18 and older, any sex, with Subarachnoid Hemorrhage, Aneurysmal or Delayed Cerebral Ischemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Participants With Adverse EventsPrimary· 90 days
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
Venous Thromboembolism
Group
Value
95% CI
GSK2256294
2
Placebo
0
Myocardial Infarction
Group
Value
95% CI
GSK2256294
0
Placebo
0
Seizure
Group
Value
95% CI
GSK2256294
1
Placebo
1
Any Documented Infection
Group
Value
95% CI
GSK2256294
4
Placebo
6
Cerebral Salt Wasting
Group
Value
95% CI
GSK2256294
3
Placebo
2
Leukopenia
Group
Value
95% CI
GSK2256294
0
Placebo
1
Aneurysm Rebleed
Group
Value
95% CI
GSK2256294
0
Placebo
1
Acute Respiratory Distress Syndrome
Group
Value
95% CI
GSK2256294
0
Placebo
1
Study Day 7 and Study Day 10 Serum and CSF EET/ Dihyroxyeicosatrienoic (DHET) Ratio, by Mass Spectroscopic Analysis (ng/mL)Secondary· 10 days
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.
Study day 7 CSF 14,15-EET/DHET ratio
Group
Value
95% CI
GSK2256294
.17
± .07
Placebo
.19
± .16
Study day 10 CSF 14,15-EET/DHET ratio
Group
Value
95% CI
GSK2256294
.45
± .78
Placebo
.52
± 1.04
Study day 7 serum 14,15-EET/DHET ratio
Group
Value
95% CI
GSK2256294
.30
± .11
Placebo
.12
± .03
Study day 10 serum 14,15-EET/DHET ratio
Group
Value
95% CI
GSK2256294
.27
± .07
Placebo
.12
± .02
Study Day 7 and Study Day 10 Serum Epoxyoctadecenoic Acid (EPOME) to Dihydroxyoctadec-12-enoic Acid (DPOME) Ratio, by Mass Spectroscopic Analysis (ng/mL)Secondary· 10 days
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.
Day 7 serum 12,13 EpOME/DiHOME ratio
Group
Value
95% CI
GSK2256294
6.0
± 4.3
Placebo
1.8
± .92
Day 10 serum 12,13 EpOME/DiHOME ratio
Group
Value
95% CI
GSK2256294
8.7
± 7.1
Placebo
1.7
± .90
Serum Biomarkers of Endothelial Injury From Blood Samples Obtained on Study Day 7 and Study Day 10Secondary· 10 days
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).
Serum Day 7 ICAM
Group
Value
95% CI
GSK2256294
8.4
± 7.5
Placebo
8.3
± 6.8
Serum Day 10 ICAM
Group
Value
95% CI
GSK2256294
17.8
± 27
Placebo
6.7
± 6.6
Serum Day 7 VCAM
Group
Value
95% CI
GSK2256294
8.3
± 3.0
Placebo
7.9
± 2.0
Serum Day 10 VCAM
Group
Value
95% CI
GSK2256294
8.9
± 2.9
Placebo
7.9
± 2.1
Serum Day 7 PECAM-1
Group
Value
95% CI
GSK2256294
1.4
± .56
Placebo
1.7
± .90
Serum Day 10 PECAM-1
Group
Value
95% CI
GSK2256294
1.7
± .90
Placebo
1.6
± .65
Serum Day 7 E-Selectin
Group
Value
95% CI
GSK2256294
46.6
± 25.3
Placebo
48.0
± 33.0
Serum Day 10 E-Selectin
Group
Value
95% CI
GSK2256294
53.0
± 23.8
Placebo
44.7
± 30.3
CSF Biomarkers of Neuroinflammation, From Blood Samples Obtained on Study Day 7 and Study Day 10Secondary· 10 days
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)
CSF Day 7 IFN-gamma
Group
Value
95% CI
GSK2256294
1.9
± 1.0
Placebo
4.6
± 6.8
CSF Day 10 IFN-gamma
Group
Value
95% CI
GSK2256294
1.5
± .84
Placebo
5.8
± 12.9
CSF Day 7 IL-1b
Group
Value
95% CI
GSK2256294
1.6
± .82
Placebo
5.0
± 9.6
CSF Day 10 IL-1b
Group
Value
95% CI
GSK2256294
1.0
± .50
Placebo
4.4
± 9.2
CSF Day 7 IL-6
Group
Value
95% CI
GSK2256294
2991.2
± 3420.0
Placebo
3417.9
± 4110.2
CSF Day 10 IL-6
Group
Value
95% CI
GSK2256294
2089.4
± 3248.4
Placebo
2051.6
± 3570.7
CSF Day 7 IL-8
Group
Value
95% CI
GSK2256294
1652.4
± 1374.4
Placebo
3971.0
± 3298.9
CSF Day 10 IL-8
Group
Value
95% CI
GSK2256294
1093.6
± 775.3
Placebo
1485.8
± 1002.2
Hospital Length of Stay in DaysSecondary· 90 days
The hospital length of stay will be recorded in days, at the time of hospital discharge.
Group
Value
95% CI
GSK2256294
16.9
± 3.3
Placebo
28.8
± 19.8
Discharge DispositionSecondary· 90 days
The 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
Group
Value
95% CI
GSK2256294
7
Placebo
2
GSK2256294
3
Placebo
7
Number of Participants With New Stroke on Hospital Discharge ImagingSecondary· 90 days
The 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.
Group
Value
95% CI
GSK2256294
1
Placebo
1
Modified Rankin Scale (mRS) at Hospital Discharge and 90 Day Follow upSecondary· 90 days
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 - se
Hospital Discharge mRS
Group
Value
95% CI
GSK2256294
3.4
± 1.5
Placebo
4.1
± 1.4
90 day follow-up mRS
Group
Value
95% CI
GSK2256294
2.2
± 1.6
Placebo
3.3
± 1.7
Extended Glasgow Outcome Scale (GOSE) Score at 90 Day Follow upSecondary· 90 days
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.
Group
Value
95% CI
GSK2256294
5.4
± 2.4
Placebo
4.1
± 2.4
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data was collected up to 90 days after hospital discharge at the time of followup phone visit.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Soluble epoxide hydrolase (sEH) is the metabolizing enzyme of epoxyeicosatrienoic acids (EETs), which may play a role in reducing neuroinflammation and regulating cerebral blood flow after subarachnoid hemorrhage (SAH). Hypotheses: Pharmacologic inhibition of the sEH enzyme is safe and will result in increased EETs availability in the blood and cerebrospinal fluid. This study is a double-blind, placebo-controlled, phase 1b randomized trial to evaluate the safety and efficacy of GSK2256294, a novel soluble epoxide hydrolase inhibitor in patients with aneurysmal SAH.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02262689 — To Evaluate Effects of GSK2256294 on Pulmonary Artery Pressure in Healthy Volunteers Under Normoxic and Hypoxic Conditio
· Phase 1
· completed
NCT02006537 — A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of GSK2256294 in Healthy Young Males and Elderly
· Phase 1
· completed
NCT01762774 — A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of GSK2256294 in Healt
· Phase 1
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Oregon Health and Science University
Last refreshed: 22 January 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03318783.