Long-term safety and efficacy of clobazam for Lennox–Gastaut syndrome: Interim results of an open-label extension study

• DOI: 10.1016/j.yebeh.2012.09.039
• Publication Date: 2012-11-07T05:45:23Z
• Authors: Yu-Tze Ng; Joan Conry; Juliann Paolicchi; Lydia Kernitsky; Wendy Mitchell; Rebecca Drummond; Jouko Isojarvi; Deborah Lee; Randall Owen
• Keywords: Adult; Male; Time Factors; Efficacy; Adolescent; Clinical Neurology; Drop seizures; Open-label extension trial; Behavioral Neuroscience; Benzodiazepines; Young Adult; 03 medical and health sciences; 0302 clinical medicine; Intellectual Disability; Humans; Child; Benzodiazepine; Lennox Gastaut Syndrome; Middle Aged; 3. Good health; Dosing; Treatment Outcome; Neurology; Child, Preschool; Clobazam; Anticonvulsants; Female; Safety; Spasms, Infantile; Lennox–Gastaut syndrome; Antiepileptic drug

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.