Clobazam.

Catastrophic childhood epilepsies such as infantile spasms (IS), progressive myoclonic epilepsy, and Lennox-Gastaut syndrome (LGS) are rare but debilitating and frequently persist into adulthood. Early, targeted use of medications that have demonstrated efficacy in the management of LGS or its associated epilepsies may simplify the patient's treatment regimen and reduce the incidence of adverse events. Key to the overall benefit to the patient is to maximize seizure control while minimizing adverse effects, especially behavioral and cognitive problems. Clobazam has demonstrated clinical benefit and has been administered safely in more than 50 European studies in which data were reported on greater than 3000 pediatric and adult patients with epilepsy, 300 of whom were diagnosed with LGS; therefore, its use is now being investigated in the U.S. This review will explore the use of clobazam in the treatment of epilepsy, particularly with regard to its potential benefit in LGS. Though not currently approved for use in the U.S., a program is underway to gain Food and Drug Administration approval for the treatment of pediatric and adult patients with refractory epilepsy, specifically in LGS. A phase 2 study will be completed in late 2006 to investigate the safety and efficacy of clobazam as adjunctive therapy in 68 pediatric and adult patients with LGS.