Trial Outcomes & Findings for Safety and Pharmacokinetics of MCI-186 in Subjects With Acute Ischemic Stroke (NCT NCT00821821)
NCT ID: NCT00821821
Last Updated: 2026-01-08
Results Overview
Additional Outcome Measures are included in Tables for Serious Adverse Events and Other Adverse Events to report their numbers and frequency.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
87days
Results posted on
2026-01-08
Participant Flow
Participant milestones
| Measure |
MCI-186 Cohort1
Edaravone: circa 1000 mg / 72-hour infusion
|
MCI-186 Cohort2
Edaravone: circa 2000 mg / 72-hour infusion
|
Placebo Group
Cohort1:circa 1000mg / 72-hour infusion matching placebo
Cohort2:circa 2000mg / 72-hour infusion matching placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
11
|
|
Overall Study
COMPLETED
|
12
|
13
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Pharmacokinetics of MCI-186 in Subjects With Acute Ischemic Stroke
Baseline characteristics by cohort
| Measure |
MCI-186 Cohort1
n=12 Participants
Edaravone: circa 1000 mg / 72-hour infusion
|
MCI-186 Cohort2
n=13 Participants
Edaravone: circa 2000 mg / 72-hour infusion
|
Placebo Group
n=11 Participants
Cohort1:circa 1000mg / 72-hour infusion matching placebo
Cohort2:circa 2000mg / 72-hour infusion matching placebo
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=18 Participants
|
9 Participants
n=17 Participants
|
2 Participants
n=35 Participants
|
16 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=18 Participants
|
4 Participants
n=17 Participants
|
9 Participants
n=35 Participants
|
20 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=18 Participants
|
4 Participants
n=17 Participants
|
3 Participants
n=35 Participants
|
9 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=18 Participants
|
9 Participants
n=17 Participants
|
8 Participants
n=35 Participants
|
27 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 87daysAdditional Outcome Measures are included in Tables for Serious Adverse Events and Other Adverse Events to report their numbers and frequency.
Outcome measures
| Measure |
MCI-186 Cohort1
n=12 Participants
Edaravone: circa 1000 mg / 72-hour infusion
|
MCI-186 Cohort2
n=13 Participants
Edaravone: circa 2000 mg / 72-hour infusion
|
Placebo Group
n=11 Participants
Cohort1:circa 1000mg / 72-hour infusion matching placebo
Cohort2:circa 2000mg / 72-hour infusion matching placebo
|
|---|---|---|---|
|
Number of Participants That Experienced Adverse Events
Deaths
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants That Experienced Adverse Events
Serious Adverse Events
|
0 participants
|
2 participants
|
1 participants
|
|
Number of Participants That Experienced Adverse Events
Other Adverse Events
|
12 participants
|
10 participants
|
10 participants
|
SECONDARY outcome
Timeframe: 72 hoursPopulation: The subjects with reliable measured values for plasma concentration were selected for pharmacokinetic analysis: 5 subjects in MCI-186 Cohort 1 and 11 subjects in MCI-186 Cohort 2.
The geometric mean values of MCI-186 plasma concentration at the end of the infusion (at 72h) in cohorts 1 and 2 were determined.
Outcome measures
| Measure |
MCI-186 Cohort1
n=5 Participants
Edaravone: circa 1000 mg / 72-hour infusion
|
MCI-186 Cohort2
n=11 Participants
Edaravone: circa 2000 mg / 72-hour infusion
|
Placebo Group
Cohort1:circa 1000mg / 72-hour infusion matching placebo
Cohort2:circa 2000mg / 72-hour infusion matching placebo
|
|---|---|---|---|
|
Plasma MCI-186 Pharmacokinetics
|
391 ng / ml
Geometric Coefficient of Variation 24.21 • Interval 45.81 to 3338.0
|
1595 ng / ml
Geometric Coefficient of Variation 51.57 • Interval 958.3 to 2655.0
|
—
|
SECONDARY outcome
Timeframe: throughout studyOutcome measures
Outcome data not reported
Adverse Events
MCI-186 Cohort1
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
MCI-186 Cohort2
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo Group
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MCI-186 Cohort1
n=12 participants at risk
