Trial Outcomes & Findings for Subarachnoid Hemorrhage and Soluble Epoxide Hydrolase Inhibition Trial (NCT NCT03318783)
NCT ID: NCT03318783
Last Updated: 2021-01-22
Results Overview
Summary tables and listings will be provided for all reported adverse events, defined as adverse events that start on or after the first administration of study drug. The reported adverse event term will be assigned a standardized preferred term. Adverse events will be summarized based on the number and percentage of patients experiencing the event. In the event a patient experiences repeat episodes of the same adverse event, then the event with the highest severity grade and strongest causal relationship to study treatment will be used for purposes of incidence tabulations. All deaths will be reported in a patient listing, which will include the primary cause of death and the number of days between the date of the last dose of study drug and death.
COMPLETED
PHASE1/PHASE2
20 participants
90 days
2021-01-22
Participant Flow
Participant milestones
| Measure |
GSK2256294
10mg capsules of GSK2256294 will be administered in a single dose once daily enterally for a duration of 10 days.
GSK2256294: GSK2256294 will be administered in a single dose once daily enteral for a duration of 10 days.
|
Placebo
10mg matched placebo capsules will be administered in a single dose once daily enterally for a duration of 10 days.
Placebo: Placebo will be administered in a single dose once daily enteral for a duration of 10 days.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
GSK2256294
10mg capsules of GSK2256294 will be administered in a single dose once daily enterally for a duration of 10 days.
GSK2256294: GSK2256294 will be administered in a single dose once daily enteral for a duration of 10 days.
|
Placebo
10mg matched placebo capsules will be administered in a single dose once daily enterally for a duration of 10 days.
Placebo: Placebo will be administered in a single dose once daily enteral for a duration of 10 days.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Subarachnoid Hemorrhage and Soluble Epoxide Hydrolase Inhibition Trial
Baseline characteristics by cohort
| Measure |
GSK2256294
n=10 Participants
10mg capsules of GSK2256294 will be administered in a single dose once daily enterally for a duration of 10 days.
GSK2256294: GSK2256294 will be administered in a single dose once daily enteral for a duration of 10 days.
|
Placebo
n=9 Participants
10mg matched placebo capsules will be administered in a single dose once daily enterally for a duration of 10 days.
Placebo: Placebo will be administered in a single dose once daily enteral for a duration of 10 days.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.2 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
60.4 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
60.8 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
28.8 kg/m^2
STANDARD_DEVIATION 6.6 • n=5 Participants
|
27.7 kg/m^2
STANDARD_DEVIATION 4.7 • n=7 Participants
|
28.2 kg/m^2
STANDARD_DEVIATION 5.6 • n=5 Participants
|
|
Smoking
Never/Passive Smoker
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Smoking
Active Smoker
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Smoking
Former Smoker
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
History of Hypertension
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
History of Seizure
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
History of Prior Brain Aneurysm
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Pre-Admission Antihypertensives
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Pre-Admission Anticoagulants
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Pre-Admission Antiplatelet Agents
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Pre-Admission Statins
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Pre-Admission Antidiabetic Agents
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Hunt and Hess Scale
|
3.0 units on a scale
STANDARD_DEVIATION .94 • n=5 Participants
|
3.0 units on a scale
STANDARD_DEVIATION 1.0 • n=7 Participants
|
3.0 units on a scale
STANDARD_DEVIATION .94 • n=5 Participants
|
|
Modified Fisher Grade
|
3.9 units on a scale
STANDARD_DEVIATION .32 • n=5 Participants
|
3.7 units on a scale
STANDARD_DEVIATION .71 • n=7 Participants
|
3.8 units on a scale
STANDARD_DEVIATION .54 • n=5 Participants
|
|
Glasgow Coma Scale at Randomization
|
13.3 units on a scale
STANDARD_DEVIATION 2.7 • n=5 Participants
|
10.7 units on a scale
