Trial Outcomes & Findings for Dl-3-n-butylphthalide and Cerebrolysin Treatment in Acute Ischemic Stroke (NCT NCT02149875)
NCT ID: NCT02149875
Last Updated: 2020-08-24
Results Overview
Scores range from 0 to 42, with higher scores indicating increasing severity
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
84 participants
Primary outcome timeframe
At 11-day and 21-day after therapy
Results posted on
2020-08-24
Participant Flow
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).
Participant milestones
| Measure |
Dl-3-n-butylphthalide
Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days
"Dl-3-n-butylphthalide", "Cerebrolysin" and "Placebo" separately
|
Cerebrolysin
Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days
"Dl-3-n-butylphthalide", "Cerebrolysin" and "Placebo" separately
|
Placebo
Intravenous infusion of 100 ml saline intravenous q.d. for 10 days
"Dl-3-n-butylphthalide", "Cerebrolysin" and "Placebo" separately
|
|---|---|---|---|
|
Overall Study
STARTED
|
27
|
28
|
29
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
9
|
Reasons for withdrawal
| Measure |
Dl-3-n-butylphthalide
Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days
"Dl-3-n-butylphthalide", "Cerebrolysin" and "Placebo" separately
|
Cerebrolysin
Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days
"Dl-3-n-butylphthalide", "Cerebrolysin" and "Placebo" separately
|
Placebo
Intravenous infusion of 100 ml saline intravenous q.d. for 10 days
"Dl-3-n-butylphthalide", "Cerebrolysin" and "Placebo" separately
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
5
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
2
|
|
Overall Study
Physician Decision
|
1
|
2
|
2
|
Baseline Characteristics
Dl-3-n-butylphthalide and Cerebrolysin Treatment in Acute Ischemic Stroke
Baseline characteristics by cohort
| Measure |
Dl-3-n-butylphthalide
n=20 Participants
Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days.
|
Cerebrolysin
n=20 Participants
Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days.
|
Placebo
n=20 Participants
Intravenous infusion of 100 ml saline intravenous q.d. for 10 days.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67.1 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
66.5 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
68.4 years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
67.3 years
STANDARD_DEVIATION 6.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Time until admission
|
5.4 hour
STANDARD_DEVIATION 3.0 • n=5 Participants
|
5.0 hour
STANDARD_DEVIATION 3.3 • n=7 Participants
|
4.8 hour
STANDARD_DEVIATION 3.7 • n=5 Participants
|
5.1 hour
STANDARD_DEVIATION 3.3 • n=4 Participants
|
|
Time until treatment
|
7.7 hour
STANDARD_DEVIATION 5.9 • n=5 Participants
|
7.6 hour
STANDARD_DEVIATION 3.6 • n=7 Participants
|
5.6 hour
STANDARD_DEVIATION 3.0 • n=5 Participants
|
7.0 hour
STANDARD_DEVIATION 4.2 • n=4 Participants
|
|
Systolic blood pressure
|
148.6 mmHg
STANDARD_DEVIATION 14.6 • n=5 Participants
|
150.7 mmHg
STANDARD_DEVIATION 13.7 • n=7 Participants
|
152.5 mmHg
STANDARD_DEVIATION 12.8 • n=5 Participants
|
150.6 mmHg
STANDARD_DEVIATION 13.7 • n=4 Participants
|
|
Diastolic blood pressure
|
88.7 mmHg
STANDARD_DEVIATION 10.7 • n=5 Participants
|
85.1 mmHg
STANDARD_DEVIATION 13.6 • n=7 Participants
|
87.2 mmHg
STANDARD_DEVIATION 12.5 • n=5 Participants
|
87.0 mmHg
STANDARD_DEVIATION 12.3 • n=4 Participants
|
|
National Institutes of Health Stroke Scale score
|
12.4 units on a scale
STANDARD_DEVIATION 4.38 • n=5 Participants
|
10.6 units on a scale
STANDARD_DEVIATION 4.74 • n=7 Participants
|
10.2 units on a scale
STANDARD_DEVIATION 3.72 • n=5 Participants
|
11.1 units on a scale
STANDARD_DEVIATION 4.28 • n=4 Participants
|
|
Barthel Index score
|
19.75 units on a scale
STANDARD_DEVIATION 6.38 • n=5 Participants
|
22.25 units on a scale
STANDARD_DEVIATION 7.16 • n=7 Participants
|
22.00 units on a scale
STANDARD_DEVIATION 6.96 • n=5 Participants
|
21.33 units on a scale
STANDARD_DEVIATION 6.83 • n=4 Participants
|
PRIMARY outcome
Timeframe: At 11-day and 21-day after therapyScores range from 0 to 42, with higher scores indicating increasing severity
Outcome measures
| Measure |
Dl-3-n-butylphthalide
n=20 Participants
Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days.
