A Phase IIa, multi-centre, randomised, double-blind, placebo controlled, clinical study investigating the safety, tolerability and pharmacokinetics of two different infusion doses over 72 hours of a new regimen and new formulation of MCI-186 in subjects with acute ischemic stroke - MCI-186-E04

Mitsubishi Pharma Corporation0 个研究点目标入组 12 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 12

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 99（—）

入选标准

•Inclusion Criteria;Subjects must meet the following criteria in order to be deemed suitable for inclusion in the study:;1. Male or female, aged 40-80 years old;2. Full functional independence prior to the present stroke (as evidenced by a pre-morbid modified Rankin Scale score of 0-2);3. Clinical diagnosis of acute stroke with CT scan ruling out intracranial hemorrhage;4. Onset of symptoms within 1-24 hours of commencement of infusion of study drug;5. Measurable deficit on NIHSS (as evidenced by a score of 3-15)
•(See protocol Amendment 2, dated 12 May 2009).;6. Full consciousness (i.e. the score for NIHSS item 1a=0);7. 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.

排除标准

•Exclusion Criteria;If subjects meet any of the following criteria, they CANNOT be entered into the study:;1. 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.;2. Subjects unlikely to survive the acute period of stroke.;3. Subjects with severe illness with life expectancy less than 6 months.;4. Body weight in excess of 120 kg.;5. Subjects who have received rTPA or other thrombolytics (e.g. urokinase, streptokinase, reteplase, tenecteplase) within the previous 24 hours.;6. Subjects who have infection under antibiotic treatment at the enrollment.;7. Likelihood of forbidden concomitant therapy such as vascular surgery, coronary artery bypass graft (CABG), valve replacement, or carotid endarterectomy (CEA).;8. Evidence of cerebral herniation.;9. Subjects with confounding neurological diseases such as dementia.;10. Subjects with CADASIL, Moya Moya, or carotid dissection.;11. 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).;12. History of peripheral vascular disease.;13. Subjects with Diabetes Mellitus who have a history of peripheral neuropathy or significant evidence of peripheral neuropathy on routine neurological examination.;14. Known severe kidney disorder (or estimated creatinine clearance of <30 mL/min).;15. Known severe hepatic disorder, or elevated liver enzymes (at least 2 of ALT, AST, and gamma GT) greater than 3 times the upper limit of normal (>3 x ULN).;16. Evidence from admission imaging tests of infarction involving >1/3 of MCA territory, orentire 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).;17. Pathology other than cerebral infarction on any admission imaging tests (e.g. ICH or SAH, AV malformation, cerebral aneurysm, or cerebral neoplasm);18. Current or previous known excessive alcohol use or dependence.;19. Current known illicit drug use or dependence.;20. Participation in a previous clinical study within 30 days.;21. Subjects unlikely to be able and willing to attend all study follow-up visits.;22. Any other conditions which in the opinion of the investigator deem the subject ineligible for inclusion.;23. 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.

研究者

发起方

Mitsubishi Pharma Corporation

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