To evaluate the short-term effects of adjunctive perampanel on language and coordination in adolescents with refractory partial-onset seizures (POS), supplementing previously reported primary cognition outcomes (
Meador et al., AAN 2014).
Methods
In this Phase II study, 133 adolescents (12–17 years) with uncontrolled POS were randomised 2:1 to receive perampanel (target dose 8–12 mg/day) or placebo (PBO). Patients received blinded treatment over a 6-week titration phase and 13-week maintenance phase. Effects on language were assessed at various study visits using the Controlled Oral Word Association Test (COWAT), which consists of two parts (letter fluency and category fluency). The Lafayette Grooved Pegboard Test (LGPT) was used to evaluate the effects on coordination skills. For each assessment, mean change from baseline to end of treatment was calculated from the cognition population and results were compared between treatment groups.
Results
Of the 133 randomised adolescent patients, 123 adolescents (PBO, n=44; perampanel, n=79) were included in the cognition population. No difference in the mean change in COWAT letter fluency scores from baseline to end of treatment was observed between PBO and perampanel (+0.5 and +0.7, respectively). Although a small difference in the mean change in COWAT category fluency scores from baseline to end of treatment was observed between PBO (+0.3) and perampanel (–0.5), this difference was not considered clinically relevant. Results of the LGPT indicated that patients' motor skills did not worsen with perampanel treatment compared with PBO.
Conclusion
Assessment of language and coordination using COWAT and LGPT, respectively, in adolescent patients with POS receiving adjunctive perampanel showed that there was no clinically relevant changes in these parameters with perampanel treatment. Acknowledgements: Study sponsor: Eisai Inc. Medical writing: Choice Healthcare Solutions, funded by Eisai Ltd.