STANDARD_DEVIATION 3.6 • n=7 Participants
|
12.1 units on a scale
STANDARD_DEVIATION 3.3 • n=5 Participants
|
|
Location of Aneurysm
Anterior Cerebral Artery/Branches
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Location of Aneurysm
Middle Cerebral/Internal Carotid Artery/Branches
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Location of Aneurysm
Posterior Cerebral Artery/Branches
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Location of Aneurysm
Vertebrobasilar System
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Treatment of Aneursym
Craniotomy
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Treatment of Aneursym
Endovascular
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Treatment of Aneursym
Unsecured
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Baseline Aspartate Aminotransferase
|
22.7 units/liter
STANDARD_DEVIATION 5.7 • n=5 Participants
|
25.5 units/liter
STANDARD_DEVIATION 11.8 • n=7 Participants
|
24.1 units/liter
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Baseline Aanine Transaminase
|
27.5 units/liter
STANDARD_DEVIATION 13.4 • n=5 Participants
|
24.4 units/liter
STANDARD_DEVIATION 15.7 • n=7 Participants
|
26.1 units/liter
STANDARD_DEVIATION 14.2 • n=5 Participants
|
|
Baseline QTc Interval
|
451.5 milliseconds
STANDARD_DEVIATION 24.3 • n=5 Participants
|
456.4 milliseconds
STANDARD_DEVIATION 31.5 • n=7 Participants
|
453.2 milliseconds
STANDARD_DEVIATION 27.0 • n=5 Participants
|
|
Admitted Intubated
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 90 daysSummary tables and listings will be provided for all reported adverse events, defined as adverse events that start on or after the first administration of study drug. The reported adverse event term will be assigned a standardized preferred term. Adverse events will be summarized based on the number and percentage of patients experiencing the event. In the event a patient experiences repeat episodes of the same adverse event, then the event with the highest severity grade and strongest causal relationship to study treatment will be used for purposes of incidence tabulations. All deaths will be reported in a patient listing, which will include the primary cause of death and the number of days between the date of the last dose of study drug and death.
Outcome measures
| Measure |
GSK2256294
n=10 Participants
10mg capsules of GSK2256294 will be administered in a single dose once daily enterally for a duration of 10 days.
GSK2256294: GSK2256294 will be administered in a single dose once daily enteral for a duration of 10 days.
|
Placebo
n=9 Participants
10mg matched placebo capsules will be administered in a single dose once daily enterally for a duration of 10 days.
Placebo: Placebo will be administered in a single dose once daily enteral for a duration of 10 days.
|
|---|---|---|
|
Participants With Adverse Events
Venous Thromboembolism
|
2 Participants
|
0 Participants
|
|
Participants With Adverse Events
Myocardial Infarction
|
0 Participants
|
0 Participants
|
|
Participants With Adverse Events
Seizure
|
1 Participants
|
1 Participants
|
|
Participants With Adverse Events
Any Documented Infection
|
4 Participants
|
6 Participants
|
|
Participants With Adverse Events
Cerebral Salt Wasting
|
3 Participants
|
2 Participants
|
|
Participants With Adverse Events
Leukopenia
|
0 Participants
|
1 Participants
|
|
Participants With Adverse Events
Aneurysm Rebleed
|
0 Participants
|
1 Participants
|
|
Participants With Adverse Events
Acute Respiratory Distress Syndrome
|
0 Participants
|
1 Participants
|
|
Participants With Adverse Events
Death
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 10 daysPopulation: Missing data occurred due to no sample collection from the CSF in patients who had external ventricular drains removed as part of their standard ICU care, prior to the study visit for sample collection. Missing serum samples are the result of one patient in the placebo group who died prior to sample collection visit, and multiple unsuccessful attempts at blood collection from another patient.
Day 7 and day 10 serum EET/DHET ratios will be measured by liquid chromatography and mass spectroscopy of collected blood samples. Day 7 and day 10 CSF EET/DHET ratios will be measured by liquid chromatography and mass spectroscopy of collected CSF samples.
Outcome measures
| Measure |
GSK2256294
n=10 Participants
10mg capsules of GSK2256294 will be administered in a single dose once daily enterally for a duration of 10 days.
