Assessment of the long-term efficacy and safety of adjunctive perampanel in tonic-clonic seizures: Analysis of four open-label extension studies.

ABSTRACT:

Objective

This post hoc analysis evaluated long-term efficacy and safety in patients with focal to bilateral tonic-clonic seizures (FBTCS) or generalized tonic-clonic seizures (GTCS) who entered open-label extension (OLEx) studies to receive long-term adjunctive perampanel.

Methods

Patients aged 12 years and older who completed phase II or III randomized, double-blind, placebo-controlled studies could enter an OLEx study, each comprising a blinded conversion period followed by an open-label maintenance period (32-424 weeks; maximum perampanel dose = 12 mg/d). Exposure, seizure outcomes, and treatment-emergent adverse events (TEAEs) were analyzed.

Results

Baseline characteristics were generally balanced between patients with FBTCS (n = 720) and GTCS (n = 138). Mean (st

SUBMITTER: Rektor I 

PROVIDER: S-EPMC7497073 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature