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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

Tracking Information
First Submitted Date  ICMJE May 16, 2014
First Posted Date  ICMJE May 29, 2014
Results First Submitted Date  ICMJE April 12, 2016
Results First Posted Date  ICMJE May 18, 2016
Last Update Posted Date June 23, 2016
Study Start Date  ICMJE January 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2016)
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
Original Primary Outcome Measures  ICMJE
 (submitted: May 23, 2014)
National Institutes of Health Stroke Scale (NIHSS) score [ Time Frame: At 11-day and 21-day after therapy ]
Scores range from 0 to 42, with higher scores indicating increasing severity
Change History Complete list of historical versions of study NCT02149875 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2016)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2014)
Barthel Index [ 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dl-3-n-butylphthalide and Cerebrolysin Treatment in Acute Ischemic Stroke
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Cerebral Stroke Within 12 Hours for the First Time
Intervention  ICMJE
  • 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
  • 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
  • Drug: Placebo
    100 ml saline intravenous infusion once daily for 10 days.
    Other Name: Hebei Tiancheng Pharmaceutical Co., Ltd., Cangzhou, China
Study Arms  ICMJE
  • Experimental: Dl-3-n-butylphthalide
    Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days
    Intervention: Drug: Dl-3-n-butylphthalide
  • Experimental: Cerebrolysin
    Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days
    Intervention: Drug: Cerebrolysin
  • Placebo Comparator: Placebo
    Intravenous infusion of 100 ml saline intravenous q.d. for 10 days
    Intervention: Drug: Placebo
Publications * 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. Epub 2016 Mar 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 18, 2016)
84
Original Actual Enrollment  ICMJE
 (submitted: May 23, 2014)
60
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02149875
Other Study ID Numbers  ICMJE 605872
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hao Chen, Shanghai 6th People's Hospital
Study Sponsor  ICMJE Shanghai 6th People's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hao Chen, Doctor Shanghai 6th People's Hospital
PRS Account Shanghai 6th People's Hospital
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP