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

August 8, 2020 updated by: Hao Chen, Shanghai 6th People's Hospital

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200233
        • Shanghai Sixth People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • Hebei Tiancheng Pharmaceutical Co., Ltd., Cangzhou, China

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At 11-day and 21-day after therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At 11-day and 21-day after therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 6th People's Hospital

Investigators

  • Study Director: Lixia Xue, M.D., Ph.D., Shanghai 6th people's hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

May 16, 2014

First Submitted That Met QC Criteria

May 23, 2014

First Posted (Estimate)

May 29, 2014

Study Record Updates

Last Update Posted (Actual)

August 24, 2020

Last Update Submitted That Met QC Criteria

August 8, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 605872

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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