Externally Funded Clinical Trials

BLOCK-SAH is a multicenter randomized controlled trial, funded by NIH-NINDS and led by the University of Florida (Drs. Busl, Maciel, Smith, Hoh) to investigate the efficacy and safety of pterygopalatine fossa blocks (PPF-blocks) as an innovative opioid-sparing approach for headaches in patients with aneurysmal subarachnoid hemorrhage.

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.

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.

A Phase 2, multicenter, double-blind, randomized, placebo controlled, study to assess the safety of amantadine hydrochloride intravenous (IV) solution (MR-301), 50 mg/mL, in patients with severe traumatic brain injury (TBI).

ELASTIC is a phase 1 randomized, allocation-concealed, open-label clinical trial aiming to evaluate safety and feasibility of controlled cerebrospinal fluid (CSF) external lumbar drainage in reducing intracranial pressure (ICP) burden and improving outcomes of select severe traumatic brain injury (TBI) patients. The study is sponsored by the Military Traumatic Brain Injury Initiative (MTBI²) and is led by Dr. Ivan da Silva at the University of Florida.