Cognitive effects of adjunctive perampanel for partial-onset seizures: A randomized trial

Kimford Meador, Haichen Yang, Jesus Eric Piña-Garza, Antonio Laurenza, Dinesh Kumar, Keith Wesnes

Research output: Contribution to journalArticlepeer-review

62 Citations (Scopus)
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Abstract

Objective - Assess cognitive effects of adjunctive perampanel in adolescents. Methods - In this double-blind study (ClinicalTrials.gov identifier: NCT01161524), patients aged 12 to<18 years with partial-onset seizures despite receiving 1–3 antiepileptic drugs were randomized (2:1) to perampanel or placebo. Perampanel was increased weekly in 2-mg increments to 8–12 mg/day (6-week titration; 13-week maintenance). Changes in neuropsychological outcomes were assessed at end of maintenance: Cognitive Drug Research (CDR) System Global Cognition Score (primary end point), five CDR System domain T-scores (secondary end points), letter fluency, category fluency, and Lafayette Grooved Pegboard Test (LGPT). Results - One hundred thirty-three patients were randomized. In the full analysis set, there were no differences of perampanel (n = 79) vs. placebo (n = 44) in CDR System Global Cognition Score (least squares mean change, −0.6 vs. 1.6; p = 0.145), Quality of Working Memory (1.1 vs. 2.0; p = 0.579), or Power of Attention (−6.9 vs. −2.7; p = 0.219). There were small differences with perampanel vs. placebo in other CDR System domains: improvements in Quality of Episodic Memory (3.0 vs. −1.2; p = 0.012), and worsening in Continuity of Attention (−3.3 vs. 1.6; p = 0.013) and Speed of Memory (0.3 vs. 7.0; p = 0.032). Letter fluency, category fluency, and LGPT were not significantly different between groups. The most frequent adverse events with perampanel were dizziness (30.6%) and somnolence (15.3%). Significance - Perampanel did not differ from placebo in the global cognitive score, two of five subdomains, and four other cognitive measures. Perampanel was worse on two and better on one subdomain.
Original languageEnglish
Pages (from-to)243-251
JournalEpilepsia
Volume57
Issue number2
Early online date1 Jan 2016
DOIs
Publication statusPublished - Feb 2016

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