Subarachnoid Hemorrhage and Soluble Epoxide Hydrolase Inhibition Trial

• Status: Completed
• Trial end date: 2020-01-09
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oregon Health and Science University
• Collaborators: Foundation for Anesthesia Education and Research; GlaxoSmithKline

Criteria

Inclusion Criteria:

1. Age > 18

2. Head CT evidence of subarachnoid hemorrhage

3. Digital subtraction cerebral angiography or CT angiogram documenting the presence of a cerebral aneurysm.

Exclusion Criteria:

1. Symptom onset compatible with SAH of > 3 days prior to admission to OHSU

2. Absence of an indwelling external ventricular drain

3. Administration of any of the following inducers/inhibitors of CYP3A4: ritonavir, indinavir, nelfinavir, saquinavir, clarithromycin, telithromycin, chloramphenicol, ketoconazole, itraconazole, nefazodone, cobicistat or enzalutamide.

4. Suspected or confirmed pregnancy

5. Preexisting severe neurologic deficit or condition

6. Chronic renal failure requiring dialysis

7. Severe terminal disease with life expectancy <6 months

8. Unable to read or understand written or spoken English or Spanish

9. Refusal of informed consent