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NCT Number: NCT02149875

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

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.

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Key information

Conditions

Acute Cerebral Stroke Within 12 Hours for the First Time Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

30 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Shanghai Sixth People's Hospital

Shanghai, 200233, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DL-3-n-butylphthalide

Drug

Intravenous infusion of 100 ml dl-3-n-butylphthalide and sodium chloride injection for 10 days, twice daily.

Other names: CSPC NBP Pharmaceutical Co., Ltd., Shijiazhuang, China

Cerebrolysin

Drug

Intravenous infusion of 30 ml Cerebrolysin per day in 100 ml normal saline for 10 days.

Other names: Ever Pharma, Unterach am Attersee, Austria

Placebo

Drug

100 ml saline intravenous infusion once daily for 10 days.

Other names: Hebei Tiancheng Pharmaceutical Co., Ltd., Cangzhou, China

Primary outcomes

  1. National Institutes of Health Stroke Scale Score

    Time frame: At 11-day and 21-day after therapy

    Scores range from 0 to 42, with higher scores indicating increasing severity

Secondary outcomes

  1. Barthel Index Score

    Time frame: At 11-day and 21-day after therapy

    Range from 0, indicating complete dependence on help with activities of daily living, to 100, indicating independence

Sponsors and collaborators

Lead sponsor

Shanghai 6th People's Hospital

Other

Registry information

Official study 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.

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 29, 2014
Registry last updated
Aug 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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