GSK2256294: GSK2256294 will be administered in a single dose once daily enteral for a duration of 10 days.
|
Placebo
n=9 Participants
10mg matched placebo capsules will be administered in a single dose once daily enterally for a duration of 10 days.
Placebo: Placebo will be administered in a single dose once daily enteral for a duration of 10 days.
|
|---|---|---|
|
Study Day 7 and Study Day 10 Serum and CSF EET/ Dihyroxyeicosatrienoic (DHET) Ratio, by Mass Spectroscopic Analysis (ng/mL)
Study day 7 CSF 14,15-EET/DHET ratio
|
.17 ration
Standard Deviation .07
|
.19 ration
Standard Deviation .16
|
|
Study Day 7 and Study Day 10 Serum and CSF EET/ Dihyroxyeicosatrienoic (DHET) Ratio, by Mass Spectroscopic Analysis (ng/mL)
Study day 10 CSF 14,15-EET/DHET ratio
|
.45 ration
Standard Deviation .78
|
.52 ration
Standard Deviation 1.04
|
|
Study Day 7 and Study Day 10 Serum and CSF EET/ Dihyroxyeicosatrienoic (DHET) Ratio, by Mass Spectroscopic Analysis (ng/mL)
Study day 7 serum 14,15-EET/DHET ratio
|
.30 ration
Standard Deviation .11
|
.12 ration
Standard Deviation .03
|
|
Study Day 7 and Study Day 10 Serum and CSF EET/ Dihyroxyeicosatrienoic (DHET) Ratio, by Mass Spectroscopic Analysis (ng/mL)
Study day 10 serum 14,15-EET/DHET ratio
|
.27 ration
Standard Deviation .07
|
.12 ration
Standard Deviation .02
|
SECONDARY outcome
Timeframe: 10 daysPopulation: Missing data occurred due to no sample collection from the CSF in patients who had external ventricular drains removed as part of their standard ICU care, prior to the study visit for sample collection. Missing serum samples are the result of one patient in the placebo group who died prior to sample collection visit, and multiple unsuccessful attempts at blood collection from another patient.
Study day 7 and study day 10 serum epoxyoctadecenoic acid (EPOME) to dihydroxyoctadec-12-enoic acid (DPOME) ratio, will be measure by mass spectroscopic analysis of collected blood samples.
Outcome measures
| Measure |
GSK2256294
n=10 Participants
10mg capsules of GSK2256294 will be administered in a single dose once daily enterally for a duration of 10 days.
GSK2256294: GSK2256294 will be administered in a single dose once daily enteral for a duration of 10 days.
|
Placebo
n=9 Participants
10mg matched placebo capsules will be administered in a single dose once daily enterally for a duration of 10 days.
Placebo: Placebo will be administered in a single dose once daily enteral for a duration of 10 days.
|
|---|---|---|
|
Study Day 7 and Study Day 10 Serum Epoxyoctadecenoic Acid (EPOME) to Dihydroxyoctadec-12-enoic Acid (DPOME) Ratio, by Mass Spectroscopic Analysis (ng/mL)
Day 7 serum 12,13 EpOME/DiHOME ratio
|
6.0 ration
Standard Deviation 4.3
|
1.8 ration
Standard Deviation .92
|
|
Study Day 7 and Study Day 10 Serum Epoxyoctadecenoic Acid (EPOME) to Dihydroxyoctadec-12-enoic Acid (DPOME) Ratio, by Mass Spectroscopic Analysis (ng/mL)
Day 10 serum 12,13 EpOME/DiHOME ratio
|
8.7 ration
Standard Deviation 7.1
|
1.7 ration
Standard Deviation .90
|
SECONDARY outcome
Timeframe: 10 daysPopulation: Missing data occurred due to no sample collection from the CSF in patients who had external ventricular drains removed as part of their standard ICU care, prior to the study visit for sample collection. Missing serum samples are the result of one patient in the placebo group who died prior to sample collection visit, and multiple unsuccessful attempts at blood collection from another patient.
