The USA's Ovation Pharmaceuticals reported results from a domestic study designed to evaluate the safety and efficacy of clobazam as adjunctive therapy in patients with Lennox-Gastaut syndrome, one of the most severe forms of childhood epilepsy, demonstrating that the benzodiazepine is well-tolerated.
In the trial, data from which were presented at the North American Regional Epilepsy Congress, held in San Diego, California, clobazam was effective in significantly reducing drop seizures, the most debilitating of the LGS seizure types, which can result in severe trauma to the brain and body, 85.3% compared to baseline (in the high-dose group versus 12% in the low-dose arm; p=0.0001). According to the Illinois-based firm, this Phase II, multicenter, randomized, double-blind, dose-finding trial was the first evaluation conducted in the USA to assess the safety and efficacy of the agent as adjuvant therapy in LGS.
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