Edaravone: circa 1000mg / 72-hour infusion
|
MCI-186 Cohort2
n=13 participants at risk
Edaravone: circa 2000mg / 72-hour infusion
|
Placebo Group
n=11 participants at risk
Cohort1:circa 1000mg / 72-hour infusion matching placebo
Cohort2:circa 2000mg / 72-hour infusion matching placebo
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/12 • 87 days
|
7.7%
1/13 • 87 days
|
0.00%
0/11 • 87 days
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/12 • 87 days
|
0.00%
0/13 • 87 days
|
9.1%
1/11 • 87 days
|
|
Nervous system disorders
Ischaemic Stroke
|
0.00%
0/12 • 87 days
|
7.7%
1/13 • 87 days
|
0.00%
0/11 • 87 days
|
Other adverse events
| Measure |
MCI-186 Cohort1
n=12 participants at risk
Edaravone: circa 1000mg / 72-hour infusion
|
MCI-186 Cohort2
n=13 participants at risk
Edaravone: circa 2000mg / 72-hour infusion
|
Placebo Group
n=11 participants at risk
Cohort1:circa 1000mg / 72-hour infusion matching placebo
Cohort2:circa 2000mg / 72-hour infusion matching placebo
|
|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/12 • 87 days
|
15.4%
2/13 • 87 days
|
0.00%
0/11 • 87 days
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/12 • 87 days
|
7.7%
1/13 • 87 days
|
0.00%
0/11 • 87 days
|
|
Eye disorders
Cataract
|
0.00%
0/12 • 87 days
|
0.00%
0/13 • 87 days
|
9.1%
1/11 • 87 days
|
|
Eye disorders
Vision Blurred
|
0.00%
0/12 • 87 days
|
0.00%
0/13 • 87 days
|
9.1%
1/11 • 87 days
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/12 • 87 days
|
7.7%
1/13 • 87 days
|
0.00%
0/11 • 87 days
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • 87 days
|
0.00%
0/13 • 87 days
|
18.2%
2/11 • 87 days
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
1/12 • 87 days
|
0.00%
0/13 • 87 days
|
0.00%
0/11 • 87 days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/12 • 87 days
|
0.00%
0/13 • 87 days
|
9.1%
1/11 • 87 days
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/12 • 87 days
|
7.7%
1/13 • 87 days
|
0.00%
0/11 • 87 days
|
|
Gastrointestinal disorders
Mouth Ulceration
|
0.00%
0/12 • 87 days
|
7.7%
1/13 • 87 days
|
0.00%
0/11 • 87 days
|
|
Gastrointestinal disorders
Nausea
|
41.7%
5/12 • 87 days
|
7.7%
1/13 • 87 days
|
18.2%
2/11 • 87 days
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • 87 days
|
0.00%
0/13 • 87 days
|
9.1%
1/11 • 87 days
|
|
General disorders
Fatigue
|
8.3%
1/12 • 87 days
|
0.00%
0/13 • 87 days
|
0.00%
0/11 • 87 days
|
|
General disorders
Infusion Site Phlebitis
|
8.3%
1/12 • 87 days
|
0.00%
0/13 • 87 days
|
0.00%
0/11 • 87 days
|
|
General disorders
Oedema Peripheral
|
0.00%
0/12 • 87 days
|
0.00%
0/13 • 87 days
|
9.1%
1/11 • 87 days
|
|
General disorders
Pyrexia
|
0.00%
0/12 • 87 days
|
0.00%
0/13 • 87 days
|
9.1%
1/11 • 87 days
|
|
General disorders
Vessel Puncture Site Haematoma
|
8.3%
1/12 • 87 days
|
0.00%
0/13 • 87 days
|
9.1%
1/11 • 87 days
|
|
Infections and infestations
Eczema Infected
|
0.00%
0/12 • 87 days
|
7.7%
1/13 • 87 days
|
0.00%
0/11 • 87 days
|
|
Infections and infestations
Groin Abscess
|
0.00%
0/12 • 87 days
|
0.00%
0/13 • 87 days
|
9.1%
1/11 • 87 days
|
|
Infections and infestations
Infusion Site Infection
|
0.00%
0/12 • 87 days
|
7.7%
1/13 • 87 days
|
0.00%
0/11 • 87 days
|
|
Infections and infestations
Pneumonia
|
8.3%
1/12 • 87 days
|
0.00%
0/13 • 87 days
|
0.00%
0/11 • 87 days
|
|
Infections and infestations
Sinusitis
|
8.3%
1/12 • 87 days
|
0.00%
0/13 • 87 days
|
0.00%
0/11 • 87 days
|
|
Infections and infestations
Urinary Tract Infection
|
8.3%
1/12 • 87 days
|
0.00%
0/13 • 87 days
|
0.00%
0/11 • 87 days
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.00%
0/12 • 87 days
|
7.7%
1/13 • 87 days
|
0.00%
0/11 • 87 days
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/12 • 87 days
|
0.00%
0/13 • 87 days
|
9.1%
1/11 • 87 days
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/12 • 87 days
|
0.00%
0/13 • 87 days
|
9.1%
1/11 • 87 days
|
|
Investigations
Blood Uric Acid Increased
|
0.00%
0/12 • 87 days
|
0.00%
0/13 • 87 days
|
9.1%
1/11 • 87 days
|
|
Investigations
C-Reactive Protein Increased
|
8.3%
