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

Primary Purpose

Acute Cerebral Stroke Within 12 Hours for the First Time

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Dl-3-n-butylphthalide
Cerebrolysin
Placebo
Sponsored by
Shanghai 6th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Cerebral Stroke Within 12 Hours for the First Time focused on measuring Acute ischemic stroke, Dl-3-n-butylphthalide, Cerebrolysin

Eligibility Criteria

30 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai Sixth People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Dl-3-n-butylphthalide

Cerebrolysin

Placebo

Arm Description

Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days

Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days

Intravenous infusion of 100 ml saline intravenous q.d. for 10 days

Outcomes

Primary Outcome Measures

National Institutes of Health Stroke Scale Score
Scores range from 0 to 42, with higher scores indicating increasing severity

Secondary Outcome Measures

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

Full Information

First Posted
May 16, 2014
Last Updated
August 8, 2020
Sponsor
Shanghai 6th People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02149875
Brief Title
Dl-3-n-butylphthalide and Cerebrolysin Treatment in Acute Ischemic Stroke
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 Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 6th People's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Cerebral Stroke Within 12 Hours for the First Time
Keywords
Acute ischemic stroke, Dl-3-n-butylphthalide, Cerebrolysin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dl-3-n-butylphthalide
Arm Type
Experimental
Arm Description
Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days
Arm Title
Cerebrolysin
Arm Type
Experimental
Arm Description
Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intravenous infusion of 100 ml saline intravenous q.d. for 10 days
Intervention Type
Drug
Intervention Name(s)
Dl-3-n-butylphthalide
Other Intervention Name(s)
CSPC NBP Pharmaceutical Co., Ltd., Shijiazhuang, China
Intervention Description
Intravenous infusion of 100 ml dl-3-n-butylphthalide and sodium chloride injection for 10 days, twice daily.
Intervention Type
Drug
Intervention Name(s)
Cerebrolysin
Other Intervention Name(s)
Ever Pharma, Unterach am Attersee, Austria
Intervention Description
Intravenous infusion of 30 ml Cerebrolysin per day in 100 ml normal saline for 10 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Hebei Tiancheng Pharmaceutical Co., Ltd., Cangzhou, China
Intervention Description
100 ml saline intravenous infusion once daily for 10 days.
Primary Outcome Measure Information:
Title
National Institutes of Health Stroke Scale Score
Description
Scores range from 0 to 42, with higher scores indicating increasing severity
Time Frame
At 11-day and 21-day after therapy
Secondary Outcome Measure Information:
Title
Barthel Index Score
Description
Range from 0, indicating complete dependence on help with activities of daily living, to 100, indicating independence
Time Frame
At 11-day and 21-day after therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lixia Xue, M.D., Ph.D.
Organizational Affiliation
Shanghai 6th People's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Sixth People's Hospital
City
Shanghai
ZIP/Postal Code
200233
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27168844
Citation
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. doi: 10.3892/etm.2016.3139. Epub 2016 Mar 10.
Results Reference
derived

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

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