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

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ClinicalTrials.gov Identifier: NCT02149875
Recruitment Status : Completed
First Posted : May 29, 2014
Results First Posted : May 18, 2016
Last Update Posted : June 23, 2016
Sponsor:
Information provided by (Responsible Party):
Hao Chen, Shanghai 6th People's Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Cerebral Stroke Within 12 Hours for the First Time Drug: Dl-3-n-butylphthalide Drug: Cerebrolysin Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : January 2010
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Arm Intervention/treatment
Experimental: Dl-3-n-butylphthalide
Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days
Drug: Dl-3-n-butylphthalide
Intravenous infusion of 100 ml dl-3-n-butylphthalide and sodium chloride injection for 10 days, twice daily.
Other Name: CSPC NBP Pharmaceutical Co., Ltd., Shijiazhuang, China

Experimental: Cerebrolysin
Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days
Drug: Cerebrolysin
Intravenous infusion of 30 ml Cerebrolysin per day in 100 ml normal saline for 10 days.
Other Name: Ever Pharma, Unterach am Attersee, Austria

Placebo Comparator: Placebo
Intravenous infusion of 100 ml saline intravenous q.d. for 10 days
Drug: Placebo
100 ml saline intravenous infusion once daily for 10 days.
Other Name: Hebei Tiancheng Pharmaceutical Co., Ltd., Cangzhou, China




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02149875


Locations
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China
Shanghai Sixth People's Hospital
Shanghai, China
Sponsors and Collaborators
Shanghai 6th People's Hospital
Investigators
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Principal Investigator: Hao Chen, Doctor Shanghai 6th People's Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hao Chen, Doctor, Shanghai 6th People's Hospital
ClinicalTrials.gov Identifier: NCT02149875     History of Changes
Other Study ID Numbers: 605872
First Posted: May 29, 2014    Key Record Dates
Results First Posted: May 18, 2016
Last Update Posted: June 23, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hao Chen, Shanghai 6th People's Hospital:
Acute ischemic stroke
Dl-3-n-butylphthalide
Cerebrolysin

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebrolysin
3-n-butylphthalide
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Nootropic Agents
Platelet Aggregation Inhibitors