NCT02149875

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 29, 2014

Completed
2 years until next milestone

Results Posted

Study results publicly available

May 18, 2016

Completed
Last Updated

August 24, 2020

Status Verified

August 1, 2020

Enrollment Period

4 months

First QC Date

May 16, 2014

Results QC Date

April 12, 2016

Last Update Submit

August 8, 2020

Conditions

Acute Cerebral Stroke Within 12 Hours for the First Time

Keywords

Acute ischemic strokeDl-3-n-butylphthalideCerebrolysin

Outcome Measures

Primary Outcomes (1)

  • National Institutes of Health Stroke Scale Score

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

    At 11-day and 21-day after therapy

Secondary Outcomes (1)

  • Barthel Index Score

    At 11-day and 21-day after therapy

Study Arms (3)

Dl-3-n-butylphthalide

EXPERIMENTAL

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

Drug: Dl-3-n-butylphthalide

Cerebrolysin

EXPERIMENTAL

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

Drug: Cerebrolysin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Dl-3-n-butylphthalideDRUG

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

Also known as: CSPC NBP Pharmaceutical Co., Ltd., Shijiazhuang, China
Dl-3-n-butylphthalide
CerebrolysinDRUG

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

Also known as: Ever Pharma, Unterach am Attersee, Austria
Cerebrolysin
PlaceboDRUG

100 ml saline intravenous infusion once daily for 10 days.

Also known as: Hebei Tiancheng Pharmaceutical Co., Ltd., Cangzhou, China
Placebo

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Sixth People's Hospital

Shanghai, 200233, China

Location

Related Publications (1)

  • 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.

    PMID: 27168844DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

3-n-butylphthalideLong-Term Synaptic Depressioncerebrolysin

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Neuronal PlasticityNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

Foremost is the relatively small sample size, and only patients with moderate severity of stroke were enrolled, so the efficacy results of this study should be interpreted with caution.

Results Point of Contact

Title
Dr. Hao Chen
Organization
Shanghai Sixth People's Hospital
chenhao_316@aliyun.com
02164369181

Study Officials

  • Lixia Xue, M.D., Ph.D.

    Shanghai 6th People's Hospital

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 16, 2014

First Posted

May 29, 2014

Study Start

January 1, 2010

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

August 24, 2020

Results First Posted

May 18, 2016

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)