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

NCT00821821 | Completed Phase 2 Results DMC

• 1 other identifier: MCI-186-E04
• Study Type: interventional
• Target: 36
• Locations: 3 countries
• Sites: 3

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)

Outcome Measures

Primary Outcomes (1)

• Number of Participants That Experienced Adverse Events

  Additional Outcome Measures are included in Tables for Serious Adverse Events and Other Adverse Events to report their numbers and frequency.

  87days

Secondary Outcomes (2)

• Plasma MCI-186 Pharmacokinetics

  72 hours

• mRS, NIHSS, Barthel Index

  throughout study

Study Arms (2)

MCI-186

EXPERIMENTAL

Drug: MCI-186

Placebo Group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

MCI-186 DRUG

Cohort 1: Edaravone: circa 1000 mg / 72-hour infusion Cohort 2: Edaravone: circa 2000 mg / 72-hour infusion

Also known as: Edaravone

MCI-186

Placebo DRUG

Cohort1:circa 1000mg / 72-hour infusion matching placebo Cohort2:circa 2000mg / 72-hour infusion matching placebo

Placebo Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (3)

Helsinki University Central Hospital

Helsinki, Finland

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 24135530 RESULT

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Edaravone

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Antipyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma Corporation

cti-inq-ml.JP@ml.tanabe-pharma.com

Study Officials

• Professor

  Information at Mitsubishi Pharma Europe

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2009
• First Posted: January 14, 2009
• Study Start: February 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: January 8, 2026
• Results First Posted: May 12, 2014

Record last verified: 2025-12

Locations

GB (1); FI (1); NL (1)