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

Sponsor
Shanghai 6th People's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02149875
Collaborator
(none)
84
Enrollment
1
Location
3
Arms
3.9
Duration (Months)
21.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
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 :
Jan 1, 2010
Actual Primary Completion Date :
May 1, 2010
Actual Study Completion Date :
May 1, 2010

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. National Institutes of Health Stroke Scale Score [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 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai Sixth People's Hospital Shanghai China 200233

    Sponsors and Collaborators

    • Shanghai 6th People's Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hao Chen, Doctor, Shanghai 6th People's Hospital
    ClinicalTrials.gov Identifier:
    NCT02149875
    Other Study ID Numbers:
    • 605872
    First Posted:
    May 29, 2014
    Last Update Posted:
    Aug 24, 2020
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Hao Chen, Doctor, Shanghai 6th People's Hospital
    Acute ischemic stroke
    Dl-3-n-butylphthalide
    Cerebrolysin
    Additional relevant MeSH terms:
    Stroke
    Ischemic Stroke
    Cerebrolysin
    3-n-butylphthalide

    Study Results

    Participant Flow

    Recruitment Details From January 2010 to May 2010, a randomized, double-blind trial was conducted, which involved patients with AIS in the Neurology Ward of Shanghai Jiao Tong University Affiliated Sixth People's Hospital (Shanghai, China).
    Pre-assignment Detail
    Arm/Group Title Dl-3-n-butylphthalide Cerebrolysin Placebo
    Arm/Group Description Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days "Dl-3-n-butylphthalide", "Cerebrolysin" and "Placebo" separately Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days "Dl-3-n-butylphthalide", "Cerebrolysin" and "Placebo" separately Intravenous infusion of 100 ml saline intravenous q.d. for 10 days "Dl-3-n-butylphthalide", "Cerebrolysin" and "Placebo" separately
    Period Title: Overall Study
    STARTED 27 28 29
    COMPLETED 20 20 20
    NOT COMPLETED 7 8 9

    Baseline Characteristics

    Arm/Group Title Dl-3-n-butylphthalide Cerebrolysin Placebo Total
    Arm/Group 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. Total of all reporting groups
    Overall Participants 20 20 20 60
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    67.1
    (6.3)
    66.5
    (8.1)
    68.4
    (4.2)
    67.3
    (6.2)
    Sex: Female, Male (Count of Participants)
    Female
    11
    55%
    11
    55%
    10
    50%
    32
    53.3%
    Male
    9
    45%
    9
    45%
    10
    50%
    28
    46.7%
    Time until admission (hour) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [hour]
    5.4
    (3.0)
    5.0
    (3.3)
    4.8
    (3.7)
    5.1
    (3.3)
    Time until treatment (hour) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [hour]
    7.7
    (5.9)
    7.6
    (3.6)
    5.6
    (3.0)
    7.0
    (4.2)
    Systolic blood pressure (mmHg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmHg]
    148.6
    (14.6)
    150.7
    (13.7)
    152.5
    (12.8)
    150.6
    (13.7)
    Diastolic blood pressure (mmHg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmHg]
    88.7
    (10.7)
    85.1
    (13.6)
    87.2
    (12.5)
    87.0
    (12.3)
    National Institutes of Health Stroke Scale score (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    12.4
    (4.38)
    10.6
    (4.74)
    10.2
    (3.72)
    11.1
    (4.28)
    Barthel Index score (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    19.75
    (6.38)
    22.25
    (7.16)
    22.00
    (6.96)
    21.33
    (6.83)

    Outcome Measures

    1. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Dl-3-n-butylphthalide Cerebrolysin Placebo
    Arm/Group 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.
    Measure Participants 20 20 20
    Day 11
    8.78
    (2.48)
    7.80
    (5.81)
    8.85
    (4.43)
    Day 21
    5.48
    (2.34)
    5.90
    (3.96)
    7.30
    (4.78)
    2. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Dl-3-n-butylphthalide Cerebrolysin Placebo
    Arm/Group 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.
    Measure Participants 20 20 20
    Day 11
    35.25
    (10.57)
    36.00
    (10.81)
    31.00
    (8.68)
    Day 21
    54.00
    (14.01)
    53.75
    (13.10)
    43.75
    (15.50)

    Adverse Events

    Time Frame 21 days
    Adverse Event Reporting Description Systematic methods include a physical examination (including heart rate, blood pressure and oxygen concentration), laboratory tests (including urine test, complete blood count, occult blood test, renal function, liver function, electrolyte and blood-glucose), electrocardiogram, cranial CT or MRI and chest radiograph.
    Arm/Group Title Dl-3-n-butylphthalide Cerebrolysin Placebo
    Arm/Group 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.
    All Cause Mortality
    Dl-3-n-butylphthalide Cerebrolysin Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Dl-3-n-butylphthalide Cerebrolysin Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 8/20 (40%) 7/20 (35%) 11/20 (55%)
    Blood and lymphatic system disorders
    Coagulation disorder 6/20 (30%) 10 3/20 (15%) 6 5/20 (25%) 8
    Cardiac disorders
    Cardiac failure 1/20 (5%) 1 3/20 (15%) 3 4/20 (20%) 5
    Nervous system disorders
    Epilepsy 1/20 (5%) 1 0/20 (0%) 0 1/20 (5%) 1
    Cerebral hemorrhage 0/20 (0%) 0 1/20 (5%) 1 1/20 (5%) 1
    Other (Not Including Serious) Adverse Events
    Dl-3-n-butylphthalide Cerebrolysin Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 16/20 (80%) 12/20 (60%) 12/20 (60%)
    Blood and lymphatic system disorders
    Anemia 5/20 (25%) 7 4/20 (20%) 6 2/20 (10%) 4
    Gastrointestinal disorders
    Diarrhea 1/20 (5%) 1 2/20 (10%) 4 3/20 (15%) 5
    General disorders
    Fever 5/20 (25%) 9 3/20 (15%) 5 4/20 (20%) 7
    Nausea/vomiting 4/20 (20%) 7 2/20 (10%) 5 2/20 (10%) 6
    Skin and subcutaneous tissue disorders
    Erythrema 1/20 (5%) 1 1/20 (5%) 1 1/20 (5%) 1

    Limitations/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.

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Hao Chen
    Organization Shanghai Sixth People's Hospital
    Phone 02164369181 ext 8405
    Email chenhao_316@aliyun.com
    Responsible Party:
    Hao Chen, Doctor, Shanghai 6th People's Hospital
    ClinicalTrials.gov Identifier:
    NCT02149875
    Other Study ID Numbers:
    • 605872
    First Posted:
    May 29, 2014
    Last Update Posted:
    Aug 24, 2020
    Last Verified:
    Aug 1, 2020