title: Clobazam as add-on therapy in children with epileptic encephalopathy.
abstract: BACKGROUND
  Clobazam has been used successfully in adults and children with partial epilepsy. The purpose of this study was to evaluate the safety and efficacy of clobazam as add-on therapy in children with epileptic encephalopathy.
  
  
  METHODS
  This was a retrospective study conducted at the pediatric epilepsy clinic of our university hospital. Children less than 18-years of age with epileptic encephalopathy were included in the study. Clobazam was introduced as add-on therapy, starting with 5 mg/Kg/day and increased in minimally effective doses, up to the maximum tolerated dose. Data were obtained from clinical files and follow-up visits.
  
  
  RESULTS
  Ninety-seven patients were included in the study (39 girls), aged between 1 and 17-years-old (mean = 9.9). Twenty-six patients had Lennox-Gastaut syndrome, seven had myoclonic astatic epilepsy, nine had West syndrome and, in 57 patients, the type of epileptic encephalopathy could not be determined. Clobazam dosage ranged from 5 to 60 mg/day (mean = 37.5 mg/day). Forty (41%) patients presented with adverse events, most of which were mild and transitory, and clobazam needed to be withdrawn in only 11 patients. Nine (9.2%) patients were seizure-free after clobazam adjunctive therapy. In 11 (11.3%) patients seizure improvement was >75%, in 16 (16.5%) it was >50%, in 17 (17.5%) improvement was <50% and in 44 (45.5%) there was no change in seizure frequency. Three patients were lost to follow-up. In 85% of the patients with seizure improvement, the results lasted for more than one year.
  
  
  CONCLUSIONS
  Clobazam is safe and effective in the treatment of epileptic encephalopathies of childhood.
authors.affiliation: Department of Neurology, State University of Campinas, São Paulo, Brazil.
authors.forename: Rosana Carvalho
authors.initials: RC
authors.lastname: Silva
authors.forename: Maria Augusta
authors.initials: MA
authors.lastname: Montenegro
authors.forename: Carlos A M
authors.initials: CA
authors.lastname: Guerreiro
authors.forename: Marilisa M
authors.initials: MM
authors.lastname: Guerreiro
mesh_terms: D000293:Adolescent; D000927:Anticonvulsants / Q000008:administration & dosage* / Q000009:adverse effects; D001569:Benzodiazepines / Q000008:administration & dosage* / Q000009:adverse effects; D001921:Brain / Q000002:abnormalities* / Q000187:drug effects* / Q000503:physiopathology; D002648:Child; D002675:Child, Preschool; D000078306:Clobazam; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004351:Drug Resistance / Q000502:physiology; D004357:Drug Synergism; D004569:Electroencephalography / Q000187:drug effects; D004831:Epilepsies, Myoclonic / Q000188:drug therapy / Q000503:physiopathology / Q000517:prevention & control; D004827:Epilepsy / Q000188:drug therapy* / Q000503:physiopathology / Q000517:prevention & control; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D009421:Nervous System Malformations / Q000150:complications*; D010352:Patient Dropouts / Q000706:statistics & numerical data; D012189:Retrospective Studies; D013036:Spasms, Infantile / Q000188:drug therapy / Q000503:physiopathology / Q000517:prevention & control; D016896:Treatment Outcome
chemical_list: D000927:Anticonvulsants; D001569:Benzodiazepines; D000078306:Clobazam