The following serum biomarkers will be obtained from collected blood samples by Luminex assay: e-selectin, p-selectin, Vascular cell adhesion marker (VCAM-1), Platelet endothelial cell adhesion marker (PECAM-1, CD31), intercellular adhesion molecule (ICAM-1).
Outcome measures
| Measure |
GSK2256294
n=10 Participants
10mg capsules of GSK2256294 will be administered in a single dose once daily enterally for a duration of 10 days.
GSK2256294: GSK2256294 will be administered in a single dose once daily enteral for a duration of 10 days.
|
Placebo
n=9 Participants
10mg matched placebo capsules will be administered in a single dose once daily enterally for a duration of 10 days.
Placebo: Placebo will be administered in a single dose once daily enteral for a duration of 10 days.
|
|---|---|---|
|
Serum Biomarkers of Endothelial Injury From Blood Samples Obtained on Study Day 7 and Study Day 10
Serum Day 7 ICAM
|
8.4 ng/mL
Standard Deviation 7.5
|
8.3 ng/mL
Standard Deviation 6.8
|
|
Serum Biomarkers of Endothelial Injury From Blood Samples Obtained on Study Day 7 and Study Day 10
Serum Day 10 ICAM
|
17.8 ng/mL
Standard Deviation 27
|
6.7 ng/mL
Standard Deviation 6.6
|
|
Serum Biomarkers of Endothelial Injury From Blood Samples Obtained on Study Day 7 and Study Day 10
Serum Day 7 VCAM
|
8.3 ng/mL
Standard Deviation 3.0
|
7.9 ng/mL
Standard Deviation 2.0
|
|
Serum Biomarkers of Endothelial Injury From Blood Samples Obtained on Study Day 7 and Study Day 10
Serum Day 10 VCAM
|
8.9 ng/mL
Standard Deviation 2.9
|
7.9 ng/mL
Standard Deviation 2.1
|
|
Serum Biomarkers of Endothelial Injury From Blood Samples Obtained on Study Day 7 and Study Day 10
Serum Day 7 PECAM-1
|
1.4 ng/mL
Standard Deviation .56
|
1.7 ng/mL
Standard Deviation .90
|
|
Serum Biomarkers of Endothelial Injury From Blood Samples Obtained on Study Day 7 and Study Day 10
Serum Day 10 PECAM-1
|
1.7 ng/mL
Standard Deviation .90
|
1.6 ng/mL
Standard Deviation .65
|
|
Serum Biomarkers of Endothelial Injury From Blood Samples Obtained on Study Day 7 and Study Day 10
Serum Day 7 E-Selectin
|
46.6 ng/mL
Standard Deviation 25.3
|
48.0 ng/mL
Standard Deviation 33.0
|
|
Serum Biomarkers of Endothelial Injury From Blood Samples Obtained on Study Day 7 and Study Day 10
Serum Day 10 E-Selectin
|
53.0 ng/mL
Standard Deviation 23.8
|
44.7 ng/mL
Standard Deviation 30.3
|
|
Serum Biomarkers of Endothelial Injury From Blood Samples Obtained on Study Day 7 and Study Day 10
Serum Day 7 P-Selectin
|
1.4 ng/mL
Standard Deviation .83
|
1.1 ng/mL
Standard Deviation .28
|
|
Serum Biomarkers of Endothelial Injury From Blood Samples Obtained on Study Day 7 and Study Day 10
Serum Day 10 P-Selectin
|
1.7 ng/mL
Standard Deviation .90
|
2.0 ng/mL
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: 10 daysPopulation: Missing data occurred due to no sample collection from the CSF in patients who had external ventricular drains removed as part of their standard ICU care, prior to the study visit for sample collection. Missing serum samples are the result of one patient in the placebo group who died prior to sample collection visit, and multiple unsuccessful attempts at blood collection from another patient.
