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

Acute Cerebral Stroke Within 12 Hours for the First Time Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02149875
• Other study ID #: 605872
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 2010
• Est. completion date: May 2010

Study information

• Verified date: August 2020
• Source: Shanghai 6th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Cerebral Stroke Within 12 Hours for the First Time
• Stroke

Intervention

Drug:
• Dl-3-n-butylphthalide
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 per day in 100 ml normal saline for 10 days.
• Placebo
100 ml saline intravenous infusion once daily for 10 days.

Locations

Country	Name	City	State
China	Shanghai Sixth People's Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 6th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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