|
Cerebrolysin
n=20 Participants
Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days.
|
Placebo
n=20 Participants
Intravenous infusion of 100 ml saline intravenous q.d. for 10 days.
|
|---|---|---|---|
|
National Institutes of Health Stroke Scale Score
Day 11
|
8.78 units on a scale
Standard Deviation 2.48
|
7.80 units on a scale
Standard Deviation 5.81
|
8.85 units on a scale
Standard Deviation 4.43
|
|
National Institutes of Health Stroke Scale Score
Day 21
|
5.48 units on a scale
Standard Deviation 2.34
|
5.90 units on a scale
Standard Deviation 3.96
|
7.30 units on a scale
Standard Deviation 4.78
|
SECONDARY outcome
Timeframe: At 11-day and 21-day after therapyRange from 0, indicating complete dependence on help with activities of daily living, to 100, indicating independence
Outcome measures
| Measure |
Dl-3-n-butylphthalide
n=20 Participants
Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days.
|
Cerebrolysin
n=20 Participants
Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days.
|
Placebo
n=20 Participants
Intravenous infusion of 100 ml saline intravenous q.d. for 10 days.
|
|---|---|---|---|
|
Barthel Index Score
Day 11
|
35.25 units on a scale
Standard Deviation 10.57
|
36.00 units on a scale
Standard Deviation 10.81
|
31.00 units on a scale
Standard Deviation 8.68
|
|
Barthel Index Score
Day 21
|
54.00 units on a scale
Standard Deviation 14.01
|
53.75 units on a scale
Standard Deviation 13.10
|
43.75 units on a scale
Standard Deviation 15.50
|
Adverse Events
Dl-3-n-butylphthalide
Serious events: 8 serious events
Other events: 16 other events
Deaths: 0 deaths
Cerebrolysin
Serious events: 7 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo
Serious events: 11 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dl-3-n-butylphthalide
n=20 participants at risk
Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days.
|
Cerebrolysin
n=20 participants at risk
Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days.
|
Placebo
n=20 participants at risk
Intravenous infusion of 100 ml saline intravenous q.d. for 10 days.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Coagulation disorder
|
30.0%
6/20 • Number of events 10 • 21 days
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.
|
15.0%
3/20 • Number of events 6 • 21 days
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.
|
25.0%
5/20 • Number of events 8 • 21 days
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.
|
|
Cardiac disorders
Cardiac failure
|
5.0%
1/20 • Number of events 1 • 21 days
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.
|
15.0%
3/20 • Number of events 3 • 21 days
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.
|
20.0%
4/20 • Number of events 5 • 21 days
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.
|
|
Nervous system disorders
Epilepsy
|
5.0%
1/20 • Number of events 1 • 21 days
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.
|
0.00%
0/20 • 21 days
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.
|
5.0%
1/20 • Number of events 1 • 21 days
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.
|
|
Nervous system disorders
Cerebral hemorrhage
|
0.00%
0/20 • 21 days
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.
|
5.0%
1/20 • Number of events 1 • 21 days
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.
|
5.0%
1/20 • Number of events 1 • 21 days
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.
|
Other adverse events
| Measure |
Dl-3-n-butylphthalide
n=20 participants at risk
Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days.
|
Cerebrolysin
n=20 participants at risk
Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days.
|
Placebo
n=20 participants at risk
Intravenous infusion of 100 ml saline intravenous q.d. for 10 days.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Erythrema
|
5.0%
1/20 • Number of events 1 • 21 days
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.
|
5.0%
1/20 • Number of events 1 • 21 days
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.
|
5.0%
1/20 • Number of events 1 • 21 days
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.
|
|
General disorders
Fever
|
25.0%
5/20 • Number of events 9 • 21 days
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.
|
15.0%
3/20 • Number of events 5 • 21 days
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.
|
20.0%
4/20 • Number of events 7 • 21 days
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.
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
1/20 • Number of events 1 • 21 days
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.
|
10.0%
2/20 • Number of events 4 • 21 days
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.
|
15.0%
3/20 • Number of events 5 • 21 days
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.
|
|
General disorders
Nausea/vomiting
|
20.0%
4/20 • Number of events 7 • 21 days
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.
|
10.0%
2/20 • Number of events 5 • 21 days
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.
|
10.0%
2/20 • Number of events 6 • 21 days
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.
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
5/20 • Number of events 7 • 21 days
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.
|
20.0%
4/20 • Number of events 6 • 21 days
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.
|
10.0%
2/20 • Number of events 4 • 21 days
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place