Long-term safety and efficacy of clobazam for Lennox-Gastaut syndrome: interim results of an open-label extension study.
Publication/Presentation Date
12-1-2012
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.
Volume
25
Issue
4
First Page
687
Last Page
694
ISSN
1525-5069
Published In/Presented At
Ng, Y. T., Conry, J., Paolicchi, J., Kernitsky, L., Mitchell, W., Drummond, R., Isojarvi, J., Lee, D., Owen, R., & OV-1004 study investigators (2012). Long-term safety and efficacy of clobazam for Lennox-Gastaut syndrome: interim results of an open-label extension study. Epilepsy & behavior : E&B, 25(4), 687–694. https://doi.org/10.1016/j.yebeh.2012.09.039
Disciplines
Medicine and Health Sciences
PubMedID
23141144
Department(s)
Department of Medicine
Document Type
Article