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

Shanghai Jiao Tong University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Acute Cerebral Stroke Within 12 Hours for the First Time

Treatments: Drug: Cerebrolysin; Drug: Dl-3-n-butylphthalide; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02149875

605872

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 30 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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84 participants in 3 patient groups, including a placebo group

Dl-3-n-butylphthalide

Experimental group

Description:

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

Treatment:

Drug: Dl-3-n-butylphthalide

Cerebrolysin

Experimental group

Description:

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

Treatment:

Drug: Cerebrolysin

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo