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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-05-31

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.

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Detailed Description

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Conditions

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Acute Cerebral Stroke Within 12 Hours for the First Time

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Dl-3-n-butylphthalide

Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days

Group Type EXPERIMENTAL

Dl-3-n-butylphthalide

Intervention Type DRUG

Intravenous infusion of 100 ml dl-3-n-butylphthalide and sodium chloride injection for 10 days, twice daily.

Cerebrolysin

Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days

Group Type EXPERIMENTAL

Cerebrolysin

Intervention Type DRUG

Intravenous infusion of 30 ml Cerebrolysin per day in 100 ml normal saline for 10 days.

Placebo

Intravenous infusion of 100 ml saline intravenous q.d. for 10 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

100 ml saline intravenous infusion once daily for 10 days.

Interventions

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Dl-3-n-butylphthalide

Intravenous infusion of 100 ml dl-3-n-butylphthalide and sodium chloride injection for 10 days, twice daily.

Intervention Type DRUG

Cerebrolysin

Intravenous infusion of 30 ml Cerebrolysin per day in 100 ml normal saline for 10 days.

Intervention Type DRUG

Placebo

100 ml saline intravenous infusion once daily for 10 days.

Intervention Type DRUG

Other Intervention Names

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CSPC NBP Pharmaceutical Co., Ltd., Shijiazhuang, China Ever Pharma, Unterach am Attersee, Austria Hebei Tiancheng Pharmaceutical Co., Ltd., Cangzhou, China

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No