Acute Ischemic Stroke (AIS)Phase 2NCT00821821
Safety and Pharmacokinetics of MCI-186 in Subjects With Acute Ischemic Stroke
A Phase 2 study testing MCI-186 in people with Acute Ischemic Stroke (AIS), run by Shionogi at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke (AIS)
- What is being tested?
- MCI-186
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 28 Feb 2009to 30 Nov 2010
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United Kingdom1 site
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle
About this study
Official title: A Phase IIa, Multi-centre, Randomised, Double-blind, Placebo Controlled, Clinical Study Investigating the Safety, Tolerability and Pharmacokinetics of MCI-186 in Subjects With Acute Ischemic Stroke
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)
- Being tested
- MCI-186, Placebo
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCI-186Drug
Also called Edaravone
Cohort 1: Edaravone: circa 1000 mg / 72-hour infusion
Cohort 2: Edaravone: circa 2000 mg / 72-hour infusion
PlaceboDrug
Cohort1:circa 1000mg / 72-hour infusion matching placebo
Cohort2:circa 2000mg / 72-hour infusion matching placebo
| Study group | Role | What they receive |
|---|---|---|
| MCI-186 | Experimental | Not described Receives: Drug: MCI-186 |
| Placebo Group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 87days
Secondary outcomes (2)
Plasma MCI-186 Pharmacokinetics
The geometric mean values of MCI-186 plasma concentration at the end of the infusion (at 72h) in cohorts 1 and 2 were determined.
Measured: 72 hours
mRS, NIHSS, Barthel Index
Measured: throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study start28 Feb 2009
- Primary completion30 Nov 2010
- Study completion30 Nov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic Stroke (AIS)Studies of the same condition, open and under way.
- More trials run by ShionogiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shionogi Clinical Trials Administrator Clinical Support Help Line, Study director, Shionogi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821821
- Sponsor's protocol ID
- MCI-186-E04
- Status last verified
- Jun 2026
- First submitted
- 13 Jan 2009
- Last updated
- 16 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 24135530