Perampanel in real-world clinical care of patients with epilepsy: Interim analysis of a phase IV study.

ABSTRACT:

Objective

To assess the retention rate, efficacy, safety, and dosing of perampanel administered to patients with epilepsy during routine clinical care in the retrospective phase IV, PROVE Study (NCT03208660).

Methods

Exposure, efficacy, and safety data were obtained from the medical records of patients initiating perampanel after January 1, 2014, across 29 US study sites. The cutoff date for this interim analysis was October 10, 2018. The primary efficacy endpoint was retention rate. Secondary efficacy endpoints included median percent changes in seizure frequency, seizure-freedom rate, and overall investigator impression of seizure effect.

Results

All enrolled patients (N = 1121) received perampanel. Mean (standard deviation [SD]) cumulative duration of exposure to p

SUBMITTER: Wheless J 

PROVIDER: S-EPMC7918328 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature