Subarachnoid Hemorrhage and Soluble Epoxide Hydrolase Inhibition Trial

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Subarachnoid Hemorrhage, Aneurysmal, Delayed Cerebral Ischemia, Vasospasm, Cerebral, Endothelial Dysfunction

In brief

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.

Key facts

Study ID

NCT03318783

Run by

Oregon Health and Science University

People needed

20

Starts

2018-05-02

Expected to finish

2020-01-09

Last updated by the study team

2021-01-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 18
• Head CT evidence of subarachnoid hemorrhage
• Digital subtraction cerebral angiography or CT angiogram documenting the presence of a cerebral aneurysm.

You may not qualify if…

• Symptom onset compatible with SAH of > 3 days prior to admission to OHSU
• Absence of an indwelling external ventricular drain
• Administration of any of the following inducers/inhibitors of CYP3A4: ritonavir, indinavir, nelfinavir, saquinavir, clarithromycin, telithromycin, chloramphenicol, ketoconazole, itraconazole, nefazodone, cobicistat or enzalutamide.
• Suspected or confirmed pregnancy
• Preexisting severe neurologic deficit or condition
• Chronic renal failure requiring dialysis
• Severe terminal disease with life expectancy <6 months
• Unable to read or understand written or spoken English or Spanish
• Refusal of informed consent

Where it is running

• Oregon Health & Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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