학술논문
Long-term safety and efficacy of clobazam for Lennox–Gastaut syndrome: Interim results of an open-label extension study
Document Type
Article
Author
Source
Subject
*LENNOX-Gastaut syndrome
*RANDOMIZED controlled trials
*DRUG efficacy
*MEDICATION safety
*BENZODIAZEPINES
*DRUG dosage
*SEIZURES (Medicine)
*THERAPEUTICS
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Language
ISSN
1525-5050
Abstract
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 ≤2.0mg/kg/day (≤80mg/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 ≥12months, 128 for ≥18months, and 94 for ≥24months. 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 0.94mg/kg and 1.22mg/kg for those who had received clobazam for ≥1year. 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. [Copyright &y& Elsevier]