Safety and Pharmacokinetics of MCI-186 in Subjects With Acute Ischemic Stroke (NCT00821821) | Clinical Trial Compass
CompletedPhase 2
Safety and Pharmacokinetics of MCI-186 in Subjects With Acute Ischemic Stroke
Finland, Netherlands, United Kingdom36 participantsStarted 2009-02
Plain-language 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.
Who can participate
Age range40 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Number of Participants That Experienced Adverse Events