Safety and efficacy of one-dose nocturnal levetiracetam for the treatment of self-limited epilepsy with centrotemporal spikes: a randomized clinical trial

单剂量夜间左乙拉西坦治疗伴有中央颞区棘波的自限性癫痫的安全性和有效性:一项随机临床试验

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Abstract

Self-limited epilepsy with centrotemporal spikes (SeLECTS) is associated with infrequent seizures but may cause behavioral problems and require more acceptable and effective intervention options. We aimed to compare the efficacy, adherence and safety of different levetiracetam administration methods for SeLECTS. We conducted a prospective, open-label and non-inferiority study; 192 children with SeLECTS were randomized into three groups: Group A (65 patients) received 2/3 of the daily dose in the evening and 1/3 in the morning; Group B (62 patients) took a single night-time dose; and Group C (65 patients) received equal split doses twice daily. After 6- and 12-months of treatment, Groups A and B were non-inferior to Group C in terms of seizure control and electroencephalogram normalization rate. Group B required the lowest effective dose, while Group C had higher blood drug concentrations (P < 0.05). Group B had lower Conners Parent Symptom Questionnaire scores for conduct problems, psychosomatic problems and anxiety compared to Group C (P < 0.05). Groups A and B had higher levels of satisfaction and adherence than Group C (P < 0.05), with no difference in adverse events. Collectively, these results demonstrated that for SeLECTS patients, a night-time single administration of levetiracetam ensures efficacy and improves both medication adherence and satisfaction.

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