Lundbeck reports positive phase III study results for clobazam in the adjunctive treatment of seizures
H. Lundbeck A/S presented positive data from its pivotal phase III study to determine the efficacy and safety profiles of the investigational compound clobazam as adjunctive therapy in treating seizures associated with Lennox-Gastaut syndrome (LGS). In the study, clobazam met its primary efficacy endpoint and was further supported by several key secondary efficacy endpoints. LGS is a rare and severe form of epilepsy that is typically diagnosed in childhood and persists into adulthood. Results from this largest clinical trial to date in LGS patients were presented at the 64th annual meeting of the American Epilepsy Society in San Antonio, Texas.
This prospective, double-blind, placebo controlled study randomized 238 patients diagnosed with LGS to one of three different dosages of clobazam or placebo. Efficacy analyses were done for the modified intent to treat population (mITT), which included all randomized patients who had baseline data, at least one dose of study drug and at least one daily seizure measurement during the maintenance period (N=217).
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