The following CSF biomarker will be obtained from collected CSF samples by Luminex assay: Tumor necrosis factor alpha (TNF-α) (pg/mL), Interleukin 1β (IL-1β) (pg/mL), Interferon gamma (IFN-γ) (pg/mL), Interleukin 6 (IL-6) (pg/mL), Interleukin 8 (IL-8) (pg/mL), Monocyte chemoattractant protein 1 (MCP-1) (pg/mL)
Outcome measures
| Measure |
GSK2256294
n=10 Participants
10mg capsules of GSK2256294 will be administered in a single dose once daily enterally for a duration of 10 days.
GSK2256294: GSK2256294 will be administered in a single dose once daily enteral for a duration of 10 days.
|
Placebo
n=9 Participants
10mg matched placebo capsules will be administered in a single dose once daily enterally for a duration of 10 days.
Placebo: Placebo will be administered in a single dose once daily enteral for a duration of 10 days.
|
|---|---|---|
|
CSF Biomarkers of Neuroinflammation, From Blood Samples Obtained on Study Day 7 and Study Day 10
CSF Day 7 TNF-alpha
|
7.8 pg / mL
Standard Deviation 2.6
|
13.1 pg / mL
Standard Deviation 15.6
|
|
CSF Biomarkers of Neuroinflammation, From Blood Samples Obtained on Study Day 7 and Study Day 10
CSF Day 10 IL-6
|
2089.4 pg / mL
Standard Deviation 3248.4
|
2051.6 pg / mL
Standard Deviation 3570.7
|
|
CSF Biomarkers of Neuroinflammation, From Blood Samples Obtained on Study Day 7 and Study Day 10
CSF Day 7 IL-8
|
1652.4 pg / mL
Standard Deviation 1374.4
|
3971.0 pg / mL
Standard Deviation 3298.9
|
|
CSF Biomarkers of Neuroinflammation, From Blood Samples Obtained on Study Day 7 and Study Day 10
CSF Day 10 IL-8
|
1093.6 pg / mL
Standard Deviation 775.3
|
1485.8 pg / mL
Standard Deviation 1002.2
|
|
CSF Biomarkers of Neuroinflammation, From Blood Samples Obtained on Study Day 7 and Study Day 10
CSF Day 10 TNF-alpha
|
5.9 pg / mL
Standard Deviation 2.8
|
8.1 pg / mL
Standard Deviation 9.9
|
|
CSF Biomarkers of Neuroinflammation, From Blood Samples Obtained on Study Day 7 and Study Day 10
CSF Day 7 IFN-gamma
|
1.9 pg / mL
Standard Deviation 1.0
|
4.6 pg / mL
Standard Deviation 6.8
|
|
CSF Biomarkers of Neuroinflammation, From Blood Samples Obtained on Study Day 7 and Study Day 10
CSF Day 10 IFN-gamma
|
1.5 pg / mL
Standard Deviation .84
|
5.8 pg / mL
Standard Deviation 12.9
|
|
CSF Biomarkers of Neuroinflammation, From Blood Samples Obtained on Study Day 7 and Study Day 10
CSF Day 7 IL-1b
|
1.6 pg / mL
Standard Deviation .82
|
5.0 pg / mL
Standard Deviation 9.6
|
|
CSF Biomarkers of Neuroinflammation, From Blood Samples Obtained on Study Day 7 and Study Day 10
CSF Day 10 IL-1b
|
1.0 pg / mL
Standard Deviation .50
|
4.4 pg / mL
Standard Deviation 9.2
|
|
CSF Biomarkers of Neuroinflammation, From Blood Samples Obtained on Study Day 7 and Study Day 10
CSF Day 7 IL-6
|
2991.2 pg / mL
Standard Deviation 3420.0
|
3417.9 pg / mL
Standard Deviation 4110.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 daysThe hospital length of stay will be recorded in days, at the time of hospital discharge.
Outcome measures
| Measure |
GSK2256294
n=10 Participants
10mg capsules of GSK2256294 will be administered in a single dose once daily enterally for a duration of 10 days.
GSK2256294: GSK2256294 will be administered in a single dose once daily enteral for a duration of 10 days.
|
Placebo
n=9 Participants
10mg matched placebo capsules will be administered in a single dose once daily enterally for a duration of 10 days.
