How many patients do you need? Investigating trial designs for anti-seizure treatment in acute brain injury patients.

ABSTRACT:

Background/objectives

Epileptiform activity (EA), including seizures and periodic patterns, worsens outcomes in patients with acute brain injuries (e.g., aneurysmal subarachnoid hemorrhage [aSAH]). Randomized control trials (RCTs) assessing anti-seizure interventions are needed. Due to scant drug efficacy data and ethical reservations with placebo utilization, and complex physiology of acute brain injury, RCTs are lacking or hindered by design constraints. We used a pharmacological model-guided simulator to design and determine the feasibility of RCTs evaluating EA treatment.

Methods

In a single-center cohort of adults (age >18) with aSAH and EA, we employed a mechanistic pharmacokinetic-pharmacodynamic framework to model treatment response using observational data. We subse

SUBMITTER: Parikh H 

PROVIDER: S-EPMC11251465 | biostudies-literature | 2024 Jul

REPOSITORIES: biostudies-literature