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

Completed

Phase 1/2 Results

Trial Description

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

Interventions

  • Cerebrolysin Drug
    Other Names: Ever Pharma, Unterach am Attersee, Austria
    Intervention Desc: Intravenous infusion of 30 ml Cerebrolysin per day in 100 ml normal saline for 10 days.
    ARM 1: Kind: Experimental
    Label: Cerebrolysin
    Description: Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days
  • Placebo Drug
    Intervention Desc: 100 ml saline intravenous infusion once daily for 10 days.
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Intravenous infusion of 100 ml saline intravenous q.d. for 10 days
  • "Dl-3-n-butylphthalide", "Cerebrolysin" and "Placebo" separately Drug
    ARM 1: Kind: Experimental
    Label: Dl-3-n-butylphthalide
    Description: Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days
    ARM 2: Kind: Experimental
    Label: Cerebrolysin
    Description: Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days
    ARM 3: Kind: Experimental
    Label: Placebo
    Description: Intravenous infusion of 100 ml saline intravenous q.d. for 10 days
  • "Dl-3-n-butylphthalide", "Cerebrolysin" and "Placebo" separately Drug
    ARM 1: Kind: Experimental
    Label: Dl-3-n-butylphthalide
    Description: Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days
    ARM 2: Kind: Experimental
    Label: Cerebrolysin
    Description: Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days
    ARM 3: Kind: Experimental
    Label: Placebo
    Description: Intravenous infusion of 100 ml saline intravenous q.d. for 10 days
  • Dl-3-n-butylphthalide Drug
    Other Names: CSPC NBP Pharmaceutical Co., Ltd., Shijiazhuang, China
    Intervention Desc: Intravenous infusion of 100 ml dl-3-n-butylphthalide and sodium chloride injection for 10 days, twice daily.
    ARM 1: Kind: Experimental
    Label: Dl-3-n-butylphthalide
    Description: Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary National Institutes of Health Stroke Scale (NIHSS) score At 11-day and 21-day after therapy No
Secondary Barthel Index At 11-day and 21-day after therapy No
Primary National Institutes of Health Stroke Scale Score At 11-day and 21-day after therapy No
Secondary Barthel Index Score At 11-day and 21-day after therapy No

Sponsors