Placebo: Placebo will be administered in a single dose once daily enteral for a duration of 10 days.
|
|---|---|---|
|
Hospital Length of Stay in Days
|
16.9 days
Standard Deviation 3.3
|
28.8 days
Standard Deviation 19.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 daysThe disposition from the hospital in one of the following categories: home, home with services, rehab, long term acute care facility, skilled nursing facility, hospice, death
Outcome measures
| Measure |
GSK2256294
n=10 Participants
10mg capsules of GSK2256294 will be administered in a single dose once daily enterally for a duration of 10 days.
GSK2256294: GSK2256294 will be administered in a single dose once daily enteral for a duration of 10 days.
|
Placebo
n=9 Participants
10mg matched placebo capsules will be administered in a single dose once daily enterally for a duration of 10 days.
Placebo: Placebo will be administered in a single dose once daily enteral for a duration of 10 days.
|
|---|---|---|
|
Discharge Disposition
Discharged to home
|
7 Participants
|
2 Participants
|
|
Discharge Disposition
Discharged to rehab, long term acute care facility, skilled nursing facility, hospice, death
|
3 Participants
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 daysThe last head CT or other brain imaging to detect the presence of a new area of cerebral infarction will be reviewed at the time of hospital discharge. A cerebral infarction will be defined as a one identified on hospital discharge that was not present on imaging between 24-48 hours after aneurysm occlusion, and not attributable to other causes such as surgical clipping or endovascular treatment. Hypodensities resulting from extraventricular drains or residual intraparencyhmal hematomas will not be considered new strokes.
Outcome measures
| Measure |
GSK2256294
n=10 Participants
10mg capsules of GSK2256294 will be administered in a single dose once daily enterally for a duration of 10 days.
GSK2256294: GSK2256294 will be administered in a single dose once daily enteral for a duration of 10 days.
|
Placebo
n=9 Participants
10mg matched placebo capsules will be administered in a single dose once daily enterally for a duration of 10 days.
Placebo: Placebo will be administered in a single dose once daily enteral for a duration of 10 days.
|
|---|---|---|
|
Number of Participants With New Stroke on Hospital Discharge Imaging
|
1 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 daysPopulation: One subject in GSK2256294 group lost to followup
The mRS score will be determined by patient or surrogate interview, at both hospital discharge and 90 day follow up. Scores will be assigned based on the following: 0 - no symptoms, 1 - no significant disability, able to carry out all usual activities despite some symptoms, 2 - slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities, 3 - moderate disability, requires some help, but able to walk unassisted, 4 - moderately severe disability, unable to attend to own bodily needs without assistance, and unable to walk unassisted, 5 - severe disability, requires constant nursing care and attention, bedridden, incontinent, 6 - deceased.
Outcome measures
| Measure |
GSK2256294
n=10 Participants
10mg capsules of GSK2256294 will be administered in a single dose once daily enterally for a duration of 10 days.
GSK2256294: GSK2256294 will be administered in a single dose once daily enteral for a duration of 10 days.
|
Placebo
n=9 Participants
10mg matched placebo capsules will be administered in a single dose once daily enterally for a duration of 10 days.
Placebo: Placebo will be administered in a single dose once daily enteral for a duration of 10 days.
|
|---|---|---|
|
Modified Rankin Scale (mRS) at Hospital Discharge and 90 Day Follow up
Hospital Discharge mRS
|
3.4 units on a scale
Standard Deviation 1.5
|
4.1 units on a scale
Standard Deviation 1.4
|
|
Modified Rankin Scale (mRS) at Hospital Discharge and 90 Day Follow up
90 day follow-up mRS
|
2.2 units on a scale
Standard Deviation 1.6
|
3.3 units on a scale
Standard Deviation 1.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 daysPopulation: Missing data due to one subject in the GSK2256294 lost to followup
At 90 day follow up, the GOSE will be determined by patient or surrogate telephone interview, based on a structured interview of 19 questions. The GOSE is a scale of 1-8 where 1 - deceased, 2 - vegetative state, 3 - low severe disability, 4 - upper severe disability, 5 - low moderate disability, 6 -upper moderate disability, 7 - low good recovery, 8 - upper good recovery.
