Time to prerandomization monthly seizure count in perampanel trials: A novel epilepsy endpoint.

ABSTRACT:

Objective

To determine whether a novel endpoint of time to prerandomization monthly seizure count could be used to differentiate efficacious and nonefficacious therapies in clinical trials of new add-on antiepileptic drugs (AEDs).

Methods

This analysis used data from 3 randomized, double-blind, placebo-controlled phase III trials of perampanel as an add-on therapy in patients with epilepsy who were experiencing refractory partial seizures: studies 304 (ClinicalTrials.gov identifier NCT00699972), 305 (NCT00699582), and 306 (NCT00700310). Time to prerandomization monthly seizure count was evaluated post hoc for each trial, and findings were compared with the original primary outcomes (median percent change in seizure frequency and 50% responder rate). Outcomes were assessed fo

SUBMITTER: French JA 

PROVIDER: S-EPMC4442101 | biostudies-literature | 2015 May

REPOSITORIES: biostudies-literature