Dl-3-n-butylphthalide and Cerebrolysin Treatment in Acute Ischemic Stroke

Study Overview
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Brief Summary
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The investigators conducted a randomized, double-blind, trial enrolled 60 patients within 12 hours of acute ischemic stroke (AIS) in China. Patients were randomly assigned to receive a 10-day infusion of dl-3-n-butylphthalide (NBP) or cerebrolysin, or placebo. National Institutes of Health Stroke Scale (NIHSS) and Barthel Index (BI) were used to evaluate the efficacy in the patients with AIS at 11-day and 21-day after therapy. Adverse events were also analyzed among the three groups.

Official Title
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A Comparison of Safety and Efficacy of Dl-3-n-butylphthalide and Cerebrolysin on Neurological and Behavioral Outcomes in Acute Ischemic Stroke: a Randomized, Double-blind Study.

Conditions
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Acute Cerebral Stroke Within 12 Hours for the First Time

Intervention / Treatment
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* Drug: Dl-3-n-butylphthalide
* Drug: Cerebrolysin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute ischemic stroke within 12 hours for the first time before entry into the study National Institutes of Health Stroke Scale (NIHSS) score between 6 and 25 Exclusion Criteria: with lacunar infarction with cerebral hemorrhagic infarction with epilepsy or epileptic persons with history of neurological diseases with myocardial infarction, with renal and hepatic abnormalities with metabolic diseases with contraindications to antiplatelet treatments

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dl-3-n-butylphthalide<br>Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days | Drug: Dl-3-n-butylphthalide<br>* Intravenous infusion of 100 ml dl-3-n-butylphthalide and sodium chloride injection for 10 days, twice daily.<br>* Other names: CSPC NBP Pharmaceutical Co., Ltd., Shijiazhuang, China;|
| Experimental: Cerebrolysin<br>Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days | Drug: Cerebrolysin<br>* Intravenous infusion of 30 ml Cerebrolysin per day in 100 ml normal saline for 10 days.<br>* Other names: Ever Pharma, Unterach am Attersee, Austria;|
| Placebo Comparator: Placebo<br>Intravenous infusion of 100 ml saline intravenous q.d. for 10 days | Drug: Placebo<br>* 100 ml saline intravenous infusion once daily for 10 days.<br>* Other names: Hebei Tiancheng Pharmaceutical Co., Ltd., Cangzhou, China;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| National Institutes of Health Stroke Scale Score | Scores range from 0 to 42, with higher scores indicating increasing severity | At 11-day and 21-day after therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barthel Index Score | Range from 0, indicating complete dependence on help with activities of daily living, to 100, indicating independence | At 11-day and 21-day after therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute ischemic stroke, Dl-3-n-butylphthalide, Cerebrolysin