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.
Sponsor study identifier
interventional
84
1 country
1
Study Start
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2010
Actual (reported)Study Completion
May 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2010
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
May 2010
Actual (reported)May 2010
Actual (reported)May 16, 2014
Actual (reported)May 29, 2014
Actual (reported)May 18, 2016
Actual (reported)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
Barthel Index Score
At 11-day and 21-day after therapy
Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days
Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days
Intravenous infusion of 100 ml saline intravenous q.d. for 10 days
Intravenous infusion of 100 ml dl-3-n-butylphthalide and sodium chloride injection for 10 days, twice daily.
Intravenous infusion of 30 ml Cerebrolysin per day in 100 ml normal saline for 10 days.
Shanghai Sixth People's Hospital
Shanghai, 200233, China
Xue LX, Zhang T, Zhao YW, Geng Z, Chen JJ, Chen H. Efficacy and safety comparison of DL-3-n-butylphthalide and Cerebrolysin: Effects on neurological and behavioral outcomes in acute ischemic stroke. Exp Ther Med. 2016 May;11(5):2015-2020. doi: 10.3892/etm.2016.3139. Epub 2016 Mar 10.
Foremost is the relatively small sample size, and only patients with moderate severity of stroke were enrolled, so the efficacy results of this study should be interpreted with caution.
Lixia Xue, M.D., Ph.D.
Shanghai 6th People's Hospital
84 participants (actual enrollment reported by the registry).
First Submitted
May 16, 2014
First Posted
May 29, 2014
Study Start
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
Early Administration of Cerebrolysin on the Outcome of Patients With Acute Stroke Undergoing EVT
100 ml saline intravenous infusion once daily for 10 days.
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Primary Completion
May 2010
Actual (reported)Study Completion
May 2010
Actual (reported)Last Updated
August 24, 2020
Results First Posted
May 18, 2016
Record last verified: 2020-08
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Source: ClinicalTrials.gov.
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