue disorders Eczema asteatotic	0.00% 0/7 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	33.3% 1/3 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/5 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.
Skin and subcutaneous tissue disorders Erythema	14.3% 1/7 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/3 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/5 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/7 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	33.3% 1/3 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/5 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/7 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	33.3% 1/3 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.	0.00% 0/5 • Adverse events occurring in subjects up to 3 months after the start of investigational product treatment were investigated.