Outcome measures
| Measure |
GSK2256294
n=9 Participants
10mg capsules of GSK2256294 will be administered in a single dose once daily enterally for a duration of 10 days.
GSK2256294: GSK2256294 will be administered in a single dose once daily enteral for a duration of 10 days.
|
Placebo
n=9 Participants
10mg matched placebo capsules will be administered in a single dose once daily enterally for a duration of 10 days.
Placebo: Placebo will be administered in a single dose once daily enteral for a duration of 10 days.
|
|---|---|---|
|
Extended Glasgow Outcome Scale (GOSE) Score at 90 Day Follow up
|
5.4 score on a scale
Standard Deviation 2.4
|
4.1 score on a scale
Standard Deviation 2.4
|
Adverse Events
GSK2256294
Placebo
Serious adverse events
| Measure |
GSK2256294
n=10 participants at risk
10mg capsules of GSK2256294 will be administered in a single dose once daily enterally for a duration of 10 days.
GSK2256294: GSK2256294 will be administered in a single dose once daily enteral for a duration of 10 days.
|
Placebo
n=10 participants at risk；n=9 participants at risk
10mg matched placebo capsules will be administered in a single dose once daily enterally for a duration of 10 days.
Placebo: Placebo will be administered in a single dose once daily enteral for a duration of 10 days.
|
|---|---|---|
|
Nervous system disorders
Delayed Cerebral Ischemia
|
20.0%
2/10 • Number of events 2 • Adverse event data was collected up to 90 days after hospital discharge at the time of followup phone visit
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected up to 90 days after hospital discharge at the time of followup phone visit
|
|
Nervous system disorders
Rebleed of Unsecured Aneurysm
|
0.00%
0/10 • Adverse event data was collected up to 90 days after hospital discharge at the time of followup phone visit
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected up to 90 days after hospital discharge at the time of followup phone visit
|
|
Infections and infestations
Aspiration Pneumonia
|
10.0%
1/10 • Number of events 1 • Adverse event data was collected up to 90 days after hospital discharge at the time of followup phone visit
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected up to 90 days after hospital discharge at the time of followup phone visit
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/10 • Adverse event data was collected up to 90 days after hospital discharge at the time of followup phone visit
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected up to 90 days after hospital discharge at the time of followup phone visit
|
|
Blood and lymphatic system disorders
Deep Vein Thrombosis
|
20.0%
2/10 • Number of events 2 • Adverse event data was collected up to 90 days after hospital discharge at the time of followup phone visit
|
0.00%
0/9 • Adverse event data was collected up to 90 days after hospital discharge at the time of followup phone visit
|
|
Infections and infestations
Central Line Associated Bloodstream Infection
|
10.0%
1/10 • Number of events 1 • Adverse event data was collected up to 90 days after hospital discharge at the time of followup phone visit
|
0.00%
0/9 • Adverse event data was collected up to 90 days after hospital discharge at the time of followup phone visit
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
0.00%
0/10 • Adverse event data was collected up to 90 days after hospital discharge at the time of followup phone visit
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected up to 90 days after hospital discharge at the time of followup phone visit
|
|
Infections and infestations
Pseudomonas Ventriculitis, Bacteremia, Urinary Tract Infection
|
0.00%
0/10 • Adverse event data was collected up to 90 days after hospital discharge at the time of followup phone visit
|
11.1%
1/9 • Number of events 1 • Adverse event data was collected up to 90 days after hospital discharge at the time of followup phone visit
|
|
Infections and infestations
Urinary Tract Infection
|
10.0%
1/10 • Number of events 1 • Adverse event data was collected up to 90 days after hospital discharge at the time of followup phone visit
|
22.2%
2/9 • Number of events 2 • Adverse event data was collected up to 90 days after hospital discharge at the time of followup phone visit
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place