title: Long-term safety and efficacy of clobazam for Lennox-Gastaut syndrome: interim results of an open-label extension study.
abstract: In an ongoing open-label extension (OV-1004), patients with Lennox-Gastaut syndrome who had completed 1 of 2 randomized controlled trials (OV-1002 [Phase II] or OV-1012 [Phase III]) are receiving clobazam at dosages ≤2.0 mg/kg/day (≤80 mg/day). Of 306 eligible patients from OV-1002 or OV-1012, 267 entered the open-label extension. As of the interim date, July 1, 2010, 213 patients (79.8%) had remained in the trial, and 189 had received clobazam for ≥12 months, 128 for ≥18 months, and 94 for ≥24 months. Median percentage decreases in average weekly rates of drop seizures were 71.1% and 91.6% at Months 3 and 24. Mean modal and mean maximum daily dosages were 0.94 mg/kg and 1.22 mg/kg for those who had received clobazam for ≥1 year. The 4 most common adverse events were upper respiratory tract infection (18.4%), fall (14.2%), pneumonia (13.9%), and somnolence (12.7%). Clobazam's adverse event profile was consistent with its profile in controlled trials.
authors.affiliation: University of Oklahoma Health Sciences Center, Oklahoma City, OK 73104, USA. y-ng@ouhsc.edu
authors.forename: Yu-Tze
authors.initials: YT
authors.lastname: Ng
authors.forename: Joan
authors.initials: J
authors.lastname: Conry
authors.forename: Juliann
authors.initials: J
authors.lastname: Paolicchi
authors.forename: Lydia
authors.initials: L
authors.lastname: Kernitsky
authors.forename: Wendy
authors.initials: W
authors.lastname: Mitchell
authors.forename: Rebecca
authors.initials: R
authors.lastname: Drummond
authors.forename: Jouko
authors.initials: J
authors.lastname: Isojarvi
authors.forename: Deborah
authors.initials: D
authors.lastname: Lee
authors.forename: Randall
authors.initials: R
authors.lastname: Owen
mesh_terms: D000293:Adolescent; D000328:Adult; D000927:Anticonvulsants / Q000008:administration & dosage / Q000627:therapeutic use*; D001569:Benzodiazepines / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D000078306:Clobazam; D005260:Female; D006801:Humans; D008607:Intellectual Disability / Q000188:drug therapy*; D065768:Lennox Gastaut Syndrome; D008297:Male; D008875:Middle Aged; D013036:Spasms, Infantile / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000927:Anticonvulsants; D001569:Benzodiazepines; D000078306:Clobazam