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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acute Cerebral Stroke Within 12 Hours for the First Time
Interventions Drug: Dl-3-n-butylphthalide
Drug: Cerebrolysin
Drug: Placebo
Enrollment 84
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 Details  
Arm/Group Title Dl-3-n-butylphthalide Cerebrolysin Placebo
Hide 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
Reason Not Completed
Lost to Follow-up             3             4             5
Withdrawal by Subject             3             2             2
Physician Decision             1             2             2
Arm/Group Title Dl-3-n-butylphthalide Cerebrolysin Placebo Total
Hide 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 Number of Baseline Participants 20 20 20 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 20 participants 60 participants
67.1  (6.3) 66.5  (8.1) 68.4  (4.2) 67.3  (6.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 60 participants
Female
11
  55.0%
11
  55.0%
10
  50.0%
32
  53.3%
Male
9
  45.0%
9
  45.0%
10
  50.0%
28
  46.7%
Time until admission  
Mean (Standard Deviation)
Unit of measure:  Hour
Number Analyzed 20 participants 20 participants 20 participants 60 participants
5.4  (3.0) 5.0  (3.3) 4.8  (3.7) 5.1  (3.3)
Time until treatment  
Mean (Standard Deviation)
Unit of measure:  Hour
Number Analyzed 20 participants 20 participants 20 participants 60 participants
7.7  (5.9) 7.6  (3.6) 5.6  (3.0) 7.0  (4.2)
Systolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 20 participants 20 participants 20 participants 60 participants
148.6  (14.6) 150.7  (13.7) 152.5  (12.8) 150.6  (13.7)
Diastolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 20 participants 20 participants 20 participants 60 participants
88.7  (10.7) 85.1  (13.6) 87.2  (12.5) 87.0  (12.3)
National Institutes of Health Stroke Scale score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants 20 participants 20 participants 60 participants
12.4  (4.38) 10.6  (4.74) 10.2  (3.72) 11.1  (4.28)
[1]
Measure Description: The scores range from 0 to 42, with higher scores indicating increasing severity. A score of < 4 represented low-degree impairment, between 4 and 15 represented medium-degree impairment, and a score of > 15 represented severe-degree impairment.
Barthel Index score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants 20 participants 20 participants 60 participants
19.75  (6.38) 22.25  (7.16) 22.00  (6.96) 21.33  (6.83)
[1]
Measure Description: The scores range from 0, indicating complete dependence on help with activities of daily living, to 100, indicating independence.
1.Primary Outcome
Title National Institutes of Health Stroke Scale Score
Hide Description Scores range from 0 to 42, with higher scores indicating increasing severity
Time Frame At 11-day and 21-day after therapy
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dl-3-n-butylphthalide Cerebrolysin Placebo
Hide 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.
Overall Number of Participants Analyzed 20 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dl-3-n-butylphthalide Cerebrolysin Placebo
Hide 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.
Overall Number of Participants Analyzed 20 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
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
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dl-3-n-butylphthalide Cerebrolysin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/20 (40.00%)      7/20 (35.00%)      11/20 (55.00%)    
Blood and lymphatic system disorders       
Coagulation disorder  1  6/20 (30.00%)  10 3/20 (15.00%)  6 5/20 (25.00%)  8
Cardiac disorders       
Cardiac failure  1  1/20 (5.00%)  1 3/20 (15.00%)  3 4/20 (20.00%)  5
Nervous system disorders       
Epilepsy * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 1/20 (5.00%)  1
Cerebral hemorrhage  1  0/20 (0.00%)  0 1/20 (5.00%)  1 1/20 (5.00%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, TESS
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dl-3-n-butylphthalide Cerebrolysin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/20 (80.00%)      12/20 (60.00%)      12/20 (60.00%)    
Blood and lymphatic system disorders       
Anemia  1  5/20 (25.00%)  7 4/20 (20.00%)  6 2/20 (10.00%)  4
Gastrointestinal disorders       
Diarrhea * 1  1/20 (5.00%)  1 2/20 (10.00%)  4 3/20 (15.00%)  5
General disorders       
Fever * 1  5/20 (25.00%)  9 3/20 (15.00%)  5 4/20 (20.00%)  7
Nausea/vomiting * 1  4/20 (20.00%)  7 2/20 (10.00%)  5 2/20 (10.00%)  6
Skin and subcutaneous tissue disorders       
Erythrema * 1  1/20 (5.00%)  1 1/20 (5.00%)  1 1/20 (5.00%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, TESS
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Hao Chen
Organization: Shanghai Sixth People's Hospital
Phone: 02164369181 ext 8405
Responsible Party: Hao Chen, Shanghai 6th People's Hospital
ClinicalTrials.gov Identifier: NCT02149875     History of Changes
Other Study ID Numbers: 605872
First Submitted: May 16, 2014
First Posted: May 29, 2014
Results First Submitted: April 12, 2016
Results First Posted: May 18, 2016
Last Update Posted: June 23, 2016