Factors associated with placebo response rate in randomized controlled trials of antiseizure medications for focal epilepsy.

ABSTRACT:

Objective

Randomized controlled trials (RCTs) are necessary to evaluate the efficacy of novel treatments for epilepsy. However, there have been concerning increases in the placebo responder rate over time. To understand these trends, we evaluated features associated with increased placebo responder rate.

Methods

Using individual-level data from 20 focal-onset seizure trials provided by seven pharmaceutical companies, we evaluated associations with change in seizure frequency in participants randomized to placebo. We used multivariable logistic regression to evaluate participant and study factors associated with differing rates of 50% reduction in seizure frequency during blinded placebo treatment, as compared to pre-randomization baseline seizure frequency. In addition, we f

SUBMITTER: Kerr WT 

PROVIDER: S-EPMC11827720 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature