Externally Funded Clinical Trials

Brain Oxygen Optimization in Severe TB, phase III

BOOST-3

BOOST-3 is a randomized clinical trial in partnership with the Emergency Medicine department. Boost-3 aims to determine the comparative effectiveness of two strategies for monitoring and treating patients with traumatic brain injury (TBI) in the intensive care unit (ICU). The study will determine the safety and efficacy of a strategy guided by treatment goals based on both intracranial pressure (ICP) and brain tissue oxygen (PbtO2) as compared to a strategy guided by treatment goals based on ICP monitoring alone.

Ganaloxone for status epilepticus, phase III

RAISE

RAISE is a double-blind randomized, placebo-controlled study to evaluate the safety, tolerability, efficacy, and pharmacokinetics of intravenous ganaxolone as adjunctive therapy to treat subjects with status epilepticus.

Sensor Evaluation of Neurologic Status in Emergencies, phase II

Sense

SENSE is a partnership study with the Emergency Medicine department. It is a Prospective, Two-Stage, Non-randomized, Multi-center Within Patient Comparison Study to Evaluate the SENSE Device’s Ability to Monitor Intracranial Hemorrhage

Early Vigabatrin Augmenting GABA-ergic Pathways in Post-Anoxic Status Epilepticus, phase IIa

VIGAB-STAT

VIGAB-STAT is a phase IIa, single-centered, open-label, pilot feasibility clinical trial with blinded outcome assessment, of early administration of a single dose of vigabatrin in post-anoxic status epilepticus with the goal of demonstrating absorption and feasibility of GABA catabolism inhibition in the post-cardiac arrest period.