Safety and Pharmacokinetics of MCI-186 in Subjects With Acute Ischemic Stroke

NCT ID: NCT00821821

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2010-11-30

Brief Summary

The objectives of this study are to assess the safety, tolerability and local tolerance, and to investigate the plasma levels and terminal elimination half life of MCI-186, and to review the routine clinical and neurological assessments data of MCI-186 in subjects with acute ischemic stroke.

Conditions

Acute Ischemic Stroke (AIS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MCI-186

Group Type: EXPERIMENTAL

MCI-186

Intervention Type: DRUG

Cohort 1: Edaravone: circa 1000 mg / 72-hour infusion

Cohort 2: Edaravone: circa 2000 mg / 72-hour infusion

Placebo Group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Cohort1:circa 1000mg / 72-hour infusion matching placebo

Cohort2:circa 2000mg / 72-hour infusion matching placebo

Interventions

MCI-186

Cohort 1: Edaravone: circa 1000 mg / 72-hour infusion

Cohort 2: Edaravone: circa 2000 mg / 72-hour infusion

Intervention Type: DRUG

Placebo

Cohort1:circa 1000mg / 72-hour infusion matching placebo

Cohort2:circa 2000mg / 72-hour infusion matching placebo

Intervention Type: DRUG

Other Intervention Names

Edaravone

Eligibility Criteria

Inclusion Criteria

• Full functional independence prior to the present stroke (as evidenced by a pre-morbid modified Rankin Scale score of 0-2
• Clinical diagnosis of acute stroke with CT scan ruling out intracranial hemorrhage
• Onset of symptoms within 1-24 hours of commencement of infusion of study drug
• Measurable deficit on NIHSS (as evidenced by a score of 3-15)
• Full consciousness (i.e. the score for NIHSS item 1a=0)
• Written valid informed consent is obtained from the subject or his/her next of kin or legal representative if the subject is fully conscious (i.e. the score for NIHSS item 1a = 0) but unable to read and/or sign the ICF, in accordance with National legislation and local IRB requirements

Exclusion Criteria

• Subjects who are unlikely to complete the infusion of investigational product and/or are unlikely to undergo active medical management during that period due to a severe clinical condition
• Subjects with severe illness with life expectancy less than 6 months
• Body weight in excess of 120 kg
• Subjects who have received rTPA or other thrombolytics (e.g. urokinase, streptokinase, reteplase, tenecteplase) within the previous 24 hours
• Likelihood of forbidden concomitant therapy such as vascular surgery, coronary artery bypass graft (CABG), valve replacement, or carotid endarterectomy (CEA)
• Evidence of cerebral herniation
• Subjects with confounding neurological diseases such as dementia
• Subjects with CADASIL, Moya Moya, or carotid dissection
• Subjects who have experienced a stroke within the previous 3 months (Note: subjects who have recently experienced a TIA, but whose premorbid mRS prior to their stroke is 0-2, will be allowed to enter the study)
• Evidence from admission imaging tests of infarction involving >1/3 of MCA territory, or entire ACA territory involvement, or internal carotid artery (ICA) occlusions without coexisting separate occlusion of the middle cerebral artery (because of the difficulty distinguishing between chronic and acute ICA lesions in such subjects)
• Pathology other than cerebral infarction on any admission imaging tests (e.g. ICH or SAH, AV malformation, cerebral aneurysm, or cerebral neoplasm)
• Current or previous known excessive alcohol use or dependence
• Current known illicit drug use or dependence
• Participation in a previous clinical study within 30 days
• Subjects unlikely to be able and willing to attend all study follow-up visits
• Any other conditions which in the opinion of the investigator deem the subject ineligible for inclusion
• Females who are pregnant or intend to become pregnant or subjects (male and female) who do not agree to use effective contraception for 3 months after end of treatment

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanabe Pharma Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Professor

Role: STUDY_CHAIR

Information at Mitsubishi Pharma Europe

Locations

Helsinki University Central Hospital

Helsinki, , Finland

Erasmus Medical Center

Rotterdam, , Netherlands

Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle, , United Kingdom

Countries

Finland; Netherlands; United Kingdom

References

Kaste M, Murayama S, Ford GA, Dippel DW, Walters MR, Tatlisumak T; MCI-186 study group. Safety, tolerability and pharmacokinetics of MCI-186 in patients with acute ischemic stroke: new formulation and dosing regimen. Cerebrovasc Dis. 2013;36(3):196-204. doi: 10.1159/000353680. Epub 2013 Oct 12.

Reference Type: RESULT

PMID: 24135530 (View on PubMed)

Other Identifiers

MCI-186-E04

Identifier Type: -

Identifier Source: org_study_id