On October 21, 2011, the FDA approved clobazam for the adjunctive treatment of Lennox-Gastaut syndrome in adults and children aged 2 years or older. Clobazam has been available in Europe since 1975 and its merits are well known to epileptologists. In a phase 3, double-blind, placebo-controlled, randomized study of 238 patients, drop attacks were significantly reduced for all 3 doses in a dose-dependent manner. Average weekly drop seizure rates decreased 12.1% for placebo vs 41.2% (P = .0120) (low dose, 0.25 mg/kg/day), 49.4% (P = .0015) (medium dose, 0.5 mg/kg/day), and 68.3% (P < .0001) (high dose, 1.0 mg/kg/day). Clobazam joins clonazepam, felbamate, lamotrigine, topiramate, and rufinamide as FDA-approved drugs for Lennox-Gastaut syndrome. Drop attacks are perhaps the most disabling seizure type, often leading to facial and head injuries, which makes clobazam particularly valuable as an additional treatment option. Adverse effects of clobazam include constipation, drooling, lethargy, pyrexia, and somnolence.
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Cite this: Andrew N. Wilner. The Year in Neurology: Studies Not to Miss From 2011 - Medscape - Nov 23, 2011.