Time to prerandomization seizure count design sufficiently assessed the safety and tolerability of perampanel for the treatment of focal seizures.

ABSTRACT:

Objective

In traditionally designed randomized clinical trials of antiseizure medications, participants take a blinded treatment for a prespecified number of weeks, irrespective of continued seizures. The alternative design time to prerandomization monthly seizure count (T-PSC) allows participants to end the blinded treatment after an individually prespecified number of seizures, which shortens exposure to placebo and ineffective treatment. Previous reanalyses have shown that T-PSC replicated the efficacy conclusions of trials; therefore, we evaluated whether T-PSC also could replicate tolerability and safety conclusions.

Methods

We retrospectively applied the T-PSC design to analyze treatment-emergent adverse events (TEAEs) from three blinded, placebo-controlled trials of p

SUBMITTER: Kerr WT 

PROVIDER: S-EPMC12353813 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature