Add-on Trial of Clobazam in Intractable Adult Epilepsy with Plasma Level Correlations

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Abstract
Clobazam, a novel benzodiazepine, was used as an add-on agent in 47 adult patients with intractable epilepsy and a variety of seizure types. A > 75% reduction in seizure frequency was observed in 42% (18) of the patients and a > 50% reduction in 65% (29) of the patients which was sustained over a mean follow-up period of 13.3 (.+-. 5.6) months. Nine patients had to discontinue the drug due to minor adverse effects or increased seizures. Possible tolerance developed in 6 patients. Plasma levels of the active metabolite N-desmethyclobazam were linearly related to dosage and appeared to correlate with both therapeutic and toxic responses. Clobazam appears to be a safe and effective add-on antiepileptic for a wide variety of seizure types in intractable epilepsy.