Cerebrolysin and Recovery after Stroke (CARS) - A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase II Clinical Study. - CERE-REHA-1

EVER Neuro Pharma GmbH0 个研究点目标入组 236 人开始时间: 2009年8月13日最近更新: 2017年1月23日

试验速览

暂无简介。

•- stroke onset 24-72 hours prior to first infusion of study drug
•- stroke is ischemic in origin, supratentorial, radiologically confirmed (CT or MRI) and has volume > 4 cc
•- age between 18-80 years inclusive
•- no significant pre-stroke disability (pre-stroke Modified Rankin Score of 0 or 1)
•- no other stroke in 3 months preceding index stroke
•- Action Research Arm Test Score < 50 (corresponding to the half of the body showing hemiparesis)
•- a score of >2 in the Goodglass and Kaplan Communication Scale
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- progresive or unstable stroke
•- pre-existing and active major neurological disease
•- pre-existing and active (e.g. on chronic medication) major psychiatric disease, such as major depression, schizophrenia, bipolar disease or dementia
•- a history of significant alcohol or drug abuse in the prior 3 years
•- advanced liver, kidney, cardiac or pulmonary disease
•- a terminal medical diagnosis consistent with survival < 1 year
•- substantial decrease in alertness at time of randomization, defined as score of 2 on NIH stroke scale question 1a, 1b or 1c
•- pregnancy or lactating; note that a negative pregnancy test will be required if the patient is female in reproductive years
•- any condition that would represent a contraindication to Cerebrolysin, including allergy to Cerebrolysin
•- current enrolment in another therapeutic study of stroke or stroke recovery

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