NCT02149875

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

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.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Shanghai 6th People's Hospital · Academic / Other
• Sex: All
• Age: 30 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Acute Cerebral Stroke Within 12 Hours for the First Time

Interventions

Type	Name	Description
DRUG	Dl-3-n-butylphthalide	Intravenous infusion of 100 ml dl-3-n-butylphthalide and sodium chloride injection for 10 days, twice daily.
DRUG	Cerebrolysin	Intravenous infusion of 30 ml Cerebrolysin per day in 100 ml normal saline for 10 days.
DRUG	Placebo	100 ml saline intravenous infusion once daily for 10 days.

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2014-05-29
• Last updated: 2020-08-24
• Results posted: 2016-05-18

Locations

1 site across 1 country: China