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Research Article: Efficacy and safety of adjunctive clobazam in Chinese patients with drug-resistant epilepsy: a single-center real-world study

Date Published: 2026-03-26

Abstract:
This study evaluated the efficacy and safety of adjunctive clobazam (CLB) in Chinese patients with drug-resistant epilepsy (DRE). We retrospectively included 121 DRE patients receiving adjunctive CLB at the Epilepsy Center of the Seventh Affiliated Hospital of Sun Yat-sen University (Jan 2023-May 2025). Patients were followed at 1, 3, 6, 9, and 12?months or longer. Data collected included epilepsy etiology, seizure type, frequency, treatment duration, dosage, and adverse events. Response was defined as ?50% reduction in seizure frequency from baseline. A total of 121 patients were included (age at medication use 32.4?±?13.5?years; mean three prior failed antiseizure medications; mean follow-up 12?months). Seizure types were focal (18.2%), generalized (7.4%), and both (74.4%). At first follow-up, 51.2% achieved ?50% seizure reduction and 39.7% were seizure freedom; at last follow-up, 85.9% responded and 51.6% were seizure freedom. Response rates increased over time (all p <?0.001). Adults had higher response ( p =?0.046) and seizure freedom rates ( p =?0.041) than children. Concomitant oxcarbazepine (OXC) was associated with increased seizure freedom ( p =?0.03), whereas valproate (VPA) was associated with low response rate ( p =?0.013) but not with seizure freedom. Age at medication (OR?=?1.032, p =?0.035), CLB dosage (OR?=?1.093, p =?0.004), and OXC co-therapy (OR?=?2.311, p =?0.04) were independent predictors of seizure freedom. Most common adverse events were somnolence/mental fatigue (9.9%) and hypersomnia (5%). Adjunctive CLB significantly reduced seizures in DRE with sustained efficacy. Higher dosage, longer treatment duration, and concomitant OXC use were associated with improved outcomes. CLB showed favorable efficacy, wide applicability, and acceptable safety.

Introduction:
Epilepsy is a common chronic neurological disorder affecting approximately 60 million people worldwide, characterized by recurrent seizures that substantially impair quality of life and social functioning ( 1 ). Although antiseizure medications (ASMs) effectively control seizures in the majority of patients, nearly one-third remain refractory to treatment with two or more adequately dosed ASMs and ultimately develop drug-resistant epilepsy (DRE) ( 2–4 ). For this population, monotherapy is often insufficient,…

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