Clinical efficacy of ketogenic diet combined with perampanel in epilepsy treatment: A randomized controlled trial

Abstract

Objective: This study evaluated the therapeutic effectiveness and safety of combining the ketogenic diet with perampanel, a newly developed antiseizure medication, in individuals with epilepsy.

Methods: A prospective randomized controlled trial enrolled 140 epilepsy patients at the department of neurology in a tertiary general hospital in Beijing, China from January 2022 to November 2024. Patients were randomly assigned to either a control or an observation group (n = 70 in each group). The epilepsy seizure counts and seizure duration, as well as serum biomarkers (BDNF, NSE, S100β), cognitive functions (MMSE, MoCA), clinical efficacy, and adverse reaction events were compared pre- and post- treatment.

Results: Compared to the pre-treatment period, both groups exhibited significant reductions in epilepsy seizure counts and seizure duration, along with decreases in serum BDNF, NSE, and S100β levels (P < 0.05), as well as improvements in MMSE and MoCA scores post-treatment (P < 0.05). In addition, the intervention group displayed fewer epilepsy seizure counts and shorter epilepsy seizure durations, as well as lower levels of BDNF, NSE, and S100β, and higher MMSE and MoCA scores after treatment, compared to the control group (all P < 0.05). The intervention group demonstrated a significantly higher total effective rate and a lower incidence of adverse events compared to the control group (all P < 0.05).

Conclusion: Combining the ketogenic diet with perampanel showed good clinical effectiveness and a favorable adverse event profile in treating epilepsy.