title: Initial and long-term effects of cloxazolam with intractable epilepsy.
abstract: Cloxazolam has been used mainly as an anxiolytic agent. The present study was designed to evaluate the effectiveness of cloxazolam as an add-on antiepileptic drug in patients with intractable epilepsy. A total of 32 patients with intractable epilepsy were treated with cloxazolam: 13 with generalized epilepsy, 15 with focal epilepsy, and 4 with undetermined type of epilepsy. The initial effects were evaluated at 1 month after reaching a maintenance dose (0.3-0.5 mg/kg). The long-term effects were investigated at 2 years after reaching a maintenance dose. With cloxazolam, seizure frequency was reduced by ≥ 50% in 19/32 patients (59%) during initial therapy and in 6/23 patients (26%) during long-term therapy. Two became seizure free throughout the cloxazolam therapy. During initial therapy, 8/32 patients (25%) developed 11 episodes of adverse events during the initial therapy, including 5 with drowsiness, 3 with hyperactivity, 2 with irritability, and 1 with loss of appetite. During long-term therapy, 2/23 (9%) developed drowsiness. The mean dose of cloxazolam in patients with an effective response was 0.30 ± 0.18 mg/kg for initial therapy and 0.26 ± 0.20 mg/kg for long-term therapy. Seven of the 19 effective responders developed tolerance (37%). Cloxazolam is an effective and safe antiepileptic drug for intractable epilepsy.
authors.affiliation: Department of Pediatrics, Shiga Medical Center for Children, Moriyama, Japan. kim21@beach.ocn.ne.jp
authors.forename: Nobusuke
authors.initials: N
authors.lastname: Kimura
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Fujii
authors.forename: Tomoko
authors.initials: T
authors.lastname: Miyajima
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Kumada
authors.forename: Takayasu
authors.initials: T
authors.lastname: Mikuni
authors.forename: Masatoshi
authors.initials: M
authors.lastname: Ito
mesh_terms: D000293:Adolescent; D000328:Adult; D000927:Anticonvulsants / Q000009:adverse effects / Q000627:therapeutic use; D001569:Benzodiazepines / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D002648:Child; D002675:Child, Preschool; D004361:Drug Tolerance; D004827:Epilepsy / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D013995:Time; D016896:Treatment Outcome
chemical_list: D000927:Anticonvulsants; D001569:Benzodiazepines; C005522:cloxazolam