1/12 • 87 days
|
0.00%
0/13 • 87 days
|
0.00%
0/11 • 87 days
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
8.3%
1/12 • 87 days
|
0.00%
0/13 • 87 days
|
9.1%
1/11 • 87 days
|
|
Investigations
Hepatic Enzyme Increased
|
8.3%
1/12 • 87 days
|
0.00%
0/13 • 87 days
|
0.00%
0/11 • 87 days
|
|
Investigations
Liver Function Test Abnormal
|
0.00%
0/12 • 87 days
|
0.00%
0/13 • 87 days
|
9.1%
1/11 • 87 days
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
8.3%
1/12 • 87 days
|
7.7%
1/13 • 87 days
|
0.00%
0/11 • 87 days
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/12 • 87 days
|
0.00%
0/13 • 87 days
|
18.2%
2/11 • 87 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/12 • 87 days
|
15.4%
2/13 • 87 days
|
0.00%
0/11 • 87 days
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
16.7%
2/12 • 87 days
|
0.00%
0/13 • 87 days
|
0.00%
0/11 • 87 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.3%
1/12 • 87 days
|
7.7%
1/13 • 87 days
|
0.00%
0/11 • 87 days
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.3%
1/12 • 87 days
|
7.7%
1/13 • 87 days
|
0.00%
0/11 • 87 days
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/12 • 87 days
|
7.7%
1/13 • 87 days
|
0.00%
0/11 • 87 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12 • 87 days
|
7.7%
1/13 • 87 days
|
0.00%
0/11 • 87 days
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/12 • 87 days
|
0.00%
0/13 • 87 days
|
9.1%
1/11 • 87 days
|
|
Nervous system disorders
Cerebrovascular Accident
|
8.3%
1/12 • 87 days
|
0.00%
0/13 • 87 days
|
9.1%
1/11 • 87 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • 87 days
|
7.7%
1/13 • 87 days
|
0.00%
0/11 • 87 days
|
|
Nervous system disorders
Headache
|
33.3%
4/12 • 87 days
|
30.8%
4/13 • 87 days
|
36.4%
4/11 • 87 days
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/12 • 87 days
|
7.7%
1/13 • 87 days
|
0.00%
0/11 • 87 days
|
|
Nervous system disorders
Neuralgia
|
8.3%
1/12 • 87 days
|
7.7%
1/13 • 87 days
|
0.00%
0/11 • 87 days
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/12 • 87 days
|
7.7%
1/13 • 87 days
|
0.00%
0/11 • 87 days
|
|
Nervous system disorders
Simple Partial Seizures
|
0.00%
0/12 • 87 days
|
0.00%
0/13 • 87 days
|
9.1%
1/11 • 87 days
|
|
Nervous system disorders
Somnolence
|
0.00%
0/12 • 87 days
|
0.00%
0/13 • 87 days
|
9.1%
1/11 • 87 days
|
|
Nervous system disorders
Speech Disorder
|
0.00%
0/12 • 87 days
|
7.7%
1/13 • 87 days
|
0.00%
0/11 • 87 days
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/12 • 87 days
|
0.00%
0/13 • 87 days
|
9.1%
1/11 • 87 days
|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12 • 87 days
|
0.00%
0/13 • 87 days
|
0.00%
0/11 • 87 days
|
|
Psychiatric disorders
Depression
|
0.00%
0/12 • 87 days
|
0.00%
0/13 • 87 days
|
9.1%
1/11 • 87 days
|
|
Psychiatric disorders
Insomnia
|
8.3%
1/12 • 87 days
|
0.00%
0/13 • 87 days
|
0.00%
0/11 • 87 days
|
|
Renal and urinary disorders
Urethral Haemorrhage
|
0.00%
0/12 • 87 days
|
0.00%
0/13 • 87 days
|
9.1%
1/11 • 87 days
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/12 • 87 days
|
0.00%
0/13 • 87 days
|
9.1%
1/11 • 87 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/12 • 87 days
|
7.7%
1/13 • 87 days
|
0.00%
0/11 • 87 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Fibrosis
|
0.00%
0/12 • 87 days
|
7.7%
1/13 • 87 days
|
0.00%
0/11 • 87 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/12 • 87 days
|
7.7%
1/13 • 87 days
|
0.00%
0/11 • 87 days
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/12 • 87 days
|
0.00%
0/13 • 87 days
|
9.1%
1/11 • 87 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
1/12 • 87 days
|
0.00%
0/13 • 87 days
|
9.1%
1/11 • 87 days
|
|
Skin and subcutaneous tissue disorders
Stasis Dermatitis
|
0.00%
0/12 • 87 days
|
7.7%
1/13 • 87 days
|
0.00%
0/11 • 87 days
|
|
Vascular disorders
Hypertension
|
25.0%
3/12 • 87 days
|
15.4%
2/13 • 87 days
|
36.4%
4/11 • 87 days
|
|
Vascular disorders
Hypotension
|
0.00%
0/12 • 87 days
|
7.7%
1/13 • 87 days
|
0.00%
0/11 • 87 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER